Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer

A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.

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The authors noted that the treatment strategy for colorectal cancer depends on tumor characteristics, feasibility of surgical resection, and mutations. For tumors that are unresectable, advanced, or recurrent, bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF) is one of the main anticancer treatment options. The bevacizumab reference product, Avastin, was launched in 2004, and works by inhibiting angiogenesis, thereby impairing tumor growth. Bevacizumab is used to treat a number of cancers, and randomized controlled trials have demonstrated improved overall and progression-free survival in patients treated with chemotherapy plus bevacizumab compared to chemotherapy alone.

Multiple bevacizumab biosimilars have been approved in different regions, and ABP 215 (Mvasi; Amgen) was the first approved by the FDA and the second approved in Japan. Although previous studies on ABP 215 have been conducted in colorectal cancer, according to the authors, there have been no reports on efficacy and safety of ABP 215 in Japanese patients with colorectal cancer. Their retrospective observational study compared progression-free survival (PFS), adverse events, and costs between the reference product and ABP 215 at a single center in Japan.

The study included 121 patients receiving the reference product and 38 receiving the biosimilar. PFS was evaluated over 2 years, and no significant difference between groups was found (HR, 1.07; 95% CI, 0.89-1.29). Median PFS was 8.41 months (95% CI, 7.33-9.43 months) in patients treated with the reference product and 7.13 months (95% CI, 5.03-9.66) in those treated with ABP 215.

The most common adverse events (AEs) in both cohorts were hypoalbuminemia, anemia, and decreased neutrophil count. Hypoalbuminemia occurred in approximately 90% of patients, and the authors said this may have been because many patients developed cachexia. The most common serious AEs with grade of 3 or higher in both groups were anemia and neutropenia. These bone marrow suppression-related AEs were likely due to fluoropyrimidine-based chemotherapy patients received along with bevacizumab, the authors said. Proteinuria was observed in approximately 70% of patients in both groups and hypertension in 40%. The authors noted these are typical adverse events related to bevacizumab treatment. The incidence rates of any adverse event and grade 3 or higher adverse events did not differ between groups.

The median numbers of bevacizumab treatments and median doses were 13.0 and 5 mg/kg in patients treated with the reference product and 10.0 and 5 mg/kg in patients treated with ABP 215. The mean costs per patient were 1,157,707 and 362,630 Japanese yen in the originator and biosimilar groups, suggesting a potential savings of about 800,000 Japanese yen per patient.

The authors noted their PFS results were in line with previous clinical trials and retrospective studies. Although their study was small and conducted in a single center, they said, it is first study to demonstrate that ABP 215 is as effective and safe as the reference product in a real-world Japanese population with colorectal cancer, and based on their results, ABP 215 should be recommended in Japan to reduce medical costs.

Reference

Sumimoto T, Tanaka R, Tatsuta R, Kubota M, Itoh H. Comparison of efficacy, safety, and economic outcomes between biosimilar ABP 215 and originator bevacizumab in Japanese patients with colorectal cancer. Cureus. 2024;16(10):e72260. doi:10.7759/cureus.72260