FDA Approves AstraZeneca's Dual Immunotherapy Combination for Unresectable Liver Cancer
Key Insights
The FDA has approved AstraZeneca's Imfinzi (durvalumab) combined with Imjudo (tremelimumab) for adult patients with unresectable hepatocellular carcinoma (search), marking the first regulatory approval for Imjudo.
Phase III HIMALAYA trial results demonstrated a 22% reduction in death risk compared to sorafenib, with 31% of patients still alive after three years versus 20% with sorafenib alone.
The novel STRIDE dosing regimen involves a single 300mg dose of Imjudo added to 1,500mg of Imfinzi, followed by Imfinzi maintenance therapy every four weeks.
The US Food and Drug Administration has approved AstraZeneca's dual immunotherapy combination of Imfinzi (durvalumab) and Imjudo (tremelimumab) for adult patients with unresectable hepatocellular carcinoma (search) (HCC), the most common type of liver cancer (search). This marks the first regulatory approval for Imjudo, establishing a new treatment option for patients facing limited therapeutic alternatives.
HIMALAYA Trial Demonstrates Survival Benefit
The approval was based on positive results from the HIMALAYA Phase III trial, which showed patients treated with the combination experienced a 22% reduction in the risk of death versus sorafenib, with a hazard ratio of 0.78 (95% confidence interval 0.66-0.92, p=0.0035). The trial results, published in the New England Journal of Medicine Evidence, revealed that an estimated 31% of patients treated with the combination were still alive after three years, compared to 20% of patients treated with sorafenib at the same follow-up duration.
The HIMALAYA trial was a randomized, open-label, multicentre, global Phase III study that included 1,324 patients with unresectable, advanced HCC who had not received prior systemic therapy and were not eligible for locoregional therapy. The trial was conducted across 181 centres in 16 countries, including the US, Canada, Europe, South America and Asia.
Novel STRIDE Dosing Regimen
The approved therapy utilizes a unique dosing schedule called STRIDE (Single Tremelimumab Regular Interval Durvalumab), which comprises a single priming dose of 300mg of the anti-CTLA-4 (search) antibody Imjudo added to 1,500mg of the anti-PD-L1 (search) antibody Imfinzi, followed by Imfinzi maintenance therapy every four weeks.
"Patients with unresectable liver cancer (search) are in need of well-tolerated treatments that can meaningfully extend overall survival," said Dr. Ghassan Abou-Alfa, Attending Physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA trial. "In addition to this regimen demonstrating a favourable three-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease."
Addressing Critical Unmet Need
Liver cancer (search) represents the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. In the United States, it is the fastest rising cause of cancer-related deaths, with approximately 36,000 new diagnoses each year. About 75% of all primary liver cancers in adults are HCC, and between 80-90% of all patients with HCC also have cirrhosis.
More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear, creating a critical unmet need for patients with HCC who face limited treatment options.
"In the past, patients living with liver cancer (search) had few treatment options and faced poor prognoses," stated Andrea Wilson Woods, President & Founder at Blue Faery: The Adrienne Wilson Liver Cancer Foundation (search). "With today's approval, we are grateful and optimistic for new, innovative, therapeutic options. These new treatments can improve long-term survival for those living with unresectable hepatocellular carcinoma (search)."
Safety Profile and Global Expansion
The safety profiles of the combination of Imjudo added to Imfinzi and for Imfinzi alone were consistent with the known profiles of each medicine, and no new safety signals were identified. This favorable safety profile is particularly important for liver cancer (search) patients who often have underlying advanced liver disease.
Regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe, Japan and several other countries for the treatment of patients with advanced liver cancer (search) based on the HIMALAYA results, potentially expanding access to this dual immunotherapy approach globally.