Amgen and Allergan’s Phase III study of biosimilar candidate ABP 215 met its primary and secondary endpoints in patients with advanced non-squamous non-small cell lung cancer (NSCLC). The study evaluated the efficacy and safety of ABP 215 compared with Genentech’s Avastin (bevacizumab).

The primary endpoint, an assessment of objective response rates (ORR), showed clinical equivalence. Safety and immunogenicity of ABP 215 were comparable to bevacizumab. Secondary endpoint results were consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS).

ABP 215 is being developed as a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

“Amgen is committed to bringing high-quality, reliably supplied medicines to patients and we’re excited to leverage our development and manufacturing capabilities in oncology for our biosimilars. The positive Phase 3 results from ABP 215 study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab,” said Sean E. Harper, M.D., executive vice president of R&D at Amgen. “Non-small cell lung cancer is the leading cause of cancer death in both men and women in the U.S. and the EU. ABP 215 holds the potential to advance access to treatment options for oncology patients.”

“The positive Phase III results of ABP 215 mark an important step forward in the development of biosimilar treatment options for patients with advanced non-small cell lung cancer,” said David Nicholson, executive vice president and president of Global R&D of Allergan. “Allergan is committed to developing biosimilars that provide safe, high-quality and effective therapies in key disease areas for patients.”

Amgen and Allergan are collaborating on four oncology biosimilars. Amgen has a total of nine biosimilars in development. Allergan is also independently developing biosimilars.