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201 results on '"Stroyakovskiy, Daniil"'

2. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600–Mutant Unresectable or Metastatic Melanoma

Author

Dummer, Reinhard, Long, Georgina V, Robert, Caroline, Tawbi, Hussein A, Flaherty, Keith T, Ascierto, Paolo A, Nathan, Paul D, Rutkowski, Piotr, Leonov, Oleg, Dutriaux, Caroline, Mandalà, Mario, Lorigan, Paul, Ferrucci, Pier Francesco, Grob, Jean Jacques, Meyer, Nicolas, Gogas, Helen, Stroyakovskiy, Daniil, Arance, Ana, Brase, Jan C, Green, Steven, Haas, Tomas, Masood, Aisha, Gasal, Eduard, Ribas, Antoni, and Schadendorf, Dirk

Subjects
Clinical Research, Genetics, Cancer, Clinical Trials and Supportive Activities, Human Genome, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adolescent, Adult, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Humans, Imidazoles, Melanoma, Mutation, Neoplasms, Second Primary, Oximes, Proto-Oncogene Proteins B-raf, Pyridones, Pyrimidinones, Receptors, Death Domain, Skin Neoplasms, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposePreclinical data suggest the combination of an anti-programmed death receptor 1 antibody plus dabrafenib and trametinib to have superior antitumor activity compared with dabrafenib plus trametinib alone. These observations are supported by translational evidence suggesting that immune checkpoint inhibitors plus targeted therapy may improve treatment outcomes in patients with BRAF V600-mutant metastatic melanoma. COMBI-i is a phase III trial evaluating spartalizumab, an anti-programmed death receptor 1 antibody, in combination with dabrafenib and trametinib (sparta-DabTram), versus placebo plus dabrafenib and trametinib (placebo-DabTram) in patients with BRAF V600-mutant unresectable or metastatic melanoma.MethodsPatients received spartalizumab 400 mg intravenously every 4 weeks plus dabrafenib 150 mg orally twice daily and trametinib 2 mg orally once daily or placebo-DabTram. Participants were age ≥ 18 years with unresectable or metastatic BRAF V600-mutant melanoma. The primary end point was investigator-assessed progression-free survival. Overall survival was a key secondary end point (ClinicalTrials.gov identifier: NCT02967692).ResultsAt data cutoff (July 1, 2020), the median progression-free survival was 16.2 months (95% CI, 12.7 to 23.9 months) in the sparta-DabTram arm versus 12.0 months (95% CI, 10.2 to 15.4 months) in the placebo-DabTram arm (hazard ratio, 0.82 [95% CI, 0.66 to 1.03]; P = .042 [one-sided; nonsignificant]). The objective response rates were 69% (183 of 267 patients) versus 64% (170 of 265 patients), respectively. Grade ≥ 3 treatment-related adverse events occurred in 55% (146 of 267) of patients in the sparta-DabTram arm and 33% (88 of 264) in the placebo-DabTram arm.ConclusionThe study did not meet its primary end point; broad first-line use of sparta-DabTram is not supported by these results. Further biomarker-driven investigation may identify patient subpopulations who could benefit from checkpoint inhibitor plus targeted therapy combinations.

Published
2022

3. 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation–Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study5-Year Outcomes with Cobimetinib + Vemurafenib in Melanoma

Author

Ascierto, Paolo A, Dréno, Brigitte, Larkin, James, Ribas, Antoni, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Atkinson, Victoria, Dutriaux, Caroline, Garbe, Claus, Hsu, Jessie, Jones, Surai, Li, Haocheng, McKenna, Edward, Voulgari, Athina, and McArthur, Grant A

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Azetidines, Follow-Up Studies, Humans, Melanoma, Mutation, Piperidines, Proto-Oncogene Proteins B-raf, Skin Neoplasms, Vemurafenib, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation-positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized.Patients and methodsEligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1-21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily).Results495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3-28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0-19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5-14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6-7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports.ConclusionsExtended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation-positive advanced melanoma.

Published
2021

4. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study

Author

Qin, Shukui, Chan, Stephen L, Cheng, Ann-Lii, Kaseb, Ahmed, Vogel, Arndt, Gu, Shanzhi, Bai, Yuxian, Ren, Zhenggang, Lin, Xiaoyan, Chen, Zhendong, Jia, Weidong, Jin, Yongdong, Guo, Yabing, Hu, Xiaohua, Meng, Zhiqiang, Liang, Jun, Cheng, Ying, Xiong, Jianping, Ren, Hong, Yang, Fang, Li, Wei, Chen, Yajin, Zeng, Yong, Sultanbaev, Alexander, Pazgan-Simon, Monika, Pisetska, Margaryta, Melisi, Davide, Ponomarenko, Dmitriy, Osypchuk, Yurii, Sinielnikov, Ivan, Yang, Tsai-Sheng, Liang, Xiao, Chen, Chunxia, Wang, Linna, Zhang, Mingxiang, Xu, Li, Yuan, Xianglin, Li, Da, Ying, Jierer, Zhang, Jingdong, Zhang, Tao, Gu, Kangsheng, He, Yifu, Hao, Ping, Jiang, Da, Zhang, Shu, Xing, Baocai, Zhang, Baihong, Wang, Dong, Zhai, Xiaofeng, Liang, Houjie, Cybulska-Stopa, Bozena, Dvorkin, Mikhail, Stroyakovskiy, Daniil, Nechaeva, Marina, Yen, Chia-Jui, Su, Wei-Wen, Chen, Yen-Hao, Bondarenko, Igor, Yang, Lin, Fang, Weijia, Gomez-Martin, Carlos, Ryu, Min-Hee, Kim, Han-Sang, Kim, Jee-Hyun, Zarubenkov, Oleg, Orlova, Rashida, Poddubskaya, Elena, Fadeeva, Natalia, Makarova, Yulia, Chao, Yee, Hung, Chao-Hung, Neffa, Maryna, Vynnychenko, Oleksandr, Burgoyne, Adam, Hao, Chunyi, Mohr, Raphael U, Diaz-Beveridge, Roberto, Feliu-Batlle, Jaime, Cubillo-Gracian, Antonio, Lee, Ann-Shing, Daniele, Bruno, Antonuzzo, Lorenzo, Sangiovanni, Angelo, Gasbarrini, Antonio, Scartozzi, Mario, Ahn, Mi Sun, Oh, Sung-Yong, Orlov, Sergey, Harputluoglu, Hakan, Oksuzoglu, Berna, Hsu, Chiun, Rau, Kun-Ming, Krechkovskyi, Oleksandr, Yareshko, Vladimir, Xiong, Henry, Lee, Fa-Chyi, Jiang, Yixing, Gabayan, Afshin, Crow, Mary, Van Steenkiste, Christophe, and Verset, Gontran

Published
2023
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5. Overall survival with first-line atezolizumab in combination with vemurafenib and cobimetinib in BRAFV600 mutation-positive advanced melanoma (IMspire150): second interim analysis of a multicentre, randomised, phase 3 study

Author

Ascierto, Paolo A, Stroyakovskiy, Daniil, Gogas, Helen, Robert, Caroline, Lewis, Karl, Protsenko, Svetlana, Pereira, Rodrigo P, Eigentler, Thomas, Rutkowski, Piotr, Demidov, Lev, Zhukova, Natalia, Schachter, Jacob, Yan, Yibing, Caro, Ivor, Hertig, Christian, Xue, Cloris, Kusters, Lieke, McArthur, Grant A, and Gutzmer, Ralf

Published
2023
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6. DESTINY-Breast07: Dose-expansion interim analysis of T-DXd monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ mBC.

Author

Andre, Fabrice, primary, Hamilton, Erika P., additional, Loi, Sherene, additional, Anders, Carey K., additional, Schmid, Peter, additional, Stroyakovskiy, Daniil, additional, Villanueva, Rafael, additional, Pedrini, Jose Luiz, additional, Doval, Dinesh Chandra, additional, Zurawski, Bogdan, additional, Chen, Shin-Cheh, additional, Boston, Sarice Renee, additional, Konpa, Adam, additional, Pierotti, Barbara, additional, Fabbri, Giulia, additional, and Jhaveri, Komal L., additional

Published
2024
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7. Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study

Author

Hurvitz, Sara A, Martin, Miguel, Jung, Kyung Hae, Huang, Chiun-Sheng, Harbeck, Nadia, Valero, Vicente, Stroyakovskiy, Daniil, Wildiers, Hans, Campone, Mario, Boileau, Jean-François, Fasching, Peter A, Afenjar, Karen, Spera, Gonzalo, Lopez-Valverde, Vanesa, Song, Chunyan, Trask, Peter, Boulet, Thomas, Sparano, Joseph A, Symmans, W Fraser, Thompson, Alastair M, and Slamon, Dennis

Subjects
Clinical Trials and Supportive Activities, Patient Safety, Breast Cancer, Cancer, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Carboplatin, Chemotherapy, Adjuvant, Disease-Free Survival, Docetaxel, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoadjuvant Therapy, Receptor, ErbB-2, Trastuzumab, Receptor, erbB-2, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe KRISTINE study compared neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P) for the treatment human epidermal growth factor receptor 2-positive stage II to III breast cancer. T-DM1+P led to a lower pathologic complete response rate (44.4% v 55.7%; P = .016), but fewer grade 3 or greater and serious adverse events (AEs). Here, we present 3-year outcomes from KRISTINE.MethodsPatients were randomly assigned to neoadjuvant T-DM1+P or TCH+P every 3 weeks for six cycles. Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Secondary end points included event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS; measured from surgery).ResultsOf patients, 444 were randomly assigned (T-DM1+P, n = 223; TCH+P, n = 221). Median follow-up was 37 months. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%] v 0). Risk of an IDFS event after surgery was similar between arms (HR, 1.11 [95% CI, 0.52 to 2.40]). Pathologic complete response was associated with a reduced risk of an IDFS event (HR, 0.24 [95% CI, 0.09 to 0.60]) regardless of treatment arm. Overall, grade 3 or greater AEs (31.8% v 67.7%) were less common with T-DM1+P. During adjuvant treatment, grade 3 or greater AEs (24.5% v 9.9%) and AEs leading to treatment discontinuation (18.4% v 3.8%) were more common with T-DM1+P. Patient-reported outcomes favored T-DM1+P during neoadjuvant treatment and were similar to trastuzumab plus pertuzumab during adjuvant treatment.ConclusionCompared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery, a similar risk of an IDFS event, fewer grade 3 or greater AEs during neoadjuvant treatment, and more AEs leading to treatment discontinuation during adjuvant treatment.

