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3. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial

Author

Thompson, Alexander, Danta, Mark, Poursoltan, Pirooz, Kiberu, Andrew, Chittajallu, Renuka, Sood, Siddarth, Stauber, Rudolf, Pinter, Matthias, Peck-Radosavljevic, Markus, Decaestecker, Jochen, Cuyle, Pieter-Jan, Verset, Gontran, Van Vlierberghe, Hans, De Azevedo, Sergio, Andrade, Livia, Cunha Júnior, Ademar, Faria, Luiza, Yen, Cheng Tzu, Colli, Leandro, Asselah, Jamil, Kavan, Petr, Marquez, Vladimir, Brahmania, Mayur, Li, Qiang, Xing, Baocai, Guo, Yabing, Chen, Zhendong, Zhao, Haitao, Peng, Tao, Wang, Liming, Wang, Lu, Liu, Hongming, Wu, Feixiang, Qin, Lunxiu, Zheng, Qichang, Ying, Jieer, Li, Haitao, Wen, Tianfu, Qin, Shukui, Wen, Xiaoyu, Liu, Yunpeng, Chen, Minshan, Wang, Boqing, Bai, Yuxian, He, Yifu, Zhao, Hong, Zhou, Dong, Dai, Chaoliu, Teng, Gaojun, Cui, Shuzhong, Gao, Yi, Zhang, Xizhi, Lu, Zheng, Yin, Tao, Ding, Youming, Jia, Weidong, Xia, Yongxiang, Sun, Beicheng, Xia, Qiang, Yuan, Yufeng, Sun, Huichuan, Shi, Xuetao, Guzmán, Adrián, Corrales, Luis, Kral, Zdenek, Priester, Peter, Kubala, Eugen, Blanc, Jean Frederic, Bourliere, Marc, Peron, Jean Marie, Borg, Christophe, Bronowicki, Jean-Pierre, Ganne, Nathalie, Decaens, Thomas, Uguen, Thomas, Heurgue, Alexandra, Trojan, Joerg, Gonzalez-Carmona, Maria Angeles, Roderburg, Christoph, Ettrich, Thomas, Schotten, Clemens, Kandulski, Arne, Yau, Thomas, Chan, Lam, Scartozzi, Mario, Masi, Gianluca, Fanello, Silvia, Battezzati, Pier Maria, Leonardi, Francesco, Ghidini, Michele, Numata, Kazushi, Morimoto, Manabu, Hidaka, Hisashi, Tsuchiya, Kaoru, Yamashita, Tatsuya, Kato, Naoya, Kudo, Masatoshi, Hagihara, Atsushi, Koga, Hironori, Arakawa, Tomohiro, Nakamura, Ikuo, Kawamura, Yusuke, Kawaoka, Tomokazu, Shimada, Mitsuo, Hasegawa, Kiyoshi, Marusawa, Hiroyuki, Nakamura, Shinchiro, Hiraoka, Atsushi, Hayashi, Hiromitsu, Takeda, Shin, Lee, Han Chu, Paik, Seung Woon, Kim, Do Young, Lee, Jung Il, Jeong, Sook-Hyang, Kim, Won, Tak, Won Young, Heo, Jeong, Kim, Hyeyeong, Chon, Hong Jae, Cheong, Jaeyoun, Yoon, Seung Kew, Yoon, Jung-Hwan, Villalobos, Ricardo, Martinez Rodriguez, Jorge Luis, Oyervides Juarez, Victor, Hernández, Carlos Alberto, Klumpen, Heinz-Josef, de Vos-Geelen, Judith, Gane, Edward, Montenegro, Paola, Torres Mattos, Cesar, Janczewska, Ewa, Kawecki, Maciej, Nowakowska-Zajdel, Ewa, Fedenko, Alexander, Granov, Dmitrii, Alyasova, Anna, Sekacheva, Marina, Ledin, Evgeny, Samol, Jens, Toh, Han Chong, Calvo Campos, Mariona, Gomez Martin, Carlos, Lopez Lopez, Carlos, Muñoz Martin, Andres Jesus, Calleja Panero, Jose Luis, Montero Alvarez, Jose Luis, Reig Monzón, Maria, Delgado Mingorance, Ignacio, Minguez Rosique, Beatriz, Cheng, Ann Lii, Huang, Yi-Hsiang, Lin, Shi-Ming, Huang, Jee-Fu, Yu, Ming-Lung, Su, Wei-Wen, Korphaisarn, Krittiya, Maneenil, Kunlatida, Samdaengpan, Chayanee, Tharavichitkul, Ekkapong, Ozguroglu, Mustafa, Kose, Fatih, Harputluoglu, Hakan, Buchschacher, Gary, Thuluvath, Paul, Xiong, Henry, Patel, Mital, Gold, Philip, Li, Daneng, Brooks, Gabriel, Masood, Ashiq, Patel, Reema, George, Ben, Salgia, Reena, Manji, Gulam, Crow, Mary, Kaseb, Ahmed, Dugan, Matthew, Kadakia, Kunal, Kardosh, Adel, Gibbs, John, Shah, Ashesh, Burris III, Howard, Hsiehchen, David, Cheng, Ann-Lii, Kaseb, Ahmed O, Yopp, Adam C, Zhou, Jian, Nakamura, Shinichiro, Cha, Edward, Hack, Stephen P, Lian, Qinshu, Ma, Ning, Spahn, Jessica H, Wang, Yulei, Wu, Chun, and Chow, Pierce K H

