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# Positive Keytruda Data in Lung Cancer: Merck
- URL: https://www.fdaweb.com/positive-keytruda-data-in-lung-cancer-merck/
- Published: 2023-10-10T12:00:00.000Z
- Updated: 2026-09-14T19:01:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155531

Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS). During a recent interim analysis, the company says “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 in these patients.”

Merck says the data represent a significant milestone in treating this patient population as it represents the first Phase 3 study to show a statistically significant overall survival benefit. “As previously [announced](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fmerck-announces-phase-3-keynote-671-trial-met-primary-endpoint-of-event-free-survival-efs-in-patients-with-resectable-stage-ii-iiia-or-iiib-non-small-cell-lung-cancer%2F&esheet=53584650&newsitemid=20231010865018&lan=en-US&anchor=announced&index=1&md5=4f876cf537c561bd9d4b85b4bbb12a80&ref=fdaweb.com), at the first interim analysis, KEYNOTE-671 met the other one of its dual primary endpoints, event-free survival (EFS), as well as its key secondary endpoints of pathological complete response (pCR) and major pathological response (mPR),” it adds.

The company notes that data from the study is included in a supplemental BLA, which has a review action target date of 10/16.