On May 5, 2015 Merrimack reported the initiation of a randomized, double-blinded, placebo-controlled Phase 2 clinical trial of MM-141, a bispecific antibody targeting IGF-1R and ErbB3, in combination with nab-paclitaxel and gemcitabine, versus nab-paclitaxel and gemcitabine alone in patients with newly-diagnosed metastatic pancreatic cancer who have high serum levels of free IGF-1 Schedule your 30 min Free 1stOncology Demo! "Pancreatic cancer is the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2020. Merrimack is committed to advancing the standard of care for patients with inoperable, metastatic pancreatic cancer. We are taking steps to move our therapeutics forward based on matching them to the biology of individual tumors," said Chrystal Louis, M.D., Medical Director of MM-141 at Merrimack. "Data from our Phase 1 trial supports further clinical evaluation of MM-141 in patients with high serum levels of free IGF-1. Patients with this biomarker profile may have the greatest potential of benefit from the use of MM-141 combined with standard chemotherapies, and we look forward to further validating this in our Phase 2 trial."
(Press release, Merrimack, MAY 5, 2015, View Source [SID:1234503584]).
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As part of this trial, 146 front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1 will be randomized (1:1) to receive either MM-141 plus nab-paclitaxel/gemcitabine or nab-paclitaxel/gemcitabine alone. Eligible patients for the trial must have received no prior radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. The primary endpoint of the trial is progression free survival (PFS). Secondary endpoints include overall survival, objective response rate, safety and tolerability. Merrimack plans to conduct the trial at sites in the United States, Canada and Europe. Initial trial sites located at St. Jude Heritage in Fullerton, California and Northwestern University in Chicago, Illinois are now open to screen patients in the United States. For more information, please visit clinicaltrials.gov (Identifier: NCT02399137).
About MM-141
MM-141 is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3 (HER3). IGF-1R and ErbB3 complexes both activate a major signaling pathway that allows tumor cells to grow and develop resistance to chemotherapy. MM-141 has been tested in a Phase 1 dose-escalation clinical trial. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for MM-141 for the treatment of pancreatic cancer. This orphan drug designation could provide Merrimack with seven-year marketing exclusivity and other benefits for MM-141 when approved by the FDA