Merrimack Pharmaceuticals Inc (NASDAQ:MACK) reported that, subsequent to a recent independent DSMB recommendation and later futility assessment, it has decided to halt the Phase II HERMIONE trial of MM-302 in HER2 positive metastatic breast cancer subjects who had initially been treated with pertuzumab, ado-trastuzumab emtansine and trastuzumab.
The decision to halt the study was taken following the DSMB’s viewpoint that continuing would not likely show benefit versus the comparator therapies. Subsequent to this suggestion, a futility evaluation was conducted that asserted the DSMB’s stance. Both the control and treatment arms were stated to have shorter than projected median progression free survival. Prominently, there were no unexpected or new safety issues. Patients currently registered in the study may select to continue on their given treatment based upon talk with their trial physician.
Istvan Molnar, MD, the VP of Clinical Development at Merrimack, said that late stage HER2 positive breast cancer is extremely tough to treat, particularly in this new and initially unstudied group of subjects who appear to witness rapid cancer progression after treatment with pertuzumab, ado-trastuzumab emtansine and trastuzumab.
While the company is disappointed with this result, they would prefer to thank the investigators, the trial Steering Committee and, most importantly, the subjects who enrolled in the HERMIONE study. They will release their learnings from this trial at a later date. In light of this advancement, Merrimack now projects to offer additional details on MM-302, and the report of its full pipeline assessment, in January.
Merrimack missed 3Q2016 revenue consensus following some delayed milestone payments, however the firm surpassed the EPS projections. Onivyde revenues have jumped 13% sequentially, and the firm disclosed that shipments from distributors to clients were up 18% compared to 2Q2016. The firm is in midst of reorganization which should drive in savings of nearly $200 million in the upcoming two years. Its product pipeline will likely be negatively influenced by cost-cutting, but the firm plans to continue to emphasis on programs with the increased probability of success.