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Phase 3 trial of pembrolizumab for advanced HCC fails to meet primary endpoints
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The addition of pembrolizumab to best supportive care failed to extend survival among patients with advanced hepatocellular carcinoma who received prior systemic therapy, according to study results released by the agent’s manufacturer.
The randomized phase 3 KEYNOTE-240 trial included 413 patients with advanced HCC who received prior systemic therapy.
Researchers assigned patients to best supportive care plus either placebo or the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) dosed at 200 mg every 3 weeks for up to 35 cycles.
OS and PFS served as co-primary endpoints. Secondary endpoints included objective response rate, duration of response, disease control rate and time to progression.
Results showed pembrolizumab-treated patients achieved longer OS (HR = 0.78; 95% CI, 0.61-0.99) and PFS (HR = 0.78; 95% CI, 0.61-0.99), but the differences did not reach statistical significance per the prespecified statistical plan.
Investigators did not formally test ORR because OS and PFS superiority was not reached.
The safety profile of pembrolizumab appeared consistent with that observed in prior studies.
Results of KEYNOTE-240 will be presented at a future medical meeting.
The FDA previously approved pembrolizumab for treatment of patients with HCC who received sorafenib (Nexavar, Bayer).