Merck's Lead Cancer Drug Meets Primary Goal In Certain Type Of Lung Cancer Patients

Merck & Co Inc MRK reported topline data from the Phase 3 KEYNOTE-671 trial investigating Keytruda, Merck's anti-PD-1 therapy, as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC).

The perioperative period is the period of a patient's surgical procedure.

The study met its dual primary endpoint of overall survival (OS).

Keytruda plus chemotherapy before surgery (neoadjuvant), followed by resection and Keytruda as a single agent after surgery (adjuvant), demonstrated a statistically significant and clinically meaningful improvement in OS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo.

Also Read: Merck's Keytruda Combo Therapy Less Effective Than Chemo In Lung Cancer Patients, Data Shows.

Full results from this analysis of KEYNOTE-671 will be presented at the European Society for Medical Oncology Congress 2023.

As previously announced, at the first interim analysis, KEYNOTE-671 met the other one of its dual primary endpoints, event-free survival, and its key secondary endpoints of pathological complete response and major pathological response. 

The FDA has accepted Merck's new supplemental marketing application with a Prescription Drug User Fee Act, or target action, date of October 16, 2023.

Price Action: MRK shares are down 0.11% at $104.38 on the last check Tuesday.