Pfizer has announced positive top-line results from a comparative, confirmatory safety and efficacy study of an investigational bevacizumab biosimilar referenced on Avastin.
Pfizer has announced positive top-line results from a comparative, confirmatory safety and efficacy study of an investigational bevacizumab biosimilar referenced on Avastin. The trial demonstrated equivalence between the reference bevacizumab and Pfizer's PF-06439535 in terms of objective response rate in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
The REFLECTIONS B7391003 study, a comparative, randomized, double-blind clinical trial, included 719 patients. The study sought to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of PF-06439535 administered together with carboplatin and paclitaxel compared with the same characteristics of the reference bevacizumab administered with carboplatin and paclitaxel in first-line treatment of patients with advanced non-squamous NSCLC. The study met its primary endpoint of demonstrating equivalent objective response rate, defined as the proportion of patients with a reduction in tumor size of a predefined amount for a minimum time period.
“We are encouraged by this data, and its importance in helping to advance physician confidence in, and understanding of, the potential value of biosimilar medicines for cancer patients around the world,” said Salomon Azoulay, MD, senior vice president and chief medical officer of Pfizer Essential Health. “As Pfizer’s second proposed oncology monoclonal antibody biosimilar to achieve positive top line data results, we continue to focus on and commit to advancing our pipeline of proposed biosimilars, with the goal of expanding patient access to these important therapeutic options.”
The promising results are welcome news for Pfizer, which suffered a setback to its biosimilars program earlier this year; in June, the FDA issued the drug maker a second complete response letter (CRL) for its biosimilar epoetin alfa (referenced on Epogen and Procrit), citing concerns related to the company’s manufacturing plant.
In addition to its troubled epoetin alfa and its PF-06439535, Pfizer reports an additional 4 biosimilar candidates in its late-stage pipeline; the drug maker is developing a biosimilar adalimumab (referenced on Humira), infliximab for commercialization in markets outside the European Economic Area (referenced on Remicade), rituximab, (referenced on Rituxan, MabThera), and trastuzumab (referenced on Herceptin).
Less enthusiastic about the bevacizumab study’s results, however, may be reference biologic maker Roche, which earned $6.75 billion in sales of Avastin in 2016. Roche already suffered a setback this month when the FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of another biosimilar candidate, Amgen’s ABP 215. Regulatory action on Amgen's biosimilar bevacizumab product is expected in September.