New Data From Phase II I-SPY 2 TRIAL Shows Improved Outcomes With Combination Of Merck & Co.’s KEYTRUDA (Pembrolizumab) Plus Standard Neoadjuvant Therapy In Patients With High-Risk Breast Cancer

KENILWORTH, N.J. & SAN FRANCISCO--(BUSINESS WIRE)--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.

KEYTRUDA in combination with standard therapy tripled the rate of pathologic complete responses in HER2- patients in the I-SPY 2 Trial,” said Laura J. Esserman, M.D., MBA, professor of surgery and radiology and director of the Carol Franc Buck Breast Care Center at UCSF Helen Diller Family Comprehensive Cancer Center, and the overall principal investigator for the I-SPY TRIALS. “The regimen indicates a new and important treatment pathway and gives us well-grounded hope for new options for patients with these aggressive breast cancers – and that’s potentially very good news.”

We recognize that there is a critical unmet need for patients with certain breast cancer subtypes and believe that combination regimens will be important to advancing patient care,” said Dr. Eric Rubin, vice president of early-stage development, clinical oncology, Merck Research Laboratories. “The results presented at ASCO, which add to the growing body of evidence for KEYTRUDA in various types of breast cancer, are exciting and demonstrate the potential benefit of KEYTRUDA in these patients.”

The I-SPY 2 TRIAL (NCT01042379), sponsored by QuantumLeap Healthcare Collaborative, is a standing Phase 2 randomized, controlled, multi-center trial for women with newly diagnosed, locally advanced breast cancer (Stage II/III), and is designed to screen promising new treatments and identify which therapies are most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is an adaptive study design assessing the combination of biologically targeted investigational drugs with standard chemotherapy in the neoadjuvant setting, compared to standard chemotherapy alone. The primary endpoint is to determine whether the combination of certain therapies increases the probability of pCR in the breast and the lymph nodes at the time of surgery. The data presented at ASCO from the I-SPY 2 TRIAL were based on results observed in patients at high risk of relapse using up-front tumor profiling (including HR status, HER2 status, and the MammaPrint 70-gene signature test). Patients were treated with weekly standard chemotherapy (paclitaxel) for 12 weeks, with or without KEYTRUDA (pembrolizumab), followed by doxorubicin and cyclophosphamide (AC) every 3 weeks for four cycles. Sixty-nine patients were adaptively randomized to receive KEYTRUDA in the trial from December 2015 until it graduated in November 2016. In total, 46 patients have undergone surgery; the other 23 have on-therapy MRI assessments.

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