Published
2019

10. IMpower150 Final Exploratory Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in Key NSCLC Patient Subgroups With EGFR Mutations or Metastases in the Liver or Brain

Author

Nogami, Naoyuki, Barlesi, Fabrice, Socinski, Mark A., Reck, Martin, Thomas, Christian A., Cappuzzo, Federico, Mok, Tony S.K., Finley, Gene, Aerts, Joachim G., Orlandi, Francisco, Moro-Sibilot, Denis, Jotte, Robert M., Stroyakovskiy, Daniil, Villaruz, Liza C., Rodríguez-Abreu, Delvys, Wan-Teck Lim, Darren, Merritt, David, Coleman, Shelley, Lee, Anthony, Shankar, Geetha, Yu, Wei, Bara, Ilze, and Nishio, Makoto

Published
2022
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11. Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation–positive melanoma

Author

Dréno, Brigitte, Ascierto, Paolo A, Atkinson, Victoria, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Bartley, Karen, Karagiannis, Thomas, Chang, Ilsung, Rooney, Isabelle, Koralek, Daniel O, Larkin, James, McArthur, Grant A, and Ribas, Antoni

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Antineoplastic Combined Chemotherapy Protocols, Azetidines, Double-Blind Method, Female, Humans, Longitudinal Studies, Male, Melanoma, Mutation, Piperidines, Placebos, Proto-Oncogene Proteins B-raf, Quality of Life, Vemurafenib, vemurafenib, cobimetinib, MEK inhibitor, BRAF inhibitor, HRQOL, EORTC QLQ-C30, metastatic melanoma, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundIn the coBRIM study, cobimetinib plus vemurafenib (C+V) significantly improved survival outcomes vs placebo and vemurafenib (P+V) in patients with advanced/metastatic BRAFV600-mutated melanoma. An analysis of health-related quality of life (HRQOL) from coBRIM is reported.MethodsPatients completing the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline and ⩾1 time point thereafter constituted the analysis population. Change from baseline ⩾10 points was considered clinically meaningful.ResultsMean baseline scores for all QLQ-C30 domains were similar between arms. Most on-treatment scores for QLQ-C30 domains were also comparable between arms. A transient deterioration in role function in cycle 1 day 15 (C1D15; -14.7 points) in the P+V arm and improvement in insomnia in the C+V arm at C2D15 (-12.4 points) was observed. Among patients who experienced a ⩾10-point change from baseline (responders), between-group differences were greatest for insomnia (16%), social functioning (10%), fatigue (9%) and pain (7%), all favouring C+V. Diarrhoea, photosensitivity reaction, pyrexia, and rash did not meaningfully affect global health status (GHS). Serous retinopathy was associated with a transient decrease in GHS at C1D15 assessment.ConclusionsIn patients with advanced/metastatic BRAFV600-mutated melanoma, treatment with C+V maintained HRQOL compared with P+V, with superior efficacy.

Published
2018

12. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC

Author

Socinski, Mark A., Nishio, Makoto, Jotte, Robert M., Cappuzzo, Federico, Orlandi, Francisco, Stroyakovskiy, Daniil, Nogami, Naoyuki, Rodríguez-Abreu, Delvys, Moro-Sibilot, Denis, Thomas, Christian A., Barlesi, Fabrice, Finley, Gene, Kong, Shengchun, Lee, Anthony, Coleman, Shelley, Zou, Wei, McCleland, Mark, Shankar, Geetha, and Reck, Martin

Published
2021
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13. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial

Author

Sweeney, Christopher, Bracarda, Sergio, Sternberg, Cora N, Chi, Kim N, Olmos, David, Sandhu, Shahneen, Massard, Christophe, Matsubara, Nobuaki, Alekseev, Boris, Parnis, Francis, Atduev, Vagif, Buchschacher, Gary L, Jr, Gafanov, Rustem, Corrales, Luis, Borre, Michael, Stroyakovskiy, Daniil, Alves, Gustavo Vasconcelos, Bournakis, Evangelos, Puente, Javier, Harle-Yge, Marie-Laurence, Gallo, Jorge, Chen, Geng, Hanover, Justin, Wongchenko, Matthew J, Garcia, Josep, and de Bono, Johann S

Published
2021
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14. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial

Author

Lesimple, Thierry, Maio, Michele, Linette, Gerald, Mortier, Laurent, Svane, Inge Marie, Schachter, Jacob, Brown, Michael, Hersey, Peter, Barrow, Catherine, Kudchadkar, Ragini, Dutriaux, Caroline, Song, Xinni, Quaglino, Pietro, Queirolo, Paola, Meier, Friedegund, Stroyakovskiy, Daniil, Guillot, Bernard, Romero, Pablo Luis Ortiz, Bastholt, Lars, Garbe, Claus, Grange, Florent, Mohr, Peter, Algazi, Alain, Bechter, Oliver, Hernberg, Micaela, Loquai, Carmen, Meiss, Frank, Chiarion Sileni, Vanna, Bar-Sela, Gil, Fitzharris, Bernard, Saiag, Philippe, Arnault, Jean-Philippe, Simon, Jan-Christoph, Stephens, Rosalie, Baurain, Jean-Francois, Lebbe, Célèste, Combemale, Patrick, Dummer, Reinhard, Hauschild, Axel, Parente, Phillip, Yamazaki, Naoya, Milhem, Mohammed, Leccia, Marie-Thérèse, Geoffrois, Lionel, Kretschmer, Lutz, Dunwoodie, Elaine, Walker, John, Lotem, Michal, Hendler, Daniel, Mackiewicz, Andrzej, Sekulovic, Lidija, Dzienis, Marcin, Hospers, Geke A.P., Siano, Marco, Hassel, Jessica, Corrie, Philippa, Passos, Maria-Jose, Levin, Max, Hoeller, Christoph, Machet, Laurent, Hallmeyer, Sigrun, Waterston, Ashita, Descamps, Vincent, Kiecker, Felix, Aarts, Maureen, Schmidt, Henrik, Raimundo, Ana, Nyakas, Marta, Lacour, Jean-Philippe, Berking, Carola, Ferrucci, Pier Francesco, Jameson, Michael, Kim, Kevin, Yokota, Kenji, Kerger, Joseph, Aubin, François, Groenewegen, Gerard, Kapiteijn, Helena, Boehncke, Wolf-Henning, Utikal, Jochen, Casasola, Richard, Marshall, Ernest, Ferraresi, Virginia, Richtig, Erika, Matkovic, Suzana, Inozume, Takashi, Crook, Timothy, McNeil, Catriona, Kiyohara, Yoshio, Avril, Marie-Francoise, Hein, Rüdiger, Terheyden, Patrick, Nathan, Paul, Aoi, Jun, Skytta, Tanja, Jouary, Thomas, Takenouchi, Tatsuya, Straume, Oddbjorn, Martins, César, Mukhametshina, Guzel, Bottomley, Andrew, Coens, Corneel, Mierzynska, Justyna, Blank, Christian U, Mandalà, Mario, Long, Georgina V, Atkinson, Victoria G, Dalle, Stéphane, Haydon, Andrew M, Meshcheryakov, Andrey, Khattak, Adnan, Carlino, Matteo S, Sandhu, Shahneen, Puig, Susana, Ascierto, Paolo A, Larkin, James, Lorigan, Paul C, Rutkowski, Piotr, Schadendorf, Dirk, Koornstra, Rutger, Hernandez-Aya, Leonel, Di Giacomo, Anna Maria, van den Eertwegh, Alfonsus J M, Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, van Akkooi, Alexander C J, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, Robert, Caroline, and Eggermont, Alexander M M

Published
2021
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15. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial

Author

Menzies, Alex, Lesimple, Thierry, Maio, Michele, Linette, Gerald, Brown, Michael, Hersey, Peter, Svane, Inge Marie, Mortier, Laurent, Schachter, Jacob, Barrow, Catherine, Kudchadkar, Ragini, Song, Xinni, Dutriaux, Caroline, Quaglino, Pietro, Meier, Friedegund, Queirolo, Paola, Stroyakovskiy, Daniil, Bastholt, Lars, Guillot, Bernard, Garbe, Claus, Ortiz Romero, Pablo Luis, Grange, Florent, Mohr, Peter, Algazi, Alain, Bechter, Oliver, Hernberg, Micaela, Arnault, Jean-Philippe, Saiag, Philippe, Loquai, Carmen, Meiss, Frank, Simon, Jan-Christoph, Bar-Sela, Gil, Chiarion Sileni, Vanna, Fitzharris, Bernard, McCrystal, Mike, Parente, Phillip, Baurain, Jean-Francois, Combemale, Patrick, Lebbe, Célèste, Hauschild, Axel, Yamazaki, Naoya, Dummer, Reinhard, Milhem, Mohammed, Dzienis, Marcin, Walker, John, Geoffrois, Lionel, Leccia, Marie-Thérèse, Kretschmer, Lutz, Hendler, Daniel, Lotem, Michal, Mackiewicz, Andrzej, Sekulovic, Lidija, Dunwoodie, Elaine, Hoeller, Christoph, Machet, Laurent, Hassel, Jessica, Hospers, Geke A.P., Passos, Maria-Jose, Levin, Max, Fehr, Martin, Corrie, Philippa, Waterston, Ashita, Hallmeyer, Sigrun, Schmidt, Henrik, Descamps, Vincent, Lacour, Jean-Philippe, Berking, Carola, Kiecker, Felix, Ferrucci, Pier Francesco, Yokota, Kenji, Aarts, Maureen, Jameson, Michael, Winge-Main, Anna Katharina, Ferreira, Paula, Kim, Kevin, McNeil, Catriona, Hofmann-Wellenhof, Reiner, Kerger, Joseph, Aubin, François, Utikal, Jochen, Ferraresi, Virginia, Inozume, Takashi, Kiyohara, Yoshio, Groenewegen, Gerard, Kapiteijn, Helena, Matkovic, Suzana, Boehncke, Wolf-Henning, Casasola, Richard, Crook, Timothy, Marshall, Ernest, Skytta, Tanja, Avril, Marie-Francoise, Jouary, Thomas, Hein, Rüdiger, Terheyden, Patrick, Aoi, Jun, Takenouchi, Tatsuya, Straume, Oddbjorn, Martins, César, Mukhametshina, Guzel, Nathan, Paul, Eggermont, Alexander M M, Blank, Christian U, Mandalà, Mario, Long, Georgina V, Atkinson, Victoria G, Dalle, Stéphane, Haydon, Andrew M, Meshcheryakov, Andrey, Khattak, Adnan, Carlino, Matteo S, Sandhu, Shahneen, Larkin, James, Puig, Susana, Ascierto, Paolo A, Rutkowski, Piotr, Schadendorf, Dirk, Koornstra, Rutger, Hernandez-Aya, Leonel, Di Giacomo, Anna Maria, van den Eertwegh, Alfonsus J M, Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, Lorigan, Paul C, van Akkooi, Alexander C J, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, and Robert, Caroline

