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1. Exposure‐response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy

Author

Wit, Ronald, Powles, Thomas, Castellano, Daniel, Necchi, Andrea, Lee, Jae‐Lyun, Heijden, Michiel S, Matsubara, Nobuaki, Bamias, Aristotelis, Fléchon, Aude, Sternberg, Cora N, Drakaki, Alexandra, Yu, Evan Y, Zimmermann, Annamaria H, Long, Amanda, Walgren, Richard A, Gao, Ling, Bell‐McGuinn, Katherine M, and Petrylak, Daniel P

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Humans, Platinum, Urinary Bladder Neoplasms, exposure-response, overall survival, progression-free survival, ramucirumab, urothelial carcinoma, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

AimsPatients with advanced urothelial carcinoma (UC) who progress after platinum-based chemotherapy have a poor prognosis, and there is a medical need to improve current treatment options. Ramucirumab plus docetaxel significantly improved progression-free survival but not overall survival (OS) in platinum-refractory advanced UC (RANGE trial; NCT02426125). Here, we report the exposure-response (ER) of ramucirumab plus docetaxel using data from the RANGE trial.MethodsPharmacokinetic (PK) samples were collected (cycle 1-3, 5, 9 [day 1] and 30 days from treatment discontinuation), and PK data were analysed using population PK (popPK) analysis. The minimum ramucirumab concentration after first dose administration (Cmin,1 , or trough concentration immediately prior to the second dose) was derived by popPK analysis and used as the exposure parameter for ER analysis. Cox proportional hazards regression models and matched case-control analyses were used to evaluate the relationship between Cmin,1 and OS. The Cmin,1 relationship with safety was assessed descriptively.ResultsSeveral poor prognostic factors (ECOG 1, haemoglobin concentration

Published
2022

2. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy.

Author

Garon, Edward B, Scagliotti, Giorgio Vittorio, Gautschi, Oliver, Reck, Martin, Thomas, Michael, Iglesias Docampo, Lara, Kalofonos, Haralabos, Kim, Joo-Hang, Gans, Steven, Brustugun, Odd Terje, Orlov, Sergey V, Cuyun Carter, Gebra, Zimmermann, Annamaria H, Oton, Ana B, Alexandris, Ekaterine, Lee, Pablo, Wolff, Katharina, Stefaniak, Victoria Jennifer, Socinski, Mark A, and Pérol, Maurice

Subjects
Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Disease Progression, Platinum, Antineoplastic Combined Chemotherapy Protocols, Neoplasm Staging, Female, Antibodies, Monoclonal, Humanized, Docetaxel, chemotherapy, metastatic, non-squamous, squamous, vascular endothelial growth factor receptor, Lung, Clinical Research, Clinical Trials and Supportive Activities, Lung Cancer, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions
Abstract

Non-small-cell lung cancer (NSCLC) is a heterogeneous disease. Front-line therapy may affect responses to subsequent treatment regimens, thus influencing second-line therapy decision making. In the randomised phase 3 REVEL study, second-line ramucirumab plus docetaxel (ram+doc) versus docetaxel (doc) improved survival of patients with metastatic NSCLC. We explore efficacy, safety and quality-of-life (QoL) in REVEL based on front-line therapy. Patients were grouped by specific front-line therapy received. Overall survival (OS), progression-free survival (PFS), objective response rate, safety and QoL were assessed descriptively. Kaplan-Meier estimation and Cox proportional hazards modelling were used; frequencies reported in percentages. Baseline characteristics of 1253 patients were generally well balanced between treatment arms within each front-line therapy subgroup. For patients with non-squamous disease (n=912), induction therapies included platinum-based chemotherapy plus a taxane (n=227; 25%) or pemetrexed (n=449; 49%), with (n=172; 19%) or without bevacizumab. For patients with squamous disease (n=328), induction therapies included platinum-based chemotherapy plus gemcitabine (n=176; 54%) or a taxane (n=69; 21%). A highly selected subgroup (n=127; 14%) received pemetrexed continuation maintenance therapy. Ram+doc improved median OS and PFS versus doc across front-line therapy subgroups, as reflected by HRs ranging from 0.78 to 0.91 and 0.66 to 0.92, respectively, similar to results in the overall intention-to-treat cohort (HRs: 0.86 and 0.76, respectively). High-grade treatment-emergent adverse events of special interest (including neutropenia, febrile neutropenia, leucopenia and hypertension) were generally higher in ram+doc-treated patients relative to doc-treated patients regardless of front-line therapy. No clear differences in safety or QoL were seen across front-line therapy subgroups; outcomes were consistent with those reported in the overall intention-to-treat cohort. Results of this exploratory analysis suggest that second-line ram+doc may be effective regardless of prior treatment with platinum-based chemotherapy plus a taxane, pemetrexed, gemcitabine or bevacizumab. Overall, ram+doc is clinically beneficial across a wide range of patients with metastatic NSCLC who have progressed after various front-line therapies. NCT01168973.

