The FDA approved Keytruda as a single agent for patients with first-line metastatic or unresectable colorectal cancer that carries the biomarker MSI-H or dMMR. The drug was the first to win a biomarker-based, tumor-agnostic label, in 2017.
Drug regulators in the U.S., Canada and Australia simultaneously approved Merck's Keytruda and Eisai's Lenvima for advanced endometrial carcinoma following a collaborative review under a program called Project Orbis.
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The study, by Personal Genome Diagnostics and academic researchers, was able to predict responses to checkpoint inhibitor therapy in patients with MSI-H and high tumor mutational burden.
The company also advanced a therapy, a personalized cancer vaccine in melanoma, into a Phase II study as the first patient in the trial consented.
The study, by US and Korean researchers, found Guardant360's detection of MSI-H/dMMR "highly concordant" with that of standard tissue biopsy, including in a subset of gastric cancer patients who responded to immunotherapy.
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche's Tecentriq.
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The company said it had shared data from the Phase III study with the FDA. However, per FDA regulations, there is a risk that the accelerated approval for hepatocellular carcinoma could be withdrawn.