Durvalumab regimen confers durable survival benefit in unresectable liver cancer
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The combination of durvalumab and tremelimumab-actl conferred a sustained OS benefit at 4 years among patients with unresectable hepatocellular carcinoma, according to phase 3 trial results from the agents’ manufacturer.
Durvalumab (Imfinzi, AstraZeneca), binds to the PD-L1 protein and blocks interactions between PD-L1 and PD-1 and CD80 proteins. Tremelimumab-actl (Imjudo, AstraZeneca) blocks the activity of cytotoxic T-lymphocyte-associated protein 4, thus contributing to T-cell activation and priming the immune response to cancer.
The randomized, phase 3 HIMALAYA trial assessed the efficacy of the human monoclonal antibody combination vs. sorafenib (Nexavar, Bayer) among patients with unresectable hepatocellular carcinoma who had no prior systemic therapy and did not qualify for locoregional therapy.
Researchers randomly assigned 782 patients to receive either durvalumab monotherapy and a regimen consisting of a single priming dose of 300 mg tremelimumab-actl in addition to 1,500 mg durvalumab every 4 weeks (n = 393) vs. sorafenib, a standard-of-care multikinase inhibitor (n = 389).
Results, presented at ESMO World Congress on Gastrointestinal Cancer, showed median OS of 16.4 months (95% CI, 14.2-19.6) among patients in the investigative arm and 13.8 months (95% CI, 12.3-16.1) in the standard-of-care arm.
After 4 years of follow-up, the combination conferred a 22% reduction in risk for death compared with sonafenib (HR = 0.78; 95% CI, 0.67-0.92; 78% data maturity). Results showed 4-year OS rates of 25.2% with the combination and 15.1% with sorafenib alone.
“Historically, only [7%] of patients with advanced liver cancer have survived 5 years, making the HIMALAYA long-term survival data especially meaningful,” Bruno Sangro, MD, PhD, director of the liver unit and professor of internal medicine at Clínica Universidad de Navarra in Pamplona, Spain, and a lead investigator in the trial, said in a press release. “One in four patients treated with the [investigative] regimen were still alive at 4 years, reinforcing this novel regimen as a standard of care in this setting.”
Grade 3 or higher treatment-related adverse events occurred in 17.5% of patients treated with the investigative regimen and 9.6% of patients treated with sorafenib, with no new safety signals observed.
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