Published
2023
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6. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Azevedo, Sergio, Braghiroli, Maria Ignez, Girotto, Gustavo, Bragagnoli, Arinilda, Branco, Ricardo, Faccio, Adilson, Moretto, Andrea, Skare, Nils, Dutra, Jamille, Viola, Luciana, Vianna, Karina, Meton, Fernando, Sette, Claudia, Faulhaber, Amanda, Tam, Vincent C., Couture, Felix, Biagi, Jim, Castel, Helene, Mulder, Karen, Ko, Yoo-Joung, Zbuk, Kevin, Welch, Stephen, Beaudoin, Annie, Heurgué, Alexandra, Assenat, Eric, Archambeaud, Isabelle, Tougeron, David, Peron, Jean-Marie, Gilabert, Marine, Bronowicki, Jean-Pierre, Cattan, Stephane, Blanc, Jean-Frederic, Bouattour, Mohamed, Phelip, Jean-Marc, Boige, Valerie, Michel, Pierre, Frin, Anne-Claire, De Toni, Enrico N., Berres, Marie-Luise, Vogel, Arndt, Berg, Thomas, Ettrich, Thomas, Waldschmidt, Dirk, Wedemeyer, Hans Heinrich, Worns, Marcus-Alexander, Bitzer, Michael, Weiss, Karl-Heinz, Lau, George, Chan, Stephen L., Yau, Thomas, Tai, Yin Ping, Lee, Ann Shing, Thungappa, Satheesh Chiradoni, N, Lokesh K., Sureshchand Ostwal, Vikas, Ashok, Kattimani Kiran, Mittal, Sushant, Goyal, Hari, Srinivasan, Sankar, Biswas, Ghanashyam, Mohan, Mallavarapu, Limaye, Sewanti, Asarawala, Nirav, Rimassa, Lorenza, Falcone, Alfredo, Gianni, Luca, Gasbarrini, Antonio, Daniele, Bruno, Avallone, Antonio, Paolo Frassineti, Giovanni Luca, Roila, Fausto, Kudo, Masatoshi, Kawaoka, Tomokazu, Morimoto, Manabu, Takikawa, Yasuhiro, Kato, Naoya, Yamashita, Tatsuya, Osaki, Yukio, Motomura, Kenta, Tateishi, Ryosuke, Ohkawa, Kazuyoshi, Wada, Yoshiyuki, Onishi, Hideki, Sasahira, Naoki, Inaba, Yoshitaka, Kurosaki, Masayuki, Tsuji, Kunihiko, Takei, Yoshiyuki, Aramaki, Takeshi, Hagihara, Atsushi, Furuse, Junji, Kioka, Kiyohide, Koga, Hironori, Sasaki, Yutaka, Numata, Kazushi, Tada, Toshifumi, Kawaguchi, Yasunori, Nadano, Seijin, Vasilyev, Alexander, Breder, Valery, Lipatov, Oleg, Dvorkin, Mikhail, Zarubenkov, Oleg, Kutukova, Svetlana, Ponomarev, Roman, Shostka, Kirill, Alyasova, Anna, Topuzov, Eldar, Severtsev, Alexey, Petrov, Yuryi, Erygin, Dmitriy, Berdov, Boris, Kang, Yoon-Koo, Tak, Won-Young, Park, Joong-Won, Lim, Ho Yeong, Heo, Jeong, Kim, Jee Hyun, Kim, Tae-You, Choi, Hye Jin, Varela, María, Reig Monzon, María Elisa, Sangro, Bruno, Martin, Carlos Gómez, Ponce, Carmen Guillén, López, Carlos, Cheng, Ann-Lii, Chao, Yee, Feng, Yin-Hsun, Jeng, Long-Bin, Hung, Chao-Hung, Hou, Ming-Mo, Wang Tsang-En Wang, Jing-Houng, Yen, Chia-Jui, Sukeepaisarnjaroen, Wattana, Sunpaweravong, Patrapim, Charoentum, Chaiyut, Tanasanvimon, Suebpong, Sirachainan, Ekaphop, Ungtrakul, Teerapat, Prasongsook, Naiyarat, Maneenil, Kunlatida, Jitpewngarm, Wittawat, Ostapenko, Yurii, Skoryi, Denys, Bondarenko, Igor, Shparyk, Yaroslav, Trukhin, Dmytro, Hotko, Yevhen, Ursol, Grygorii, Kryzhanivska, Anna, Abou-Alfa, Ghassan K., Mody, Kabir, Dayyani, Farshid, Al-Rajabi, Raed, Yarchoan, Mark, Gandhi, Sunil, Crysler, Oxana, He, Aiwu Ruth, Reeves, James, Bahary, Nathan, Mahipal, Amit, Kelley, Robin Kate, Dasgupta, Anirudha, Rowe, Julie, Thota, Ramya, Beg, Muhammad, Morse, Michael, Choi, Sung-hee, Crocenzi, Todd, Somer, Bradley, Abrams, Thomas, Denlinger, Crystal, Zhang, Yue, Sharma, Nisha, Dao, Tu V., Thinh, Nguyen Tien, Tuyet Phuong, Le Thi, Sangro, B., Chan, S.L., Kelley, R.K., Lau, G., Kudo, M., Sukeepaisarnjaroen, W., Yarchoan, M., De Toni, E.N., Furuse, J., Kang, Y.K., Galle, P.R., Rimassa, L., Heurgué, A., Tam, V.C., Van Dao, T., Thungappa, S.C., Breder, V., Ostapenko, Y., Reig, M., Makowsky, M., Paskow, M.J., Gupta, C., Kurland, J.F., Negro, A., and Abou-Alfa, G.K.

Published
2024
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8. Safety and efficacy of cabozantinib for patients with advanced hepatocellular carcinoma who advanced to Child-Pugh B liver function at study week 8: a retrospective analysis of the CELESTIAL randomised controlled trial.

Author

El-Khoueiry, Anthony, Meyer, Tim, Cheng, Ann-Lii, Rimassa, Lorenza, Sen, Suvajit, Milwee, Steven, Kelley, Robin, and Abou-Alfa, Ghassan

Subjects
Cabozantinib, Child–Pugh B, Hepatocellular carcinoma, Adult, Anilides, Antineoplastic Agents, Carcinoma, Hepatocellular, Humans, Liver Cirrhosis, Liver Neoplasms, Prospective Studies, Pyridines, Retrospective Studies
Abstract

BACKGROUND: Patients with hepatocellular carcinoma (HCC) and Child-Pugh B liver cirrhosis have poor prognosis and are underrepresented in clinical trials. The CELESTIAL trial, in which cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with HCC and Child-Pugh A liver cirrhosis at baseline, was evaluated for outcomes in patients who had Child-Pugh B cirrhosis at Week 8. METHODS: This was a retrospective analysis of adult patients with previously treated advanced HCC. Child-Pugh B status was assessed by the investigator. Patients were randomised 2:1 to cabozantinib (60 mg once daily) or placebo. RESULTS: Fifty-one patients receiving cabozantinib and 22 receiving placebo had Child-Pugh B cirrhosis at Week 8. Safety and tolerability of cabozantinib for the Child-Pugh B subgroup were consistent with the overall population. For cabozantinib- versus placebo-treated patients, median OS from randomisation was 8.5 versus 3.8 months (HR 0.32, 95% CI 0.18-0.58), median PFS was 3.7 versus 1.9 months (HR 0.44, 95% CI 0.25-0.76), and best response was stable disease in 57% versus 23% of patients. CONCLUSIONS: These encouraging results with cabozantinib support the initiation of prospective studies in patients with advanced HCC and Child-Pugh B liver function. CLINICAL TRIAL REGISTRATION: NCT01908426.

Published
2022

9. Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade

Author

Kelley, Robin Kate, Miksad, Rebecca, Cicin, Irfan, Chen, YenHsun, Klümpen, Heinz-Josef, Kim, Stefano, Lin, Zhong-Zhe, Youkstetter, Jillian, Hazra, Saswati, Sen, Suvajit, Cheng, Ann-Lii, El-Khoueiry, Anthony B, Meyer, Tim, and Abou-Alfa, Ghassan K

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Digestive Diseases, Liver Cancer, Clinical Trials and Supportive Activities, Liver Disease, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Administration, Oral, Adult, Aged, Aged, 80 and over, Anilides, Bilirubin, Carcinoma, Hepatocellular, Female, Humans, Liver Function Tests, Liver Neoplasms, Male, Middle Aged, Pyridines, Retrospective Studies, Serum Albumin, Survival Analysis, Treatment Outcome, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundAlbumin-bilirubin (ALBI) grade is an objective measure of liver function for patients with hepatocellular carcinoma (HCC). The tyrosine kinase inhibitor cabozantinib is approved for patients with advanced HCC who have received prior sorafenib based on the phase 3 CELESTIAL trial (NCT01908426). Cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated HCC.MethodsPatients were randomised 2:1 to receive cabozantinib 60 mg or placebo orally every day. Clinical outcomes in patients with ALBI grade 1 or 2 at baseline were evaluated in CELESTIAL. ALBI scores were retrospectively calculated based on baseline serum albumin and total bilirubin, with an ALBI grade of 1 defined as  ≤ -2.60 score and a grade of 2 as a score of > -2.60 to  ≤ -1.39.ResultsCabozantinib improved OS and PFS versus placebo in both ALBI grade 1 (hazard ratio [HR] [95% CI]: 0.63 [0.46-0.86] and 0.42 [0.32-0.56]) and ALBI grade 2 (HR [95% CI]: 0.84 [0.66-1.06] and 0.46 [0.37-0.58]) subgroups. Adverse events were consistent with those in the overall population. Rates of grade 3/4 adverse events associated with hepatic decompensation were generally low and were more common among patients in the ALBI grade 2 subgroup.DiscussionThese results provide initial support of cabozantinib in patients with advanced HCC irrespective of ALBI grade 1 or 2.Trial registration numberClinicalTrials.gov number, NCT01908426.

