Follow-up of the HIMALAYA phase III trial in the Journal of Hepatology establishes a new survival benchmark and informs future treatment decisions for this advanced liver cancer

Amsterdam, July 22, 2025 – A new exploratory analysis of the HIMALAYA phase III trial involving patients with unresectable hepatocellular carcinoma (uHCC, an advanced liver cancer that could not be treated with surgery or other localized treatments) has shown that one in five (19.6%) participants treated with STRIDE (Single Tremelimumab Regular Interval Durvalumab) a combination of two immunotherapies, remained alive after five years of follow-up versus one in 10 (9.4%) participants treated with sorafenib, a standard treatment for uHCC when the study was designed. The findings from the new exploratory analysis of the HIMALAYA study in the Journal of Hepatology, published by Elsevier, establish a new survival benchmark for people living with uHCC and may inform future treatment decisions by doctors and patients.

Advanced hepatocellular carcinoma (HCC) is a devastating disease that has historically carried a poor prognosis, with limited long-term survival largely due to late diagnosis and underlying advanced chronic liver disease. Previously reported results from the HIMALAYA study showed that participants treated with STRIDE lived longer than participants who received sorafenib. Now, findings from this exploratory analysis determined how long participants lived after five years of follow-up, and whether how long they lived was linked to changes in the size of their tumors after receiving treatment.

Lead investigator of the five-year analysis, Lorenza Rimassa, MD, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy, notes, “Our finding that one in five participants treated with STRIDE is alive after five years represents a key clinical breakthrough in the advancement of treatment for uHCC. This remarkable five-year survival in a phase III trial was unimaginable only a few years ago and sets an unprecedented milestone that will inform clinical practice for years to come.”

Key Findings:

• HIMALAYA is the first phase III study to report five-year overall survival in uHCC.
• At five years, STRIDE sustained an overall survival benefit versus sorafenib and manageable safety – there were no new, late-onset serious side effects reported related to STRIDE.
• The overall survival rate at five years was 19.6% with STRIDE versus 9.4% with sorafenib, and participants who took durvalumab alone continued to live at least as long as those who took sorafenib.
• Overall survival with STRIDE was improved with disease control and any degree of tumor shrinkage, regardless of Response Evaluation Criteria in Solid Tumors (RECIST v1.1 response).
• Extended long-term overall survival with STRIDE occurred across all clinically relevant subgroups.

Author of an accompanying editorial, Pierre Nahon, MD, PhD, AP-HP, Hôpitaux Universitaires Paris Seine Saint-Denis, Liver Unit, Bobigny; France, comments, “The most striking result of this analysis is that one in five patients treated with STRIDE remained alive after five years, a milestone that underscores the long-term potential of dual immunotherapy in uHCC. The findings of this study offer a new horizon of hope for patients and healthcare providers alike, reshaping clinical expectations and treatment goals in liver oncology.”

International coordinating investigator of the HIMALAYA trial, Ghassan K. Abou-Alfa, MD, JD, MBA, PhD, Department of Medicine, Memorial Sloan Kettering Cancer Center, and Weill Medical College, Cornell University, New York, New York; and Trinity College, Dublin, Ireland, concludes, “Overall survival is often discussed as a statistical endpoint in clinical trials, but for patients, it carries more personal meaning. Patients are often most concerned with their individual likelihood of living for a certain number of years, surviving to attend key milestones like a child’s graduation or travel to see the world while preserving their quality of life to enjoy time with loved ones. The findings we report in this long-term follow-up of the HIMALAYA study are worth celebrating and may help patients understand what these outcomes mean for them personally in terms of real time that may be gained.”