Published
2021
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16. Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial

Author

Jotte, Robert, Cappuzzo, Federico, Vynnychenko, Ihor, Stroyakovskiy, Daniil, Rodríguez-Abreu, Delvys, Hussein, Maen, Soo, Ross, Conter, Henry J., Kozuki, Toshiyuki, Huang, Kuan-Chieh, Graupner, Vilma, Sun, Shawn W., Hoang, Tien, Jessop, Helen, McCleland, Mark, Ballinger, Marcus, Sandler, Alan, and Socinski, Mark A.

Published
2020
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17. Efficacy and safety of trifluridine/tipiracil in combination with bevacizumab in older and younger patients with refractory metastatic colorectal cancer: A subgroup analysis of the phase 3 SUNLIGHT trial.

Author

Taieb, Julien, primary, Prager, Gerald W., additional, Fakih, Marwan, additional, Ciardello, Fortunato, additional, Van Cutsem, Eric, additional, Elez, Elena, additional, Cruz, Felipe Melo, additional, Wyrwicz, Lucjan S., additional, Stroyakovskiy, Daniil, additional, Papai, Zsuzsanna, additional, Poureau, Pierre-Guillaume, additional, Liposits, Gabor, additional, Cremolini, Chiara, additional, Bondarenko, Igor, additional, Modest, Dominik Paul, additional, Roby, Lucas, additional, Barboux, Valentine, additional, Amellal, Nadia, additional, and Tabernero, Josep, additional

Published
2024
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18. Efficacy and safety of nurulimab+prolgolimab with continued prolgolimab therapy compared to prolgolimab alone as first-line therapy in patients with unresectable or metastatic melanoma: final results of the phase II OBERTON clinical study

Author

Samoylenko, Igor V., primary, Demidov, Lev V., additional, Moiseenko, Fedor V., additional, Dvorkin, Mikhail V., additional, Demidova, Svetlana A., additional, Protsenko, Svetlana A., additional, Stroyakovskiy, Daniil L., additional, Kozlov, Vadim V., additional, Odintsova, Svetlana V., additional, Kirtbaya, Dmitry V., additional, Tantsyrev, Denis A., additional, Mochalova, Anastasia S., additional, Orlova, Rashida V., additional, Mukhametshina, Guzel Z., additional, Fadeeva, Natalia V., additional, Fomin, Evgeny A., additional, Chapko, Yana S., additional, Tarasova, Anna V., additional, Ermakov, Nikolay B., additional, Shemerovskiy, Alexander K., additional, Vaschenko, Vera A., additional, Chistyakov, Valery M., additional, Zinkina-Orikhan, Arina V., additional, Lin'kova, Yulia N., additional, Kryukov, Fedor B., additional, Sorokina, Irina V., additional, and Siliutina, Anna A., additional

Published
2023
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19. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial

Author

Reck, Martin, Mok, Tony SK, Nishio, Makoto, Jotte, Robert M, Cappuzzo, Federico, Orlandi, Francisco, Stroyakovskiy, Daniil, Nogami, Naoyuki, Rodríguez-Abreu, Delvys, Moro-Sibilot, Denis, Thomas, Christian A, Barlesi, Fabrice, Finley, Gene, Lee, Anthony, Coleman, Shelley, Deng, Yu, Kowanetz, Marcin, Shankar, Geetha, Lin, Wei, Socinski, Mark A, and Mok, Tony S K

