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Sangro, B.; Chan, S.L.; Kelley, R.K.; Yarchoan, M.; Furuse, J.; Kang, Y.K.; Galle, P.R.; Heurgué, A.; Van Dao, T.; Breder, V.; Reig, M.; Negro, A.; Abou-Alfa, G.K.; Branco, Ricardo; Faccio, Adilson; Skare, Nils; Dutra, Jamille; Viola, Luciana; Vianna, Karina; Sette, Claudia; Faulhaber, Amanda; Tam, Vincent C.; Mulder, Karen; Zbuk, Kevin; Beaudoin, Annie; Assenat, Eric; Tougeron, David; Peron, Jean-Marie; Cattan, Stephane; Phelip, Jean-Marc; Michel, Pierre; Vogel, Arndt; Berg, Thomas; Wedemeyer, Hans Heinrich; Worns, Marcus-Alexander; Tai, Yin Ping; Lee, Ann Shing; N, Lokesh K.; Ashok, Kattimani Kiran; Mittal, Sushant; Goyal, Hari; Srinivasan, Sankar; Mohan, Mallavarapu; Asarawala, Nirav; Gasbarrini, Antonio; Daniele, Bruno; Roila, Fausto; Osaki, Yukio; Motomura, Kenta; Tsuji, Kunihiko; Takei, Yoshiyuki; Aramaki, Takeshi; Kioka, Kiyohide; Koga, Hironori; Sasaki, Yutaka; Tada, Toshifumi; Nadano, Seijin; Vasilyev, Alexander; Kutukova, Svetlana; Ponomarev, Roman; Petrov, Yuryi; Erygin, Dmitriy; Kang, Yoon-Koo; Lim, Ho Yeong; Kim, Jee Hyun; Kim, Tae-You; Choi, Hye Jin; Sangro, Bruno; Martin, Carlos Gómez; López, Carlos; Cheng, Ann-Lii; Feng, Yin-Hsun; Hou, Ming-Mo; Wang Tsang-En Wang, Jing-Houng; Yen, Chia-Jui; Sunpaweravong, Patrapim; Charoentum, Chaiyut; Tanasanvimon, Suebpong; Sirachainan, Ekaphop; Ungtrakul, Teerapat; Ostapenko, Yurii; Skoryi, Denys; Bondarenko, Igor; Shparyk, Yaroslav; Trukhin, Dmytro; Hotko, Yevhen; Kryzhanivska, Anna; Mody, Kabir; Al-Rajabi, Raed; Crysler, Oxana; He, Aiwu Ruth; Reeves, James; Mahipal, Amit; Dasgupta, Anirudha; Thota, Ramya; Crocenzi, Todd; Denlinger, Crystal; Sharma, Nisha; Dao, Tu V.; Tuyet Phuong, Le Thi
Annals of oncology, 20/May , Volume: 35, Issue: 5Journal Article
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. 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). 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. 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. •This updated analysis of the phase III HIMALAYA study in uHCC showed sustained OS benefit with STRIDE vs sorafenib.•Four-year OS rates were 25.2% with STRIDE vs 15.1% with sorafenib.•STRIDE improved OS vs sorafenib across subgroups and further improved 3- and 4-year OS rates in those with disease control.•Subsequent anticancer systemic therapy was more common in the sorafenib vs STRIDE arm.•No new serious treatment-related AEs occurred after the primary analysis for STRIDE.
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