Date: 2015-09-23
Type of information: Results
phase: 3
Announcement: results
Company: Amgen (USA - CA) Allergan (Ireland)
Product: ABP 215 (bevacizumab - biosimilar version of Avastin®)
Action
mechanism: monoclonal antibody/biosimilar. ABP 215 is being developed as a biosimilar to bevacizumab, which is approved in specific combinations in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non small cell lung cancer as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications. Bevacizumab binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.
Disease: metastatic non small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Australia, Bulgaria, Canada, Czech Republic, Germany, Greece, Hong Kong, Hungary, Italy, Mexico, The Netherlands, Poland, Romania, Russian Federation, Spain, Taiwan, USA
Trial
details: The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer. This was a randomized, double-blind, active-controlled study (study number 20120265) that evaluated safety and efficacy of ABP 215 compared to bevacizumab in adult patients with advanced non-squamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel. There were 642 patients enrolled and randomized (1:1) to receive investigational product (ABP 215 or bevacizumab) at a dose of 15 mg/kg administered as an IV infusion every 3 weeks (Q3W) for up to 6 cycles. Among them, there were 328 patients randomized to the ABP 215 group and 314 patients to the bevacizumab group. The duration of the treatment included a screening period of up to 4 weeks, followed by up to 6 Q3W treatment cycles and an end of treatment visit 21 days after the last dose of investigational product or study specified chemotherapy. Following the end of treatment visit, patients were followed for disease progression and overall survival (OS) until the end of the clinical study, consent was withdrawn, they were lost to follow-up, death or had proscribed therapy (e.g. commercial bevacizumab, non-study anti-cancer treatment). Clinical equivalence of the primary endpoint was demonstrated by comparing the confidence interval of the risk ratio in ORR between ABP 215 and bevacizumab to a prespecified margin. Response was determined by independent review based on RECIST criteria. (NCT01966003)
Latest
news: * On September 23, 2015, Amgen and Allergan announced a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints. The study evaluated the efficacy and safety of ABP 215 compared with Avastin® (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC). The primary endpoint, an assessment of objective response rates (ORR), was within the prespecified margin for ABP 215 compared to bevacizumab, showing 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).Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in development. Allergan is also independently developing biosimilars.
