The EC has granted approval to the company’s Keytruda + Pt-based CT as neoadjuvant treatment followed by Keytruda monotx. as adjuvant treatment, for treating adults with resectable NSCLC at high risk of recurrence
The approval was supported by the P-III (KEYNOTE-671) study assessing the safety & efficacy of Keytruda + neoadjuvant CT, followed by surgery & Keytruda monotx. as adjuvant treatment vs PBO + neoadjuvant CT, followed by resection & adjuvant PBO for treating resectable stage II, IIIA or IIIB NSCLC patients (n=797)
The study, at a median follow-up of 29.8mos., demonstrated an improved OS by 28% with mOS not attained vs 52.4mos. & an improved EFS by 41% with mEFS of 47.2mos. vs 18.3 mos.
Ref: Merck | Image: Merck
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