A groundbreaking five-year analysis of the HIMALAYA phase III trial has demonstrated that STRIDE immunotherapy achieves unprecedented survival outcomes in patients with unresectable hepatocellular carcinoma (uHCC), with nearly one in five patients (19.6%) remaining alive after five years compared to less than one in ten (9.4%) patients treated with the standard therapy sorafenib.
The exploratory analysis, published in the Journal of Hepatology, represents the first phase III study to report five-year overall survival data in advanced liver cancer, establishing a new survival benchmark for this devastating disease that has historically carried a poor prognosis due to late diagnosis and underlying advanced chronic liver disease.
Clinical Breakthrough in Advanced Liver Cancer Treatment
STRIDE (Single Tremelimumab Regular Interval Durvalumab) combines two immunotherapies to treat patients with advanced liver cancer that cannot be treated with surgery or other localized treatments. The remarkable survival outcomes represent what lead investigator Lorenza Rimassa, MD, from Humanitas University and IRCCS Humanitas Research Hospital in Milan, Italy, describes as "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," Rimassa noted.
Sustained Long-Term Benefits Across Patient Populations
The analysis revealed that STRIDE sustained its overall survival benefit versus sorafenib at the five-year mark while maintaining manageable safety, with no new, late-onset serious side effects reported. Importantly, patients who received durvalumab alone continued to live at least as long as those who took sorafenib.
The survival benefits extended across all clinically relevant subgroups, demonstrating the broad applicability of this treatment approach. Additionally, overall survival with STRIDE improved with disease control and any degree of tumor shrinkage, regardless of Response Evaluation Criteria in Solid Tumors (RECIST v1.1 response).
Reshaping Clinical Expectations
Pierre Nahon, MD, PhD, from AP-HP, Hôpitaux Universitaires Paris Seine Saint-Denis, who authored an accompanying editorial, emphasized the significance of these findings: "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."
Personal Impact Beyond Statistical Endpoints
International coordinating investigator Ghassan K. Abou-Alfa, MD, JD, MBA, PhD, from Memorial Sloan Kettering Cancer Center and Weill Medical College, Cornell University, highlighted the personal significance of these survival outcomes for patients and their families.
"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," Abou-Alfa explained.
The HIMALAYA trial findings represent a transformative advancement in the treatment landscape for unresectable hepatocellular carcinoma, offering patients and healthcare providers a new standard of care with unprecedented long-term survival potential.
