New Immunotherapy Combination Sets 5-Year Survival Record for Advanced Liver Cancer

STRIDE regimen offers unprecedented long-term hope for unresectable HCC patients.

A significant breakthrough in treating advanced liver cancer has emerged, with a new analysis revealing that one in five patients receiving a specific immunotherapy combination lived for five years. This finding, stemming from the HIMALAYA trial, establishes a vital new benchmark for survival in unresectable hepatocellular carcinoma (HCC).

Unprecedented 5-Year Survival Achieved

The exploratory analysis of the phase III HIMALAYA trial demonstrated that 19.6% of participants treated with the STRIDE regimen—a combination of tremelimumab and durvalumab—were still alive after five years. This starkly contrasts with the 9.4% survival rate observed in patients treated with sorafenib, the standard of care at the time.

“Our finding that one in five participants treated with STRIDE is alive after 5 years represents a key clinical breakthrough in the advancement of treatment for unresectable HCC. This remarkable 5-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.”

—Lorenza Rimassa, MD, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy

STRIDE Continues to Show Efficacy and Safety

The HIMALAYA trial is notable as the first phase III study to report on 5-year overall survival for unresectable HCC. The STRIDE combination not only sustained its overall survival advantage over sorafenib but also exhibited manageable safety with no new, serious late-onset side effects reported. The survival benefit with STRIDE was linked to disease control and any degree of tumor shrinkage, irrespective of specific response criteria.

Survival rates with durvalumab monotherapy also remained comparable to those on sorafenib. Extended long-term survival with STRIDE was observed across all clinically relevant patient subgroups.

Immunotherapy Offers New Horizon of Hope

Commenting on the findings, Pierre Nahon, MD, PhD, of Hôpitaux Universitaires Paris Seine Saint-Denis, noted the striking result of one in five patients surviving five years.

“The most striking result of this analysis is that one in five patients treated with STRIDE remained alive after 5 years, a milestone that underscores the long-term potential of dual immunotherapy in unresectable HCC. The findings of this study offer a new horizon of hope for patients and health-care providers alike, reshaping clinical expectations and treatment goals in liver oncology.”

—Pierre Nahon, MD, PhD, Hôpitaux Universitaires Paris Seine Saint-Denis

Advanced HCC has historically presented a grim prognosis due to late diagnosis and underlying liver disease. The long-term survival data from HIMALAYA, as highlighted by international coordinating investigator Ghassan K. Abou-Alfa, MD, JD, MBA, PhD, offers a more personal perspective on treatment success.

“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 traveling 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.”

—Ghassan K. Abou-Alfa, MD, JD, MBA, PhD, Memorial Sloan Kettering Cancer Center

This advancement in HCC treatment comes as the overall cancer survival rate in the United States has been steadily increasing, with over 67% of cancer patients living at least five years after diagnosis, according to the National Cancer Institute (National Cancer Institute, 2024).

The findings were published in the Journal of Hepatology. Full author disclosures are available on the journal’s website.