Outcomes of Patients With Hepatocellular Carcinoma Treated With Durvalumab Plus Tremelimumab in Real‐World Clinical Practice Who Met or Did Not Meet the Inclusion Criteria for the Phase 3 HIMALAYA Trial

BACKGROUND AND AIM: This study evaluated clinical outcomes in patients with hepatocellular carcinoma (HCC) treated with durvalumab plus tremelimumab (Dur/Tre) in routine practice, stratified by whether they fulfilled the eligibility criteria of the phase 3 HIMALAYA trial. METHODS: A total of 412 patients with unresectable HCC receiving Dur/Tre at 30 Japanese institutions were enrolled. Of these, 92 fulfilled the HIMALAYA trial eligibility criteria (HIMALAYA group) and 320 did not (non-HIMALAYA group). RESULTS: (hazard ratio [HR], 0.780; 95% confidence interval [CI], 0.612-0.993; p = 0.044) and portal vein invasion (HR, 1.509; 95% CI, 1.049-2.170; p = 0.027) as independent predictors of PFS. Median overall survival (OS) was 19.4 months in the HIMALAYA group versus 15.4 months in the non-HIMALAYA group (p = 0.014). Multivariable analysis showed Eastern Cooperative Oncology Group performance status ≥ 1 (HR, 1.878; 95% CI, 1.253-2.814; p = 0.002) and albumin-bilirubin grade ≥ 2 (HR, 2.032; 95% CI, 1.319-3.318; p = 0.001) as independent determinants of OS. Any-grade endocrine dysfunction occurred in 13 (14.1%) and 21 (6.6%) patients (p = 0.030), with grade ≥ 3 events in 5 (5.4%) and 2 (0.6%), respectively (p = 0.007). Subgroup analysis suggested that non-HIMALAYA patients with ALBI grade 1 may have OS comparable to the HIMALAYA group. CONCLUSIONS: Patients fulfilling the HIMALAYA trial eligibility criteria and those who did not but had preserved hepatic function demonstrated favorable survival outcomes with Dur/Tre.

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Journal
Journal of Gastroenterology and Hepatology
Published
2026-05-22
DOI
https://doi.org/10.1111/jgh.70422
Primary Topic
Hepatocellular Carcinoma Treatment and Prognosis
Type
article
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article

Outcomes of Patients With Hepatocellular Carcinoma Treated With Durvalumab Plus Tremelimumab in Real‐World Clinical Practice Who Met or Did Not Meet the Inclusion Criteria for the Phase 3 HIMALAYA Trial

Hideko Ohama, Norio Itokawa, Yuki Kanayama, Hidenao Noritake et al.
Journal of Gastroenterology and Hepatology
Hepatocellular Carcinoma Treatment and Prognosis
article

Outcomes of Patients With Hepatocellular Carcinoma Treated With Durvalumab Plus Tremelimumab in Real‐World Clinical Practice Who Met or Did Not Meet the Inclusion Criteria for the Phase 3 HIMALAYA Trial

Hideko Ohama, Norio Itokawa, Yuki Kanayama, Hidenao Noritake, Kazuya Kariyama, Hirayuki Enomoto, Kazuhiro Nouso, Hideyuki Tamai, Shinya Fukunishi, Takuya Nagano, Hisashi Kosaka, Yutaka Yata, Yuichi Koshiyama, Fujimasa Tada, Kosuke Matsui, Kazuto Tajiri, Soo Ki Kim, Takumi Fukumoto, Michitaka Imai, Hidekatsu Kuroda, Osamu Yoshida, Satoru Kakizaki, Masatoshi Kudo, Koichi Takaguchi, Jumpei Okamura, Shinichiro Nakamura, Joji Tani, Atsushi Hiraoka, Chikara Ogawa, Masaki Kaibori, Toshifumi Tada, Hidenori Toyoda, Takashi Nishimura, Kazuhito Kawata, Takanori Matsuura, Tomomi Okubo, Akemi Tsutsui, Masashi Hirooka, Kunihiko Tsuji, Ei Itobayashi, Yoshiko Nakamura, Toru Ishikawa, Atsushi Naganuma, Hiroki Nishikawa, Yoichi Hiasa, Takeshi Hatanaka, Taeang Arai, Takashi Kumada, Kazunari Tanaka, Hironori Ochi, Hironori Tanaka, Yoshihide Ueda, Masanori Atsukawa, Asahiro Morishita, Tomomitsu Matono, Tomoko Aoki, Shohei Komatsu
article en

