Date: 2017-01-02
Type of information: Halting of the trial
phase: 2-3
Announcement: halting of the trial
Company: Merrimack Pharmaceuticals (USA - MA)
Product: MM-302
Action
mechanism: antibody drug conjugate. MM-302 is a novel antibody-drug conjugated liposomal doxorubicin that specifically targets cancer cells overexpressing the HER2 receptor. As a liposomal encapsulation of doxorubicin, MM-302 is designed to allow for the selective uptake of drug into tumor cells while limiting exposure to healthy tissues, such as those of the heart. Unlike other HER2-targeted agents, MM-302 is not designed to inhibit HER2 signaling pathways and relies on HER2 as a means to identify and gain access to the cancer cells. Once inside the cancer cell, the liposome breaks down and releases doxorubicin inside the cell, promoting cell death.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country: Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Spain, USA
Trial
details: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. (NCT02213744)
Latest
news: * On December 21, 2016, Merrimack Pharmaceuticals announced that, following a recent independent Data and Safety Monitoring Board (DSMB) recommendation and subsequent futility analysis, it has decided to stop the Phase 2 HERMIONE study of MM-302 (HER2 antibody-targeted liposomal doxorubicin) in HER2-positive metastatic breast cancer patients who had previously been treated with trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine (T-DM1, Kadcyla®). The decision to stop the trial was made following the DSMB's opinion that continuing would be unlikely to demonstrate benefit over the comparator treatments. Subsequent to this recommendation, a futility assessment was performed that confirmed the DSMB's opinion. Both the treatment and control arms were found to have shorter than expected median progression free survival. Importantly, there were no new or unexpected safety concerns. Patients currently enrolled in the trial may choose to continue on their assigned treatment based upon discussion with their study physician. In light of this development, Merrimack now expects to provide further details about MM-302, as well as the results of its full pipeline review, in January.
