FDA ALERT

FDA Approves Pembrolizumab With Chemotherapy to Treat Primary Advance or Recurrent Endometrial Carcinoma in Patients

Jessica Ganga

In June, the FDA approved the use of pembrolizumab with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for patients with primary advanced or recurrent endometrial carcinoma.

The approval follows a multicenter, randomized, double-blind, placebo-controlled trial (KEYNOTE-868/NRG-GY018 [NCT03914612]). In total, 810 patients with advanced or recurrent endometrial carcinoma were enrolled in the study. The patients were divided into two cohorts based on mismatch repair status: 222 patients in the mismatch repair deficient (dMMR) cohort, and 588 patients in the mismatch repair (pMMR) proficient cohort. Progression-free survival (PFS) was the major efficacy outcome measure.

Patients were randomized (1:1) to receive one of the following treatments:

  • Pembrolizumab 200 mg every 3 weeks, paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for six cycles, followed by pembrolizumab 400 mg every 6 weeks for up to 14 cycles.
  • Placebo every 3 weeks, paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for 6 cycles, followed by placebo every 6 weeks for up to 14 cycles.

In the dMMR cohort, the median PFS was not reached in the pembrolizumab and chemotherapy arm (95% CI: 30.7, not reached). For the placebo and chemotherapy arm, median PFS was 6.5 months (95% CI: 6.4, 8.7). In the pMMR cohort, median PFS was 11.1 months in the chemotherapy arm (95% CI: 8.7, 13.5) and 8.5 months for the placebo and chemotherapy arm (95% CI: 7.2, 8.8).

“The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months,” according to the press release.

Adverse reactions were similar to those previously reported for pembrolizumab or chemotherapy except for a higher incidence of a rash in patients. Additional adverse reactions can be found in the prescribing information.

 

Reference:

FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma. News release. US Food and Drug Administration; June 17, 2024. Accessed August 1, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-primary-advanced-or-recurrent-endometrial-carcinoma