Results from a phase 3 clinical trial showed equivalence between the bevacizumab biosimilar, BCD-021, and the reference product, bevacizumab (Avastin), in terms of overall response rate (ORR) in patients with stage IIIB or IV nonsquamous non–small-cell lung cancer. Safety, pharmacokinetics (PK), and immunogenicity parameters were also comparable between the 2 agents. These findings were reported in a poster presentation by Natalia Fadeeva, MD, PhD, Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine, Russia, and colleagues during the 2021 European Society for Medical Oncology virtual meeting.
A total of 357 patients from Russia and India were randomized 1:1 and 2:1, respectively, to receive either BCD-201 or reference bevacizumab plus paclitaxel and carboplatin once every 3 weeks for 6 cycles. Patients had at least 1 computed tomography scan after initiation of therapy. At week 18, patients who had stable disease or who acheived a complete or partial response were given the opportunity to continue treatment with BCD-021 until disease progression, death, or intolerable toxicity.
The primary efficacy end point was ORR based on responses achieved by week 19 and confirmed 4 weeks thereafter. The primary PK end point was AUC(0-t) after first infusion. Secondary end points included safety, PK, and immunogenicity.
Results showed an ORR of 34.6% in the BCD-021 group and 33.8% in the reference bevacizumab group. Complete response rates were 1.5% and 0.7%, respectively, and partial response rates were 33.2% and 33.1%, respectively. The percentage of patients with stable disease in the biosimilar and reference drug groups were 31.7% and 33.8%, respectively.
PK parameters and the incidence of antidrug antibodies were also comparable between BCD-021 and reference bevacizumab.
The rates of any grade adverse events (AEs) were 91.3% in the BCD-021 group versus 93.4% in the reference bevacizumab group. Serious AEs were observed in 13.6% and 10.9% of patients, respectively. The most frequently occurring AEs were anemia, neutropenia, and alopecia.
“This study demonstrated equivalence between BCD-021 and bevacizumab in terms of ORR risk difference and risk ratio. PK equivalence of BCD-021 and bevacizumab was also confirmed. Safety and immunogenicity parameters were comparable between BCD-021 and bevacizumab,” noted Dr Fadeeva and colleagues in their poster.