Published
2022

11. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): final results of a randomised phase 3 study

Author

Yau, Thomas, Kaseb, Ahmed, Cheng, Ann-Lii, Qin, Shukui, Zhu, Andrew X, Chan, Stephen L, Melkadze, Tamar, Sukeepaisarnjaroen, Wattana, Breder, Valery, Verset, Gontran, Gane, Edward, Borbath, Ivan, Rangel, Jose David Gomez, Ryoo, Baek-Yeol, Makharadze, Tamta, Merle, Philippe, Benzaghou, Fawzi, Milwee, Steven, Wang, Zhong, Curran, Dominic, Kelley, Robin Kate, and Rimassa, Lorenza

Published
2024
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12. Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study

Author

Kelley, Robin Kate, Sangro, Bruno, Harris, William, Ikeda, Masafumi, Okusaka, Takuji, Kang, Yoon-Koo, Qin, Shukui, Tai, David W-M, Lim, Ho Yeong, Yau, Thomas, Yong, Wei-Peng, Cheng, Ann-Lii, Gasbarrini, Antonio, Damian, Silvia, Bruix, Jordi, Borad, Mitesh, Bendell, Johanna, Kim, Tae-You, Standifer, Nathan, He, Philip, Makowsky, Mallory, Negro, Alejandra, Kudo, Masatoshi, and Abou-Alfa, Ghassan K

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, HIV/AIDS, Orphan Drug, Rare Diseases, Cancer, Biotechnology, Clinical Research, Digestive Diseases, Clinical Trials and Supportive Activities, Liver Cancer, Patient Safety, Liver Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Carcinoma, Hepatocellular, Female, Humans, Liver Neoplasms, Male, Middle Aged, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeThis phase I/II study evaluated tremelimumab (anticytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody) and durvalumab (antiprogrammed death ligand-1 monoclonal antibody) as monotherapies and in combination for patients with unresectable hepatocellular carcinoma (HCC), including a novel regimen featuring a single, priming dose of tremelimumab (ClinicalTrials.gov identifier: NCT02519348).Patients and methodsPatients with HCC who had progressed on, were intolerant to, or refused sorafenib were randomly assigned to receive T300 + D (tremelimumab 300 mg plus durvalumab 1,500 mg [one dose each during the first cycle] followed by durvalumab 1,500 mg once every 4 weeks), durvalumab monotherapy (1,500 mg once every 4 weeks), tremelimumab monotherapy (750 mg once every 4 weeks [seven doses] and then once every 12 weeks), or T75 + D (tremelimumab 75 mg once every 4 weeks plus durvalumab 1,500 mg once every 4 weeks [four doses] followed by durvalumab 1,500 mg once every 4 weeks). Safety was the primary end point. Secondary end points included objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors v1.1 and overall survival; exploratory end points included circulating lymphocyte profiles.ResultsA total of 332 patients were enrolled (T300 + D, n = 75; durvalumab, n = 104; tremelimumab, n = 69; and T75 + D, n = 84). Tolerability was acceptable across arms, with grade ≥ 3 treatment-related adverse events occurring in 37.8%, 20.8%, 43.5%, and 24.4%, respectively. Confirmed ORRs (95% CI) were 24.0% (14.9 to 35.3), 10.6% (5.4 to 18.1), 7.2% (2.4 to 16.1), and 9.5% (4.2 to 17.9), respectively. An early expansion of CD8+ lymphocytes was associated with response across arms, with highest proliferating CD8+ lymphocyte levels occurring in the T300 + D arm. The median (95% CI) overall survival was 18.7 (10.8 to 27.3), 13.6 (8.7 to 17.6), 15.1 (11.3 to 20.5), and 11.3 (8.4 to 15.0) months in the T300 + D, durvalumab, tremelimumab, and T75 + D arms, respectively.ConclusionAll regimens were found to be tolerable and clinically active; however, the T300 + D regimen demonstrated the most encouraging benefit-risk profile. The unique pharmacodynamic activity and association with ORR of the T300 + D regimen further support its continued evaluation in HCC.

Published
2021

13. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of hepatocellular carcinoma

Author

Greten, Tim F, Abou-Alfa, Ghassan K, Cheng, Ann-Lii, Duffy, Austin G, El-Khoueiry, Anthony B, Finn, Richard S, Galle, Peter R, Goyal, Lipika, He, Aiwu Ruth, Kaseb, Ahmed O, Kelley, Robin Kate, Lencioni, Riccardo, Lujambio, Amaia, Hrones, Donna Mabry, Pinato, David J, Sangro, Bruno, Troisi, Roberto I, Woods, Andrea Wilson, Yau, Thomas, Zhu, Andrew X, and Melero, Ignacio

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Trials and Supportive Activities, Liver Cancer, Digestive Diseases, Rare Diseases, Vaccine Related, Cancer, Clinical Research, Liver Disease, Chronic Liver Disease and Cirrhosis, Patient Safety, Immunization, Good Health and Well Being, Carcinoma, Hepatocellular, Guidelines as Topic, Humans, Immunotherapy, Liver Neoplasms, antineoplastic protocols, immunotherapy, guidelines as topic, liver neoplasms, Oncology and carcinogenesis
Abstract

Patients with advanced hepatocellular carcinoma (HCC) have historically had few options and faced extremely poor prognoses if their disease progressed after standard-of-care tyrosine kinase inhibitors (TKIs). Recently, the standard of care for HCC has been transformed as a combination of the immune checkpoint inhibitor (ICI) atezolizumab plus the anti-vascular endothelial growth factor (VEGF) antibody bevacizumab was shown to offer improved overall survival in the first-line setting. Immunotherapy has demonstrated safety and efficacy in later lines of therapy as well, and ongoing trials are investigating novel combinations of ICIs and TKIs, in addition to interventions earlier in the course of disease or in combination with liver-directed therapies. Because HCC usually develops against a background of cirrhosis, immunotherapy for liver tumors is complex and oncologists need to account for both immunological and hepatological considerations when developing a treatment plan for their patients. To provide guidance to the oncology community on important concerns for the immunotherapeutic care of HCC, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). The expert panel drew on the published literature as well as their clinical experience to develop recommendations for healthcare professionals on these important aspects of immunotherapeutic treatment for HCC, including diagnosis and staging, treatment planning, immune-related adverse events (irAEs), and patient quality of life (QOL) considerations. The evidence- and consensus-based recommendations in this CPG are intended to give guidance to cancer care providers treating patients with HCC.

Published
2021

14. Pharmacodynamic Biomarkers Predictive of Survival Benefit with Lenvatinib in Unresectable Hepatocellular Carcinoma: From the Phase III REFLECT StudyBiomarker Analysis Following Lenvatinib in Unresectable HCC

Author

Finn, Richard S, Kudo, Masatoshi, Cheng, Ann-Lii, Wyrwicz, Lucjan, Ngan, Roger KC, Blanc, Jean-Frederic, Baron, Ari D, Vogel, Arndt, Ikeda, Masafumi, Piscaglia, Fabio, Han, Kwang-Hyub, Qin, Shukui, Minoshima, Yukinori, Kanekiyo, Michio, Ren, Min, Dairiki, Ryo, Tamai, Toshiyuki, Dutcus, Corina E, Ikezawa, Hiroki, Funahashi, Yasuhiro, and Evans, Thomas R Jeffry

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Clinical Trials and Supportive Activities, Clinical Research, Antineoplastic Agents, Biomarkers, Tumor, Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Phenylurea Compounds, Predictive Value of Tests, Quinolines, Sorafenib, Survival Rate, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeIn REFLECT, lenvatinib demonstrated an effect on overall survival (OS) by confirmation of noninferiority to sorafenib in unresectable hepatocellular carcinoma. This analysis assessed correlations between serum or tissue biomarkers and efficacy outcomes from REFLECT.Experimental designSerum biomarkers (VEGF, ANG2, FGF19, FGF21, and FGF23) were measured by ELISA. Gene expression in tumor tissues was measured by the nCounter PanCancer Pathways Panel. Pharmacodynamic changes in serum biomarker levels from baseline, and associations of clinical outcomes with baseline biomarker levels, were evaluated.ResultsFour hundred and seven patients were included in the serum analysis set (lenvatinib n = 279, sorafenib n = 128); 58 patients were included in the gene-expression analysis set (lenvatinib n = 34, sorafenib n = 24). Both treatments were associated with increases in VEGF; only lenvatinib was associated with increases in FGF19 and FGF23 at all time points. Lenvatinib-treated responders had greater increases in FGF19 and FGF23 versus nonresponders at cycle 4, day 1 (FGF19: 55.2% vs. 18.3%, P = 0.014; FGF23: 48.4% vs. 16.4%, P = 0.0022, respectively). Higher baseline VEGF, ANG2, and FGF21 correlated with shorter OS in both treatment groups. OS was longer for lenvatinib than sorafenib [median, 10.9 vs. 6.8 months, respectively; HR, 0.53; 95% confidence interval (CI), 0.33-0.85; P-interaction = 0.0397] with higher baseline FGF21. In tumor tissue biomarker analysis, VEGF/FGF-enriched groups showed improved OS with lenvatinib versus the intermediate VEGF/FGF group (HR, 0.39; 95% CI, 0.16-0.91; P = 0.0253).ConclusionsHigher baseline levels of VEGF, FGF21, and ANG2 may be prognostic for shorter OS. Higher baseline FGF21 may be predictive for longer OS with lenvatinib compared with sorafenib, but this needs confirmation.

