Merck Terminates Phase III KEYLYNK-008 Trial of Keytruda Plus Lynparza in Metastatic Squamous Non-Small Cell Lung Cancer

On December 7, MSD announced the termination of the Phase III KEYLYNK-008 trial, which evaluated the efficacy of the PD-1 inhibitor Keytruda (pembrolizumab) in combination with the maintenance therapy PARP inhibitor Lynparza (olaparib) for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

This decision to terminate the study was primarily based on the recommendation of the independent Data Monitoring Committee (DMC), which reviewed the data from the planned interim analysis (IA3). In the interim analysis, compared to treatment with Keytruda plus placebo following Keytruda combined with chemotherapy, patients receiving Keytruda in combination with Lynparza after Keytruda plus chemotherapy did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints.

Another primary endpoint of the study, progression-free survival (PFS), did not reach statistical significance in the second interim analysis but showed numerical improvement compared to the control group. The safety profile of the trial was consistent with previously reported findings from personalized therapy studies, with no new safety signals identified.

MSD has an extensive clinical development program in lung cancer and is advancing several registrational studies targeting early stages of NSCLC. Key studies evaluating Keytruda combination therapy for NSCLC include KEYLYNK-006, KEYLYNK-012, KEYVIBE-003, KEYVIBE-006, and KEYVIBE-007.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reproduce it, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.