Efficacy & Safety of Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Non-small Cell Lung Cancer(MAPLE):A Randomized,Double-blind,Phase 3 Study

Purpose: This phase 3 study compared clinical efficacy and safety of the biosimilar ABP 215 with bevacizumab reference product (RP) in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients & Methods: Patients were randomized 1:1 to ABP 215 or bevacizumab 15 mg/kg Q3W for 6 cycles. All patients received carboplatin and paclitaxel Q3W for ≥4 and ≤6 cycles. The primary efficacy endpoint was risk ratio of objective response rate(ORR); clinical equivalence was confirmed if the 2-sided 90% CI of the risk ratio was within the margin of 0.67, 1.5. Secondary endpoints included risk difference of ORR, duration of response(DOR), progression-free survival(PFS), and overall survival(OS); pharmacokinetics, adverse events(AEs), and incidence of antidrug antibodies(ADAs) were monitored. Results: 820 patients were screened; 642 were randomized to ABP 215 (n=328) and bevacizumab (n=314). 128 (39.0%) and 131 (41.7%) patients in the ABP 215 and bevacizumab group, respectively, had objective responses (ORR risk ratio: 0.93 [90% CI: 0.80, 1.09]). In the ABP 215 and bevacizumab group, 308 (95.1%) and 289 (93.5%) patients, respectively, had at least 1 AE; 13 (4.0%) and 11 (3.6%) experienced a fatal AE. Anti-VEGF toxicity was low and comparable between treatment groups. At week 19, median trough serum drug concentration was 132 μg/mL (ABP 215 group) and 129 μg/mL (bevacizumab group). No patient tested positive for neutralizing antibodies. Conclusions: ABP 215 is similar to bevacizumab RP with respect to clinical efficacy, safety, immunogenicity, and pharmacokinetics. The totality of evidence supports clinical equivalence of ABP 215 and bevacizumab.

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