CHMP positive for Keytruda (pembrolizumab) + chemotherapy to treat FIGO 2024 Stage III-IVA locally advanced cervical cancer
Merck Inc.,( known as MSD outside of the United States and Canada) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynecologic cancers.
The first opinion recommends the approval of Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy. The second positive opinion recommends the approval of Keytruda in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and final decisions are expected in the fourth quarter of 2024.
The recommendation in newly diagnosed patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer is based on the KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, in which Keytruda in combination with concurrent CRT demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and PFS versus CRT alone. If approved, this would mark the second indication for Keyruda in cervical cancer in Europe. Keytruda plus chemotherapy, with or without bevacizumab, was approved in April 2022 for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 1). In January 2024 , Keytruda in combination with CRT was aApproved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer
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