Successful results of REFLECTIONS B3271002 study for PF 05280014 trastuzumab biosimilar from Pfizer.
Pfizer Inc.has 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 is being developed by Pfizer as a potential biosimilar to Herceptin. The trial demonstrated equivalence in the primary endpoint of objective response rate (ORR) of PF-05280014 versus Herceptin, taken in combination with paclitaxel, in first line patients with HER2-positive metastatic breast cancer. ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum period of time.
A separate comparative, randomized, double-blind clinical trial [REFLECTIONS B3271004] in early breast cancer patients [N=226] also met its primary endpoint of steady-state Ctrough concentrations (PK) in patients treated with PF-05280014 and Herceptin.
Comment: Pfizer follows Mylan + Biocon who have filed at the FDA via the 351(k) pathway their trastuzumab biosimilar, MYL 14010, evidenced by the confirmatory HERITAGE trial.
Comment: Herceptin EU patents expired in July 2014 and will expire in the US in 2019.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins