Merck: Phase 3 Trial Met Primary Endpoints in High-Risk Early-Stage Triple-Negative Breast Cancer

 In Pivotal Study, KEYTRUDA® (pembrolizumab) In Combination With Chemotherapy Before Surgery and Continuing as a Single Agent After Surgery Showed Statistically Significant Improvement in EFS Versus Pre-Operative Chemotherapy

KEYTRUDA Is the First Anti-PD-1 Therapy to Show a Statistically Significant Improvement in EFS as Neoadjuvant and Adjuvant Therapy for TNBC

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery. KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone. As previously communicated, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

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