Published
2020

3. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Wong, Suet-Lai Shirley, Tan, Thean Hsiang, Hovey, Elizabeth Jane, Clay, Timothy Dudley, Wan Ng, Siobhan Su, Rutten, Annemie, Machiels, Jean-Pascal, Dumez, Herlinde, Cheng, Susanna Yee-Shan, Ferrario, Cristiano, Sengeloev, Lisa, Jensen, Niels Viggo, Thibault, Constance, Laguerre, Brigitte, Joly, Florence, Culine, Stéphane, Becht, Catherine, Niegisch, Günter, Stöckle, Michael, Grimm, Marc-Oliver, Schwentner, Christina A, Schultze-Seemann, Wolfgang, Kalofonos, Haralambos, Mavroudis, Dimitrios, Papandreou, Christos, Karavasilis, Vasilis, Révész, Janos, Rosenbaum, Eli, Leibowitz-Amit, Raya, Kejzman, Daniel, Sarid, David, Scagliotti, Giorgio Vittorio, Bracarda, Sergio, Massari, Francesco, Osawa, Takahiro, Miyajima, Naoto, Shinohara, Nobuo, Fukuta, Fumimasa, Ohyama, Chikara, Obara, Wataru, Yamashita, Shinichi, Tomita, Yoshihiko, Kawai, Koji, Fukasawa, Satoshi, Oyama, Masafumi, Yonese, Junji, Nagata, Masayoshi, Uemura, Motohide, Nishimura, Kazuo, Kawakita, Mutsushi, Tsunemori, Hiroyuki, Hashine, Katsuyoshi, Inokuchi, Junichi, Yokomizo, Akira, Nagamori, Satoshi, Lee, Hyo Jin, Park, Se Hoon, Rha, Sun Young, Kim, Yu Jung, Lee, Yun-Gyoo, Vazquez Cortés, Leticia, Lorena Urzua Flores, Claudia, Blaisse, Reinoud J.B., Erdkamp, Fransiscus L.G., Aarts, Maureen J.B., Wojcik-Tomaszewska, Joanna, Tomczak, Piotr, Sikora-Kupis, Bozena, Schenker, Michael, Herzal, Alina Amalia, Udrea, Anghel Adrian, Karlov, Petr, Fomkin, Roman, Gajate Borau, Pablo, Grande, Enrique, Delgado Mignorance, Juan Ignacio, Su, Yu-Li, Li, Jian-Ri, Lin, Chien-Liang, Lin, Chia-Chi, Yeh, Su-Peng, Erman, Mustafa, Urun, Yuksel, Golovko, Yuriy, Bondarenko, Igor, Sinielnikov, Ivan, Crabb, Simon J., Syndikus, Isabel, Huddart, Robert, Sundar, Santhanam, Chowdhury, Simon, Sarwar, Naveed, Flaig, Thomas W., Pan, Chong Xian, Schwarz, James K., Cultrera, Jennifer Lyn, Acs, Peter Istvan, Hainsworth, John D., Herms, Benjamin T., Lawler, William Eyre, Lowe, Thomas Eugene, Petrylak, Daniel P, de Wit, Ronald, Chi, Kim N, Drakaki, Alexandra, Sternberg, Cora N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan Y, van der Heijden, Michiel S, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan Senol, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor J, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Hamid, Oday, Liepa, Astra M, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard A, Zimmermann, Annamaria H, Hozak, Rebecca R, Bell-McGuinn, Katherine M, and Powles, Thomas

Published
2020
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4. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Author

Wong, Suet-Lai Shirley, Tan, Thean Hsiang, Hovey, Elizabeth Jane, Clay, Timothy Dudley, Ng, Siobhan Su Wan, Rutten, Annemie, Machiels, Jean-Pascal, Dumez, Herlinde, Cheng, Susanna Yee-Shan, Chi, Kim Nguyen, Ferrario, Cristiano, Sengeloev, Lisa, Jensen, Niels Viggo, Thibault, Constance, Laguerre, Brigitte, Laestadius, Fredrik, Joly, Florence, Flechon, Aude, Culine, Stéphane, Becht, Catherine, Niegisch, Günter, Stöckle, Michael, Grimm, Marc-Oliver, Gakis, Georgios, Schultze-Seemann, Wolfgang, Kalofonos, Haralambos, Mavroudis, Dimitrios, Papandreou, Christos, Karavasilis, Vasilis, Bamias, Aristotelis, Révész, Janos, Geczi, Lajos, Rosenbaum, Eli, Leibowitz-Amit, Raya, Kejzman, Daniel, Peer, Avivit, Sarid, David, Scagliotti, Giorgio Vittorio, Sternberg, Cora N, Tortora, Giampaolo, Bracarda, Sergio, Necchi, Andrea, Massari, Francesco, Osawa, Takahiro, Miyajima, Naoto, Shinohara, Nobuo, Fukuta, Fumimasa, Ohyama, Chikara, Obara, Wataru, Yamashita, Shinichi, Tomita, Yoshihiko, Kawai, Koji, Fukasawa, Satoshi, Matsubara, Nobuaki, Oyama, Masafumi, Yonese, Junji, Nagata, Masayoshi, Uemura, Motohide, Nishimura, Kazuo, Kawakita, Mutsushi, Tsunemori, Hiroyuki, Hashine, Katsuyoshi, Inokuchi, Junichi, Yokomizo, Akira, Nagamori, Satoshi, Lee, Jae-Lyun, Lee, Hyo Jin, Park, Se Hoon, Rha, Sun Young, Kim, Yu Jung, Lee, Yun-Gyoo, Cortés, Leticia Vazquez, Flores, Claudia Lorena Urzua, Blaisse, Reinoud J B, van der Heijden, Michiel S, de Wit, Ronald, Erdkamp, Fransiscus L G, Aarts, Maureen J B, Wojcik-Tomaszewska, Joanna, Tomczak, Piotr, Sikora-Kupis, Bozena, Schenker, Michael, Herzal, Alina Amalia, Udrea, Anghel Adrian, Karlov, Petr, Safina, Sufia Z, Alekseev, Boris, Semenov, Andrey, Fomkin, Roman, Pulido, Enrique Grande, Del Muro, F Xavier García, Mignorance, Juan Ignacio Delgado, Gauna, Daniel Castellano, Rodríguez-Vida, Alejo, Su, Yu-Li, Ou, Yen-Chuan, Lin, Chien-Liang, Su, Wen-Pin, Lin, Chia-Chi, Yeh, Su-Peng, Çiçin, Irfan, Harputluoglu, Hakan, Erman, Mustafa, Coskun, Hasan Senol, Urun, Yuksel, Golovko, Yurii, Bondarenko, Igor, Sinielnikov, Ivan, Powles, Thomas, Crabb, Simon, Syndikus, Isabel, Huddart, Robert, Sundar, Santhanam, Chowdhury, Simon, Sarwar, Naveed, Drakaki, Alexandra, Flaig, Thomas, Pan, Chong Xian, Petrylak, Daniel, Schwarz, James, Percent, Ivor, Cultrera, Jennifer, Hainsworth, John, Herms, Benjamin, Lawler, William, Lowe, Thomas, Tagawa, Scott, Aragon-Ching, Jeanny, Vaishampayan, Ulka, Petrylak, Daniel P, Chi, Kim N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed, Fléchon, Aude, Yu, Evan Y, Géczi, Lajos, Hegemann, Miriam, Percent, Ivor J, Tucci, Marcello, Safina, Sufia, del Muro, Xavier Garcia, Rodriguez-Vida, Alejo, Cicin, Irfan, Widau, Ryan C, Liepa, Astra M, Walgren, Richard A, Hamid, Oday, Zimmermann, Annamaria H, and Bell-McGuinn, Katherine M

Published
2017
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5. Table S2 from RELAY Subgroup Analyses by EGFR Ex19del and Ex21L858R Mutations for Ramucirumab Plus Erlotinib in Metastatic Non–Small Cell Lung Cancer

Author

Nakagawa, Kazuhiko, primary, Nadal, Ernest, primary, Garon, Edward B., primary, Nishio, Makoto, primary, Seto, Takashi, primary, Yamamoto, Nobuyuki, primary, Park, Keunchil, primary, Shih, Jin-Yuan, primary, Paz-Ares, Luis, primary, Frimodt-Moller, Bente, primary, Zimmermann, Annamaria H., primary, Wijayawardana, Sameera, primary, Visseren-Grul, Carla, primary, and Reck, Martin, primary

Published
2023
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7. Exposure-response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy.

