Imfinzi-Imjudo Combo Provides Survival Benefit Over 4 Years in Liver Cancer Subset

At four years, the combination of Imfinzi and Imjudo reduced the risk of death by 22% compared with Nexavar (sorafenib) in patients with unresectable HCC.

Imfinzi (durvalumab) plus Imjudo (tremelimumab) to treat patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer, continued to provide a survival benefit at four-year follow-up, as demonstrated by updated trial results.

Findings from the phase 3 HIMALAYA trial were presented at a recent oncology conference.

At four years, the combination of Imfinzi and Imjudo reduced the risk of death by 22% compared with Nexavar (sorafenib) in patients with unresectable HCC who were not previously treated with systemic therapy (treatment with substances through the blood stream to reach cells throughout the body) and not eligible for localized treatment (therapy directed to a specific organ or area of the body), according to a press release from AstraZeneca, the manufacturer of Imfinzi.

The phase 3 HIMALAYA trial assessed a regimen involving single dose of Imjudo plus regular interval Imfinzi — what’s referred to as the STRIDE regimen — in patients with unresectable HCC. More patients assigned the STRIDE regimen were alive at four years versus those assigned Nexavar (25.2% versus 15.1%).

“Historically, only 7% of patients with advanced liver cancer have survived five years, making the HIMALAYA long-term survival data especially meaningful,” Dr. Bruno Sangro, director of the liver unit and professor of internal medicine at Clínica Universidad de Navarra in Pamplona, Spain, and lead investigator in the trial, said in the release. “One in four patients treated with the STRIDE regimen were still alive at four years, reinforcing this novel regimen as a standard of care in this setting.”

Researchers also performed an exploratory analysis of the data, which demonstrated that the effects of the STRIDE regimen, when compared with Nexavar, were consistent in all patient subgroups and in those who survived at least three years, according to the release. This effect persisted regardless of underlying disease such as hepatitis B and C viruses and other patient demographics at the start of the trial.

“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,” Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, said in the release. “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.”

No new safety signals were observed with the STRIDE regimen throughout follow-up. Serious side effects related to treatment occurred in 17.5% of patients assigned the STRIDE regimen compared with 9.6% in those assigned Nexavar, according to the release. Of note, these specific side effects were graded as severe or life-threatening and included death.

In 2022, Imfinzi plus Imjudo was approved by the Food and Drug Administration to treat adults with advanced or resectable HCC.

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