Policy & Regulation
FDA grants priority review to Merck's KEYTRUDA plus chemotherapy for endometrial carcinoma
20 February 2024 -

Biopharmaceutical company Merck (NYSE: MRK) announced on Tuesday that its anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in combination with standard chemotherapy, has received priority review from the FDA for treating primary advanced or recurrent endometrial carcinoma. The pivotal Phase 3 NRG-GY018 trial demonstrated a significant improvement in progression-free survival, with a target action date of 21 June 2024.

Results from the trial showed a 46% risk reduction in disease progression or death for mismatch repair proficient (pMMR) patients and a 70% reduction for mismatch

The trial, sponsored by the U.S. National Cancer Institute, involves international partners under Project Orbis, including Israel, Canada, Australia, Singapore and Brazil.

If approved, KEYTRUDA would be the first immunotherapy for frontline treatment, regardless of mismatch repair status.

Merck currently holds two approved indications for KEYTRUDA in endometrial cancer. One is in combination with LENVIMA and the other as a single agent.

KEYTRUDA's broader clinical development program spans breast and gynecologic cancers, with ongoing Phase 3 studies evaluating its efficacy in various settings.

The randomized Phase 3 trial demonstrated the efficacy of KEYTRUDA with standard chemotherapy versus placebo plus chemotherapy in treating endometrial cancer. The trial included 816 patients with primary advanced or recurrent disease.

Endometrial carcinoma is the most common gynecological cancer globally. In 2024, an estimated 67,880 new cases and 13,250 deaths are expected in the US.

Merck's extensive immuno-oncology clinical research program comprises over 1,600 trials exploring KEYTRUDA® across diverse cancers and settings. The program aims to understand KEYTRUDA's role and predictive factors for patient benefit.

KEYTRUDA holds two indications in endometrial cancer, including a combination with LENVIMA® and as a single agent. Additionally, Merck is evaluating KEYTRUDA in other gynecologic cancers.

LENVIMA, in combination with pembrolizumab, is indicated for advanced endometrial carcinoma, providing additional treatment options.

Merck's Focus on CancerMerck is committed to translating breakthrough science into innovative oncology medicines, focusing on immuno-oncology and exploring new possibilities to bring hope to cancer patients worldwide.