Abstract

BACKGROUND AND AIM: This study evaluated clinical outcomes in patients with hepatocellular carcinoma (HCC) treated with durvalumab plus tremelimumab (Dur/Tre) in routine practice, stratified by whether they fulfilled the eligibility criteria of the phase 3 HIMALAYA trial. METHODS: A total of 412 patients with unresectable HCC receiving Dur/Tre at 30 Japanese institutions were enrolled. Of these, 92 fulfilled the HIMALAYA trial eligibility criteria (HIMALAYA group) and 320 did not (non-HIMALAYA group). RESULTS: (hazard ratio [HR], 0.780; 95% confidence interval [CI], 0.612-0.993; p = 0.044) and portal vein invasion (HR, 1.509; 95% CI, 1.049-2.170; p = 0.027) as independent predictors of PFS. Median overall survival (OS) was 19.4 months in the HIMALAYA group versus 15.4 months in the non-HIMALAYA group (p = 0.014). Multivariable analysis showed Eastern Cooperative Oncology Group performance status ≥ 1 (HR, 1.878; 95% CI, 1.253-2.814; p = 0.002) and albumin-bilirubin grade ≥ 2 (HR, 2.032; 95% CI, 1.319-3.318; p = 0.001) as independent determinants of OS. Any-grade endocrine dysfunction occurred in 13 (14.1%) and 21 (6.6%) patients (p = 0.030), with grade ≥ 3 events in 5 (5.4%) and 2 (0.6%), respectively (p = 0.007). Subgroup analysis suggested that non-HIMALAYA patients with ALBI grade 1 may have OS comparable to the HIMALAYA group. CONCLUSIONS: Patients fulfilling the HIMALAYA trial eligibility criteria and those who did not but had preserved hepatic function demonstrated favorable survival outcomes with Dur/Tre.

Journal of Gastroenterology and Hepatology
Hiroshima University (JP), Kansai Medical University (JP), Iwate Medical University (JP), Kagawa University (JP), Hamamatsu University School of Medicine (JP), Wakayama Rosai Hospital (JP), Niigata Cancer Center Hospital (JP), Takamatsu Red Cross Hospital (JP), Saiseikai Niigata Daini Hospital (JP), National Hospital Organization Takasaki Medical Center (JP), Matsuyama Red Cross Hospital (JP), Ogaki Municipal Hospital (JP), Himeji Medical Center (JP), Hanwa Memorial Hospital (JP), Gunma Saiseikai Maebashi Hospital (JP), Himeji Red Cross Hospital (JP), Kagawa University Hospital (JP), Teine Keijinkai Hospital (JP), Asahi General Hospital (JP), Toyama University Hospital (JP), Ehime Prefectural Central Hospital (JP), Edogawa Hospital (JP), Kobe Asahi Hospital (JP), Kagawa Prefectural Central Hospital (JP), Takarazuka City Hospital (JP), Ehime University (JP), Gifu Kyoritsu University (JP), Kobe University (JP), Nippon Medical School (JP), Hyogo University (JP), Osaka University of Pharmaceutical Sciences (JP), Kindai University (JP)
Reduced inequalities
Openalex Percentile: Top 6%
Hepatocellular Carcinoma Treatment and Prognosis
DOISourceOpenAlex
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