On October 21, the U.S. Food and Drug Administration (FDA) approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the combination, which includes a single dose of the anti–CTLA-4 antibody tremelimumab at 300 mg added to the anti–PD-L1 antibody durvalumab at 1,500 mg followed by durvalumab every 4 weeks, is called the STRIDE regimen (single tremelimumab, regular-interval durvalumab).
HIMALAYA Trial
The FDA approval was based on positive results from the phase III HIMALAYA trial. In HIMALAYA, patients treated with the combination of tremelimumab and durvalumab experienced a 22% reduction in the risk of death vs those receiving sorafenib (hazard ratio [HR] = 0.78, 95% confidence interval = 0.66–0.92 P = .0035). Results published by Abou-Alfa et al in The New England Journal of Medicine Evidence showed that an estimated 31% of patients treated with the combination were still alive after 3 years, with 20% of patients treated with sorafenib still alive at the same duration of follow-up.
Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center and principal investigator of the HIMALAYA trial, said, “Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favorable 3-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.”
Andrea Wilson Woods, President & Founder, Blue Faery: The Adrienne Wilson Liver Cancer Foundation, said: “In the past, patients living with liver cancer had few treatment options and faced poor prognoses. 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 HCC, the most common form of liver cancer. We appreciate the patients, their families, and the broader liver cancer community who continue to fight for new treatments and advocate for others.”
The safety profiles of the combination of tremelimumab and durvalumab and for durvalumab alone were consistent with the known profiles of each medicine, and no new safety signals were identified.
Regulatory applications for tremelimumab in combination with durvalumab are currently under review in Europe, Japan, and several other countries for the treatment of patients with advanced liver cancer based on the HIMALAYA results.
