Clinical Trials

Date: 2017-07-24

Type of information: Results

phase: 3

Announcement: results

Company: Pfizer (USA - NY)

Product: PF-06439535 (biosimilar version of bevacizumab - Avastin®)

Action mechanism:

biosimilar/monoclonal antibody. PF-06439535 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Avastin® (bevacizumab). Avastin® is approved in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous lung cancer in addition to metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.
The Pfizer biosimilars pipeline consists of eight distinct biosimilar molecules in mid to late stage development, and several others in early stage development.

Disease: advanced non-squamous non-small cell lung cancer

Therapeutic area: Cancer - Oncology

Country: Czech Republic, Hong Kong, Slovakia

Trial details:

REFLECTIONS B7391003 is a comparative, randomized, double blind, clinical trial [N=719] evaluating the efficacy, safety, pharmacokinetics (PK) and immunogenicity of PF-06439535 (a potential biosimilar to Avastin® [bevacizumab]) in combination with carboplatin/paclitaxel versus Avastin in combination with carboplatin/paclitaxel for the first line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC). The primary endpoint is objective response rate (ORR) which is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum period of time (NCT02364999)

Latest news:

• On July 24, 2017, Pfizer announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin® (bevacizumab), met its primary objective. The trial demonstrated equivalence in the primary endpoint of objective response rate (ORR) of PF-06439535 versus Avastin, taken in combination with carboplatin/paclitaxel, for the first line treatment of patients with advanced non-squamous non-small cell lung cancer.