Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending the approval of KEYTRUDA® (pembrolizumab) for two gynecologic cancer indications.
The first recommendation is for 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 eligible for systemic therapy. The second positive opinion supports the approval of KEYTRUDA in combination with chemoradiotherapy (CRT) for adults with FIGO 2014 Stage III-IVA locally advanced cervical cancer who have not received prior definitive therapy. The European Commission will now review the CHMP’s recommendations, with final decisions anticipated in the fourth quarter of 2024.
“At Merck, we are dedicated to expanding the role of KEYTRUDA to improve outcomes for patients with challenging gynecologic cancers,” said Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories. “These positive CHMP opinions bring us closer to offering new immunotherapy-based regimens to patients with endometrial and cervical cancer in the European Union. We eagerly await the European Commission’s decisions.”
The endometrial carcinoma recommendation is based on the NRG-GY018 trial (KEYNOTE-868), which evaluated KEYTRUDA with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent. This regimen showed a significant improvement in progression-free survival (PFS) compared to the placebo plus carboplatin and paclitaxel combination. If approved, this would be the third indication for KEYTRUDA in endometrial cancer in Europe. Previous approvals include the combination of KEYTRUDA with LENVIMA® (lenvatinib) in November 2021, and KEYTRUDA monotherapy in April 2022, both for patients with advanced or recurrent endometrial carcinoma. In June 2024, the same combination of KEYTRUDA with carboplatin and paclitaxel was approved in the U.S. for similar patients.
The cervical cancer recommendation stems from the KEYNOTE-A18 trial (ENGOT-cx11/GOG-3047), which showed significant improvements in overall survival (OS) and PFS with KEYTRUDA plus CRT compared to CRT alone. If approved, this would be KEYTRUDA’s second indication for cervical cancer in Europe. Previously, in April 2022, KEYTRUDA in combination with chemotherapy, with or without bevacizumab, was approved for persistent, recurrent, or metastatic cervical cancer in patients whose tumors express PD-L1. In January 2024, KEYTRUDA combined with CRT was approved in the U.S. for FIGO 2014 Stage III-IVA cervical cancer.
