Merck's study of liver cancer PhIII for Keytruda fails on two key parameters, just three months after the FDA gave it the green light – Endpoints News



At a rare failure, Merck suffered a key Phase III failure for Keytruda, which could jeopardize its business prospects.

Roy Baynes

The pharmaceutical industry giant announced Tuesday after the market closed that Keytruda had failed the KEYNOTE-240 study regarding hepatocellular carcinoma, the most common type of liver cancer. The trial lacked overall survival and progression-free survival. This news came just three months after the FDA had proposed accelerated approval for liver cancer, based on their previous drug data.

To stay in the market, Merck needs positive pivotal data. Questions about the future of this drug in liver cancer have diverted the stock of Merck $ MRK, which had dropped a little over 1% after the release of the release.

Merck was quick to note that he was studying Keytruda as part of many other liver cancer studies, but the benefit has now clearly shifted to Opdivo, which has always lagged behind Keytruda after have failed in the treatment of lung cancer, where Merck stands on the front line. advantage.

This was not the only phase III confirmatory study to fail. Just a few weeks ago, Eli Lilly had to suspend the commercialization of Lartruvo after the failure of its pivot for soft tissue sarcoma. These consecutive setbacks, however, are not likely to slow down the FDA, which has been eager to issue accelerated approvals – particularly for cancer drugs – in recent years.

"Although we are disappointed that KEYNOTE-240 did not achieve its primary endpoints, overall survival, progression-free survival, and objective response rates are generally consistent with the results of the phase study. II KEYNOTE-224, which led to the accelerated approval of KEYTRUDA for the treatment of patients with hepatocellular carcinoma who had previously been treated with sorafenib, "said Roy Baynes, executive vice president and head of global clinical development and physician Chief, Merck Research Laboratories.


Photo credit: AP Images.


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