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NICE Recommends Keytruda for Metastatic MSI-High, Mismatch Repair-Deficient Colorectal Cancer

NEW YORK -- The UK's National Institute for Health and Care Excellence (NICE) on Friday recommended that the National Health Service provide pembrolizumab (Merck's Keytruda) as a treatment for newly diagnosed metastatic colorectal cancer patients whose tumors have high microsatellite instability (MSI) or mismatch repair deficiency (dMMR).

NICE issued a draft guidance recommending pembrolizumab for previously untreated patients based on results from the Phase III Keynote-177 trial, which randomized patients with confirmed MSI-high or dMMR cancers to receive either pembrolizumab or the investigator's choice of standard-of-care therapy. After two years of follow-up, 48.3 percent of patients who received the pembrolizumab were alive without disease progression, versus 18.6 percent of those on chemotherapy. Based on these results, the US Food and Drug Administration approved pembrolizumab for this same indication in June 2020. The European Commission followed suit in January 2021.

Because Keynote-177 did not report a survival benefit with pembrolizumab treatment beyond the two-year mark, NICE is only recommending advanced colorectal cancer patients receive the PD-1 inhibitor for 24 months. If after that time a patient has not experienced disease progression, NICE said pembrolizumab should be stopped.

If NICE's recommendation is finalized in June 2021 as expected, the guidance would make pembrolizumab an option for roughly 450 patients with treatment-naïve, metastatic MSI-high or dMMR colorectal cancer in the UK.

The treatment, administered intravenously every three weeks, has an average list price of £5,260 ($7,407) per infusion, though Merck has offered to provide the drug to the NHS at an undisclosed discounted price.