CHMP recommends Keytruda + chemotherapy to treat metastatic cervical cancer. Merck Inc.,
Merck Inc.,has announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab (the Keytruda regimen), for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 1).
The recommendation is based on results from the Phase III KEYNOTE-826 trial, in which the Keytruda regimen demonstrated a statistically significant improvement in overall survival (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy with or without bevacizumab (the chemotherapy regimen) in this patient population. additionally, more patients responded to the keytruda regimen than to the chemotherapy regimen, with an objective response rate (orr) of 68% (95% ci, 62-74) versus 50% (95% ci, 44-56), respectively. the chmp’s recommendation will now be reviewed by the european commission for marketing authorization in the european union, and a final decision is expected in the second quarter of 2022.></0.0001)>
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