New Data From Phase 2 I-SPY 2 TRIAL Shows Improved Outcomes with Combination of Merck’s KEYTRUDA® (pembrolizumab) Plus Standard Neoadjuvant Therapy in Patients with High-Risk Breast Cancer 

Data to Be Presented at 2017 ASCO Annual Meeting Include Findings in

Patients with Locally Advanced Triple-Negative (TNBC) and
Hormone Receptor-Positive/HER2-Negative (HR+/HER2-) Breast Cancers

KENILWORTH, N.J. & SAN FRANCISCO, June 5, 2017 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and QuantumLeap Healthcare Collaborative, today announced results from the Phase 2 I-SPY 2 TRIAL investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with standard therapy [paclitaxel followed by doxorubicin and cyclophosphamide (AC)] as a neoadjuvant (pre-operative) treatment for patients with locally advanced triple-negative breast cancer (TNBC) or hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer. Findings showed that the addition of KEYTRUDA increased the estimated pathologic complete response (pCR) rate nearly threefold in patients with TNBC (60% vs 20%) and in patients with HR+/HER2- breast cancer (34% vs 13%) compared to standard therapy. Overall, based on Bayesian predictive probability of success in a confirmatory Phase 3 trial, KEYTRUDA has graduated from the I-SPY 2 TRIAL for all signatures in which it was tested (TNBC, all HER2-, and HR+/HER2-). Data will be presented today by Dr. Rita Nanda, The University of Chicago, during an oral session at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #506) and will also be presented in subsequent “Best of ASCO” events scheduled throughout the year.

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