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Merrimack Presents Expanded Analysis from Seribantumab (MM-121) Phase 2 Breast Cancer Study at the AACR Precision Medicine Series

CAMBRIDGE, Mass., May 17, 2016 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (MACK) today presented an expanded analysis of its Phase 2 study of seribantumab (MM-121) in combination with exemestane in HER2-negative, hormone receptor positive metastatic breast cancer. Top line results from this study were announced in 2014. The final analysis, as well as a poster on Merrimack's investigational companion diagnostic for seribantumab, were presented this week at the AACR Precision Medicine Series: Targeting the Vulnerabilities of Cancer, in Miami, Florida.

"This data package underscores the most significant finding from all of our seribantumab Phase 2 studies – the identification of a heregulin-positive cancer cell phenotype that infiltrates approximately 30-50% of tumors and that may directly impact response to current standard-of-care therapies. This hypothesis is supported by a strong consistent data set that spans three solid tumor types where we saw improved progression free survival when seribantumab was added to each of the standard-of-care regimens," said Akos Czibere, MD, Ph.D., Senior Medical Director and Team Lead for the seribantumab program. "We are currently pursuing a registration study for seribantumab in patients with non-small cell lung cancer whose disease has progressed following immunotherapy."

"These additional analyses from our Phase 2 breast cancer study reinforce the significant opportunity for seribantumab to be the first therapy to treat heregulin-positive disease," said Robert Mulroy, President and CEO of Merrimack. "We are focused on executing our strategy in NSCLC as our near term path to registration for seribantumab and its heregulin diagnostic."

A randomized trial of exemestane +/- seribantumab (MM-121) in postmenopausal women with locally advanced or metastatic ER/PR+ HER2- breast cancer: Final analysis and extended subgroup analysis

Final analysis and extended subgroup analysis of a Phase 2 study of seribantumab in combination with exemestane in metastatic HER2-negative, ER/PR+ breast cancer was presented. The study was randomized, double-blinded and placebo-controlled to evaluate whether the combination of seribantumab and exemestane was more effective in prolonging progression free survival (PFS) than exemestane in ER/PR+ metastatic breast cancer (n=118) who had previously failed anti-estrogen therapy. Of the patients with tissue available for heregulin testing, 45% (n=34/76) were heregulin-positive. Patients in the heregulin-positive group who received seribantumab had a 74% decrease in risk of progression, (HR 0.26; 95% CI [0.11 — 0.63], p=0.003) compared with patients who did not receive seribantumab. The study did not meet its primary endpoint of PFS though the overall study population trended in favor of the MM-121 arm (HR 0.772; 95% CI [0.496 — 1.201]). Notably...


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