Merck announces CHMP recommendation for two Keytruda indications

Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, adopted opinions recommending approval of Keytruda, 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 opinion recommends the approval of Keytruda in combination with chemoradiotherapy for the treatment of FIGO 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, and final decisions are expected in the fourth quarter of 2024. The recommendation in primary advanced or recurrent endometrial carcinoma is based on the NRG-GY018 trial, also known as KEYNOTE-868, evaluating Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent. In this study, the Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus placebo plus carboplatin and paclitaxel. If approved, this would mark the third indication for Keytruda in endometrial cancer in Europe.