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Merck Says Phase 3 KEYNOTE-522 Trial Met Dual Primary Endpoint In Patients With Breast Cancer

Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, announced Thursday 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.

KEYNOTE-522 had also met its other dual primary endpoint of pathological complete response (pCR) earlier. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies and no new safety signals were identified.

KEYTRUDA Is the first anti-PD-1 therapy to show a statistically significant improvement in EFS as neoadjuvant and adjuvant Therapy for TNBC.

The KEYTRUDA clinical development program for TNBC encompasses several internal studies and external collaborative trials, including the ongoing studies KEYNOTE-242 and KEYNOTE-355. There are about 20 registrational studies ongoing.

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