Published
2019
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20. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Koroveshi, Dhurata, Bouzid, Kamel, Casalnuovo, Monica, Cascallar, Diana, Korbenfeld, Ernesto Pablo, Bastick, Patricia, Beith, Jane, Colosimo, Maree, Friedlander, Michael, Ganju, Vinod, Green, Michael, Patterson, Kevin, Redfern, Andrew, Richardson, Gary, Ceric, Timur, Gordana, Kecman, Beato, Carlos Augusto, Ferrari, Marcela, Hegg, Roberto, Helena, Vanessa, Ismael, Gustavo Fernando, Lessa, Alvaro Edson, Mano, Max, Morelle, Alessandra, Nogueira, Jose Alberto, Timcheva, Konstanta, Tomova, Antoaneta, Tsakova, Maya, Zlatareva-Petrova, Ani, Asselah, Jamil, Assi, Hazem, Brezden-Masley, Christine, Chia, Stephen, Freedman, Ori, Harb, Mohammed, Joy, Anil Abraham, Kulkarni, Swati, Prady, Catherine, Gaete, Alejandro Andres Acevedo, Matamala, Luis, Torres, Roberto, Yanez, Eduardo, Franco, Sandra, Urrego, Marcela, Gugić, Damir, Vrbanec, Damir, Melichar, Bohuslav, Prausová, Jana, Vyzula, Rostislav, Pilarte, Rafael Gutierrez, León, María Isabel, Muñoz, Rene, Ramos, Glenda, Azeem, Hamdy Abdel, Aziz, Amr Abdel, El Zawahry, Heba, Osegueda, Finlander Rosales, Alexandre, Jerome, Artignan, Xavier, Barletta, Hugues, Beguier, Emmanuel, Berdah, Jean-François, Marty, Chantal Bernard, Bollet, Marc, Bourgeois, Hugues, Bressac, Claude, Burki, Franck, Campone, Mario, Coeffic, David, Cojocarasu, Oana Zveltlana, Dagada, Corinne, Dalenc, Florence, Del Piano, Francesco, Desauw, Christophe, Desmoulins, Isabelle, Dohollou, Nadine, Egreteau, Joelle, Ferrero, Jean-Marc, Foa, Cyril, Garidi, Reda, Gasnault, Laurent, Gligorov, Joseph, Guardiola, Emmanuel, Hamizi, Salima, Jarcau, Rosana, Jacquin, Jean-Philippe, Jaubert, Dominique, Jolimoy, Geneviève, Mineur, Hortense Laharie, Largillier, Remy, Leduc, Bernard, Martin, Philippe, Melis, Adrien, Monge, Jeremy, Moullet, Isabelle, Mousseau, Mireille, Nguyen, Suzanne, Orfeuvre, Hubert, Petit, Thierry, Pivot, Xavier, Priou, Frank, Bach, Isabelle Sillet, Simon, Helene, Stefani, Laetitia, Uwer, Lionel, Youssef, Ali, Aktas, Bahriye, von der Assen, Albert, Augustin, Doris, Balser, Christina, Bauer, Lelia-Eveline, Bechtner, Christina, Beyer, Greta, Brucker, Cosima, Bückner, Ute, Busch, Steffi, Christensen, Bernd, Deryal, Mustafa, Farrokh, Andre, Faust, Elke, Friedrichs, Kay, Graf, Heiko, Griesshammer, Martin, Grischke, Eva-Maria, Hänle, Claudia, Heider, Andrea, Henschen, Stephan, Hesse, Tobias, Jackisch, Christian, Kisro, Jens, Köhler, Andreas, Kuemmel, Sherko, Lampe, Dieter, Lantzsch, Tilmann, Latos, Kunibert, Lex, Benno, Liedtke, Cornelia, Luedders, Doerte, Maintz, Christoph, Müller, Volkmar, Overkamp, Friedrich, Park-Simon, Tjoung-won, Paul, Marion, Prechtl, Anita, Ringsdorf, Uta, Runnebaum, Ingo, Ruth, Sylvia, Salat, Christoph, Scheffen, Iris, Schilling, Jörg, Schmatloch, Sabine, Schmidt, Marcus, Schneeweiss, Andreas, Schrader, Iris, Seipelt, Gernot, Simon, Elke, Stefek, Andrea, Stickeler, Elmar, Thill, Marc, Tio, Joke, Tuczek, Anna, Warm, Mathias, Weigel, Michael, Wischnik, Arthur, Wojcinski, Sebastian, Ziegler-Löhr, Katja, Aravantinos, Gerasimos, Ardavanis, Alexandros, Fountzilas, George, Gogas, Helen, Kakolyris, Stylianos, Mavroudis, Dimitris, Papadimitriou, Christos, Papandreou, Christos, Papazisis, Konstantinos, Castro, Hugo, Hernandez-Monroy, Cesar Estuardo, Ngan, Roger, Yeo, Winnie, Bittner, Nora, Boer, Katalin, Csejtei, Andras, Horvath, Zsolt, Kocsis, Judit, Mangel, László Csaba, Mezei, Klara, Nagy, Zsuzsanna, Szanto, Janos, Atmakusuma, Djumhana, Fadjari, Heri, Kurnianda, Djohan, Prayogo, Nugroho, Tanggo, Eddie Herman, Coate, Linda, Hennessy, Bryan, Kelly, Cathy, Martin, Michael, Nasim, Saira, O'Connor, Miriam, Aieta, Michele, Allegrini, Giacomo, Amadori, Dino, Bidoli, Paolo, Biti, Giampaolo, Bordonaro, Roberto, Bottini, Alberto, Carterni, Giacomo, Cavanna, Luigi, Cazzaniga, Marina, Cognetti, Francesco, Contu, Antonio, Cruciani, Giorgio, Donadio, Michela, Falcone, Alfredo, Farci, Daniele, Forcignanò, R. Chiara, Frassoldati, Antonio, Gaion, Fernando, Gamucci, Teresa, Giotta, Francesco, de Laurentiis, Michele, Livi, Lorenzo, Lorusso, Vito, Maiello, Evaristo, Marchetti, Paolo, Mariani, Gabriella, Mion, Marta, Moscetti, Luca, Musolino, Antonino, Pazzola, Antonio, Pedrazzoli, Paolo, Pigi, Andrea, de Placido, Sabino, Caremoli, Elena Rota, Santoro, Armando, Tienghi, Amelia, Ahn, Jin-Seok, Jung, Kyung Hae, Lee, Keun Seok, Lee, Soo Hyeon, Seo, Jae Hong, Sohn, Joo-Hyuk, Cesas, Alvydas, Juozaityte, Elona, Cheah, Nellie Lay Chin, Chong, Flora Li Tze, Devi, Beena C.R., Phua, Vincent, Teoh, Darren, Ching, Lee Wei, Yusof, Mastura, Corona, Jorge, Dominguez, Adriana, Mendoza, René Lazaro González, Hernandez, Carlos Alberto, Ramiro, Alejandro Juarez, Santos, Juan Matos, Espinosa, Paola Morales, Villarreal Garza, Cynthia Mayte, Errihani, Hassan, Bakker, Sandra, van den Berkmortel, Franchette, Blaisse, R.J.B., Huinink, Daan ten Bokkel, van den Bosch, J., Braun, J.J., Dercksen, M.W., Droogendijk, Helga, Erdkamp, Frans, Haringhuizen, Annebeth, de Jongh, F.E., Kok, T.C., Los, Maartje, Madretsma, Stanley, Terwogt, Jetske M. Meerum, van der Padt, Annemieke, van Rossum-Schornagel, Quirine Clementine, Smilde, T.J., de Valk, Bart, van der Velden, Annette, van Warmerdam, Laurence, van de Wouw, A.J., North, Richard, Kersten, Christian, Mjaaland, Ingvild, Wist, Erik, Aziz, Zeba, Masood, Nehal, Rashid, Kamran, Shah, Mazhar, Alcedo, Juan Carlos, Aleman, Diana, Neciosup, Silvia, Reategui, Rocio, Valdiviezo, Natalia, Vera, Luis, Fernando, Gracieux, Roque, Fernando, Strebel, Heinrik Martin, Krzemieniecki, Krzysztof, Litwiniuk, Maria, Mruk, Andrzej, Pienkowski, Tadeusz, Sawrycki, Piotr, Slomian, Grzegorz, Tomczak, Piotr, Afonso, Noemia, Cardoso, Fátima, Damasceno, Margarida, Nave, Monica, Badulescu, Florinel, Ciule, Larisa, Curescu, Stefan, Eniu, Alexandru, Filip, Dumitru, Grecea, Daniela, Jinga, Dan-Corneliu, Lungulescu, Dan, Oprean, Cristina Marinela, Stanculeanu, Dana Lucia, Turdean, Maria, Dvornichenko, Viktoria, Emelyanov, Sergey, Lichinitser, Mikhail, Manikhas, Alexey, Sakaeva, Dina, Shirinkin, Vadim, Stroyakovskiy, Daniil, Abulkhair, Omalkhair, Zekri, Jamal, Filipovic, Sladjana, Kovcin, Vladimir, Nedovic, Jasmina, Pesic, Jasna, Vasovic, Suzana, Ng, Raymond, Bystricky, Branislav, Leskova, Jaroslava, Mardiak, Jozef, Mišurová, Etela, Wagnerova, Maria, Takač, Iztok, Demetriou, Georgia Savva, Dreosti, Lydia, Govender, Poovandren, Jordaan, Johannes Petrus, Veersamy, Petrosian, Romero, Jose Luis Alonso, Lopez, Norberto Batista, Arias, Carmen Cañabate, Chacon, Jose, Aramburo, Antonio Fernandez, Morales, Luis Antonio Fernandez, Garcia, Mirta, Estevez, Laura Garcia, Garcia-Palomo Perez, Andres, Garcia Saenz, Jose Angel, Garcia Sanchis, Laura, Cubells, Laia Garrigos, Cortijo, Lucia Gonzalez, Santiago, Santiago Gonzalez, De Aranguiz, Blanca Hernando Fernandez, Mañas, José Juan Illarramendi, Gallego, Pedro Jimenez, Cussac, Antonio Llombart, Ferrandiz, Cristina Llorca, Garrido, Maria Lomas, Alvarez, Pilar Lopez, Vega, Jose Manuel Lopez, Del Prado, Purificacion Martinez, Jañez, Noelia Martinez, Murillo, Serafin Morales, Rosales, Adolfo Murias, Jaso, Laura Murillo, Fernandez, Ignacio Pelaez, Martorell, Antonia Perello, Carrion, Ramon Perez, Simon, Sonia Pernas, Alcibar, Arrate Plazaola, Lorenzo, Jose Ponce, Garcia, Vanesa Quiroga, Asensio, Teresa Ramon y Cajal, Maicas, Maria Dolores Torregrosa, Villanueva Silva, Maria Jose, Killander, Fredrika, Svensson, Jan Henry, Fehr, Mathias, Hauser, Nik, Müller, Andreas, Pagani, Olivia, Passmann-Kegel, Heike, Popescu, Razvan, Rabaglio, Manuela, Rauch, Daniel, Schlatter, Christina, Zaman, Khalil, Chang, Tsai-Wang, Huang, Chiun-Sheng, Wang, Hwei-Chung, Yu, Jyh-Cherng, Bandidwattanawong, Chanyoot, Maneechavakajorn, Jedzada, Seetalarom, Kasan, Dejthevaporn, Thitiya (Sirisinha), Somwangprasert, Areewan, Vongsaisuwon, Mawin, Akbulut, Hakan, Altundag, Kadri, Arican, Ali, Bozcuk, Hakan, Eralp, Yesim, Idris, Mohamed, Isikdogan, Abdurrahman, Senol, Coskun Hasan, Sevinc, Alper, Uygun, Kazim, Yucel, Eftal, Yucel, Idris, Yumuk, Fulden, Shparyk, Yaroslav, Voitko, Nataliia, Jaloudi, Mohammed, Adams, Jocelyn, Agrawal, Rajiv, Ahmed, Samreen, Alhasso, Abdulla, Allerton, Rozenn, Anwar, Suhail, Archer, Caroline, Ashford, Richard, Barraclough, Lisa, Bertelli, Gianfilippo, Bishop, Jill, Branson, Tony, Butt, Mohammed, Chakrabarti, Amit, Chakraborti, Prabir, Churn, Mark, Crowley, Clare, Davis, Ruth, Dhadda, Amandeep, Eldeeb, Hany, Fraser, Judith, Hall, Julia, Hickish, Tamas, Hogg, Martin, Howe, Theresa, Joffe, Jonathan, Kelleher, Muireann, Kelly, Stephen, Kendall, Anne, Kristeleit, Hartmut, Lumsden, Graeme, Macmillan, Craig, MacPherson, Iain, Malik, Zafar, Mithal, Natasha, Neal, Anthony, Panwar, Udaiveer, Proctor, Andrew, Proctor, Steven John, Raj, Sanjay, Rehman, Shazza, Sandri, Ines, Scatchard, Kate, Sherwin, Elizabeth, Sims, Eliot, Singer, Julian, Smith, Sarah, Tahir, Saad, Taylor, Wendy, Tsalic, Medy, Verrill, Mark, Wardley, Andrew, Waters, Simon, Wheatley, Duncan, Wright, Kathryn, Yuille, Frances, Alonso, Isabel, Artagaveytia, Nora, Rodriguez, Robinson, Arbona, Esther, Garcia, Yuraima, Lion, Lorena, Marcano, Dalila, Van Thuan, Tran, Gligorov, J., Ataseven, B., Verrill, M., De Laurentiis, M., Jung, K.H., Azim, H.A., Al-Sakaff, N., Lauer, S., Shing, M., and Pivot, X.

Published
2017
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21. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial.

Author

Meric-Bernstam, Funda, Makker, Vicky, Oaknin, Ana, Oh, Do-Youn, Banerjee, Susana, González-Martín, Antonio, Jung, Kyung Hae, Ługowska, Iwona, Manso, Luis, Manzano, Aránzazu, Melichar, Bohuslav, Siena, Salvatore, Stroyakovskiy, Daniil, Fielding, Anitra, Ma, Yan, Puvvada, Soham, Shire, Norah, and Lee, Jung-Yun

Published
2024
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22. Trifluridine–Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer

Author

Prager, Gerald W., primary, Taieb, Julien, additional, Fakih, Marwan, additional, Ciardiello, Fortunato, additional, Van Cutsem, Eric, additional, Elez, Elena, additional, Cruz, Felipe M., additional, Wyrwicz, Lucjan, additional, Stroyakovskiy, Daniil, additional, Pápai, Zsuzsanna, additional, Poureau, Pierre-Guillaume, additional, Liposits, Gabor, additional, Cremolini, Chiara, additional, Bondarenko, Igor, additional, Modest, Dominik P., additional, Benhadji, Karim A., additional, Amellal, Nadia, additional, Leger, Catherine, additional, Vidot, Loïck, additional, and Tabernero, Josep, additional

Published
2023
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23. Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

Author

Ascierto, Paolo A, McArthur, Grant A, Dréno, Brigitte, Atkinson, Victoria, Liszkay, Gabrielle, Di Giacomo, Anna Maria, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Yan, Yibing, Wongchenko, Matthew, Chang, Ilsung, Hsu, Jessie J, Koralek, Daniel O, Rooney, Isabelle, Ribas, Antoni, and Larkin, James

Published
2016
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24. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer

Author

Slamon, Dennis J., Fasching, Peter A., Hurvitz, Sara, Chia, Stephen, Crown, John, Martín, Miguel, Barrios, Carlos H., Bardia, Aditya, Im, Seock-Ah, Yardley, Denise A., Untch, Michael, Huang, Chiun-Sheng, Stroyakovskiy, Daniil, Xu, Binghe, Moroose, Rebecca L., Loi, Sherene, Visco, Frances, Bee-Munteanu, Valerie, Afenjar, Karen, Fresco, Rodrigo, Taran, Tetiana, Chakravartty, Arunava, Zarate, Juan Pablo, Lteif, Agnes, and Hortobagyi, Gabriel N.

