On November 16, 2016 Boehringer Ingelheim reported new data from the Phase I INVICTAN-1 study, which show that BI 695502, its bevacizumab biosimilar candidate, is bioequivalent to U.S.-licensed and EU-approved Avastin (Press release, Boehringer Ingelheim, NOV 15, 2016, View Source [SID1234516656]).* Avastin is an angiogenesis inhibitor that is used to treat a variety of cancers.

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BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN-1 study. These data were presented in a poster at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, CO, November 13 – 17.

"This study is an important milestone for Boehringer Ingelheim, and supports our commitment to improving the lives of patients with cancer by exploring innovative ways for biosimilars to contribute to the long-term sustainability of the U.S. healthcare system," said Martina Flammer, Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to evaluating BI 695502 in our ongoing Phase III study to establish its safety and efficacy as compared to Avastin."

About BI 695502 and INVICTAN
BI 695502, a bevacizumab biosimilar candidate to Avastin, is a monoclonal antibody that may slow or stop the growth of certain tumor types by preventing the growth of blood vessels that supply the tumor.

INVICTAN-1 (NCT01608087) is a randomized, blinded, single-dose, parallel-arm Phase I clinical study, evaluating bioequivalence (how a drug is absorbed, distributed, metabolized and excreted in the body) of BI 695502 to Avastin. The study enrolled 91 healthy male individuals who were randomized evenly across treatment groups. BI 695502 was well-tolerated in this study, with no clinically relevant differences in safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups.

INVICTAN-2 (NCT02272413) is a randomized, double-blind Phase III study, evaluating efficacy and safety of BI 695502 plus chemotherapy versus Avastin plus chemotherapy in patients with advanced non-squamous non-small cell lung cancer.