The European Commission has approved the bevacizumab biosimilar, CT-P16, for the treatment of patients with metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.
The European Commission has approved the bevacizumab (Avastin) biosimilar, CT-P16 (Vegzelma), for the treatment of patients with metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.1
The regulatory decision is based on a totality of evidence, which comprised findings from a pivotal phase 3 trial done in patients with metastatic or recurrent nonsquamous NSCLC.2 Data demonstrated the equivalence of CT-P16 with the reference product with regard to overall response rate (ORR). Other end points such as pharmacokinetics (PK), quality of life (QOL), safety, and immunogenicity were also found to be comparable between the products.
“The European Commission’s approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price,” Kevin Byoung Seo Choi, senior vice president and head of the Marketing Division at Celltrion Healthcare, stated in a press release. “With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, with collectively affect hundreds of thousands of European patients each year.”
The double-blind, randomized, multicenter phase 3 trial included those with metastatic or recurrent nonsquamous NSCLC. Participants (n = 689) were randomly assigned to CT-P16 (n = 342) or bevacizumab (n = 347) in combination with carboplatin and paclitaxel for up to 6 cycles, followed by maintenance CT-P16 or bevacizumab monotherapy. Treatment was given until progressive disease or unacceptable toxicity.
ORR served as the primary end point of the trial per RECIST v1.1 criteria and independent reviewer assessment. Secondary end points comprised QOL, PK, safety, and immunogenicity.
Baseline characteristics were noted to be well balanced between the 2 treatment arms.
Findings indicated that the ORRs achieved with CT-P16 and the reference product were comparable, and the 90% confidence intervals (Cis) for the risk ratio estimate (0.7368, 1.3572) and 95% Cis for risk difference estimate (+/- 12.5%) both fell within the equivalence margin in the intention-to-treat and per-protocol sets of the trial.
Regarding safety, treatment-emergent adverse effects (AEs) occurred in 96.2% of those who received CT-P16 vs 92.4% of those given bevacizumab. Serious AEs were reported in 19.4% of those in the biosimilar arm and 20.1% of those in the bevacizumab arm. Moreover, 15.1% of those who received CT-P16 experienced toxicities that led to treatment discontinuation vs 14.5% of those who were given bevacizumab; 6.4% of those in both arms experienced AEs that resulted in death.
Additionally, the incidence of treatment-emergent antidrug antibodies proved to be comparable in the CT-P16 and bevacizumab arms at 14.2% and 16.0%, respectively.
CT-P16 is the third biosimilar from Celltrion Healthcare to receive approval for use in the European Union.