Subjects
ddc:610
Abstract

Background: Ribociclib has demonstrated a statistically significant overall survival benefit in pre- and postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer. New Adjuvant Trial with Ribociclib [LEE011] (NATALEE) is a trial evaluating the efficacy and safety of adjuvant ribociclib plus endocrine therapy (ET) versus ET alone in patients with HR+/HER2− early nonmetastatic breast cancer (EBC). Methods/design: NATALEE is a multicenter, randomized, open-label, Phase III trial in patients with HR+/HER2− EBC. Eligible patients include women, regardless of menopausal status, and men aged ⩾18 years. Select patients with stage IIA, stage IIB, or stage III disease (per the anatomic classification in the AJCC Cancer Staging Manual, 8th edition) with an initial diagnosis ⩽18 months prior to randomization are eligible. Patients receiving standard (neo)adjuvant ET are eligible if treatment was initiated ⩽12 months before randomization. Patients undergo 1:1 randomization to ribociclib 400 mg/day (3 weeks on/1 week off) +ET (letrozole 2.5 mg/day or anastrozole 1 mg/day [investigator’s discretion] plus goserelin [men or premenopausal women]) or ET alone. Ribociclib treatment duration is 36 months; ET treatment duration is ⩾60 months. The primary end point is invasive disease-free survival. Discussion: The 36-month treatment duration of ribociclib in NATALEE is extended compared with that in other adjuvant cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor trials and is intended to maximize efficacy due to longer duration of CDK4/6 inhibition. Compared with the 600-mg/day dose used in advanced breast cancer, the reduced ribociclib dose used in NATALEE may improve tolerability while maintaining efficacy. NATALEE includes the broadest population of patients with HR+/HER2− EBC of any Phase III trial currently evaluating adjuvant CDK4/6 inhibitor treatment. Trial registration: ClinicalTrials.gov identifier: NCT03701334 (https://clinicaltrials.gov/ct2/show/NCT03701334)

Published
2023

25. Trifluridine/tipiracil plus bevacizumab for third-line treatment of refractory metastatic colorectal cancer: The phase 3 randomized SUNLIGHT study.

Author

Tabernero, Josep, primary, Prager, Gerald W., additional, Fakih, Marwan, additional, Ciardiello, Fortunato, additional, Van Cutsem, Eric, additional, Elez, Elena, additional, Cruz, Felipe Melo, additional, Wyrwicz, Lucjan, additional, Stroyakovskiy, Daniil, additional, Papai, Zsuzsanna, additional, Poureau, Pierre-guillaume, additional, Liposits, Gabor, additional, Cremolini, Chiara, additional, Bondarenko, Igor, additional, Modest, Dominik Paul, additional, Benhadji, Karim A., additional, Fougeray, Ronan, additional, Leger, Catherine, additional, Amellal, Nadia, additional, and Taieb, Julien, additional

Published
2023
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26. Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma

Author

Bergerot, Cristiane, primary, Young Rha, Sun, additional, Pal, Sumanta, additional, Koralewski, Piotr, additional, Stroyakovskiy, Daniil, additional, Alekseev, Boris, additional, Parnis, Francis, additional, Castellano, Daniel, additional, Lyun Lee, Jae, additional, Sunela, Kaisa, additional, Ciuleanu, Tudor, additional, Heng, Daniel, additional, Glen, Hilary, additional, Wang, Jinyi, additional, Bennett, Lee, additional, Pan, Janice, additional, O’Hara, Karen, additional, and Puente, Javier, additional

Published
2023
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27. Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial

Author

Grob, Jean Jacques, Amonkar, Mayur M, Karaszewska, Boguslawa, Schachter, Jacob, Dummer, Reinhard, Mackiewicz, Andrzej, Stroyakovskiy, Daniil, Drucis, Kamil, Grange, Florent, Chiarion-Sileni, Vanna, Rutkowski, Piotr, Lichinitser, Mikhail, Levchenko, Evgeny, Wolter, Pascal, Hauschild, Axel, Long, Georgina V, Nathan, Paul, Ribas, Antoni, Flaherty, Keith, Sun, Peng, Legos, Jeffrey J, McDowell, Diane Opatt, Mookerjee, Bijoyesh, Schadendorf, Dirk, and Robert, Caroline

Published
2015
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28. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial

Author

Long, Georgina V, Stroyakovskiy, Daniil, Gogas, Helen, Levchenko, Evgeny, de Braud, Filippo, Larkin, James, Garbe, Claus, Jouary, Thomas, Hauschild, Axel, Grob, Jean-Jacques, Chiarion-Sileni, Vanna, Lebbe, Celeste, Mandalà, Mario, Millward, Michael, Arance, Ana, Bondarenko, Igor, Haanen, John B A G, Hansson, Johan, Utikal, Jochen, Ferraresi, Virginia, Kovalenko, Nadezhda, Mohr, Peter, Probachai, Volodymr, Schadendorf, Dirk, Nathan, Paul, Robert, Caroline, Ribas, Antoni, DeMarini, Douglas J, Irani, Jhangir G, Swann, Suzanne, Legos, Jeffrey J, Jin, Fan, Mookerjee, Bijoyesh, and Flaherty, Keith

Published
2015
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29. Dabrafenib (D) and trametinib (T) plus spartalizumab (S) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Three-year overall survival (OS) data from the randomized part 3 of the phase III COMBI-i trial.

Author

Dummer, Reinhard, primary, Long, Georgina V., additional, Tawbi, Hussein A., additional, Flaherty, Keith, additional, Ascierto, Paolo Antonio, additional, Nathan, Paul D., additional, Rutkowski, Piotr, additional, Leonov, Oleg, additional, Mandalà, Mario, additional, Lorigan, Paul, additional, Ferrucci, Pier Francesco, additional, Grob, Jean-Jacques, additional, Meyer, Nicolas, additional, Gogas, Helen, additional, Stroyakovskiy, Daniil, additional, Arance, Ana Maria, additional, Pakhle, Neha, additional, Waters, Sorcha, additional, Ribas, Antoni, additional, and Schadendorf, Dirk, additional

Published
2022
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30. Overall survival (OS) with first-line atezolizumab (A) or placebo (P) in combination with vemurafenib (V) and cobimetinib (C) in BRAFV600 mutation-positive advanced melanoma: Second interim OS analysis of the phase 3 IMspire150 study.

Author

McArthur, Grant A., primary, Gutzmer, Ralf, additional, Stroyakovskiy, Daniil, additional, Gogas, Helen, additional, Robert, Caroline, additional, Protsenko, Svetlana, additional, Pereira, Rodrigo Perez, additional, Eigentler, Thomas, additional, Rutkowski, Piotr, additional, Demidov, Lev V., additional, Zhukova, Natalia V., additional, Schachter, Jacob, additional, Yan, Yibing, additional, Caro, Ivor, additional, Hertig, Christian, additional, Xue, Cloris, additional, Kusters, Lieke, additional, Ascierto, Paolo Antonio, additional, and Lewis, Karl D., additional

Published
2022
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32. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600–Mutant Unresectable or Metastatic Melanoma

Author

Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, Long, Georgina V; https://orcid.org/0000-0001-8894-3545, Robert, Caroline; https://orcid.org/0000-0002-9493-0238, Tawbi, Hussein A; https://orcid.org/0000-0003-1942-851X, Flaherty, Keith T; https://orcid.org/0000-0002-3402-0478, Ascierto, Paolo A; https://orcid.org/0000-0002-8322-475X, Nathan, Paul D; https://orcid.org/0000-0002-2327-3250, Rutkowski, Piotr; https://orcid.org/0000-0002-8920-5429, Leonov, Oleg; https://orcid.org/0000-0001-6667-7135, Dutriaux, Caroline, Mandalà, Mario, Lorigan, Paul; https://orcid.org/0000-0002-8875-2164, Ferrucci, Pier Francesco; https://orcid.org/0000-0001-6255-5851, Grob, Jean Jacques; https://orcid.org/0000-0002-0667-153X, Meyer, Nicolas, Gogas, Helen; https://orcid.org/0000-0002-0451-2885, Stroyakovskiy, Daniil, Arance, Ana; https://orcid.org/0000-0003-2896-1957, Brase, Jan C; https://orcid.org/0000-0002-1325-2528, Green, Steven, Haas, Tomas; https://orcid.org/0000-0003-0407-1079, Masood, Aisha, Gasal, Eduard, Ribas, Antoni; https://orcid.org/0000-0003-3669-8458, Schadendorf, Dirk; https://orcid.org/0000-0003-3524-7858, Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, Long, Georgina V; https://orcid.org/0000-0001-8894-3545, Robert, Caroline; https://orcid.org/0000-0002-9493-0238, Tawbi, Hussein A; https://orcid.org/0000-0003-1942-851X, Flaherty, Keith T; https://orcid.org/0000-0002-3402-0478, Ascierto, Paolo A; https://orcid.org/0000-0002-8322-475X, Nathan, Paul D; https://orcid.org/0000-0002-2327-3250, Rutkowski, Piotr; https://orcid.org/0000-0002-8920-5429, Leonov, Oleg; https://orcid.org/0000-0001-6667-7135, Dutriaux, Caroline, Mandalà, Mario, Lorigan, Paul; https://orcid.org/0000-0002-8875-2164, Ferrucci, Pier Francesco; https://orcid.org/0000-0001-6255-5851, Grob, Jean Jacques; https://orcid.org/0000-0002-0667-153X, Meyer, Nicolas, Gogas, Helen; https://orcid.org/0000-0002-0451-2885, Stroyakovskiy, Daniil, Arance, Ana; https://orcid.org/0000-0003-2896-1957, Brase, Jan C; https://orcid.org/0000-0002-1325-2528, Green, Steven, Haas, Tomas; https://orcid.org/0000-0003-0407-1079, Masood, Aisha, Gasal, Eduard, Ribas, Antoni; https://orcid.org/0000-0003-3669-8458, and Schadendorf, Dirk; https://orcid.org/0000-0003-3524-7858