Author

de Wit, Ronald, de Wit, Ronald, Powles, Thomas, Castellano, Daniel, Necchi, Andrea, Lee, Jae-Lyun, van der Heijden, Michiel S, Matsubara, Nobuaki, Bamias, Aristotelis, Fléchon, Aude, Sternberg, Cora N, Drakaki, Alexandra, Yu, Evan Y, Zimmermann, Annamaria H, Long, Amanda, Walgren, Richard A, Gao, Ling, Bell-McGuinn, Katherine M, Petrylak, Daniel P, de Wit, Ronald, de Wit, Ronald, Powles, Thomas, Castellano, Daniel, Necchi, Andrea, Lee, Jae-Lyun, van der Heijden, Michiel S, Matsubara, Nobuaki, Bamias, Aristotelis, Fléchon, Aude, Sternberg, Cora N, Drakaki, Alexandra, Yu, Evan Y, Zimmermann, Annamaria H, Long, Amanda, Walgren, Richard A, Gao, Ling, Bell-McGuinn, Katherine M, and Petrylak, Daniel P

Abstract

AimsPatients with advanced urothelial carcinoma (UC) who progress after platinum-based chemotherapy have a poor prognosis, and there is a medical need to improve current treatment options. Ramucirumab plus docetaxel significantly improved progression-free survival but not overall survival (OS) in platinum-refractory advanced UC (RANGE trial; NCT02426125). Here, we report the exposure-response (ER) of ramucirumab plus docetaxel using data from the RANGE trial.MethodsPharmacokinetic (PK) samples were collected (cycle 1-3, 5, 9 [day 1] and 30 days from treatment discontinuation), and PK data were analysed using population PK (popPK) analysis. The minimum ramucirumab concentration after first dose administration (Cmin,1 , or trough concentration immediately prior to the second dose) was derived by popPK analysis and used as the exposure parameter for ER analysis. Cox proportional hazards regression models and matched case-control analyses were used to evaluate the relationship between Cmin,1 and OS. The Cmin,1 relationship with safety was assessed descriptively.ResultsSeveral poor prognostic factors (ECOG 1, haemoglobin concentration <100 g/L, presence of liver metastases) appeared more frequently in the lower exposure quartiles, suggesting a possible disease-PK interaction. A significant association was identified between Cmin,1 and OS (P = .0108). Higher exposure quartiles were associated with longer survival and smaller hazard ratios compared to placebo. No new exposure-safety trends were observed within the exposure range (ramucirumab 10 mg/kg once every 3 weeks).ConclusionsThis prespecified ER analyses suggests a positive relationship between efficacy and ramucirumab exposure, with an imbalance associated with disease prognostic factors. Further investigation may elucidate a possible disease-PK relationship.

Published
2022

8. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial

Author

Paz-Ares, Luis, de Marinis, Filippo, Dediu, Mircea, Thomas, Michael, Pujol, Jean-Louis, Bidoli, Paolo, Molinier, Olivier, Sahoo, Tarini Prasad, Laack, Eckart, Reck, Martin, Corral, Jesús, Melemed, Symantha, John, William, Chouaki, Nadia, Zimmermann, Annamaria H, Visseren-Grul, Carla, and Gridelli, Cesare

Published
2012
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9. Exposure‐response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy

Author

de Wit, Ronald, primary, Powles, Thomas, additional, Castellano, Daniel, additional, Necchi, Andrea, additional, Lee, Jae‐Lyun, additional, van der Heijden, Michiel S., additional, Matsubara, Nobuaki, additional, Bamias, Aristotelis, additional, Fléchon, Aude, additional, Sternberg, Cora N., additional, Drakaki, Alexandra, additional, Yu, Evan Y., additional, Zimmermann, Annamaria H., additional, Long, Amanda, additional, Walgren, Richard A., additional, Gao, Ling, additional, Bell‐McGuinn, Katherine M., additional, and Petrylak, Daniel P., additional

Published
2022
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10. RELAY Subgroup Analyses by EGFR Ex19del and Ex21L858R Mutations for Ramucirumab Plus Erlotinib in Metastatic Non–Small Cell Lung Cancer

Author

Nakagawa, Kazuhiko, primary, Nadal, Ernest, additional, Garon, Edward B., additional, Nishio, Makoto, additional, Seto, Takashi, additional, Yamamoto, Nobuyuki, additional, Park, Keunchil, additional, Shih, Jin-Yuan, additional, Paz-Ares, Luis, additional, Frimodt-Moller, Bente, additional, Zimmermann, Annamaria H., additional, Wijayawardana, Sameera, additional, Visseren-Grul, Carla, additional, and Reck, Martin, additional

Published
2021
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11. Abemaciclib combined with adjuvant endocrine therapy in patients with high risk early breast cancer who received neoadjuvant chemotherapy (NAC).

