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FDA Approves KEYTRUDA® Combination Therapy for Primary Advanced or Recurrent Endometrial Carcinoma

NextEdge Admin

19 Jun 2024

2 min 43 sec

Merck, also known as MSD outside the U.S. and Canada, has received FDA approval for KEYTRUDA (pembrolizumab) in combination with carboplatin and paclitaxel, followed by KEYTRUDA alone, for treating adult patients with primary advanced or recurrent endometrial carcinoma. This marks KEYTRUDA's 40th indication in the U.S. and is based on data from the Phase 3 NRG-GY018 trial (KEYNOTE-868).

The trial demonstrated significant benefits in progression-free survival (PFS) across two cohorts: a 40% reduction in risk for patients with mismatch repair proficient (pMMR) tumors and a 70% reduction for those with mismatch repair deficient (dMMR) tumors compared to placebo with standard chemotherapy.

Dr. Ramez N. Eskander, the principal investigator, emphasized that this approval is groundbreaking as it is the first Phase 3 trial to assess an anti-PD-1 immunotherapy in combination with chemotherapy for these patients, regardless of mismatch repair status.

KEYTRUDA's safety profile was underscored, noting immune-mediated adverse reactions that could affect multiple organ systems and the potential for severe infusion-related reactions. Management strategies, including corticosteroid administration and treatment discontinuation, were highlighted to mitigate these risks.

The approval addresses a critical medical need as endometrial cancer becomes increasingly prevalent, surpassing ovarian cancer in projected mortality rates. Dr. Gursel Aktan highlighted the significance of this approval, positioning KEYTRUDA as the first anti-PD-1-based treatment option for these patients, complementing its existing roles in advanced endometrial carcinoma treatment either alone or in combination with LENVIMA.

This milestone was achieved under Project Orbis, an FDA initiative for simultaneous international drug reviews, with ongoing evaluations in several countries. The collaboration underscores the global impact and urgency in advancing treatment options for patients with advanced or recurrent endometrial carcinoma.