- Merck & Co Inc’s (NYSE: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.
Amneal Pharmaceuticals Q4 EPS $0.18 Misses $0.20 Estimate, Sales $537.00M Miss $537.35M Estimate
Amneal Pharmaceuticals (NYSE:AMRX) reported quarterly earnings of $0.18 per share which missed the analyst consensus estimate of $0.20 by 10 percent. This is a 28.57 percent increase over earnings of $0.14 per share from
