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

PURPOSE In the phase III HIMALAYA study (ClinicalTrials.gov identifier: NCT03298451 ) in unresectable hepatocellular carcinoma (uHCC), the Single Tremelimumab Regular Interval Durvalumab (STRIDE) regimen significantly improved overall survival versus sorafenib, and durvalumab monotherapy was noninferior to sorafenib. Patient-reported outcomes (PROs), a secondary outcome from HIMALAYA, are reported here. METHODS Participants were randomly assigned to receive STRIDE, durvalumab, or sorafenib. PROs were assessed (preplanned secondary outcome) using the European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire and the 18-item HCC module. Time to deterioration (TTD), change from baseline and improvement rate in global health status/quality of life (GHS/QoL), functioning, and disease-related symptoms were analyzed. RESULTS In total, 1,171 participants were randomly assigned to STRIDE (n = 393), durvalumab (n = 389), or sorafenib (n = 389) and were evaluable for PRO assessments. Across treatment arms, compliance rates for PROs were >77% at baseline and >70% overall. Baseline scores were comparable across treatment arms. TTD in GHS/QoL, physical functioning, fatigue, appetite loss, and abdominal pain was numerically longer for both STRIDE and durvalumab versus sorafenib. Clinically meaningful deterioration in PROs was not observed in any treatment arm. However, TTD in nausea and abdominal swelling was numerically longer for STRIDE versus sorafenib, and the likelihood of clinically meaningful improvement in GHS/QoL, role, emotional and social functioning, and disease-related symptoms was greater with STRIDE and durvalumab versus sorafenib. PROs with STRIDE and durvalumab were generally similar. CONCLUSION Compared with sorafenib, STRIDE and durvalumab were associated with clinically meaningful, patient-centered GHS/QoL, functioning, and symptom benefits in people with uHCC. These findings support the benefits of the STRIDE regimen compared with sorafenib for a diverse population reflective of the global uHCC population.

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Details

Published: Aug 10, 2024
Vol/Issue: 42(23)
Pages: 2790-2799

Authors

B

Bruno Sangro

Liver Unit and HPB Oncology Area, Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain

P

Peter R. Galle

University Medical Center, Mainz, Germany

R

Robin Kate Kelley

Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA

C

Chaiyut Charoentum

Department of Internal Medicine, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand

E

Enrico N. De Toni

Department of Medicine II, University Hospital, LMU Munich, Munich, Germany

Y

Yurii Ostapenko

Department of Minimally Invasive and Endoscopic Surgery, Intervention Radiology, National Cancer Institute, Kiev, Ukraine

J

Jeong Heo

Department of Internal Medicine, College of Medicine, Pusan National University and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea

A

Ann-Lii Cheng

National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan

A

Andrea Wilson Woods

Blue Faery: The Adrienne Wilson Liver Cancer Association, Birmingham, AL

C

Charu Gupta

AstraZeneca, Wilmington, DE

J

Jayne Abraham

Patient-Centered Solutions, Scientific Services, IQVIA, New York, NY

C

Carrie L. McCoy

AstraZeneca, Gaithersburg, MD

N

Nikunj Patel

AstraZeneca, Gaithersburg, MD

A

Alejandra Negro

AstraZeneca, Gaithersburg, MD

A

Arndt Vogel

Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; Division of Gastroenterology and Hepatology, Toronto General Hospital, Medical Oncology, Princess Margaret Cancer Centre, Schwartz Reisman Liver Research Centre, University of Toronto, Toronto, ON, Canada

G

Ghassan K. Abou-Alfa

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY; Weill Medical College, Cornell University, New York, NY

Cite This Article

Bruno Sangro, Peter R. Galle, Robin Kate Kelley, et al. (2024). Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. Journal of Clinical Oncology, 42(23), 2790-2799. https://doi.org/10.1200/jco.23.01462

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

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