Date: 2015-12-22
Type of information: update on patient enrollment
phase: 2
Announcement: update on patient enrollment
Company: Merrimack Pharmaceuticals (USA - MA)
Product: MM-121 (seribantumab)
Action
mechanism: monoclonal antibody. Seribantumab (MM-121) is Merrimack's wholly owned, fully human anti-ErbB3 monoclonal antibody that targets phenotypically distinct heregulin-positive cancer cells within solid tumors. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, MM-121 is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner.
Disease: non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Canada, Germany, Hungary, Spain, USA
Trial
details: This phase 2 study aims to determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone in regards to overall survival in patients with heregulin-positive NSCLC. (NCT02387216 )
Latest
news: * On December 22, 2015, Merrimack Pharmaceuticals announced it filed an amendment to its ongoing Phase 2 clinical study of MM-121 (seribantumab) in patients with heregulin-positive non-small cell lung cancer with the FDA. The amendment includes a change in primary endpoint to overall survival to enable a potential registration opportunity for MM-121. The ongoing clinical study in NSCLC is an open-label, biomarker-selected randomized study of MM-121 in combination with docetaxel or pemetrexed compared to docetaxel or pemetrexed alone, in patients with heregulin-positive, locally advanced or metastatic NSCLC. Three prior Phase 2 clinical studies demonstrated that a subset of biomarker positive patients treated with MM-121 had a statically significant reduction in the risk of progression, with hazard ratios in a range of 0.26 - 0.37.
Under the filed amendment, Merrimack expects to enroll approximately 280 heregulin-positive patients who will be randomized (2:1) to receive MM-121 plus the investigator's choice of docetaxel or pemetrexed, or the investigator's choice of docetaxel or pemetrexed alone. Eligible patients for the study must have failed prior treatment with no more than three lines of therapy for locally advanced or metastatic disease and, where applicable, prior PDL1 therapy. The amended primary endpoint of the study will be overall survival. Secondary endpoints include progression free survival, objective response rate, safety and quality of life measures. Merrimack continues to open study sites in the United States, Canada, Asia and Europe. With this updated study design, Merrimack expects survival data in 2018.
