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NICE Recommends Keytruda for Neoadjuvant, Adjuvant Treatment of Triple-Negative Breast Cancer

NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Tuesday recommended Merck's Keytruda (pembrolizumab) with chemotherapy as a neoadjuvant treatment and single-agent Keytruda as an adjuvant treatment for patients with early or locally advanced triple-negative breast cancer.

NICE issued a draft guidance recommending the treatments after reviewing data from the Phase III KEYNOTE-522 trial, in which 63 percent of TNBC patients receiving neoadjuvant and adjuvant treatment with Keytruda responded compared to 55.6 percent in the placebo plus chemo arm.

Event-free survival was also better among Keytruda-treated patients in the trial. In the Keytruda arm, event-free survival at 42 months was 83.5 percent compared to 74.9 percent in the placebo arm. There was no statistically significant difference in overall survival between the two treatment arms, however, which may be due to immature data.

Keytruda's list price is £2,630 ($3,039) for a 100 mg infusion vial. NICE noted in its draft guidance that Merck is providing Keytruda to the National Health Service at an undisclosed discount.

"Triple-negative breast cancer has a relatively poor prognosis and there are few effective treatments compared with other types of the disease," Helen Knight, interim director of medicines evaluation at NICE, said in a statement. "Today's draft guidance means that we have now recommended three new treatments for routine use in the NHS since June, helping to address this unmet need and giving hope of a longer and a better quality of life to thousands of people."

In July, NICE also recommended Gilead's Trodelvy (sacituzumab govitecan) for previously treated locally advanced or metastatic TNBC.

NICE estimated that around 3,200 people in England have TNBC, and that half, approximately 1,600 patients, will be eligible for neoadjuvant and adjuvant treatment with Keytruda under this guidance once finalized.

NICE expects to publish a final guidance on this Keytruda indication in December.