FDA Approves KEYTRUDA + Chemo for Advanced Endometrial Carcinoma

FRIDAY, June 21, 2024 – The U.S. Food and Drug Administration (FDA) has endorsed the use of Keytruda (pembrolizumab) combined with chemotherapy for adult patients diagnosed with primary advanced or recurrent endometrial carcinoma. This marks the third instance in which Keytruda has received FDA approval for treating endometrial carcinoma.

Keytruda, an anti-programmed death receptor-1 (anti-PD-1) therapy, is approved for use alongside carboplatin and paclitaxel, followed by Keytruda alone, in treating adult patients with primary advanced or recurrent endometrial carcinoma. The FDA’s decision was influenced by data from the phase 3 KEYNOTE-868 trial. The trial revealed that Keytruda combined with carboplatin and paclitaxel, followed by Keytruda as a single agent, significantly decreased the risk of disease progression or death by 40% in patients with mismatch repair-proficient (pMMR) cancer and by 70% in those with mismatch repair-deficient (dMMR) cancer, compared to a placebo with carboplatin and paclitaxel followed by a placebo alone.

For patients with pMMR cancer, the median progression-free survival with Keytruda was 11.1 months, in contrast to 8.5 months with the placebo. For those with dMMR cancer, the median progression-free survival was not reached with Keytruda, while it was 6.5 months with the placebo.

Dr. Gursel Aktan, from Merck Research Laboratories, emphasized the significance of this approval. He noted that endometrial cancer has become the most prevalent gynecologic cancer in the United States, with deaths from the disease anticipated to exceed those from ovarian cancer in 2024. This highlights the urgent need for improved treatment options for more patients. Dr. Aktan stated, "This approval represents the first and only anti-PD-1-based option for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status, building on the established role of Keytruda in certain types of advanced endometrial carcinoma as monotherapy and in combination with Lenvima."

This new indication for Keytruda was granted to Merck, reinforcing the drug's potential to address critical gaps in cancer treatment. With the increasing incidence of endometrial carcinoma, advancements like these are essential to improving patient outcomes and offering new hope to those affected by the disease.

This FDA approval not only underscores the efficacy of Keytruda in combination with chemotherapy but also highlights the importance of continued research and development in the field of oncology. Ensuring that patients have access to the most effective treatments remains a top priority, and breakthroughs such as this represent a significant step forward in the fight against cancer.