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MEDTECH FDA Approval of Pembrolizumab Combination Therapy for Advanced or Recurrent Endometrial Cancer Shows Significant Progression-Free Survival Benefits
The FDA has approved a new treatment regimen involving pembrolizumab in combination with carboplatin and paclitaxel, followed by pembrolizumab monotherapy, for adults with advanced or recurrent endometrial carcinoma. This decision is grounded in the robust findings from the KEYNOTE-868/NRG-GY018 clinical trial, which highlighted notable improvements in progression-free survival among patients, particularly those with mismatch repair deficient (dMMR) and proficient (pMMR) statuses.
Key Points:
- Approval Date: June 17
- Combination Therapy: Pembrolizumab (Keytruda) with carboplatin and paclitaxel, followed by pembrolizumab monotherapy.
- Target Population: Adults with primary advanced or recurrent endometrial carcinoma.
- Study Basis: FDA decision based on data from the KEYNOTE-868/NRG-GY018 trial.
- Study Design: Multicenter, randomized, double-blind, placebo-controlled phase 3 trial involving 810 patients.
- Cohort Stratification: Patients divided into mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) cohorts.
- Randomization: 1:1 random assignment to pembrolizumab plus carboplatin and paclitaxel, or placebo plus carboplatin and paclitaxel.
- Progression-Free Survival (PFS):
- dMMR Cohort: Median PFS not reached in the pembrolizumab group vs. 6.5 months in the placebo group (HR, 0.30; P<.0001).
- pMMR Cohort: Median PFS of 11.1 months in the pembrolizumab group vs. 8.5 months in the placebo group (HR, 0.60; P<.0001).
- Adverse Reactions: Similar to previous studies, with a higher incidence of rash reported in KEYNOTE-868.
- Dosing: Pembrolizumab 200 mg every three weeks or 400 mg every six weeks, for up to 24 weeks or until disease progression or unacceptable toxicity.
- Previously Approved Indications: Pembrolizumab is approved for multiple cancer types, including melanoma, non-small cell lung cancer, and others.
Keytruda (pembrolizumab), a programmed death-1 (PD-1) inhibitor, was first approved by the FDA in 2014 for the treatment of melanoma. Since then, it has been approved for various other cancers, demonstrating its broad applicability and effectiveness in oncology.
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