Abstract

PURPOSE Preclinical data suggest the combination of an anti–programmed death receptor 1 antibody plus dabrafenib and trametinib to have superior antitumor activity compared with dabrafenib plus trametinib alone. These observations are supported by translational evidence suggesting that immune checkpoint inhibitors plus targeted therapy may improve treatment outcomes in patients with BRAF V600–mutant metastatic melanoma. COMBI-i is a phase III trial evaluating spartalizumab, an anti–programmed death receptor 1 antibody, in combination with dabrafenib and trametinib (sparta-DabTram), versus placebo plus dabrafenib and trametinib (placebo-DabTram) in patients with BRAF V600–mutant unresectable or metastatic melanoma. METHODS Patients received spartalizumab 400 mg intravenously every 4 weeks plus dabrafenib 150 mg orally twice daily and trametinib 2 mg orally once daily or placebo-DabTram. Participants were age ≥ 18 years with unresectable or metastatic BRAF V600–mutant melanoma. The primary end point was investigator-assessed progression-free survival. Overall survival was a key secondary end point (ClinicalTrials.gov identifier: NCT02967692 ). RESULTS At data cutoff (July 1, 2020), the median progression-free survival was 16.2 months (95% CI, 12.7 to 23.9 months) in the sparta-DabTram arm versus 12.0 months (95% CI, 10.2 to 15.4 months) in the placebo-DabTram arm (hazard ratio, 0.82 [95% CI, 0.66 to 1.03]; P = .042 [one-sided; nonsignificant]). The objective response rates were 69% (183 of 267 patients) versus 64% (170 of 265 patients), respectively. Grade ≥ 3 treatment-related adverse events occurred in 55% (146 of 267) of patients in the sparta-DabTram arm and 33% (88 of 264) in the placebo-DabTram arm. CONCLUSION The study did not meet its primary end point; broad first-line use of sparta-DabTram is not supported by these results. Further biomarker-driven investigation may identify patient subpopulations who could benefit from checkpoint inhibitor plus targeted the

Published
2022

33. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib forBRAFV600–Mutant Unresectable or Metastatic Melanoma

Author

Dummer, Reinhard, primary, Long, Georgina V., additional, Robert, Caroline, additional, Tawbi, Hussein A., additional, Flaherty, Keith T., additional, Ascierto, Paolo A., additional, Nathan, Paul D., additional, Rutkowski, Piotr, additional, Leonov, Oleg, additional, Dutriaux, Caroline, additional, Mandalà, Mario, additional, Lorigan, Paul, additional, Ferrucci, Pier Francesco, additional, Grob, Jean Jacques, additional, Meyer, Nicolas, additional, Gogas, Helen, additional, Stroyakovskiy, Daniil, additional, Arance, Ana, additional, Brase, Jan C., additional, Green, Steven, additional, Haas, Tomas, additional, Masood, Aisha, additional, Gasal, Eduard, additional, Ribas, Antoni, additional, and Schadendorf, Dirk, additional

Published
2022
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34. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600-Mutant Unresectable or Metastatic Melanoma

Author

Dummer, Reinhard Long, Georgina V. Robert, Caroline Tawbi, Hussein A. Flaherty, Keith T. Ascierto, Paolo A. Nathan, Paul D. Rutkowski, Piotr Leonov, Oleg Dutriaux, Caroline Mandalà, Mario Lorigan, Paul Ferrucci, Pier Francesco Grob, Jean Jacques Meyer, Nicolas Gogas, Helen Stroyakovskiy, Daniil Arance, Ana Brase, Jan C. Green, Steven Haas, Tomas Masood, Aisha Gasal, Eduard Ribas, Antoni Schadendorf, Dirk

Abstract

PURPOSE: Preclinical data suggest the combination of an anti-programmed death receptor 1 antibody plus dabrafenib and trametinib to have superior antitumor activity compared with dabrafenib plus trametinib alone. These observations are supported by translational evidence suggesting that immune checkpoint inhibitors plus targeted therapy may improve treatment outcomes in patients with BRAF V600-mutant metastatic melanoma. COMBI-i is a phase III trial evaluating spartalizumab, an anti-programmed death receptor 1 antibody, in combination with dabrafenib and trametinib (sparta-DabTram), versus placebo plus dabrafenib and trametinib (placebo-DabTram) in patients with BRAF V600-mutant unresectable or metastatic melanoma. METHODS: Patients received spartalizumab 400 mg intravenously every 4 weeks plus dabrafenib 150 mg orally twice daily and trametinib 2 mg orally once daily or placebo-DabTram. Participants were age ≥ 18 years with unresectable or metastatic BRAF V600-mutant melanoma. The primary end point was investigator-assessed progression-free survival. Overall survival was a key secondary end point (ClinicalTrials.gov identifier: NCT02967692). RESULTS: At data cutoff (July 1, 2020), the median progression-free survival was 16.2 months (95\% CI, 12.7 to 23.9 months) in the sparta-DabTram arm versus 12.0 months (95\% CI, 10.2 to 15.4 months) in the placebo-DabTram arm (hazard ratio, 0.82 [95\% CI, 0.66 to 1.03]; P = .042 [one-sided; nonsignificant]). The objective response rates were 69\% (183 of 267 patients) versus 64\% (170 of 265 patients), respectively. Grade ≥ 3 treatment-related adverse events occurred in 55\% (146 of 267) of patients in the sparta-DabTram arm and 33\% (88 of 264) in the placebo-DabTram arm. CONCLUSION: The study did not meet its primary end point; broad first-line use of sparta-DabTram is not supported by these results. Further biomarker-driven investigation may identify patient subpopulations who could benefit from checkpoint inhibitor plus targeted therapy combinations.

Published
2022

36. Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma

Author

Motzer, Robert J., primary, Powles, Thomas, additional, Atkins, Michael B., additional, Escudier, Bernard, additional, McDermott, David F., additional, Alekseev, Boris Y., additional, Lee, Jae-Lyun, additional, Suarez, Cristina, additional, Stroyakovskiy, Daniil, additional, De Giorgi, Ugo, additional, Donskov, Frede, additional, Mellado, Begoña, additional, Banchereau, Romain, additional, Hamidi, Habib, additional, Khan, Omara, additional, Craine, Veronica, additional, Huseni, Mahrukh, additional, Flinn, Nick, additional, Dubey, Sarita, additional, and Rini, Brian I., additional

Published
2022
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37. Multicenter prospective observational post-approval study of safety and efficacy of bevacizumab (Avegra®, BIOCAD) in patients with metastatic colorectal cancer in real world practice: APOLLON-11 and SOYUZ-APOLLON

Author

Tryakin, Alexey A., primary, Fedyanin, Mikhail Yu., additional, Moiseenko, Fedor V., additional, Mironov, Oleg V., additional, Stroyakovskiy, Daniil L., additional, Sokolov, Nikolai Iu., additional, Orlova, Svetlana A., additional, Mantsyrev, Evgenii O., additional, Sultanbaev, Alexander V., additional, Teterich, Antonina A., additional, Babina, Kseniia G., additional, Yukalchuk, Denis Yu., additional, Borzyanitsa, Stanislav M., additional, Isyangulova, Alina Z., additional, Saidullaeva, Aleksandra F., additional, Chernova, Yuliia A., additional, Bobrova, Elvira A., additional, Fadeeva, Natalia V., additional, and Chobanu, Dmitrii Yu., additional

Published
2021
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38. 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study

Author

Ascierto, Paolo A, Dréno, Brigitte, Larkin, James, Ribas, Antoni, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Atkinson, Victoria, Dutriaux, Caroline, Garbe, Claus, Hsu, Jessie, Jones, Surai, Li, Haocheng, McKenna, Edward, Voulgari, Athina, and McArthur, Grant A

Subjects
Proto-Oncogene Proteins B-raf, Skin Neoplasms, Clinical Trials and Supportive Activities, Oncology and Carcinogenesis, Evaluation of treatments and therapeutic interventions, Piperidines, Vemurafenib, Clinical Research, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Mutation, Humans, Azetidines, Oncology & Carcinogenesis, Melanoma, Follow-Up Studies, Cancer
Abstract

PurposeThe randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation-positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized.Patients and methodsEligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1-21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily).Results495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3-28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0-19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5-14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6-7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports.ConclusionsExtended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation-positive advanced melanoma.

Published
2021

39. Overall survival with first-line atezolizumab in combination with vemurafenib and cobimetinib in BRAFV600 mutation-positive advanced melanoma (IMspire150): second interim analysis of a multicentre, randomised, phase 3 study.

Author

Ascierto, Paolo A, Stroyakovskiy, Daniil, Gogas, Helen, Robert, Caroline, Lewis, Karl, Protsenko, Svetlana, Pereira, Rodrigo P, Eigentler, Thomas, Rutkowski, Piotr, Demidov, Lev, Zhukova, Natalia, Schachter, Jacob, Yan, Yibing, Caro, Ivor, Hertig, Christian, Xue, Cloris, Kusters, Lieke, McArthur, Grant A, and Gutzmer, Ralf

Subjects
*ATEZOLIZUMAB, *MELANOMA, *VEMURAFENIB, *OVERALL survival, *BRAF genes, *CREATINE kinase, *ALANINE aminotransferase
Abstract

