Merck: Phase 3 KEYNOTE-756 Trial Meets Primary Endpoint In Early-Stage ER+/HER2- Breast Cancer

(RTTNews) - Merck (MRK) announced the Phase 3 KEYNOTE-756 trial investigating KEYTRUDA in combination with chemotherapy met one of its dual primary endpoints of pathological complete response 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 breast cancer. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, the KEYTRUDA-based regimen showed a statistically significant improvement in pCR rate compared to neoadjuvant placebo plus chemotherapy.

The company said, based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of event-free survival, per the trial design. The safety profile of KEYTRUDA in the trial was consistent with that observed in previously reported studies.

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