AstraZeneca dual immunotherapy approved for US liver cancer patients

The FDA has approved Imfinzi™ combined with Imjudo for adults with unresectable liver cancer, based on a lower risk of death compared to only sorafenib.

Dual immunotherapy approved for US liver cancer patients

AstraZeneca’s Imfinzi™ (durvalumab) and Imjudo (tremelimumab) combination therapy has been approved in the US for adult patients with unresectable hepatocellular carcinoma (HCC).

Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive. The statistic for those just offered sorafenib was 20 percent.

The US Food and Drug Administration’s (FDA) approval took data from the HIMALAYA Phase III trial into consideration. Findings were published in the New England Journal of Medicine Evidence.

The therapy’s unique dosing regime, STRIDE (Single Tremelimumab Regular Interval Durvalumab), comprises of 300mg of the anti-CTLA-4 antibody Imjudo added to 1,500mg of the anti-PD-L1 antibody Imfinzi followed by Imfinzi every four weeks.

Data showed that patients who received both Imjudo and Imfinzi reduced their risk of death by 22 percent compared to sorafenib (hazard ratio [HR] of 0.78, 95 percent confidence interval [CI] 0.66-0.92 p=0.0035).

Dr Ghassan Abou-Alfa, Attending Physician at Memorial Sloan Kettering Cancer Center (MSK) and principal investigator in the trial, commented: “Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival… 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.”

The safety profiles for both Imjudo added to Imfinzi and for Imfinzi on its own were consistent with previous data for the medications. No new safety precautions were identified.

Liver cancer is the sixth most common cancer worldwide with 36,000 people diagnosed in the US every year. So ongoing regulatory applications reviews based on the outcomes is a vital step. Individuals in Europe and Japan are among those who will benefit if the further requests are accepted.

“In the past, patients living with liver cancer had few treatment options and faced poor prognoses. With today’s approval… These new treatments can improve long-term survival for those living with unresectable hepatocellular carcinoma,” stated Andrea Wilson Woods, President & Founder at Blue Faery: The Adrienne Wilson Liver Cancer Foundation.

At the beginning of 2022, Imfinzi plus tremelimumab versus sorafenib only, offered a three years survival rate for the same condition in a Phase III trial.

In 2021, a Phase III trial indicated Imfinzi improved the survival rate for liver cancer patients when compared to just sorafenib.