Merrimack Pharmaceuticals Inc (NASDAQ:MACK) stated that, subsequent to an autonomous DSMB recommendation and also following futility assessment, it has halted the Phase II HERMIONE trial of “MM-302” in people suffering with +HER2 metastatic breast cancer, but had initially been on regimen of pertuzumab, trastuzumab and ado-trastuzumab emtansine.
The decision to pause the study was taken subsequent to the DSMB’s stance that continuing this study would not present benefit when compared to the other existing therapies. Due to this suggestion, the company performed a futility evaluation that asserted the DSMB’s viewpoint. The control as well as treatment arms were confirmed to have shorter than predicted median progression free survival. Predominantly, there were no unanticipated or fresh safety concerns. Patients presently registered in the study can continue with their suggested regimen based upon discussions with respective trial physician.
Istvan Molnar, MD, who is the VP of Clinical Development, stated that late phase +HER2 breast cancer is awfully tough to cure, particularly in this fresh and initially open group of subjects who appear to record rapid cancer progression after administration of pertuzumab, trastuzumab and ado-trastuzumab emtansine.
While Merrimack Pharmaceuticals is disappointed with this report, they would appreciate the investigators, the Steering Committee appointed for trial and, most importantly, the people who registered in the HERMIONE study. The company will release the report from this trial in coming period. In light of this data, the firm now predicts to offer additional details on “MM-302,” and the report of pipeline assessment, next month.
The company fell short of 3Q2016 revenue estimates following some deferred payments, yet it succeeded in surpassing the EPS projections. The revenue of Onivyde surged 13% sequentially, and Merrimack confirmed that shipments from distributors to consumers jumped 18% compared to the preceding quarter. It is in midst of process of reorganization which can drive in savings of roughly $200 million in the imminent two years. The entire product pipeline will possibly be negatively affected by their cost-cutting measures.