ABP 215, an investigational drug being developed as a biosimilar to bevacizumab, showed clinical equivalence to bevacizumab in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC), results of a phase 3 study announced in a press release have shown.1
For the double-blind, active-controlled study, researchers evaluated the safety and efficacy of ABP 215 compared with bevacizumab in adult patients with advanced non-squamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel.
Researchers enrolled 642 patients and randomly assigned them to receive ABP 215 or bevacizumab 15 mg/kg intravenously every 3 weeks for up to 6 cycles, plus carboplatin and paclitaxel.
Results showed that the study met its primary and secondary endpoints. The primary endpoint, which was an assessment of objective response rates, was within the prespecified margin for ABP 215 compared with bevacizumab, demonstrating clinical equivalence.
“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, MD, executive vice president of Research and Development at Amgen.
“Non-small cell lung cancer is the leading cause of cancer death in both men and women in the US and the EU. ABP 215 holds the potential to advance access to treatment options for oncology patients.”
“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,” said David Nicholson, executive vice president and president of Global Research and Development of Allergan.
RELATED: High PARP1 Activity, Low PDXK Expression May Signal Poor Prognosis
Bevacizumab is a recombinant IgG1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with VEGF receptor-1 and VEGF receptor-2, thereby inhibiting angiogenesis in tumors.
- Amgen and Allergan announce positive top-line results from phase 3 study of biosimilar candidate ABP 215 [news release]. http://www.prnewswire.com/news-releases/amgen-and-allergan-announce-positive-top-line-results-from-phase-3-study-of-biosimilar-candidate-abp-215-300147691.html. Updated September 23, 2015. Accessed September 24, 2015.