ENGOT-en11/GOG-3053/KEYNOTE-B21: A Randomised, Double-Blind, Phase 3 Study of Pembrolizumab or Placebo Plus Adjuvant Chemotherapy With or Without Radiotherapy in Patients With Newly Diagnosed, High-Risk Endometrial Cancer

AI Summary

This study focuses on the use of pembrolizumab in combination with adjuvant chemotherapy in patients with newly diagnosed, high-risk endometrial cancer. The research aims to evaluate the potential benefits of this treatment approach in patients without residual macroscopic disease post-surgery. Previous findings show that pembrolizumab plus chemotherapy can be beneficial for advanced endometrial cancer, especially in patients with certain genetic phenotypes. The results of this randomized, double-blind, phase 3 study could provide valuable insights into improving outcomes for patients with high-risk endometrial cancer.

Pembrolizumab plus chemotherapy provides clinically meaningful benefit as first-line therapy for advanced (locoregional extension and residual disease after surgery)/metastatic/recurrent pMMR and dMMR endometrial cancer (EC), with greater magnitude of benefit in the dMMR phenotype. We evaluated addition of pembrolizumab to adjuvant chemotherapy (with/without radiation therapy) among patients with newly-diagnosed, high-risk EC without any residual macroscopic disease following curative-intent surgery.

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