Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• Annals of oncology, 2024-05, Vol.35 (5), p.448-457

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2024

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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.