Pfizer: PF-05280014 Versus Herceptin Study Meets Primary Endpoint
NEW YORK CITY (dpa-AFX) - Pfizer Inc.
(PFE) announced that the pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of PF-05280014 versus Herceptin (trastuzumab), met its primary endpoint. PF-05280014, a monoclonal antibody, is being developed by Pfizer as a potential biosimilar to Herceptin. The company said the results demonstrated equivalence in the primary endpoint of objective response rate of PF-05280014 versus Herceptin, taken in combination with paclitaxel, in first line patients with HER2-positive metastatic breast cancer.
Pfizer said, a separate comparative, randomized, double-blind clinical trial in early breast cancer patients also met its primary endpoint of steady-state Ctrough concentrations in patients treated with PF-05280014 and Herceptin.
Herceptin is currently approved in the U.S., EU and other markets for HER2-positive breast cancer and gastric cancer. PF-05280014 is a monoclonal antibody (mAb) that is in development as a potential biosimilar for all currently approved indications of Herceptin.
Copyright RTT News/dpa-AFX
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