Published
2021

15. Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Lau, George, Abou-Alfa, Ghassan K., Cheng, Ann-Lii, Sukeepaisarnjaroen, Wattana, Van Dao, Tu, Kang, Yoon Koo, Thungappa, Satheesh Chiradoni, Kudo, Masatoshi, Sangro, Bruno, Kelley, Robin Kate, Furuse, Junji, Park, Joong-Won, Sunpaweravong, Patrapim, Fasolo, Angelica, Yau, Thomas, Kawaoka, Tomokazu, Azevedo, Sergio, Reig, Maria, Assenat, Eric, Yarchoan, Mark, He, Aiwu Ruth, Makowsky, Mallory, Gupta, Charu, Negro, Alejandra, and Chan, Stephen L.

Published
2024
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17. Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial

Author

Strasser, Simone, Thompson, Alexander, Roohullah, Aflah, Sievert, William, Andelkovic, Vladimir, Knox, Jennifer, Davies, Janine, Asselah, Jamil, Brahmania, Mayur, Majeed, Habeeb, Villanueva, Luis, Yanez Weber, Patricio, Garrido, Marcelo, Pizarro, Gonzalo Ignacio, Yanez, Nicolas, Xu, Ruocai, Ou, Shuangyan, Ren, Zhenggang, Pan, Hongming, Meng, Zhiqiang, Gu, Kangsheng, Chen, Xi, Zhang, Tao, Hao, Chunyi, Cao, Peiguo, Guo, Yabing, Qin, Shukui, Xiao, Juxiang, Fang, Weijia, Wang, Xin, Bai, Yuxian, Chen, Xiaoming, Yan, Dong, Zhao, Hong, Ying, Jieer, Bonilla, Carlos, Urrego, Olga, Zambrano, Angela, Lema, Mauricio, Restrepo Gutierrez, Juan Carlos, Cardona, Andres, Franco Millan, Sandra, Oscar, Madiedo, Ramos, Victor, Merle, Philippe, LeSourd, Samuel, Edeline, Julien, Bronowicki, Jean-Pierre, Bourliere, Marc, Cattan, Stephane, Bouattour, Mohamed, Mineur, Laurent, Regnault, Helene, Dauvois, Barbara, Schulze, Kornelius, Folprecht, Gunnar, Geier, Andreas, Waidmann, Oliver, Finkelmeier, Fabian, Venerito, Marino, Berres, Marie-Luise, Berg, Thomas, Lange, Christian, Schmidt, Hartmut, Waldschmidt, Dirk T, Bitzer, Michael, McDermott, Ray, Duffy, Austin, Masi, Gianluca, Zagonel, Vittorina, Tonini, Giuseppe, Piscaglia, Fabio, Gori, Stefania, Rizzo, Mimma, Biscaldi, Elisa, Foltran, Luisa, Cabibbo, Giuseppe, Ikeda, Masafumi, Kudo, Masatoshi, Aikata, Hiroshi, Numata, Kazushi, Marusawa, Hiroyuki, Kato, Naoya, Kurosaki, Masayuki, Morimoto, Manabu, Yamashita, Tatsuya, Koga, Hironori, Masaki, Tsutomu, Tateishi, Ryosuke, Inaba, Yoshitaka, Arakawa, Tomohiro, Suzuki, Yoshiyuki, Akua, Norio, Kobayashi, Masahiro, Hosaka, Tetsuya, Nakamuta, Makoto, Oza, Noriko, Kondo, Shunsuke, Furuse, Junji, Nagashima, Fumio, Kitano, Masayuki, Takaguchi, Koichi, Ryoo, Baek-Yeol, Lim, Ho Yeong, Kim, Jee Hyun, Kim, Tae-You, Kim, Han Sang, Hernandez Hernandez, Carlos, Motola Kuba, Daniel, Segura Gonzalez, Manuel, Cabrera Luviano, Jesus, Huitzil Melendez, Fidel, Ramirez Godinez, Francisco, Silva-Bravo, Fernando, Gane, Edward, Stedman, Catherine, Kwiatkowski, Mariusz, Wyrwicz, Lucjan, Nowakowska-Zajdel, Ewa, Kraj, Leszek, Janczewska, Ewa, Surma-Wlodarczyk, Renata, Breder, Valeriy, Sekacheva, Marina, Orlova, Rashida, Vasilyev, Alexander, Zukov, Ruslan, Vladimirov, Vladimir, Minguez, Beatriz, Matilla Pena, Ana, Fernandez Castroagudin, Javier, Romero Gomez, Manuel, Luis Lledo, Jose, Rubin, Angel, Garcia Sanchez, Araceli, Calleja Panero, Jose, Yu, Ming-Chin, Shen, Ying-Chun, Huang, Yi-Hsiang, Jeng, Long-Bin, Chang, Ting-Tsung, Yang, Sheng-Shun, Chen, Shinn-Cherng, Dechaphunkul, Arunee, Tanwandee, Tawesak, Leerapun, Apinya, Seker, Mesut, Harputluoglu, Hakan, Cicin, Irfan, Oksuzoglu, Berna, Bilici, Mehmet, Sezgin Goksu, Sema, Artac, Mehmet, Cil, Timucin, Yalcin, Suayib, Meyer, Tim, Sarker, Debashis, Rao, Ankit, Palmer, Daniel, Evans, Jeff, Hubner, Richard, Finn, Richard, Ulahannan, Susanna, Zakari, Ahmed, Feun, Lynn, Al-Rajabi, Raed, Sung, Max, He, Aiwu, Kardosh, Adel, Goyal, Lipika, Li, Daneng, Choi, Minsig, Posada, Juan, Dodlapati, Jyothi, Shroff, Rachna, Agrawal, Saurabh, Gopaluni, Srivalli, Akce, Mehmet, Alese, Olatunji, Baron, Ari, Dunne, Richard, Loaiza-Bonilla, Arturo, Frenette, Catherine, Llovet, Josep M, Kumada, Hiromitsu, Cheng, Ann-Lii, Galle, Peter R, Kaneko, Shuichi, Wang, Anran, Mody, Kalgi, Dutcus, Corina, Dubrovsky, Leonid, Siegel, Abby B, and Finn, Richard S

Published
2023
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18. 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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21. Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma

Author

Kelley, Robin Kate, Meyer, Tim, Rimassa, Lorenza, Merle, Philippe, Park, Joong-Won, Yau, Thomas, Chan, Stephen L, Blanc, Jean-Frederic, Tam, Vincent C, Tran, Albert, Dadduzio, Vincenzo, Markby, David W, Kaldate, Rajesh, Cheng, Ann-Lii, El-Khoueiry, Anthony B, and Abou-Alfa, Ghassan K

Subjects
Cancer, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Anilides, Carcinoma, Hepatocellular, Female, Humans, Liver Neoplasms, Male, Middle Aged, Neoplasm Staging, Placebos, Prognosis, Progression-Free Survival, Protein Kinase Inhibitors, Pyridines, Reference Values, Young Adult, alpha-Fetoproteins, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe phase III CELESTIAL study demonstrated improved overall survival (OS) and progression-free survival (PFS) with cabozantinib versus placebo in patients with previously treated, advanced hepatocellular carcinoma (HCC). We analyzed outcomes by baseline alpha-fetoprotein (AFP) and on-treatment AFP changes.Patients and methodsSerum AFP was measured every 8 weeks by blinded, centralized testing. Outcomes were analyzed by baseline AFP bifurcated at 400 ng/mL and by on-treatment AFP response (≥20% decrease from baseline at Week 8). The optimal cutoff for change in AFP at Week 8 was evaluated using maximally selected rank statistics.ResultsMedian OS for cabozantinib versus placebo was 13.9 versus 10.3 months [HR, 0.81; 95% confidence interval (CI), 0.62-1.04] for patients with baseline AFP

Published
2020

22. Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial.

