FDA approves tremelimumab with durvalumab for advanced liver cancer
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The FDA approved tremelimumab in combination with durvalumab for adults with unresectable hepatocellular carcinoma.
Tremelimumab (Imjudo, AstraZeneca) is an anti-CTLA-4 monoclonal antibody. Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
The FDA based the approval on the results of the randomized phase 3 HIMALAYA trial, which included 1,324 patients with unresectable HCC who had not received prior systemic therapy and were ineligible for localized treatment.
Researchers assigned patients to one of three treatment regimens: durvalumab monotherapy; the STRIDE regimen, which includes a single 300-mg priming dose of tremelimumab with 1,500 mg durvalumab followed by durvalumab every 4 weeks; or standard-of-care sorafenib (Nexavar, Bayer), a multi-kinase inhibitor.
The study met its primary endpoint, showing a 22% reduction in risk for death with the STRIDE regimen compared with sorafenib (HR = 0.78; 95% CI, 0.66-0.92).
The study also met a key secondary endpoint, showing OS noninferiority with durvalumab monotherapy vs. sorafenib. Durvalumab also appeared more tolerable than sorafenib.
A higher percentage of patients assigned tremelimumab-durvalumab than sorafenib remained alive after 3 years (31% vs. 20%).
“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA trial, said in an AstraZeneca-issued press release. “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.”
The safety profiles of the tremelimumab-durvalumab combination appeared consistent with the known profiles of each therapy. Researchers observed no new safety signals.
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