First! Merck's PD-1 Inhibitor Keytruda Receives FDA Approval as First-Line Treatment for Advanced Endometrial Cancer

Keytruda is a PD-1 inhibitor developed by MSD, which can block the interaction between PD-1 and its ligands PD-L1 and PD-L2, releasing the PD-1 signaling pathway-mediatedImmunityResponse inhibition, thereby activating potential impactsTumor CellsAnd T lymphocytes of healthy cells, thereby enhancing the human immune system's ability to discover and eliminateCancer CellsThe ability.

Since it was first obtained in 2014FDAApproved for the treatment of advancedMelaninSince the approval of Keytruda for tumors, it has received FDA approval for the treatment of at least 16 types of cancer, as well as indications regardless of cancer type.

On June 18, 2024, the FDA approved MSD's PD-1 inhibitor Keytruda (pembrolizumab) for use in combination withCarboplatinIn combination with paclitaxel, followed by Keytruda monotherapy, for primary advanced or recurrentEndometrial CancerAdult patients.

It is reported that Keytruda is the first PD-1 targeted therapy approved by the U.S. FDA to be used in combination with chemotherapy for the treatment of adult patients with primary advanced or recurrent endometrial cancer, regardless of the patient's mismatch repair (MMR) status.

This approval was primarily based on a Phase 3 clinical trial. In this multicenter, randomized, double-blind, placebo-controlled trial, a total of 810 patients with advanced or recurrent endometrial cancer were enrolled, including two independent cohorts based on mismatch repair status: 222 patients in the mismatch repair-deficient (dMMR) cohort and 588 patients in the mismatch repair-proficient (pMMR) cohort. Patients were randomly assigned 1:1 to receive Keytruda in combination with chemotherapy (carboplatin and paclitaxel) followed by Keytruda monotherapy, or to receive placebo in combination with chemotherapy followed by placebo monotherapy.

The primary efficacy endpoint of the trial was progression-free survival (PFS). In the dMMR cohort, the median PFS was not reached in the Keytruda combination therapy group, while the median PFS in the placebo group was 6.5 months, showing a significant difference.StatisticsDifferences in studies. In the pMMR cohort, the median PFS was 11.1 months for the Keytruda combination therapy group and 8.5 months for the placebo group, with statistically significant differences. The study results were published in 2023 in The New England Journal of Medicine.

In the trial, adverse reactions related to Keytruda combination therapy were generally similar to previously reported trial results, but the incidence of rash was higher in patients.