Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma
Articolo
Data di Pubblicazione:
2024
Abstract:
Background: In the phase III HIMALAYA study (NCT03298451) in unresectable hepatocellular carcinoma (uHCC), STRIDE (Single Tremelimumab Regular Interval Durvalumab) significantly improved overall survival (OS) versus sorafenib; durvalumab monotherapy was noninferior to sorafenib for OS. Results reported herein are from a 4-year updated OS analysis of HIMALAYA. Patients and methods: Participants with uHCC and no previous systemic treatment were randomized to STRIDE (n = 393), durvalumab (n = 389), or sorafenib (n = 389). The updated data cut-off was 23 January 2023. OS and serious adverse events (AEs) were assessed. Additionally, baseline characteristics and subsequent therapies were analyzed in long-term survivors (≥36 months beyond randomization). Results: For STRIDE, durvalumab, and sorafenib, median [95% confidence interval (CI)] follow-up was 49.12 months (46.95-50.17 months), 48.46 months (46.82-49.81 months), and 47.31 months (45.08-49.15 months), respectively. OS hazard ratio (95% CI) for STRIDE versus sorafenib was 0.78 (0.67-0.92). The 36-month OS rate for STRIDE was 30.7% versus 19.8% for sorafenib. The 48-month OS rate remained higher for STRIDE at 25.2%, versus 15.1% for sorafenib. The long-term OS benefit of STRIDE was observed across clinically relevant subgroups and was further improved in participants who achieved disease control. Long-term survivors with STRIDE (n = 103) included participants across clinically relevant subgroups, and 57.3% (59/103) had no reported subsequent anticancer therapy. No new serious treatment-related AEs occurred with STRIDE from the primary analysis (17.5%; 68/388). Durvalumab maintained OS noninferiority to sorafenib and no late-onset safety signals were identified. Conclusions: These data represent the longest follow-up to date in phase III studies in uHCC. The unprecedented 3- and 4-year OS rates reinforce the sustained long-term OS benefit of STRIDE versus sorafenib. STRIDE maintained a tolerable yet differentiated safety profile from other current uHCC therapies. Results continue to support the long-term benefits of STRIDE in a diverse population, reflective of uHCC globally.
Tipologia CRIS:
1.1 Articolo in rivista
Keywords:
durvalumab; immune checkpoint inhibitor; overall survival; tremelimumab; unresectable hepatocellular carcinoma
Elenco autori:
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.; Abou-Alfa, G. K.; 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
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