Benzinga | Jan 19, 2022 07:56AM EST

Merck's Keytruda Manages To Cross The Finish Line In Liver Cancer Confirmatory Trial

Merck & Co Inc (NYSE:MRK) has posted the final results from the Phase 3 trial of Keytruda (pembrolizumab) plus best supportive care (BSC) in previously treated hepatocellular carcinoma (HCC) patients.

* Keytruda slashed the risk of death by 21% over placebo in hepatocellular carcinoma patients in Asia who had previously received sorafenib.

* Merck's Keytruda also beat placebo at shrinking tumors and preventing disease progression, according to data presented at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.

* The Company announced topline data in September.

* The results came from the Phase 3 KEYNOTE-394 trial, which is meant to serve as the new confirmatory trial for Keytruda's accelerated approval in post-Nexavar liver cancer; a previous phase 3 KEYNOTE-240 study narrowly missed its mark.

* Keytruda showed a similar 22% reduction in the risk of death in the global KEYNOTE-240 trial. But the new Asian trial met statistical significance.

* Keytruda + BSC showed a median overall survival of 14.6 months compared to 13.0 months on placebo.

* 34.3% of patients on the Keytruda regime stayed alive at two years compared to 24.9% for placebo plus BSC.

* There were three deaths in the Keytruda arm related to the study intervention.

* Price Action: MRK shares are down 0.50% at $81.13 during the premarket session on the last check Wednesday.