Author

Martin, Miguel, primary, Hegg, Roberto, additional, Kim, Sung-Bae, additional, Schenker, Michael, additional, Grecea, Daniela, additional, García-Sáenz, José A., additional, Papazisis, Konstantinos, additional, Ouyang, Quchang, additional, Lacko, Aleksandra, additional, Oksuzoglu, Berna, additional, Reeves, James Andrew, additional, Okera, Meena, additional, Testa, Laura, additional, Shimizu, Chikako, additional, Wei, Ran, additional, Forrester, Tammy D, additional, Munoz, Maria, additional, Zimmermann, Annamaria H., additional, Headley, Desiree, additional, and Johnston, Stephen R. D., additional

Published
2021
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12. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial.

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Petrylak, Daniel P, de Wit, Ronald, Chi, Kim N, Drakaki, Alexandra, Sternberg, Cora N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan Y, van der Heijden, Michiel S, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan Senol, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor J, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia Del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Hamid, Oday, Liepa, Astra M, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard A, Zimmermann, Annamaria H, Hozak, Rebecca R, Bell-McGuinn, Katherine M, Powles, Thomas, Machiels, Jean-Pascal, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Petrylak, Daniel P, de Wit, Ronald, Chi, Kim N, Drakaki, Alexandra, Sternberg, Cora N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan Y, van der Heijden, Michiel S, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan Senol, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor J, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia Del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Hamid, Oday, Liepa, Astra M, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard A, Zimmermann, Annamaria H, Hozak, Rebecca R, Bell-McGuinn, Katherine M, Powles, Thomas, and Machiels, Jean-Pascal

Abstract

Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m (60 mg/m in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved wi

Published
2020

13. RELAY+: Exploratory study of ramucirumab plus gefitinib in untreated patients (pts) with epidermal growth factor receptor (EGFR)-mutated metastatic non-small cell lung cancer (NSCLC).

Author

Nishio, Makoto, primary, Nishio, Kazuto, additional, Reck, Martin, additional, Garon, Edward B., additional, Imamura, Fumio, additional, Kawaguchi, Tomoya, additional, Yamaguchi, Hiroyuki, additional, Ikeda, Satoshi, additional, Hirano, Katsuya, additional, Visseren-Grul, Carla M, additional, Widau, Ryan C, additional, Zimmermann, Annamaria H., additional, Homma, Gosuke, additional, Enatsu, Sotaro, additional, and Nakagawa, Kazuhiko, additional

Published
2020
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14. Docetaxel with or without Ramucirumab after Platinum-Based Chemotherapy and Checkpoint Inhibitors in Advanced Urothelial Carcinoma: A Pre-Specified Subgroup Analysis from the Phase 3 RANGE Trial

Author

Drakaki, Alexandra, primary, Kirby, Conor J., additional, van der Heijden, Michiel S., additional, Petrylak, Daniel P., additional, Powles, Thomas, additional, Chi, Kim N., additional, Fléchon, Aude, additional, Necchi, Andrea, additional, Géczi, Lajos, additional, Lee, Jae-Lyun, additional, Gakis, Georgios, additional, Bracarda, Sergio, additional, Chowdhury, Simon, additional, Lin, Chia-Chi, additional, Keizman, Daniel, additional, Vaishampayan, Ulka N., additional, Zimmermann, Annamaria H., additional, Bell-McGuinn, Katherine, additional, and Castellano, Daniel, additional

