Bevacizumab Biosimilar Deemed Bioequivalent to Reference Drug in Metastatic CRC
Both the reference product and its biosimilar confer to same benefit, according to research results.
A biosimilar to bevacizumab, BEVZ92, was pharmacokinetically bioequivalent to its reference drug in a group of 142 patients with metastatic colorectal cancer, according to a recent study.1
The researchers found no significant differences in efficacy, immunogenicity, or safety between the two drugs when given in combination with FOLFOX or FOLFIRI in this patient population.
“When used in the same way as the reference product, BEVZ92 is expected to produce the same benefits with no differences in safety, and could provide an affordable alternative for patients with metastatic colorectal cancer,” the researchers wrote.
Patients were randomly assigned to BEVZ92 (69 individuals) or reference bevacizumab (71 individuals) plus FOLFOX or FOLFIRI. The primary end point was area under the concentration-versus-time curve after a single infusion and at steady state (cycle 7). Bioequivalence was established if the 90% confidence intervals [Cis] for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0–336h and AUCss were within the acceptance interval of 80% to 125%.
The geometric mean ratio fell within the acceptable interval for BEVZ92 compared with the reference drug for both AUC0-336h (99.4%; 90% CI, 90.5-109.0) and AUCSS (100%; 90% CI, 90.2-112.0).
The objective response rate for BEVZ92 was 49% compared with 56% for the reference drug. Clinical benefit was also similar between the two drugs (87% vs. 92%). The progression-free survival for BEVZ92 was 10.8 months compared with 11.1 months for reference bevacizumab.
The researchers noted no relevant differences in safety between the 2 study arms.
- Romera A. Peredpaya S, Shparyk Y, et al. Bevacizumab biosimilar BEVZ92 versus reference bevacizumab in combination with FOLFOX or FOLFIRI as first-line treatment for metastatic colorectal cancer: a multicentre, open-label, randomized controlled trial [published September 24, 2018]. Lancet Gasteoenterol Hepatol. doi: 10.1016/S2468-1253(18)30269-3