Merck Announces Phase 3 KEYNOTE-756 Trial Met Primary Endpoint of Pathological Complete Response (pCR) Rate in Patients With High-Risk, Early-Stage ER+/HER2- Breast Cancer – Merck.com
KEYTRUDA® (pembrolizumab) plus chemotherapy before surgery significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy KEYNOTE-756 is the first positive Phase 3 study with an immunotherapy regimen to demonstrate a statistically significant improvement in pCR rate in the neoadjuvant setting for this patient population Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of pathological complete response (pCR) rate following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. At a prespecified interim analysis conducted by an independent Data Monitoring Committee (DMC), the KEYTRUDA-based regimen demonstrated a
