The P-III trial (KEYNOTE-671) evaluating neoadjuvant Keytruda + CT vs PBO + CT in a ratio (1:1) in 786 patients with resectable stage II, IIIA, or IIIB (T3-4N2) NSCLC
The trial met its 1EPs of EFS as a perioperative treatment regimen while the trial will continue to evaluate the other dual 1EPs of OS. In a prespecified interim analysis, neoadjuvant Keytruda + CT showed a clinical improvement in EFS, followed by resection & adjuvant single-agent Keytruda, improvements in the 2EPs of pCR & mPR with no new safety signals
The US FDA has accepted a new sBLA of Keytruda in combination with Pt containing CT as neoadjuvant treatment, and then continued as monotx. as adjuvant treatment & the PDUFA date is expected on Oct 16, 2023
Ref: Merck | Image: Merck
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