Author

Kelley, Robin Kate, Ryoo, Baek-Yeol, Merle, Philippe, Park, Joong-Won, Bolondi, Luigi, Chan, Stephen L, Lim, Ho Yeong, Baron, Ari D, Parnis, Francis, Knox, Jennifer, Cattan, Stéphane, Yau, Thomas, Lougheed, Julie C, Milwee, Steven, El-Khoueiry, Anthony B, Cheng, Ann-Lii, Meyer, Tim, and Abou-Alfa, Ghassan K

Subjects
Humans, Carcinoma, Hepatocellular, Liver Neoplasms, Anilides, Pyridines, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Adult, Aged, Aged, 80 and over, Middle Aged, Male, Young Adult, Sorafenib, cabozantinib, hepatocellular carcinoma, sorafenib, tyrosine kinase inhibitor, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Digestive Diseases, Rare Diseases, Liver Cancer, Liver Disease, 6.1 Pharmaceuticals
Abstract

ObjectiveIn the phase 3 CELESTIAL trial, cabozantinib improved overall survival (OS) and progression-free survival (PFS) compared with placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). This subgroup analysis evaluated cabozantinib in patients who had received sorafenib as the only prior systemic therapy.MethodsCELESTIAL randomised (2:1) patients with advanced HCC and Child-Pugh class A liver function to treatment with cabozantinib (60 mg daily) or placebo. Eligibility required prior treatment with sorafenib, and patients could have received ≤2 prior systemic regimens. The primary endpoint was OS. Outcomes in patients who had received sorafenib as the only prior therapy were analysed by duration of prior sorafenib (

Published
2020

23. Comparative Efficacy of Cabozantinib and Regorafenib for Advanced Hepatocellular Carcinoma

Author

Kelley, Robin K, Mollon, Patrick, Blanc, Jean-Frédéric, Daniele, Bruno, Yau, Thomas, Cheng, Ann-Lii, Valcheva, Velichka, Marteau, Florence, Guerra, Ines, and Abou-Alfa, Ghassan K

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Digestive Diseases, Clinical Trials and Supportive Activities, Liver Cancer, Cancer, Clinical Research, Liver Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Angiogenesis Inhibitors, Anilides, Antineoplastic Agents, Carcinoma, Hepatocellular, Comparative Effectiveness Research, Disease Progression, Female, Humans, Liver Neoplasms, Male, Middle Aged, Neoplasm Staging, Outcome and Process Assessment, Health Care, Phenylurea Compounds, Progression-Free Survival, Pyridines, Randomized Controlled Trials as Topic, Sorafenib, CELESTIAL, Cabozantinib, Hepatocellular carcinoma, Indirect treatment comparison, Matching-adjusted indirect comparison, RESORCE, Regorafenib, Second-line, Systemic therapy, Targeted therapy, Pharmacology and Pharmaceutical Sciences, General Clinical Medicine, Clinical sciences, Pharmacology and pharmaceutical sciences
Abstract

BackgroundNo trials have compared cabozantinib and regorafenib for the second-line treatment of advanced hepatocellular carcinoma (HCC).ObjectivesConduct a matching-adjusted indirect comparison (MAIC) of the efficacy and safety of second-line cabozantinib and regorafenib in patients with advanced HCC and disease progression after prior sorafenib.MethodsThe CELESTIAL and RESORCE trials were used for indirect comparison of second-line cabozantinib and regorafenib in advanced HCC. Population-level data were available for RESORCE, individual patient data (IPD) for CELESTIAL. To align with RESORCE, the CELESTIAL population was limited to patients who received first-line sorafenib only. To minimize potential effect-modifying population differences, the CELESTIAL IPD were weighted to balance the distribution of clinically relevant baseline characteristics with those of RESORCE. Overall survival (OS) and progression-free survival (PFS) were evaluated for the matching-adjusted second-line CELESTIAL population and compared with those for RESORCE using weighted Kaplan-Meier curves and parametric modeling. Rates of grade 3/4 treatment-emergent adverse events (TEAEs) affecting > 5% of patients in any study arm were compared.ResultsIn the matching-adjusted second-line populations (CELESTIAL, effective sample size = 266; RESORCE, n = 573), median (95% confidence interval) OS was similar for cabozantinib and regorafenib (11.4 [8.9-17.0] versus 10.6 [9.1-12.1] months; p = 0.3474, log-rank test). Median PFS was longer for cabozantinib than regorafenib (5.6 [4.9-7.3] versus 3.1 [2.8-4.2] months; p = 0.0005, log-rank test). There was a trend for lower rates of some grade 3/4 TEAEs with regorafenib than with cabozantinib, which may reflect the exclusion of sorafenib-intolerant patients from RESORCE but not from CELESTIAL, a difference that the MAIC methods could not remove. Only diarrhea rates were statistically significantly lower for regorafenib (p  ≤ 0.001).ConclusionsCabozantinib may achieve similar OS and prolonged PFS compared with regorafenib in patients with progressive advanced HCC after prior sorafenib.

Published
2020

27. Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study

Author

Kudo, Masatoshi, Finn, Richard S., Qin, Shukui, Han, Kwang-Hyub, Ikeda, Kenji, Cheng, Ann-Lii, Vogel, Arndt, Tovoli, Francesco, Ueshima, Kazuomi, Aikata, Hiroshi, López, Carlos López, Pracht, Marc, Meng, Zhiqiang, Daniele, Bruno, Park, Joong-Won, Palmer, Daniel, Tamai, Toshiyuki, Saito, Kenichi, Dutcus, Corina E., and Lencioni, Riccardo

Published
2023
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29. Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma

Author

Sangro, Bruno, primary, Galle, Peter R., additional, Kelley, Robin Kate, additional, Charoentum, Chaiyut, additional, De Toni, Enrico N., additional, Ostapenko, Yurii, additional, Heo, Jeong, additional, Cheng, Ann-Lii, additional, Wilson Woods, Andrea, additional, Gupta, Charu, additional, Abraham, Jayne, additional, McCoy, Carrie L., additional, Patel, Nikunj, additional, Negro, Alejandra, additional, Vogel, Arndt, additional, and Abou-Alfa, Ghassan K., additional

Published
2024
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33. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial

Author

Kelley, Robin Kate, Rimassa, Lorenza, Cheng, Ann-Lii, Kaseb, Ahmed, Qin, Shukui, Zhu, Andrew X, Chan, Stephen L, Melkadze, Tamar, Sukeepaisarnjaroen, Wattana, Breder, Valery, Verset, Gontran, Gane, Edward, Borbath, Ivan, Rangel, Jose David Gomez, Ryoo, Baek-Yeol, Makharadze, Tamta, Merle, Philippe, Benzaghou, Fawzi, Banerjee, Kamalika, Hazra, Saswati, Fawcett, Jonathan, and Yau, Thomas

Published
2022
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36. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial

