Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non–small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Studyстатья
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Аннотация:Purpose: This phase III study compared clinical efficacy
and safety of the biosimilar ABP 215 with bevacizumab
reference product (RP) in patients with advanced nonsquamous non–small cell lung cancer (NSCLC).
Patients and Methods: Patients were randomized 1:1 to
ABP 215 or bevacizumab 15 mg/kg every three weeks for 6
cycles. All patients received carboplatin and paclitaxel every
three weeks 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% confidence interval (CI) of the risk ratio was within the margin of
0.67 to 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: A total of 820 patients were screened; 642 were
randomized to ABP 215 (n ¼ 328) and bevacizumab (n ¼
314). Overall, 128 (39.0%) and 131 (41.7%) patients in the
ABP 215 and bevacizumab groups, 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 mg/mL
(ABP 215 group) and 129 mg/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.