Amgen, Allergan achieve endpoints in ABP 215 biosimilar candidate study

Under the study, Amgen and Allergan evaluated the efficacy and safety of ABP 215 compared with Genentech’s Avastin (bevacizumab) in patients with advanced non-small cell lung cancer.

The primary endpoint, an assessment of objective response rates (ORR), showed clinical equivalence. Safety and immunogenicity of ABP 215 were comparable to bevacizumab.

Amgen said secondary endpoint results were consistent with the primary finding and featured risk difference of ORR, duration of response and progression-free survival (PFS).

The companies enrolled 642 patients to receive ABP 215 at a dose of 15 mg/kg administered as an IV infusion every three weeks for about six cycles.

Of the total subjects, 328 patients randomized to the ABP 215 group and 314 patients to the bevacizumab group.

Amgen executive vice president of research and development Sean Harper said: "The positive Phase 3 results from ABP 215 study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab.

"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."

Allergan executive vice president and president of global research and development David Nicholson said: "The positive Phase 3 clinical 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."

Both the companies are collaborating on four oncology biosimilars. Amgen has nine biosimilars in development. Allergan is independently developing biosimilars.