AstraZeneca’s IMFINZI/IMJUDO shows sustained OS in Phase 3 liver cancer study

AstraZeneca’s IMFINZI (durvalumab) combined with IMJUDO (tremelimumab-actl) has demonstrated an enduring overall survival (OS) benefit in patients with advanced hepatocellular carcinoma (HCC), according to the updated results from the HIMALAYA Phase 3 trial.

An unparalleled one in four patients were still alive four years after treatment with this novel combination therapy, marking the longest survival follow-up reported to date in the Phase 3 trial for advanced hepatocellular carcinoma, which is a primary form of liver cancer that occurs most often in people with chronic liver diseases like cirrhosis caused by hepatitis B or C infection.

The data reveals that the STRIDE regimen, consisting of a single priming dose of IMJUDO added to IMFINZI, reduced the risk of death by 22% compared to sorafenib after four years of follow-up. About 25.2% of patients treated with the STRIDE regimen were alive after four years, compared to 15.1% for those treated with sorafenib.

Notably, the STRIDE regimen demonstrated consistent treatment effects across all clinically significant patient subgroups. This included patients who survived at least three years, irrespective of the underlying disease cause (hepatitis B virus [HBV], hepatitis C virus [HCV], or nonviral) or other baseline demographics.

AstraZeneca’s STRIDE regimen of IMFINZI and IMJUDO demonstrates significant survival benefit in advanced liver cancer patients. Photo courtesy of AstraZeneca.

The safety profile for the STRIDE regimen remained consistent with known profiles for both medicines, with no new safety signals detected during extended follow-up. Severe treatment-related adverse events (TRAEs) were experienced by 17.5% of patients on the STRIDE regimen versus 9.6% of patients treated with sorafenib, with no new events occurring after the primary analysis for STRIDE.

Susan Galbraith — AstraZeneca Executive Vice President of Oncology R&D said: “The remarkable four-year survival benefit shown with IMFINZI and IMJUDO in this advanced liver cancer setting supports the use of the STRIDE regimen to treat a broad, eligible patient population globally. These latest results from HIMALAYA are part of a series of clinical trials aiming to deliver innovative treatments for patients at different stages of liver cancer.”

IMFINZI, in combination with IMJUDO, is approved for treating adults with advanced or unresectable hepatocellular carcinoma in the US, European Union, Japan, and several other countries. IMFINZI as a monotherapy is also approved in Japan for this condition.