Author

Yau, Thomas, Park, Joong-Won, Finn, Richard S, Cheng, Ann-Lii, Mathurin, Philippe, Edeline, Julien, Kudo, Masatoshi, Harding, James J, Merle, Philippe, Rosmorduc, Olivier, Wyrwicz, Lucjan, Schott, Eckart, Choo, Su Pin, Kelley, Robin Kate, Sieghart, Wolfgang, Assenat, Eric, Zaucha, Renata, Furuse, Junji, Abou-Alfa, Ghassan K, El-Khoueiry, Anthony B, Melero, Ignacio, Begic, Damir, Chen, Gong, Neely, Jaclyn, Wisniewski, Tami, Tschaika, Marina, and Sangro, Bruno

Published
2022
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37. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma

Author

Abou-Alfa, Ghassan K, Meyer, Tim, Cheng, Ann-Lii, El-Khoueiry, Anthony B, Rimassa, Lorenza, Ryoo, Baek-Yeol, Cicin, Irfan, Merle, Philippe, Chen, YenHsun, Park, Joong-Won, Blanc, Jean-Frederic, Bolondi, Luigi, Klümpen, Heinz-Josef, Chan, Stephen L, Zagonel, Vittorina, Pressiani, Tiziana, Ryu, Min-Hee, Venook, Alan P, Hessel, Colin, Borgman-Hagey, Anne E, Schwab, Gisela, and Kelley, Robin K

Subjects
Digestive Diseases, Rare Diseases, Clinical Trials and Supportive Activities, Clinical Research, Liver Disease, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Anilides, Antineoplastic Agents, Carcinoma, Hepatocellular, Disease-Free Survival, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Liver Neoplasms, Male, Middle Aged, Pyridines, Receptor Protein-Tyrosine Kinases, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundCabozantinib inhibits tyrosine kinases, including vascular endothelial growth factor receptors 1, 2, and 3, MET, and AXL, which are implicated in the progression of hepatocellular carcinoma and the development of resistance to sorafenib, the standard initial treatment for advanced disease. This randomized, double-blind, phase 3 trial evaluated cabozantinib as compared with placebo in previously treated patients with advanced hepatocellular carcinoma.MethodsA total of 707 patients were randomly assigned in a 2:1 ratio to receive cabozantinib (60 mg once daily) or matching placebo. Eligible patients had received previous treatment with sorafenib, had disease progression after at least one systemic treatment for hepatocellular carcinoma, and may have received up to two previous systemic regimens for advanced hepatocellular carcinoma. The primary end point was overall survival. Secondary end points were progression-free survival and the objective response rate.ResultsAt the second planned interim analysis, the trial showed significantly longer overall survival with cabozantinib than with placebo. Median overall survival was 10.2 months with cabozantinib and 8.0 months with placebo (hazard ratio for death, 0.76; 95% confidence interval [CI], 0.63 to 0.92; P=0.005). Median progression-free survival was 5.2 months with cabozantinib and 1.9 months with placebo (hazard ratio for disease progression or death, 0.44; 95% CI, 0.36 to 0.52; P

Published
2018

38. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Sangro, B., primary, Chan, S.L., additional, Kelley, R.K., additional, Lau, G., additional, Kudo, M., additional, Sukeepaisarnjaroen, W., additional, Yarchoan, M., additional, De Toni, E.N., additional, Furuse, J., additional, Kang, Y.K., additional, Galle, P.R., additional, Rimassa, L., additional, Heurgué, A., additional, Tam, V.C., additional, Van Dao, T., additional, Thungappa, S.C., additional, Breder, V., additional, Ostapenko, Y., additional, Reig, M., additional, Makowsky, M., additional, Paskow, M.J., additional, Gupta, C., additional, Kurland, J.F., additional, Negro, A., additional, Abou-Alfa, G.K., additional, Azevedo, Sergio, additional, Braghiroli, Maria Ignez, additional, Girotto, Gustavo, additional, Bragagnoli, Arinilda, additional, Branco, Ricardo, additional, Faccio, Adilson, additional, Moretto, Andrea, additional, Skare, Nils, additional, Dutra, Jamille, additional, Viola, Luciana, additional, Vianna, Karina, additional, Meton, Fernando, additional, Sette, Claudia, additional, Faulhaber, Amanda, additional, Tam, Vincent C., additional, Couture, Felix, additional, Biagi, Jim, additional, Castel, Helene, additional, Mulder, Karen, additional, Ko, Yoo-Joung, additional, Zbuk, Kevin, additional, Welch, Stephen, additional, Beaudoin, Annie, additional, Heurgué, Alexandra, additional, Assenat, Eric, additional, Archambeaud, Isabelle, additional, Tougeron, David, additional, Peron, Jean-Marie, additional, Gilabert, Marine, additional, Bronowicki, Jean-Pierre, additional, Cattan, Stephane, additional, Blanc, Jean-Frederic, additional, Bouattour, Mohamed, additional, Phelip, Jean-Marc, additional, Boige, Valerie, additional, Michel, Pierre, additional, Frin, Anne-Claire, additional, Enrico N De Toni, Germany, additional, Berres, Marie-Luise, additional, Vogel, Arndt, additional, Berg, Thomas, additional, Ettrich, Thomas, additional, Waldschmidt, Dirk, additional, Wedemeyer, Hans Heinrich, additional, Worns, Marcus-Alexander, additional, Bitzer, Michael, additional, Weiss, Karl-Heinz, additional, Lau, George, additional, Chan, Stephen L., additional, Yau, Thomas, additional, Tai, Yin Ping, additional, Lee, Ann Shing, additional, Thungappa, Satheesh Chiradoni, additional, N, Lokesh K., additional, Ostwal, Vikas Sureshchand, additional, Ashok, Kattimani Kiran, additional, Mittal, Sushant, additional, Goyal, Hari, additional, Srinivasan, Sankar, additional, Biswas, Ghanashyam, additional, Mohan, Mallavarapu, additional, Limaye, Sewanti, additional, Asarawala, Nirav, additional, Rimassa, Lorenza, additional, Falcone, Alfredo, additional, Gianni, Luca, additional, Gasbarrini, Antonio, additional, Daniele, Bruno, additional, Avallone, Antonio, additional, Paolo Frassineti, Giovanni Luca, additional, Roila, Fausto, additional, Kudo, Masatoshi, additional, Kawaoka, Tomokazu, additional, Morimoto, Manabu, additional, Takikawa, Yasuhiro, additional, Kato, Naoya, additional, Yamashita, Tatsuya, additional, Osaki, Yukio, additional, Motomura, Kenta, additional, Tateishi, Ryosuke, additional, Ohkawa, Kazuyoshi, additional, Wada, Yoshiyuki, additional, Onishi, Hideki, additional, Sasahira, Naoki, additional, Inaba, Yoshitaka, additional, Kurosaki, Masayuki, additional, Tsuji, Kunihiko, additional, Takei, Yoshiyuki, additional, Aramaki, Takeshi, additional, Hagihara, Atsushi, additional, Furuse, Junji, additional, Kioka, Kiyohide, additional, Koga, Hironori, additional, Sasaki, Yutaka, additional, Numata, Kazushi, additional, Tada, Toshifumi, additional, Kawaguchi, Yasunori, additional, Nadano, Seijin, additional, Alexander Vasilyev, Russian Federation, additional, Breder, Valery, additional, Lipatov, Oleg, additional, Dvorkin, Mikhail, additional, Zarubenkov, Oleg, additional, Kutukova, Svetlana, additional, Ponomarev, Roman, additional, Shostka, Kirill, additional, Alyasova, Anna, additional, Topuzov, Eldar, additional, Severtsev, Alexey, additional, Petrov, Yuryi, additional, Erygin, Dmitriy, additional, Berdov, Boris, additional, Kang, Yoon-Koo, additional, Tak, Won-Young, additional, Park, Joong-Won, additional, Lim, Ho Yeong, additional, Heo, Jeong, additional, Kim, Jee Hyun, additional, Kim, Tae-You, additional, Choi, Hye Jin, additional, Varela, María, additional, Reig Monzon, María Elisa, additional, Sangro, Bruno, additional, Martin, Carlos Gómez, additional, Ponce, Carmen Guillén, additional, López, Carlos, additional, Cheng, Ann-Lii, additional, Chao, Yee, additional, Feng, Yin-Hsun, additional, Jeng, Long-Bin, additional, Hung, Chao-Hung, additional, Hou, Ming-Mo, additional, Wang Tsang-En Wang, Jing-Houng, additional, Yen, Chia-Jui, additional, Sukeepaisarnjaroen, Wattana, additional, Sunpaweravong, Patrapim, additional, Charoentum, Chaiyut, additional, Tanasanvimon, Suebpong, additional, Sirachainan, Ekaphop, additional, Ungtrakul, Teerapat, additional, Prasongsook, Naiyarat, additional, Maneenil, Kunlatida, additional, Jitpewngarm, Wittawat, additional, Ostapenko, Yurii, additional, Skoryi, Denys, additional, Bondarenko, Igor, additional, Shparyk, Yaroslav, additional, Trukhin, Dmytro, additional, Hotko, Yevhen, additional, Ursol, Grygorii, additional, Kryzhanivska, Anna, additional, Abou-Alfa, Ghassan K., additional, Mody, Kabir, additional, Dayyani, Farshid, additional, Al-Rajabi, Raed, additional, Yarchoan, Mark, additional, Gandhi, Sunil, additional, Crysler, Oxana, additional, He, Aiwu Ruth, additional, Reeves, James, additional, Bahary, Nathan, additional, Mahipal, Amit, additional, Kelley, Robin Kate, additional, Dasgupta, Anirudha, additional, Rowe, Julie, additional, Thota, Ramya, additional, Beg, Muhammad, additional, Morse, Michael, additional, Choi, Sung-hee, additional, Crocenzi, Todd, additional, Somer, Bradley, additional, Abrams, Thomas, additional, Denlinger, Crystal, additional, Zhang, Yue, additional, Sharma, Nisha, additional, Dao, Tu V., additional, Thinh, Nguyen Tien, additional, and Tuyet Phuong, Le Thi, additional

