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NICE Recommends Merck's Keytruda for MSI-High, dMMR Endometrial, GI Cancers

NEW YORK – The National Institute for Health and Care Excellence (NICE) on Thursday recommended Merck's Keytruda (pembrolizumab) for patients in England with previously treated, advanced endometrial, gastric, biliary, colorectal, or small intestine cancers that are microsatellite instability (MSI)-high or DNA mismatch repair-deficient (dMMR).

In a final draft guidance, NICE determined that Keytruda's cost-effectiveness falls within a range it considers an acceptable use of the National Health Service's resources. The immune checkpoint inhibitor's list price is £2,630.00 ($3,359.42) for an infusion vial of 25 mg per 1 ml concentrate solution, but Merck is providing the drug to the NHS at an undisclosed discount.

NICE's recommendation would make Keytruda available to previously treated patients in England with these five types of cancers when they are MSI-high or dMMR. Specifically, patients with advanced or recurrent endometrial cancer must have progressed on platinum-based therapy and cannot be candidates for curative surgery or radiotherapy. Patients with unresectable or metastatic gastric, small intestine, or biliary cancer must have progressed on one treatment. Colorectal cancer patients can receive Keytruda after fluoropyrimidine combination therapy, but only if they cannot have Bristol Myers Squibb's immunotherapy combination of Opdivo (nivolumab) plus Yervoy (ipilimumab).

The institute stipulated that patients should stop Keytruda treatment after two years, or sooner if their cancer progresses.

In recommending Keytruda, NICE considered evidence from several trials, including the Phase II KEYNOTE-158 and KEYNOTE-164 studies. Last year, the European Medicines Agency's Committee for Medicinal Products for Human Use similarly recommended the drug for patients in Europe with these five MSI-high or dMMR tumors.

Keytruda is also approved in the US for first-line treatment of metastatic or unresectable colorectal cancer and previously treated metastatic uterine cancer characterized by high MSI or dMMR. Earlier this year, Merck garnered full US Food and Drug Administration approval for Keytruda when patients have any type of MSI-high and dMMR refractory solid tumor and are out of treatment options.