US FDA Nod Merck's Keytruda Plus Carboplatin And Paclitaxel

Merck reported that the US Food and Drug Administration (FDA) has approved Keytruda, the company's anti-PD-1 medication, in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This is the third endometrial cancer indication and the 40th overall for Keytruda in the United States.

Based on data from the phase 3 NRG-GY018 trial, also known as KEYNOTE-868, the approval was granted. In this clinical trial, patients whose cancer was mismatch repair proficient (pMMR) or deficient (dMMR) had a 40% lower risk of disease progression or death when treated with Keytruda plus carboplatin and paclitaxel followed by Keytruda alone, compared with patients treated with placebo with carboplatin and paclitaxel followed by placebo alone.

“This is the first phase 3 trial to statistically evaluate an anti-PD-1 immunotherapy plus chemotherapy combination in patients with pMMR and dMMR tumours as two independent cohorts,” said Dr. Ramez N. Eskander, principal investigator, associate professor in the Department of Obstetrics, Gynaecology, and Reproductive Services at University of California San Diego School of Medicine and gynecologic oncologist at Moores Cancer Center at University of California San Diego Health. “The addition of pembrolizumab to chemotherapy represents a new frontline therapeutic option for patients with primary advanced or recurrent endometrial carcinoma, demonstrating a statistically significant and clinically meaningful progression-free survival benefit compared to chemotherapy alone, regardless of mismatch repair status."