Background: Primary analysis of the phase 3 IMspire150 study showed improved investigator-assessed progression-free survival with first-line atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) versus placebo, vemurafenib, and cobimetinib (control group) in patients with BRAFV600 mutation-positive melanoma. With a median follow-up of 18·9 months (IQR 10·4-23·8) at the primary analysis, overall survival data were immature. Here, we report the results from the second, prespecified, interim overall survival analysis.Methods: The multicentre, double-blind, placebo-controlled, randomised, phase 3 IMspire150 study was done at 108 academic and community hospitals in 20 countries. Patients aged 18 years or older with previously untreated unresectable stage IIIc or stage IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible for inclusion. Patients were randomly assigned (1:1) to receive either atezolizumab (840 mg intravenously on day 1 and 15) or placebo plus vemurafenib (960 mg or 720 mg twice daily orally) and cobimetinib (60 mg once daily orally; 21 days on and 7 days off) in 28-day cycles. Atezolizumab and placebo were added to treatment regimens from cycle two onwards. Randomisation was done centrally (Durham, NC, USA) based on a permuted block randomisation scheme (block size of 4) using an interactive web-based response system and was stratified by geographical region and baseline lactate dehydrogenase concentration. Overall survival was analysed in the intention-to-treat population and safety was analysed in all patients who received at least one dose of study drug according to actual treatment received. The primary endpoint was investigator-assessed progression-free survival, which was previously reported. Here, we report the second, prespecified, interim overall survival analysis, which was planned after about 270 overall survival events had occurred. The trial is ongoing, but is no longer enrolling patients, and it is registered with ClinicalTrials.gov, NCT02908672.Findings: Between Jan 13, 2017, and April 26, 2018, 514 patients (median age 54 years [IQR 43-63]; 299 [58%] men and 215 [42%] women) were enrolled in the trial and randomly assigned to the atezolizumab group (256 [50%] patients) or the control group (258 [50%] patients). At the data cutoff (Sept 8, 2021), 273 patients had died (126 in the atezolizumab group and 147 in the control group). Median follow-up was 29·1 months (IQR 10·1-45·4) for the atezolizumab group versus 22·8 months (10·6-44·1) for the control group. Median overall survival was 39·0 months (95% CI 29·9-not estimable) in the atezolizumab group versus 25·8 months (22·0-34·6) in the control group (HR 0·84 [95% CI 0·66-1·06]; p=0·14). The most common adverse events of any grade in the atezolizumab group were blood creatine phosphokinase increased (123 [53%] of 231 patients), diarrhoea (116 [50%]), and pyrexia (115 [50%]). The most common adverse events of any grade in the control group were diarrhoea (157 [56%] of 280 patients), blood creatine phosphokinase increased (135 [48%]), and rash (119 [43%]). The most common grade 3-4 adverse events were increased lipase (54 [23%] of 231 patients in the atezolizumab group vs 62 [22%] of 280 patients in the control group), increased blood creatine phosphokinase (51 [22%] vs 50 [18%]), and increased alanine aminotransferase (32 [14%] vs 26 [9%]). Serious adverse events were reported in 112 (48%) patients in the atezolizumab group and 117 (42%) patients in the control group. Grade 5 adverse events were reported in eight (3%) patients in the atezolizumab group versus six (2%) patients in the control group. Two grade 5 adverse events (hepatitis fulminant and hepatic failure) in the atezolizumab group were considered to be associated with the triplet combination, and one event in the control group (pulmonary haemorrhage) was considered to be associated with cobimetinib.Interpretation: Additional follow-up of the IMspire150 trial showed that overall survival was not significantly improved with atezolizumab, vemurafenib, and cobimetinib compared with placebo, vemurafenib, and cobimetinib in patients with BRAFV600 mutation-positive advanced melanoma. Results of the final analysis are awaited to establish whether a significant improvement in overall survival can be achieved with long-term treatment with this triplet combination versus vemurafenib plus cobimetinib.Funding: F Hoffmann-La Roche. [ABSTRACT FROM AUTHOR]

Published
2023
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40. Crossover and rechallenge with pembrolizumab in recurrent patients from the EORTC 1325-MG/Keynote-054 phase III trial, pembrolizumab versus placebo after complete resection of high-risk stage III melanoma

Author

Eggermont, Alexander MM., primary, Meshcheryakov, Andrey, additional, Atkinson, Victoria, additional, Blank, Christian U., additional, Mandala, Mario, additional, Long, Georgina V., additional, Barrow, Catherine, additional, Di Giacomo, Anna Maria, additional, Fisher, Rosalie, additional, Sandhu, Shahneen, additional, Kudchadkar, Ragini, additional, Ortiz Romero, Pablo Luis, additional, Svane, Inge Marie, additional, Larkin, James, additional, Puig, Susana, additional, Hersey, Peter, additional, Quaglino, Pietro, additional, Queirolo, Paola, additional, Stroyakovskiy, Daniil, additional, Bastholt, Lars, additional, Mohr, Peter, additional, Hernberg, Micaela, additional, Chiarion-Sileni, Vanna, additional, Strother, Matthew, additional, Hauschild, Axel, additional, Yamazaki, Naoya, additional, van Akkooi, Alexander CJ., additional, Lorigan, Paul, additional, Krepler, Clemens, additional, Ibrahim, Nageatte, additional, Marreaud, Sandrine, additional, Kicinski, Michal, additional, Suciu, Stefan, additional, and Robert, Caroline, additional

Published
2021
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41. Randomized Double-Blind Clinical Trial Comparing Safety and Efficacy of the Biosimilar BCD-021 with Reference Bevacizumab

Author

Stroyakovskiy, Daniil, primary, Fadeeva, Natalya, additional, Matrosova, Marina, additional, Shelepen, Konstantin, additional, Adamchuk, Grigoriy, additional, Roy, Bodhisatta, additional, Nagarkar, Rajnish, additional, Kalloli, Mahesh, additional, Zhuravleva, Daria, additional, Voevodin, Georgiy, additional, Shustova, Mariya, additional, and Kryukov, Fedor, additional

Published
2021
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42. Abstract CT188: IMmotion151: updated overall survival (OS) and exploratory analysis of the association of gene expression and clinical outcomes with atezolizumab plus bevacizumab vs sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC)

Author

Rini, Brian I., primary, Atkins, Michael B., additional, Escudier, Bernard, additional, Powles, Thomas, additional, McDermott, David F., additional, Alekseev, Boris Y., additional, Lee, Jae-Lyun, additional, Stroyakovskiy, Daniil, additional, Rodriguez, Cristina Suarez, additional, De Giorgi, Ugo, additional, Donskov, Frede, additional, Mellado, Begoña, additional, Banchereau, Romain, additional, Hamidi, Habib, additional, Khan, Omara, additional, Craine, Veronica, additional, Huseni, Mahrukh, additional, Flinn, Nick, additional, Dubey, Sarita, additional, and Motzer, Robert, additional

Published
2021
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43. Phase II study evaluating trifluridine/tipiracil plus bevacizumab and capecitabine plus bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are noneligible for intensive therapy (TASCO1): Results of the final analysis on the overall survival

Author

Van Cutsem, Eric, Danielewicz, Iwona, Saunders, Mark P., Pfeiffer, Per, Argiles, Guillem, Borg, Christophe, Glynne-Jones, Robert, Punt, Cornelis J. A., van de Wouw, Agnes J., Fedyanin, Mikhail, Stroyakovskiy, Daniil, Kroening, Hendrik, Garcia-Alfonso, Pilar, Wasan, Harpreet Singh, Falcone, Alfredo, Aubel, Paul, Egorov, Anton, Amellal, Nadia, and Moiseenko, Vladimir

Published
2021

44. Crossover and rechallenge with pembrolizumab in recurrent patients from the EORTC 1325-MG/Keynote-054 phase III trial, pembrolizumab versus placebo after complete resection of high-risk stage III melanoma

Author

Eggermont, Alexander M M, Meshcheryakov, Andrey, Atkinson, Victoria, Blank, Christian U., Mandala, Mario, Long, Georgina V, Barrow, Catherine, Di Giacomo, Anna Maria, Fisher, Rosalie, Sandhu, Shahneen, Kudchadkar, Ragini, Romero, Pablo Luis Ortiz, Svane, Inge Marie, Larkin, James, Puig, Susana, Hersey, Peter, Quaglino, Pietro, Queirolo, Paola, Stroyakovskiy, Daniil, Bastholt, Lars, Mohr, Peter, Hernberg, Micaela, Chiarion-Sileni, Vanna, Strother, Matthew, Hauschild, Axel, Yamazaki, Naoya, van Akkooi, Alexander Cj, Lorigan, Paul, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, Robert, Caroline, Eggermont, Alexander M M, Meshcheryakov, Andrey, Atkinson, Victoria, Blank, Christian U., Mandala, Mario, Long, Georgina V, Barrow, Catherine, Di Giacomo, Anna Maria, Fisher, Rosalie, Sandhu, Shahneen, Kudchadkar, Ragini, Romero, Pablo Luis Ortiz, Svane, Inge Marie, Larkin, James, Puig, Susana, Hersey, Peter, Quaglino, Pietro, Queirolo, Paola, Stroyakovskiy, Daniil, Bastholt, Lars, Mohr, Peter, Hernberg, Micaela, Chiarion-Sileni, Vanna, Strother, Matthew, Hauschild, Axel, Yamazaki, Naoya, van Akkooi, Alexander Cj, Lorigan, Paul, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, and Robert, Caroline

Abstract

Background: In the phase III double-blind European Organisation for Research and Treatment of Cancer 1325/KEYNOTE-054 trial, pembrolizumab improved recurrence free and distant metastasis-free survival in patients with stage III cutaneous melanoma with complete resection of lymph nodes. In the pembrolizumab group, the incidence of grade I-V and of grade III-V immune-related adverse events (irAEs) was 37% and 7%, respectively. Methods: Patients were randomised to receive intravenous (i.v.) pembrolizumab 200 mg (N = 514) or placebo (N = 505) every 3 weeks, up to 1 year. On recurrence, patients could enter part 2 of the study: pembrolizumab 200 mg i.v. every 3 weeks up to 2 years, for crossover (those who received placebo) or rechallenge (those who had recurrence >6 months after completing 1-year adjuvant pembrolizumab therapy). For these patients, we present the safety profile and efficacy outcomes. Results: At the clinical cut-off (16-Oct-2020), in the placebo group, 298 patients had a disease recurrence, in which 155 (52%) crossed over ('crossover'). In the pembrolizumab group, 297 patients completed the 1-year treatment period; 47 had a recurrence >6 months later, in which 20 (43%) entered the rechallenge part 2 ('rechallenge'). In the crossover group, the median progression-free survival (PFS) was 8.5 months (95% confidence interval [CI] 5.7-15.2) and the 3-year PFS rate was 32% (95% CI 25-40%). Among 80 patients with stage IV evaluable disease, 31 (39%) had an objective response: 14 (18%) patients with complete response (CR) and 17 (21%) patients with partial response. The 2-year PFS rate from response was 69% (95% CI 48-83%). In the rechallenge group, the median PFS was 4.1 months (95% CI 2.6-NE). Among 9 patients with stage IV evaluable disease, 1 had an objective response (CR). Among the 175 patients, 51 (29%) had a grade I-IV irAE and 11 (6%) had a grade III-IV irAE. Conclusions: Pembrolizumab treatment after crossover yielded an overall 3-year PFS ra

