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NICE Backs Merck's Keytruda for PD-L1-Expressing Cervical Cancer

NEW YORK – The UK's National Institute for Health and Care Excellence on Wednesday recommended that the National Health Service provide Merck's Keytruda (pembrolizumab) plus chemotherapy with or without Genentech's Avastin (bevacizumab) as treatment for cervical cancer patients in England whose cancers express PD-L1 with a combined positive score of at least 1.

NICE recommended that the treatment be made available through the Cancer Drugs Fund in a final draft guidance. To reach its decision, NICE considered data from the Phase III clinical trial KEYNOTE-826, in which patients with recurrent, persistent, or metastatic cervical cancer received either Keytruda plus chemo with or without Avastin or placebo plus chemo with or without Avastin. The median overall survival in the subgroup of patients with a PD-L1 CPS score of at least 1 was not yet reached for the Keytruda-containing arm, versus 16.3 months for the placebo-containing arm.

The extent of the overall survival benefit with added Keytruda is not yet clear, though the trial is ongoing. The ongoing trial data will also help NICE establish whether Keytruda is cost effective, according to a statement from NICE. Keytruda's list price is £2,630.00 ($3,244.89) per 100 mg/4 ml concentrate for solution for infusion vial, though the company has struck a confidential commercial arrangement with Merck to provide the drug to NHS at a discount.

"Pembrolizumab shows promise as the first effective immunotherapy [for cervical cancer]," Helen Knight, the director of medicines evaluation at NICE, said in a statement. "However, to ensure the best use of limited public funding, we need additional evidence to fully analyze its clinical and cost effectiveness before it can be considered for routine NHS use. Recommending pembrolizumab to the CDF means people have faster access to care while this further evidence is gathered."

In the US and Europe, Keytruda plus chemo with or without Avastin is already approved as a first-line treatment for advanced cervical cancer patients with PD-L1 expressing tumors.