Merck's Keytruda Bags European Nod for indications in Gynaecologic Cancers

Merck, a leading pharmaceutical firm, stated that Keytruda (pembrolizumab), their anti-PD-1 therapy, has received approval from the European Commission (EC) for two additional uses in gynaecologic cancers. Keytruda has received initial approval for use alongside carboplatin and paclitaxel as the first-line treatment option for primary advanced or recurrent endometrial carcinoma in adult patients eligible for systemic therapy.

The second approval is for Keytruda, along with chemoradiotherapy (CRT), for treating adults with FIGO 2014 Stage III-IVA locally advanced cervical cancer who have not had prior definitive therapy. Keytruda has now been given approval for a total of 30 uses in the EU, which include five specifically for gynaecologic cancers – three for endometrial cancer and two for cervical cancer.

“These Keytruda-based regimens have the potential to change the treatment paradigm for people with endometrial and cervical cancer, two of the most commonly diagnosed cancers among women in Europe,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “These approvals underscore the continued expansion of the use of Keytruda in diverse patient populations and treatment settings with utility of Keytruda ranging from earlier lines of therapy to treating advanced disease.”

The EC approvals stem from data in the phase 3 clinical trials NRG-GY018 (KEYNOTE-868) and KEYNOTE-A18 (ENGOT-cx11/GOG-3047), following positive recommendations from the Committee for Medicinal Products for Human Use in September 2024.

In the study NRG-GY018/KEYNOTE-868, Keytruda with carboplatin and paclitaxel, then Keytruda alone, showed a significant and meaningful increase in progression-free survival (PFS) versus just chemotherapy.