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Pembrolizumab Misses Primary Endpoints in HCC Trial

Gina Columbus @ginacolumbusonc
Published: Wednesday, Feb 20, 2019

Dr. Roy Baynes

Roy Baynes, MD, PhD
The combination of pembrolizumab (Keytruda) plus best supportive care for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy did not improve progression-free or overall survival (OS) compared with placebo plus best supportive care alone, missing the coprimary endpoints of the KEYNOTE-240 trial (NCT02702401).1

Results of the final analysis showed that the pembrolizumab regimen did improve OS versus placebo; however, it was not deemed statistically significant per the prespecified statistical plan (HR, 0.78; 95% CI, 0.611-0.998; P = .0238). Additionally, there was a progression-free survival (PFS) improvement with pembrolizumab that also did not reach statistical significance (HR, 0.78; 95% CI, 0.61-0.99; P = .0219). Since superiority was not reached in either primary endpoint, overall response rate (ORR), which was a key secondary endpoint, was not formally tested, explained Merck, the developer of pembrolizumab, in a press release.

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