The results of a phase 3 trial demonstrated the clinical equivalence of MB02 with bevacizumab reference product in terms of efficacy, safety, and immunogenicity in patients with stage IIIB/IV nonsquamous non–small-cell lung cancer (NSCLC).
During the 2020 American Society of Clinical Oncology Virtual Scientific Program, the results of a confirmatory multinational, double-blind, randomized, parallel-group clinical study (STELLA) that compared the clinical similarity between MB02, a bevacizumab candidate, and bevacizumab reference in patients with stage IIIB/IV nonsquamous non–small-cell lung cancer (NSCLC) were reported.
Eligible patients were randomized 1:1 to receive MB02 or bevacizumab dosed at 15 mg/kg plus chemotherapy (paclitaxel 200 mg/m2 and carboplatin area under the curve 6) on day 1 of an every-3-weeks cycle for 6 cycles (week 18); this was followed by blinded MB02 or bevacizumab monotherapy until disease progression, treatment intolerance, death, patient withdrawal, or end of study (week 52). The primary end point was the objective response rate (ORR) evaluated by an independent radiological committee (IRC) at week 18; secondary end points were progression-free survival (PFS), overall survival (OS), safety, and immunogenicity at week 18 and week 52.
A total of 627 eligible patients were enrolled; of these, 315 patients were treated with MB02 and 312 patients were treated with bevacizumab reference. At week 18, the IRC-assessed ORR was similar between the treatment groups, with a risk ratio of 1.013 (90% confidence interval [CI], –0.037%-0.059%) and a risk difference of 0.011 (90% CI, –0.037%-0.059) that was contained within the predefined equivalence margins (US Food and Drug Administration, 0.73-1.36; European Medicines Agency, –12%-12%), which established criteria for equivalence between MB02 and bevacizumab reference. No significant differences were observed in OS and PFS between arms at week 18.
In the safety analysis, the nature, frequency, and severity of the adverse events observed were similar between the MB02 and bevacizumab reference groups. The most common treatment-related adverse events were anemia and hypertension, with a between-group risk difference of <5%. Among patients treated with MB02, no new safety signals or trends emerged, with a profile consistent with that previously described for bevacizumab reference. In terms of immunogenicity, no significant differences were noted between the MB02 and bevacizumab reference groups.
These results confirm the clinical equivalence of MB02 with bevacizumab reference in terms of efficacy, safety, and immunogenicity in patients with stage IIIB/IV nonsquamous NSCLC.
Reference
Millan S, et al. ASCO 2020. Abstract e21542.