Published
2020
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15. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Petrylak, Daniel P, primary, de Wit, Ronald, additional, Chi, Kim N, additional, Drakaki, Alexandra, additional, Sternberg, Cora N, additional, Nishiyama, Hiroyuki, additional, Castellano, Daniel, additional, Hussain, Syed A, additional, Fléchon, Aude, additional, Bamias, Aristotelis, additional, Yu, Evan Y, additional, van der Heijden, Michiel S, additional, Matsubara, Nobuaki, additional, Alekseev, Boris, additional, Necchi, Andrea, additional, Géczi, Lajos, additional, Ou, Yen-Chuan, additional, Coskun, Hasan Senol, additional, Su, Wen-Pin, additional, Bedke, Jens, additional, Gakis, Georgios, additional, Percent, Ivor J, additional, Lee, Jae-Lyun, additional, Tucci, Marcello, additional, Semenov, Andrey, additional, Laestadius, Fredrik, additional, Peer, Avivit, additional, Tortora, Giampaolo, additional, Safina, Sufia, additional, Garcia del Muro, Xavier, additional, Rodriguez-Vida, Alejo, additional, Cicin, Irfan, additional, Harputluoglu, Hakan, additional, Tagawa, Scott T, additional, Vaishampayan, Ulka, additional, Aragon-Ching, Jeanny B, additional, Hamid, Oday, additional, Liepa, Astra M, additional, Wijayawardana, Sameera, additional, Russo, Francesca, additional, Walgren, Richard A, additional, Zimmermann, Annamaria H, additional, Hozak, Rebecca R, additional, Bell-McGuinn, Katherine M, additional, Powles, Thomas, additional, Wong, Suet-Lai Shirley, additional, Tan, Thean Hsiang, additional, Hovey, Elizabeth Jane, additional, Clay, Timothy Dudley, additional, Wan Ng, Siobhan Su, additional, Rutten, Annemie, additional, Machiels, Jean-Pascal, additional, Dumez, Herlinde, additional, Cheng, Susanna Yee-Shan, additional, Ferrario, Cristiano, additional, Sengeloev, Lisa, additional, Jensen, Niels Viggo, additional, Thibault, Constance, additional, Laguerre, Brigitte, additional, Joly, Florence, additional, Culine, Stéphane, additional, Becht, Catherine, additional, Niegisch, Günter, additional, Stöckle, Michael, additional, Grimm, Marc-Oliver, additional, Schwentner, Christina A, additional, Schultze-Seemann, Wolfgang, additional, Kalofonos, Haralambos, additional, Mavroudis, Dimitrios, additional, Papandreou, Christos, additional, Karavasilis, Vasilis, additional, Révész, Janos, additional, Rosenbaum, Eli, additional, Leibowitz-Amit, Raya, additional, Kejzman, Daniel, additional, Sarid, David, additional, Scagliotti, Giorgio Vittorio, additional, Bracarda, Sergio, additional, Massari, Francesco, additional, Osawa, Takahiro, additional, Miyajima, Naoto, additional, Shinohara, Nobuo, additional, Fukuta, Fumimasa, additional, Ohyama, Chikara, additional, Obara, Wataru, additional, Yamashita, Shinichi, additional, Tomita, Yoshihiko, additional, Kawai, Koji, additional, Fukasawa, Satoshi, additional, Oyama, Masafumi, additional, Yonese, Junji, additional, Nagata, Masayoshi, additional, Uemura, Motohide, additional, Nishimura, Kazuo, additional, Kawakita, Mutsushi, additional, Tsunemori, Hiroyuki, additional, Hashine, Katsuyoshi, additional, Inokuchi, Junichi, additional, Yokomizo, Akira, additional, Nagamori, Satoshi, additional, Lee, Hyo Jin, additional, Park, Se Hoon, additional, Rha, Sun Young, additional, Kim, Yu Jung, additional, Lee, Yun-Gyoo, additional, Vazquez Cortés, Leticia, additional, Lorena Urzua Flores, Claudia, additional, Blaisse, Reinoud J.B., additional, Erdkamp, Fransiscus L.G., additional, Aarts, Maureen J.B., additional, Wojcik-Tomaszewska, Joanna, additional, Tomczak, Piotr, additional, Sikora-Kupis, Bozena, additional, Schenker, Michael, additional, Herzal, Alina Amalia, additional, Udrea, Anghel Adrian, additional, Karlov, Petr, additional, Fomkin, Roman, additional, Gajate Borau, Pablo, additional, Grande, Enrique, additional, Delgado Mignorance, Juan Ignacio, additional, Su, Yu-Li, additional, Li, Jian-Ri, additional, Lin, Chien-Liang, additional, Lin, Chia-Chi, additional, Yeh, Su-Peng, additional, Erman, Mustafa, additional, Urun, Yuksel, additional, Golovko, Yuriy, additional, Bondarenko, Igor, additional, Sinielnikov, Ivan, additional, Crabb, Simon J., additional, Syndikus, Isabel, additional, Huddart, Robert, additional, Sundar, Santhanam, additional, Chowdhury, Simon, additional, Sarwar, Naveed, additional, Flaig, Thomas W., additional, Pan, Chong Xian, additional, Schwarz, James K., additional, Cultrera, Jennifer Lyn, additional, Acs, Peter Istvan, additional, Hainsworth, John D., additional, Herms, Benjamin T., additional, Lawler, William Eyre, additional, and Lowe, Thomas Eugene, additional

