After Shelving Two Keytruda Trials, Merck Touts Encouraging Data From Keytruda Regime Study In Lung Cancer Patients

Merck & Co Inc's MRK Phase 3 KEYNOTE-671 trial investigating Keytruda met one of its dual primary endpoints, event-free survival (EFS), as a perioperative treatment regimen for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC).
A perioperative treatment regimen includes treatment before surgery (neoadjuvant) and continued after surgery (adjuvant).
The trial will continue to evaluate the other dual primary endpoint of overall survival (OS).
Also Read: Merck Discontinues Two Keytruda Combo Therapy Trials In Prostate & Lung Cancer Settings.
At a prespecified interim analysis conducted by an independent Data Monitoring Committee, neoadjuvant Keytruda plus chemotherapy followed by resection and adjuvant single-agent Keytruda demonstrated a statistically significant and clinically meaningful improvement in EFS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo.
Statistically significant improvements in the trial's key secondary endpoints of pathological complete response (pCR) and major pathological response (mPR) were also demonstrated. No new safety signals were observed.
The FDA has accepted Merck's new supplemental Biologics License Application (sBLA) based on these data for Keytruda with a target action date of October 16, 2023.
Price Action: MRK shares are up 0.77% at $107.08 on the last check Wednesday.