Pfizer’s Herceptin biosimilar succeeds in breast cancer study

PF-05280014 demonstrated equivalence in objective response rate to Herceptin after 25 weeks of treatment in first line patients with HER2-positive metastatic breast cancer.

The Reflections B3271002 is a comparative, randomized, double blind, clinical trial, assessing the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus Herceptin in combination with paclitaxel in first line patients with HER2-positive metastatic breast cancer.

A separate trial, dubbed Reflections B3271004, in early breast cancer patients also met its primary endpoint of steady-state Ctrough concentrations in patients treated with PF-05280014 and Herceptin.

Pfizer Essential Health head of research and development Sumant Ramachandra said: “Favorable comparative clinical data between proposed biosimilars and their respective reference product contribute to physician and patient understanding of and confidence in the value and importance of biosimilars.

“We are encouraged by these data and look forward to sharing the complete results with health authorities and the oncology community once available.”

PF-05280014, which has not secured regulatory approval in any country, is an investigational monoclonal antibody that is being developed as a potential biosimilar for all currently approved indications of Herceptin (trastuzumab).

Herceptin has received approval in the US, European Union and other markets for HER2-positive breast cancer and gastric cancer.

Earlier this year, Amgen and Allergan said that a late-stage trial of their treatment being developed as a biosimilar to Herceptin met its primary endpoint. Results demonstrated that ABP 980 was not inferior to trastuzumab.

Image: Pfizer World Headquarters New York City. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.