First Disclosure: Merck Announces Overall Survival Data from Pivotal Phase 3 KEYNOTE-671 Study at ESMO

On October 20, MSD announced for the first time the overall survival data from its pivotal Phase III KEYNOTE-671 trial and updated the event-free survival data. The study aims to evaluate MSD's PD-1 inhibitor pembrolizumab in the perioperative setting (pembrolizumab combined with chemotherapy as neoadjuvant treatment, followed by pembrolizumab monotherapy as adjuvant treatment) for resectable Stage II, IIIA, and IIIB non-small cell lung cancer. The updated data from the KEYNOTE-671 study were presented for the first time in an oral presentation session at the European Society for Medical Oncology (ESMO) Annual Congress (Abstract #LBA56).

KEYNOTE-671 Study is a randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant treatment, followed by pembrolizumab monotherapy as adjuvant treatment post-surgery, in patients with resectable Stage II, IIIA, and IIIB non-small cell lung cancer. The primary endpoints of the study are event-free survival (EFS) and overall survival (OS); key secondary endpoints include pathological complete response rate (pCR) and major pathological response rate (mPR). A total of 797 patients were enrolled in the trial and randomly assigned in a 1:1 ratio to the experimental group or control group: the experimental group received pembrolizumab combined with chemotherapy as neoadjuvant treatment and pembrolizumab monotherapy as adjuvant treatment post-surgery, while the control group received placebo combined with chemotherapy as neoadjuvant treatment and placebo as adjuvant treatment post-surgery.

MSD has a broad clinical research program in the field of lung cancer and is advancing several early-stage clinical studies in this area.

References:

1. As of now, the National Medical Products Administration (NMPA) has approved the following indications for pembrolizumab, other indications have not been approved yet:

For the treatment of unresectable or metastatic melanoma that has failed first-line therapy;

Approved by the National Medical Products Administration (NMPA) for first-line monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% as assessed by a validated test.

Editor: Mu Mian

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