Policy & Regulation
Data from Pfizer Study of Trastuzumab Biosimilar Demonstrates Equivalence in ORR for Patients with HER2-positive Metastatic Breast Cancer
12 September 2017 - - New York, New York-based biopharmaceutical and healthcare products specialist Pfizer Inc. (NYSE: PFE) has reported positive findings from REFLECTIONS B327-02 (n=707), a pivotal Phase 3 randomized, double-blind comparative safety and efficacy study of the company's investigational trastuzumab biosimilar (PF-05280014) versus Herceptin (trastuzumab), the company said.
Positive data from a supplemental study, REFLECTIONS B327-04 (n=226), has also been reported.
PF-05280014 is a monoclonal antibody that is in development as a potential biosimilar for Herceptin (trastuzumab) which is currently approved in the US, EU, and other markets for HER2-positive breast cancer and gastric cancer.
The REFLECTIONS B327-02 study achieved the primary objective for equivalence in the objective response rate (ORR) of PF-05280014 versus Herceptin in patients receiving first-line treatment, in combination with paclitaxel, for HER2-positive metastatic breast cancer [risk ratio of 0.940; within the pre-specified equivalence margin of 0.8–1.25].
ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum period of time.
Additionally, rates of one year progression-free survival and one year survival were similar across groups (56% and 88.84% vs. 52% and 87.96% for PF-05280017 and Herceptin, respectively).
The REFLECTIONS B327-04 study found there were no clinically meaningful differences between PF-05280014 and Herceptin in terms of efficacy, safety, immunogenicity, and noninferiority in pharmacokinetics, as neoadjuvant treatment taken in combination with docetaxel and carboplatin for patients with operable HER2-positive breast cancer.
Pfizer discovers, develops, manufactures, and sells healthcare products worldwide. Its global portfolio includes medicines and vaccines as well as consumer health care products.
The company collaborates with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world.
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