Merck’s Keytruda manages to cross finish line in confirmatory liver cancer trial

Merck & Co Inc. M.K.R. at published the final results of the phase 3 trial of Keytruda (pembrolizumab) plus best supportive care (BSC) in patients with previously treated hepatocellular carcinoma (HCC).

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  • Keytruda reduced the risk of death by 21% compared with placebo in patients with hepatocellular carcinoma in Asia who had previously received sorafenib.
  • Merck’s Keytruda also beat placebo in shrinking tumors and preventing disease progression, according to data presented at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium.
  • The Company has announced main data in september.
  • The results come from the KEYNOTE-394 Phase 3 trial, which is expected to serve as a new confirmatory trial for accelerated approval of Keytruda in post-Nexavar liver cancer; a previous phase 3 The KEYNOTE-240 study narrowly missed its target.
  • Keytruda showed a similar 22% reduction in the risk of death in the global KEYNOTE-240 trial. But the new Asian trial met with statistical significance.
  • Keytruda + BSC showed a median overall survival of 14.6 months versus 13.0 months on placebo.
  • 34.3% of patients on the Keytruda regimen remained alive at two years compared to 24.9% for the placebo plus BSC.
  • There were three deaths in the Keytruda arm related to the study intervention.
  • Price action: Shares of MRK are down 0.50% at $81.13 in the premarket session of the last check on Wednesday.

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