Published
2024
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39. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial

Author

Qin, Shukui, primary, Chen, Minshan, additional, Cheng, Ann-Lii, additional, Kaseb, Ahmed O, additional, Kudo, Masatoshi, additional, Lee, Han Chu, additional, Yopp, Adam C, additional, Zhou, Jian, additional, Wang, Lu, additional, Wen, Xiaoyu, additional, Heo, Jeong, additional, Tak, Won Young, additional, Nakamura, Shinichiro, additional, Numata, Kazushi, additional, Uguen, Thomas, additional, Hsiehchen, David, additional, Cha, Edward, additional, Hack, Stephen P, additional, Lian, Qinshu, additional, Ma, Ning, additional, Spahn, Jessica H, additional, Wang, Yulei, additional, Wu, Chun, additional, Chow, Pierce K H, additional, Thompson, Alexander, additional, Danta, Mark, additional, Poursoltan, Pirooz, additional, Kiberu, Andrew, additional, Chittajallu, Renuka, additional, Sood, Siddarth, additional, Stauber, Rudolf, additional, Pinter, Matthias, additional, Peck-Radosavljevic, Markus, additional, Decaestecker, Jochen, additional, Cuyle, Pieter-Jan, additional, Verset, Gontran, additional, Van Vlierberghe, Hans, additional, De Azevedo, Sergio, additional, Andrade, Livia, additional, Cunha Júnior, Ademar, additional, Faria, Luiza, additional, Yen, Cheng Tzu, additional, Colli, Leandro, additional, Asselah, Jamil, additional, Kavan, Petr, additional, Marquez, Vladimir, additional, Brahmania, Mayur, additional, Li, Qiang, additional, Xing, Baocai, additional, Guo, Yabing, additional, Chen, Zhendong, additional, Zhao, Haitao, additional, Peng, Tao, additional, Wang, Liming, additional, Liu, Hongming, additional, Wu, Feixiang, additional, Qin, Lunxiu, additional, Zheng, Qichang, additional, Ying, Jieer, additional, Li, Haitao, additional, Wen, Tianfu, additional, Qin, Shukui, additional, Liu, Yunpeng, additional, Wang, Boqing, additional, Bai, Yuxian, additional, He, Yifu, additional, Zhao, Hong, additional, Zhou, Dong, additional, Dai, Chaoliu, additional, Teng, Gaojun, additional, Cui, Shuzhong, additional, Gao, Yi, additional, Zhang, Xizhi, additional, Lu, Zheng, additional, Yin, Tao, additional, Ding, Youming, additional, Jia, Weidong, additional, Xia, Yongxiang, additional, Sun, Beicheng, additional, Xia, Qiang, additional, Yuan, Yufeng, additional, Sun, Huichuan, additional, Shi, Xuetao, additional, Guzmán, Adrián, additional, Corrales, Luis, additional, Kral, Zdenek, additional, Priester, Peter, additional, Kubala, Eugen, additional, Blanc, Jean Frederic, additional, Bourliere, Marc, additional, Peron, Jean Marie, additional, Borg, Christophe, additional, Bronowicki, Jean-Pierre, additional, Ganne, Nathalie, additional, Decaens, Thomas, additional, Heurgue, Alexandra, additional, Trojan, Joerg, additional, Gonzalez-Carmona, Maria Angeles, additional, Roderburg, Christoph, additional, Ettrich, Thomas, additional, Schotten, Clemens, additional, Kandulski, Arne, additional, Yau, Thomas, additional, Chan, Lam, additional, Scartozzi, Mario, additional, Masi, Gianluca, additional, Fanello, Silvia, additional, Battezzati, Pier Maria, additional, Leonardi, Francesco, additional, Ghidini, Michele, additional, Morimoto, Manabu, additional, Hidaka, Hisashi, additional, Tsuchiya, Kaoru, additional, Yamashita, Tatsuya, additional, Kato, Naoya, additional, Hagihara, Atsushi, additional, Koga, Hironori, additional, Arakawa, Tomohiro, additional, Nakamura, Ikuo, additional, Kawamura, Yusuke, additional, Kawaoka, Tomokazu, additional, Shimada, Mitsuo, additional, Hasegawa, Kiyoshi, additional, Marusawa, Hiroyuki, additional, Nakamura, Shinchiro, additional, Hiraoka, Atsushi, additional, Hayashi, Hiromitsu, additional, Takeda, Shin, additional, Paik, Seung Woon, additional, Kim, Do Young, additional, Lee, Jung Il, additional, Jeong, Sook-Hyang, additional, Kim, Won, additional, Kim, Hyeyeong, additional, Chon, Hong Jae, additional, Cheong, Jaeyoun, additional, Yoon, Seung Kew, additional, Yoon, Jung-Hwan, additional, Villalobos, Ricardo, additional, Martinez Rodriguez, Jorge Luis, additional, Oyervides Juarez, Victor, additional, Hernández, Carlos Alberto, additional, Klumpen, Heinz-Josef, additional, de Vos-Geelen, Judith, additional, Gane, Edward, additional, Montenegro, Paola, additional, Torres Mattos, Cesar, additional, Janczewska, Ewa, additional, Kawecki, Maciej, additional, Nowakowska-Zajdel, Ewa, additional, Fedenko, Alexander, additional, Granov, Dmitrii, additional, Alyasova, Anna, additional, Sekacheva, Marina, additional, Ledin, Evgeny, additional, Samol, Jens, additional, Toh, Han Chong, additional, Calvo Campos, Mariona, additional, Gomez Martin, Carlos, additional, Lopez Lopez, Carlos, additional, Muñoz Martin, Andres Jesus, additional, Calleja Panero, Jose Luis, additional, Montero Alvarez, Jose Luis, additional, Reig Monzón, Maria, additional, Delgado Mingorance, Ignacio, additional, Minguez Rosique, Beatriz, additional, Cheng, Ann Lii, additional, Huang, Yi-Hsiang, additional, Lin, Shi-Ming, additional, Huang, Jee-Fu, additional, Yu, Ming-Lung, additional, Su, Wei-Wen, additional, Korphaisarn, Krittiya, additional, Maneenil, Kunlatida, additional, Samdaengpan, Chayanee, additional, Tharavichitkul, Ekkapong, additional, Ozguroglu, Mustafa, additional, Kose, Fatih, additional, Harputluoglu, Hakan, additional, Buchschacher, Gary, additional, Thuluvath, Paul, additional, Xiong, Henry, additional, Patel, Mital, additional, Gold, Philip, additional, Li, Daneng, additional, Brooks, Gabriel, additional, Masood, Ashiq, additional, Patel, Reema, additional, George, Ben, additional, Salgia, Reena, additional, Manji, Gulam, additional, Crow, Mary, additional, Kaseb, Ahmed, additional, Dugan, Matthew, additional, Kadakia, Kunal, additional, Kardosh, Adel, additional, Gibbs, John, additional, Shah, Ashesh, additional, and Burris III, Howard, additional

