Merck receives positive EU CHMP opinion for KEYTRUDA

Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adults. The recommendation is based on results from the Phase 3 KEYNOTE-671 trial, in which neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as a single agent after surgical resection demonstrated statistically significant and clinically meaningful improvements in overall survival and event-free survival, the study’s dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients.