FDA Approves Pembrolizumab Plus Chemotherapy for Patients With Primary Advanced or Recurrent Endometrial Cancer

On June 17, 2024, the US Food and Drug Administration (FDA) approved pembrolizumab plus carboplatin and paclitaxel followed by single-agent pembrolizumab for patients with primary advanced or recurrent endometrial cancer. This approval was based on results from the phase 3 KEYNOTE-868/NRG-GY018 trial.

In this double-blind, placebo-controlled trial, 810 patients were enrolled into 2 cohorts, according to mismatch repair status. There were 222 patients in the mismatch repair deficient (dMMR) cohort and 588 patients in the mismatch repair proficient (pMMR) cohort. All patients were randomized on a 1-to-1 basis to receive either 200 mg pembrolizumab every 3 weeks plus paclitaxel and carboplatin for 6 cycles, followed by 400 mg pembrolizumab every 6 weeks for up to 14 cycles, or placebo every 3 weeks plus paclitaxel and carboplatin for 6 cycles, followed by placebo every 6 weeks for up to 14 cycles. Randomization was stratified by mismatch repair status, ECOG performance, and prior adjuvant chemotherapy. The primary efficacy outcome was progression-free survival (PFS) as assessed by investigator.

In the dMMR cohort, the median PFS was not reached in the pembrolizumab arm vs 6.5 months in the placebo arm (hazard ratio [HR], 0.30; P < .0001). In the pMMR cohort, the median PFS was 11.1 months in the pembrolizumab arm vs 8.5 months in the placebo arm (HR, 0.60; P < .0001). Adverse reactions associated with pembrolizumab and chemotherapy were generally similar to those previously reported with this regimen, though there was a higher incidence of rash.

The recommended dose for pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months.

Source:

FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma. Published online: June 17, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-primary-advanced-or-recurrent-endometrial-carcinoma