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Merrimack Pharmaceuticals Announces Results From A Phase 2 Study Of MM-121 (SAR256212) In Combination With Paclitaxel In Patients With Platinum-Resistant Or Refractory Advanced Ovarian Cancers
Date:10/30/2013

CAMBRIDGE, Mass., Oct. 30, 2013 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today announced results of a global, Phase 2, open-label, randomized study of MM-121 in combination with paclitaxel versus paclitaxel alone in patients with platinum-resistant or platinum-refractory advanced ovarian cancers.

This study did not meet the primary endpoint of progression free survival in the overall population.  The hazard ratio (HR) for progression free survival (PFS) was 1.0 [95% CI 0.74 - 1.4].

Ongoing analysis of a pre-specified set of biomarkers mechanistically linked to ErbB3 signaling identified a potential subpopulation of patients benefiting from MM-121 treatment in combination with paclitaxel. When using a combination of two biomarkers, the hazard ratio for PFS was 0.37 [95% CI 0.2 - 0.8] in the 34% of patients who were biomarker positive. The hazard ratio for PFS in the biomarker negative population was 1.54 [95% CI 1.0 - 2.4].

An overall increase in all grades of gastrointestinal toxicities, including diarrhea (73.6% vs. 42.5%), vomiting (31.4% vs. 18.8%) and other mucosal toxicities such as rhinitis (7.1% vs. 1.3%), epistaxis (23.6% vs. 17.5%), stomatitis (22.1% vs. 10.0%) and mucosal inflammation (22.1% vs. 1.3%), were observed in the combination as compared to paclitaxel alone, the majority of which were mild to moderate in severity. An increase in the pulmonary embolism rate was observed with the combination of MM-121 and paclitaxel (5.0% vs. 1.2%). No enhancement of paclitaxel-related peripheral neuropathy was reported with the combination.

"This unique study design lays the groundwork for future translational studies in ovarian cancer. The rapid enrollment into this study was a testament to the commitment of patients and physicians to advance our knowledge and improve upon available therapies i
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SOURCE Merrimack Pharmaceuticals, Inc.
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