Published
2021

45. Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

Author

Larkin, James, Ascierto, Paolo A., Dréno, Brigitte, Atkinson, Victoria, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Sovak, Mika A., Chang, Ilsung, Choong, Nicholas, Hack, Stephen P., McArthur, Grant A., and Ribas, Antoni

Published
2014
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46. Combined BRAF and MEK Inhibition versus BRAF Inhibition Alone in Melanoma

Author

Long, Georgina V., Stroyakovskiy, Daniil, Gogas, Helen, Levchenko, Evgeny, de Braud, Filippo, Larkin, James, Garbe, Claus, Jouary, Thomas, Hauschild, Axel, Grob, Jean Jacques, Sileni, Vanna Chiarion, Lebbe, Celeste, Mandalà, Mario, Millward, Michael, Arance, Ana, Bondarenko, Igor, Haanen, John B.A.G., Hansson, Johan, Utikal, Jochen, Ferraresi, Virginia, Kovalenko, Nadezhda, Mohr, Peter, Probachai, Volodymyr, Schadendorf, Dirk, Nathan, Paul, Robert, Caroline, Ribas, Antoni, DeMarini, Douglas J., Irani, Jhangir G., Casey, Michelle, Ouellet, Daniele, Martin, Anne-Marie, Le, Ngocdiep, Patel, Kiran, and Flaherty, Keith

Published
2014
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47. Real-World Experience with Targeted Therapy in BRAF Mutant Advanced Melanoma Patients: Results from a Multicenter Retrospective Observational Study Advanced Melanoma in Russia (Experience) (ADMIRE)

Author

Orlova, Kristina V., primary, Ledin, Evgeniy V., additional, Zhukova, Natalia V., additional, Orlova, Rashida V., additional, Karabina, Elena V., additional, Volkonskiy, Mikhail V., additional, Stroyakovskiy, Daniil L., additional, Yurchenkov, Aleksandr N., additional, Protsenko, Svetlana A., additional, Novik, Alexey V., additional, Vorotilina, Ludmila V., additional, Moiseenko, Fedor V., additional, Chang, Victor L., additional, Kazmin, Aleksandr I., additional, Tkachenko, Svetlana A., additional, Gamaunov, Sergey V., additional, Naskhletashvili, David R., additional, Samoylenko, Igor V., additional, Vikhrova, Anastasia S., additional, Utyashev, Igor A., additional, Kharkevich, Galina Yu., additional, Petenko, Natalia N., additional, Shubina, Irina Zh., additional, and Demidov, Lev V., additional

Published
2021
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48. Metastasectomy in colorectal carcinoma (CRC) patients (pts) with mBRAF: Prospective database analysis.

Author

Fedyanin, Mikhail, primary, Elsnukaeva, Kheda, additional, Demidova, Irina, additional, Stroyakovskiy, Daniil, additional, Shelygin, Yuri, additional, Tsukanov, Alexey, additional, Panina, Maria V, additional, Shubin, Vitaliy, additional, Moiseenko, Fedor Vladimirovich, additional, Karpenko, Elena, additional, Bolotina, Larisa, additional, Kudryavtseva, Anna, additional, Filipenko, Maxim, additional, Vladimirova, Liubov Yu, additional, Timoshkina, Natalya N., additional, Kit, Oleg I., additional, Stroganova, Anna, additional, Dranko, Svetlana, additional, Tryakin, Alexey, additional, and Tjulandin, Sergei, additional

Published
2021
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49. Analysis of the efficacy and safety of eribulin therapy in patients with HR+/HER2- metastatic breast cancer pretreated with CDK4/6 inhibitors in real Russian practice

Author

Kolyadina, Irina V., primary, Abidova, Natalia R., additional, Akopyan, Arshak A., additional, Antonova, Galina V., additional, Arapova, Oksana I., additional, Bobrova, Elvira A., additional, Bolotina, Larisa V., additional, Valiakhmetova, Chulpan K., additional, Vasilevskaya, Anna V., additional, Vladimirova, Lyubov Y., additional, Volkonskiy, Mikhail V., additional, Ganshina, Inna P., additional, Gudkova, Irina E., additional, Dergunov, Alexandr S., additional, Evstigneeva, Irina V., additional, Egurenkova, Viktoria S., additional, Emshanov, Aleksei V., additional, Zhukova, Lyudmila G., additional, Zueva, Elena V., additional, Karabina, Elena V., additional, Kolokolov, James J., additional, Kuzmicheva, Svetlana V., additional, Kuchevskaya, Olesya A., additional, Luev, Ivan A., additional, Maistrenko, Ksenia S., additional, Markizova, Elena V., additional, Marfutov, Vasily V., additional, Medvedev, Sergey P., additional, Merzlikina, Yulia I., additional, Nersesova, Tatyana A., additional, Ovchinnikova, Elena G., additional, Orlova, Svetlana A., additional, Samaneva, Natalia Y., additional, Stativko, Olesya A., additional, Storozhakova, Anna E., additional, Stroyakovskiy, Daniil L., additional, Sultanbaev, Alexander V., additional, Tekeeva, Asiat I., additional, Fadeeva, Natalia V., additional, Fedorova, Alina N., additional, Shalaeva, Oksana M., additional, Shangina, Irina A., additional, Shirokova, Oksana N., additional, Shumskikh, Alisa R., additional, and Yakubova, Mariam Z., additional

Published
2021
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50. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial

Author

Eggermont, Alexander M M, primary, Blank, Christian U, additional, Mandalà, Mario, additional, Long, Georgina V, additional, Atkinson, Victoria G, additional, Dalle, Stéphane, additional, Haydon, Andrew M, additional, Meshcheryakov, Andrey, additional, Khattak, Adnan, additional, Carlino, Matteo S, additional, Sandhu, Shahneen, additional, Larkin, James, additional, Puig, Susana, additional, Ascierto, Paolo A, additional, Rutkowski, Piotr, additional, Schadendorf, Dirk, additional, Koornstra, Rutger, additional, Hernandez-Aya, Leonel, additional, Di Giacomo, Anna Maria, additional, van den Eertwegh, Alfonsus J M, additional, Grob, Jean-Jacques, additional, Gutzmer, Ralf, additional, Jamal, Rahima, additional, Lorigan, Paul C, additional, van Akkooi, Alexander C J, additional, Krepler, Clemens, additional, Ibrahim, Nageatte, additional, Marreaud, Sandrine, additional, Kicinski, Michal, additional, Suciu, Stefan, additional, Robert, Caroline, additional, Menzies, Alex, additional, Lesimple, Thierry, additional, Maio, Michele, additional, Linette, Gerald, additional, Brown, Michael, additional, Hersey, Peter, additional, Svane, Inge Marie, additional, Mortier, Laurent, additional, Schachter, Jacob, additional, Barrow, Catherine, additional, Kudchadkar, Ragini, additional, Song, Xinni, additional, Dutriaux, Caroline, additional, Quaglino, Pietro, additional, Meier, Friedegund, additional, Queirolo, Paola, additional, Stroyakovskiy, Daniil, additional, Bastholt, Lars, additional, Guillot, Bernard, additional, Garbe, Claus, additional, Ortiz Romero, Pablo Luis, additional, Grange, Florent, additional, Mohr, Peter, additional, Algazi, Alain, additional, Bechter, Oliver, additional, Hernberg, Micaela, additional, Arnault, Jean-Philippe, additional, Saiag, Philippe, additional, Loquai, Carmen, additional, Meiss, Frank, additional, Simon, Jan-Christoph, additional, Bar-Sela, Gil, additional, Chiarion Sileni, Vanna, additional, Fitzharris, Bernard, additional, McCrystal, Mike, additional, Parente, Phillip, additional, Baurain, Jean-Francois, additional, Combemale, Patrick, additional, Lebbe, Célèste, additional, Hauschild, Axel, additional, Yamazaki, Naoya, additional, Dummer, Reinhard, additional, Milhem, Mohammed, additional, Dzienis, Marcin, additional, Walker, John, additional, Geoffrois, Lionel, additional, Leccia, Marie-Thérèse, additional, Kretschmer, Lutz, additional, Hendler, Daniel, additional, Lotem, Michal, additional, Mackiewicz, Andrzej, additional, Sekulovic, Lidija, additional, Dunwoodie, Elaine, additional, Hoeller, Christoph, additional, Machet, Laurent, additional, Hassel, Jessica, additional, Hospers, Geke A.P., additional, Passos, Maria-Jose, additional, Levin, Max, additional, Fehr, Martin, additional, Corrie, Philippa, additional, Waterston, Ashita, additional, Hallmeyer, Sigrun, additional, Schmidt, Henrik, additional, Descamps, Vincent, additional, Lacour, Jean-Philippe, additional, Berking, Carola, additional, Kiecker, Felix, additional, Ferrucci, Pier Francesco, additional, Yokota, Kenji, additional, Aarts, Maureen, additional, Jameson, Michael, additional, Winge-Main, Anna Katharina, additional, Ferreira, Paula, additional, Kim, Kevin, additional, McNeil, Catriona, additional, Hofmann-Wellenhof, Reiner, additional, Kerger, Joseph, additional, Aubin, François, additional, Utikal, Jochen, additional, Ferraresi, Virginia, additional, Inozume, Takashi, additional, Kiyohara, Yoshio, additional, Groenewegen, Gerard, additional, Kapiteijn, Helena, additional, Matkovic, Suzana, additional, Boehncke, Wolf-Henning, additional, Casasola, Richard, additional, Crook, Timothy, additional, Marshall, Ernest, additional, Skytta, Tanja, additional, Avril, Marie-Francoise, additional, Jouary, Thomas, additional, Hein, Rüdiger, additional, Terheyden, Patrick, additional, Aoi, Jun, additional, Takenouchi, Tatsuya, additional, Straume, Oddbjorn, additional, Martins, César, additional, Mukhametshina, Guzel, additional, and Nathan, Paul, additional

Published
2021
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