FDA Approves Imjudo Plus Imfinzi for Liver Cancer Subtype

The dual immunotherapy regimen of Imjudo and Imfinzi may provide patients with unresectable hepatocellular carcinoma a well-tolerated treatment to extend survival.

The Food and Drug Administration has approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for the treatment of adults with the most common type of liver cancer, unresectable hepatocellular carcinoma.

This approval was based on findings from the phase 3 HIMALAYA trial, which demonstrated that the combination of Imjudo and Imfinzi contributed to a 22% reduction in the risk for death compared with Nexavar (sorafenib), according to a press release from AstraZeneca, the manufacturer of Imjudo.

Results from the study, which included 1,171 patients receiving either the Imjudo-Imfinzi combination or Nexavar, also showed that approximately 31% of patients treated with the Imjudo-Imfinzi combination were alive after three years compared with 20% of patients treated with Nexavar alone.

“Patients with unresectable liver cancer 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 of the HIMALAYA trial, in the release. “In addition to this regimen demonstrating a favorable 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.”

The combination of Imjudo and Imfinzi has been called the STRIDE regimen: Single tremelimumab regular-interval durvalumab. In general, patients who undergo this treatment regimen receive a single 300-milligram dose of Imjudo added to a 1,500-milligram dose of Infinzi, followed by Imfinzi alone every four weeks, according to the release.

“With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the U.S. now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer,” said Dave Fredrickson, executive vice president of the oncology business unit for AstraZeneca, in the release.

Liver cancer is the third most common cause of cancer death in the United States and the sixth most commonly diagnosed cancer worldwide, according to the release. With approximately 36,000 patients newly diagnosed each year, it is becoming the fastest increasing cause of cancer-related deaths in the U.S.

“In the past, patients living with liver cancer had few treatment options and faced poor prognoses,” said Andrea Wilson Woods, president and founder of Blue Faery: The Adrienne Wilson Liver Cancer Foundation, in the release. “With this 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, the most common form of liver cancer.”

No new safety signals were identified in the HIMALAYA trial regarding Imjudo with Imfinzi and of Imfinzi alone, according to the release.

In particular, the most common side effects in patients from the trial, which occurred in at least 20% of patients, included diarrhea, rash, itchy skin, fatigue, musculoskeletal pain and abdominal pain. Of the patients treated with the combination in the trial, 41% of patients had serious side effects, which occurred in at least 1% of patients, included diarrhea (4%), bleeding (6%), pneumonia (2.1%), sepsis (2.1%), vomiting (1.3%), rash (1.5%), anemia (1.3%) and acute kidney injury (1.3%).

Eight percent of patients had a fatal side effect including intracranial bleeding (0.5%), death (1%), pneumonitis (0.5%), cardiac arrest (0.5%), immune-mediated liver inflammation (0.5%) and liver failure (0.5%). Fourteen percent of patients permanently discontinued the combination treatment because of a side effect.

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