The results of a randomized, double-blind phase 3 study established the equivalence of bevacizumab reference to its biosimilar MIL60 in terms of clinical efficacy, safety, population pharmacokinetics, and immunogenicity in patients with nonsquamous NSCLC.
The results of a randomized phase 3 study that compared the efficacy, safety, population pharmacokinetics (PK), and immunogenicity of MIL60, a bevacizumab biosimilar, with bevacizumab reference product in patients with advanced or recurrent nonsquamous non–small-cell lung cancer (NSCLC) were reported at the 2021 European Society for Medical Oncology Annual Meeting.
This randomized, double-blind phase 3 study (NCT03196986) randomized patients with untreated advanced/recurrent NSCLC. Between August 23, 2017, and August 1, 2019, patients received MIL60 or bevacizumab reference (15 mg/kg on day 1 of each cycle every 3 weeks) in combination with paclitaxel/carboplatin, followed by MIL60 single-agent (7.5 mg/kg) maintenance treatment until disease progression or intolerable toxicity. The primary end point was the objective response rate (ORR) at week 12.
The study included a total of 517 patients; of these, 257 received MIL60 and 260 received bevacizumab reference. At week 12, the ORRs were similar in the MIL60 and bevacizumab reference groups (48.6% vs 43.1%). The equivalence of the 2 groups was established based on an ORR ratio of 1.14 (90% confidence interval, 0.97-1.33), which fell within the prespecified equivalence boundaries (0.75-1/0.75). Updated analysis (from October 31, 2020) reported comparable median duration of response (5.7 months vs 5.6 months; hazard ratio [HR], 0.92; P = .6409), median progression-free survival (7.2 vs 8.1 months; HR, 1.01; P = .9606), and overall survival (19.3 vs 16.3 months; HR, 0.81; P = .0755). For PK parameters, there was no significant difference in the exposure of MIL60 and bevacizumab reference.
Overall, the safety and tolerability profiles of MIL60 and bevacizumab reference were comparable in terms of grade ≥3 treatment-emergent adverse events (70.3% vs 72.6%) and serious adverse events (28.1% vs 28.6%). In both the MIL60 and bevacizumab groups, antidrug antibodies were undetectable.
Based on these results, it was concluded that MIL60 and bevacizumab reference are equivalent in clinical efficacy, safety, population PK, and immunogenicity in patients with nonsquamous NSCLC.
Source: Wang J, Wang R, Dong X, et al. Efficacy and safety of MIL60, a bevacizumab biosimilar, in combination with paclitaxel/carboplatin in patients with advanced or recurrent non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter phase III study. Ann Oncol. 2021;32(suppl_5):S1023.