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EMA's CHMP Issues Positive Recommendation for Merck's Keytruda in PD-L1-Expressing Cervical Cancers

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday issued a positive opinion for Merck's Keytruda (pembrolizumab) as a treatment for advanced, PD-L1-positive cervical cancer.

The committee recommended approval for the checkpoint inhibitor plus chemotherapy with or without Genentech's VEGF inhibitor Avastin (bevacizumab) for persistent, recurrent, or metastatic cervical cancer patients whose tumors express PD-L1 with a combined positive score of at least one.

CHMP's recommendation is based on results from the Phase III KEYNOTE-826 trial, in which patients treated with the Keytruda-containing regimen lived longer overall, as well as without their diseases progressing, than patients treated with chemotherapy with or without bevacizumab.

Patients were enrolled to the trial regardless of PD-L1 expression, but among those with PD-L1-positive tumors, the median overall survival was not yet reached for patients in the immune checkpoint inhibitor arm versus 16.3 months in the control arm. The median progression-free survival was 10.4 months and 8.2 months for the pembrolizumab-containing and comparator regimens, respectively. The objective response rate among patients treated with the immunotherapy was 68 percent versus 50 percent in the control arm.

The European Commission will now review CHMP's opinion and decide whether to approve Keytruda for this indication in the second quarter of this year.

In October, the US Food and Drug Administration approved Keytruda in the same setting. In the US, Keytruda also has approval as a single agent for previously treated PD-L1-positive cervical cancer patients. For the latter indication, the FDA also approved Agilent Technologies' Dako PD-L1 IHC 22C3 pharmDx test as a companion diagnostic to identify treatment-eligible patients with PD-L1-positive tumors.