KEYTRUDA® (pembrolizumab) is the first and only immunotherapy-based regimen to show a statistically significant improvement in OS as pre-operative (neoadjuvant) treatment with chemotherapy and then as a single agent after surgery (adjuvant) compared to pre-operative chemotherapy in patients with high-risk early-stage TNBC
New OS results build on the pathological complete response and event-free survival data previously reported from the KEYNOTE-522 trial
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its overall survival (OS) endpoint, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent after surgery (adjuvant) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to pre-operative chemotherapy. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were observed. Results will be presented at an upcoming medical meeting and shared with regulatory authorities.