Published
2020
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16. Ramucirumab (RAM) exposure-response (ER) relationship in RANGE: A randomized phase III trial of RAM plus docetaxel (DOC) versus placebo (P) plus DOC in advanced platinum-refractory urothelial carcinoma (UC) patients (pts)

Author

De Wit, Ronald Powles, Thomas Castellano, Daniel E. Necchi, Andrea Lee, Jae-Lyun Van der Heijden, Michiel Simon and Matsubara, Nobuaki Bamias, Aristotelis Flechon, Aude and Sternberg, Cora N. Drakaki, Alexandra Yu, Evan Y. Hamid, Oday Zimmermann, Annamaria H. Gao, Ling Long, Amanda and Walgren, Richard A. Bell-McGuinn, Katherine M. Petrylak, Daniel Peter

Published
2019

17. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC).

Author

Nakagawa, Kazuhiko, primary, Garon, Edward B., additional, Seto, Takashi, additional, Nishio, Makoto, additional, Ponce Aix, Santiago, additional, Chiu, Chao-Hua, additional, Park, Keunchil, additional, Novello, Silvia, additional, Nadal, Ernest, additional, Imamura, Fumio, additional, Yoh, Kiyotaka, additional, Shih, Jin-Yuan, additional, Au, Kwok Hung, additional, Moro-Sibilot, Denis, additional, Enatsu, Sotaro, additional, Zimmermann, Annamaria H., additional, Frimodt-Moller, Bente, additional, Visseren Grul, Carla M., additional, and Reck, Martin, additional

Published
2019
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18. Ramucirumab (RAM) exposure-response (ER) relationship in RANGE: A randomized phase III trial of RAM plus docetaxel (DOC) versus placebo (P) plus DOC in advanced platinum-refractory urothelial carcinoma (UC) patients (pts).

Author

De Wit, Ronald, primary, Powles, Thomas, additional, Castellano, Daniel E., additional, Necchi, Andrea, additional, Lee, Jae-Lyun, additional, Van Der Heijden, Michiel Simon, additional, Matsubara, Nobuaki, additional, Bamias, Aristotelis, additional, Flechon, Aude, additional, Sternberg, Cora N., additional, Drakaki, Alexandra, additional, Yu, Evan Y., additional, Hamid, Oday, additional, Zimmermann, Annamaria H., additional, Gao, Ling, additional, Long, Amanda, additional, Walgren, Richard A., additional, Bell-McGuinn, Katherine M, additional, and Petrylak, Daniel Peter, additional

Published
2019
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19. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Author