Published
2023
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41. APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy

Author

Lau, George, Yu, Ming-Lung, Wong, Grace, Thompson, Alexander, Ghazinian, Hasmik, Hou, Jin-Lin, Piratvisuth, Teerha, Jia, Ji-Dong, Mizokami, Masashi, Cheng, Gregory, Chen, Guo-Feng, Liu, Zhen-Wen, Baatarkhuu, Oidov, Cheng, Ann Lii, Ng, Woon Leung, Lau, Patrick, Mok, Tony, Chang, Jer-Ming, Hamid, Saeed, Dokmeci, A. Kadir, Gani, Rino A., Payawal, Diana A., Chow, Pierce, Park, Joong-Won, Strasser, Simone I., Mohamed, Rosmawaiti, Win, Khin Maung, Tawesak, Tanwandee, Sarin, Shiv Kumar, and Omata, Masao

Published
2021
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42. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial

Author

Galle, Peter R, Finn, Richard S, Qin, Shukui, Ikeda, Masafumi, Zhu, Andrew X, Kim, Tae-You, Kudo, Masatoshi, Breder, Valeriy, Merle, Philippe, Kaseb, Ahmed, Li, Daneng, Mulla, Sohail, Verret, Wendy, Xu, Derek-Zhen, Hernandez, Sairy, Ding, Beiying, Liu, Juan, Huang, Chen, Lim, Ho Yeong, Cheng, Ann-Lii, and Ducreux, Michel

Published
2021
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44. Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT

Author

Okusaka, Takuji, Ikeda, Kenji, Kudo, Masatoshi, Finn, Richard, Qin, Shukui, Han, Kwang-Hyub, Cheng, Ann-Lii, Piscaglia, Fabio, Kobayashi, Masahiro, Sung, Max, Chen, Minshan, Wyrwicz, Lucjan, Yoon, Jung-Hwan, Ren, Zhenggang, Mody, Kalgi, Dutcus, Corina, Tamai, Toshiyuki, Ren, Min, Hayato, Seiichi, and Kumada, Hiromitsu

Published
2021
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46. Impact of Bevacizumab Being Skipped due to Adverse Events of Special Interest for Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma Treated with Atezolizumab plus Bevacizumab: An Exploratory Analysis of the Phase III IMbrave150 Study.

Author

Kudo, Masatoshi, Tsuchiya, Kaoru, Shao, Yu-Yun, Finn, Richard S., Galle, Peter R., Ducreux, Michel, Cheng, Ann-Lii, Yamashita, Tatsuya, Koga, Hironori, Take, Ryosuke, Yamada, Kyoko, Asakawa, Takashi, Nakagawa, Yuki, and Ikeda, Masafumi

Subjects
HEPATOCELLULAR carcinoma, OVERALL survival, PROGRESSION-free survival, BEVACIZUMAB, SPECIAL events
Abstract

Introduction: The phase III IMbrave150 study established atezolizumab + bevacizumab as the global standard of care in patients with unresectable hepatocellular carcinoma (HCC). This exploratory analysis examined the impact of bevacizumab interruption due to bevacizumab adverse events of special interest (AESIs). Methods: Patients in IMbrave150 who were randomized to atezolizumab + bevacizumab and received treatment for ≥6 months (to reduce immortal time bias) were included in group A-1 if bevacizumab had ever been skipped due to bevacizumab AESIs or to group A-2 otherwise. Efficacy analyses included overall survival (OS) and progression-free survival (PFS) by whether bevacizumab was skipped (group A-1 vs. A-2). PFS was evaluated per independent review facility (IRF)-assessed Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and HCC-modified RECIST (IRF-HCC mRECIST). Safety was also evaluated. Results: Of the 210 patients who received ≥6 months of atezolizumab + bevacizumab, 69 were assigned to group A-1 and 141 to A-2. At data cutoff (August 20, 2020), hazard ratio (HR) for OS was 1.04 (95% CI: 0.64, 1.69) for group A-1 versus A-2. HR for PFS was 1.07 (95% CI: 0.74, 1.55) per IRF-assessed RECIST 1.1 and 1.10 (95% CI: 0.76, 1.59; 15.5 vs. 9.7 months) per IRF-HCC mRECIST for group A-1 versus A-2. Safety profiles for atezolizumab and bevacizumab were largely similar between groups. More group A-1 patients had grade 3/4 adverse events. A separate analysis investigating the impact of immortal time bias in patients who received ≥3 months of atezolizumab + bevacizumab supported the appropriateness of the ≥6-month landmark analysis. Discussion/Conclusion: Efficacy was similar between patients who skipped bevacizumab due to bevacizumab AESIs and those who did not. Although this comparison was nonrandomized and exploratory, results suggest that skipping bevacizumab due to bevacizumab AESIs did not considerably impact the efficacy and safety of atezolizumab + bevacizumab. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Association between treatment‐emergent hypertension and survival with lenvatinib treatment for patients with hepatocellular carcinoma in the REFLECT study

Author

Piscaglia, Fabio, primary, Ikeda, Kenji, additional, Cheng, Ann‐Lii, additional, Kudo, Masatoshi, additional, Ikeda, Masafumi, additional, Breder, Valery, additional, Ryoo, Baek‐Yeol, additional, Mody, Kalgi, additional, Ren, Min, additional, Ramji, Zahra, additional, and Sung, Max W., additional

Published
2024
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49. Coformulated quavonlimab and pembrolizumab (pembro) in combination with lenvatinib (lenva) as first-line (1L) therapy for patients (pts) with advanced hepatocellular carcinoma (HCC): Phase 2 KEYSTEP-004 study.

Author

Rimassa, Lorenza, primary, Li, Daneng, additional, Ikeda, Masafumi, additional, Yarchoan, Mark, additional, Ryoo, Baek-Yeol, additional, Kossler, Thibaud, additional, Lim, Ho-Yeong, additional, Kwiatkowski, Mariusz, additional, Chang, Ting-Tsung, additional, Kim, Jee Hyun, additional, Casadei-Gardini, Andrea, additional, Kudo, Masatoshi, additional, Ren, Zhenggang, additional, Varela Calvo, Maria, additional, Llovet, Josep M, additional, Zhang, Yayan, additional, Hatogai, Ken, additional, Siegel, Abby B., additional, and Cheng, Ann-Lii, additional

Published
2024
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50. Lenvatinib plus pembrolizumab versus lenvatinib alone as first-line therapy for advanced hepatocellular carcinoma: Longer-term efficacy and safety results from the phase 3 LEAP-002 study.

Author

Finn, Richard S., primary, Kudo, Masatoshi, additional, Merle, Philippe, additional, Meyer, Tim, additional, Qin, Shukui, additional, Ikeda, Masafumi, additional, Xu, Ruocai, additional, Edeline, Julien, additional, Ryoo, Baek-Yeol, additional, Ren, Zhenggang, additional, Cheng, Ann-Lii, additional, Galle, Peter R., additional, Kaneko, Shuichi, additional, Kumada, Hiromitsu, additional, Wang, Anran, additional, Mody, Kalgi, additional, Dubrovsky, Leonid, additional, Siegel, Abby B., additional, and Llovet, Josep M, additional

Published
2024
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