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Pembrolizumab missed statistical cutoffs in hepatocellular carcinoma study

Key clinical point: Pembrolizumab reduced risk of death by 22% versus placebo in a phase 3 study of patients with previously treated, advanced hepatocellular carcinoma, though results did not reach statistical significance by prespecified criteria.

Major finding: For pembrolizumab vs. placebo, median overall survival was 13.9 vs. 10.6 months, and median progression-free survival was 3.0 months vs. 2.8 months.

Study details: Results of the phase 3 KEYNOTE-240 trial, which comprised 413 patients.

Disclosures: Dr. Finn reported disclosures related to AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Exelixis, Genentech/Roche, Lilly, Merck, Novartis, and Pfizer.

Citation:

Finn RS et al. ASCO 2019, Abstract 4004.