Petrylak, Daniel P, primary, de Wit, Ronald, additional, Chi, Kim N, additional, Drakaki, Alexandra, additional, Sternberg, Cora N, additional, Nishiyama, Hiroyuki, additional, Castellano, Daniel, additional, Hussain, Syed, additional, Fléchon, Aude, additional, Bamias, Aristotelis, additional, Yu, Evan Y, additional, van der Heijden, Michiel S, additional, Matsubara, Nobuaki, additional, Alekseev, Boris, additional, Necchi, Andrea, additional, Géczi, Lajos, additional, Ou, Yen-Chuan, additional, Coskun, Hasan Senol, additional, Su, Wen-Pin, additional, Hegemann, Miriam, additional, Percent, Ivor J, additional, Lee, Jae-Lyun, additional, Tucci, Marcello, additional, Semenov, Andrey, additional, Laestadius, Fredrik, additional, Peer, Avivit, additional, Tortora, Giampaolo, additional, Safina, Sufia, additional, del Muro, Xavier Garcia, additional, Rodriguez-Vida, Alejo, additional, Cicin, Irfan, additional, Harputluoglu, Hakan, additional, Widau, Ryan C, additional, Liepa, Astra M, additional, Walgren, Richard A, additional, Hamid, Oday, additional, Zimmermann, Annamaria H, additional, Bell-McGuinn, Katherine M, additional, Powles, Thomas, additional, Wong, Suet-Lai Shirley, additional, Tan, Thean Hsiang, additional, Hovey, Elizabeth Jane, additional, Clay, Timothy Dudley, additional, Ng, Siobhan Su Wan, additional, Rutten, Annemie, additional, Machiels, Jean-Pascal, additional, Dumez, Herlinde, additional, Cheng, Susanna Yee-Shan, additional, Chi, Kim Nguyen, additional, Ferrario, Cristiano, additional, Sengeloev, Lisa, additional, Jensen, Niels Viggo, additional, Thibault, Constance, additional, Laguerre, Brigitte, additional, Joly, Florence, additional, Flechon, Aude, additional, Culine, Stéphane, additional, Becht, Catherine, additional, Niegisch, Günter, additional, Stöckle, Michael, additional, Grimm, Marc-Oliver, additional, Gakis, Georgios, additional, Schultze-Seemann, Wolfgang, additional, Kalofonos, Haralambos, additional, Mavroudis, Dimitrios, additional, Papandreou, Christos, additional, Karavasilis, Vasilis, additional, Révész, Janos, additional, Geczi, Lajos, additional, Rosenbaum, Eli, additional, Leibowitz-Amit, Raya, additional, Kejzman, Daniel, additional, Sarid, David, additional, Scagliotti, Giorgio Vittorio, additional, Bracarda, Sergio, additional, Massari, Francesco, additional, Osawa, Takahiro, additional, Miyajima, Naoto, additional, Shinohara, Nobuo, additional, Fukuta, Fumimasa, additional, Ohyama, Chikara, additional, Obara, Wataru, additional, Yamashita, Shinichi, additional, Tomita, Yoshihiko, additional, Kawai, Koji, additional, Fukasawa, Satoshi, additional, Oyama, Masafumi, additional, Yonese, Junji, additional, Nagata, Masayoshi, additional, Uemura, Motohide, additional, Nishimura, Kazuo, additional, Kawakita, Mutsushi, additional, Tsunemori, Hiroyuki, additional, Hashine, Katsuyoshi, additional, Inokuchi, Junichi, additional, Yokomizo, Akira, additional, Nagamori, Satoshi, additional, Lee, Hyo Jin, additional, Park, Se Hoon, additional, Rha, Sun Young, additional, Kim, Yu Jung, additional, Lee, Yun-Gyoo, additional, Cortés, Leticia Vazquez, additional, Flores, Claudia Lorena Urzua, additional, Blaisse, Reinoud J B, additional, Erdkamp, Fransiscus L G, additional, Aarts, Maureen J B, additional, Wojcik-Tomaszewska, Joanna, additional, Tomczak, Piotr, additional, Sikora-Kupis, Bozena, additional, Schenker, Michael, additional, Herzal, Alina Amalia, additional, Udrea, Anghel Adrian, additional, Karlov, Petr, additional, Safina, Sufia Z, additional, Fomkin, Roman, additional, Pulido, Enrique Grande, additional, Del Muro, F Xavier García, additional, Mignorance, Juan Ignacio Delgado, additional, Gauna, Daniel Castellano, additional, Rodríguez-Vida, Alejo, additional, Su, Yu-Li, additional, Lin, Chien-Liang, additional, Lin, Chia-Chi, additional, Yeh, Su-Peng, additional, Çiçin, Irfan, additional, Erman, Mustafa, additional, Urun, Yuksel, additional, Golovko, Yurii, additional, Bondarenko, Igor, additional, Sinielnikov, Ivan, additional, Crabb, Simon, additional, Syndikus, Isabel, additional, Huddart, Robert, additional, Sundar, Santhanam, additional, Chowdhury, Simon, additional, Sarwar, Naveed, additional, Flaig, Thomas, additional, Pan, Chong Xian, additional, Petrylak, Daniel, additional, Schwarz, James, additional, Percent, Ivor, additional, Cultrera, Jennifer, additional, Hainsworth, John, additional, Herms, Benjamin, additional, Lawler, William, additional, Lowe, Thomas, additional, Tagawa, Scott, additional, Aragon-Ching, Jeanny, additional, and Vaishampayan, Ulka, additional

Published
2017
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20. PARAMOUNT: Final Overall Survival Results of the Phase III Study of Maintenance Pemetrexed Versus Placebo Immediately After Induction Treatment With Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

Author

Paz-Ares, Luis G., primary, de Marinis, Filippo, additional, Dediu, Mircea, additional, Thomas, Michael, additional, Pujol, Jean-Louis, additional, Bidoli, Paolo, additional, Molinier, Olivier, additional, Sahoo, Tarini Prasad, additional, Laack, Eckart, additional, Reck, Martin, additional, Corral, Jesús, additional, Melemed, Symantha, additional, John, William, additional, Chouaki, Nadia, additional, Zimmermann, Annamaria H., additional, Visseren-Grul, Carla, additional, and Gridelli, Cesare, additional

Published
2013
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