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 study
AffiliationThe Christie Hospital, Manchester, United Kingdom
MetadataShow full item record
AbstractPURPOSE: 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 = 328) and bevacizumab (n = 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 ?g/mL (ABP 215 group) and 129 ?g/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.
CitationThatcher N, Goldschmidt JH, Thomas M, Schenker M, Pan Z, Paz-Ares Rodriguez L, et al. 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 study. Clin Cancer Res. 2019; 25(7):2088-95.
JournalClinical Cancer Research
- PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin<sup>®</sup>), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study.
- Authors: Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, Bair AH, Hilton F, Liau K, Kasahara K
- Issue date: 2019 Oct
- Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study (STELLA).
- Authors: Trukhin D, Poddubskaya E, Andric Z, Makharadze T, Bellala RS, Charoentum C, Yañez Ruiz EP, Fulop A, Hyder Ali IA, Syrigos K, Katgi N, Lopez Chuken YA, Rumyana I, Reyes-Igama J, Costamilan RC, Del Campo García A, Florez A, Paravisini A, Millan S, STELLA Investigators.
- Issue date: 2021 Jul
- A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
- Authors: Reck M, Luft A, Bondarenko I, Shevnia S, Trukhin D, Kovalenko NV, Vacharadze K, Andrea F, Hontsa A, Choi J, Shin D
- Issue date: 2020 Aug
- Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial.
- Authors: Shi Y, Lei K, Jia Y, Ni B, He Z, Bi M, Wang X, Shi J, Zhou M, Sun Q, Wang G, Chen D, Shu Y, Liu L, Guo Z, Liu Y, Yang J, Wang K, Xiao K, Wu L, Yi T, Sun D, Kang M, Ma T, Mao Y, Shi J, Tang T, Wang Y, Xing P, Lv D, Liao W, Luo Z, Wang B, Wu X, Zhu X, Han S, Guo Q, Liu R, Lu Z, Zhang J, Fang J, Hu C, Ji Y, Liu G, Lu H, Wu D, Zhang J, Zhu S, Liu Z, Qiu W, Ye F, Yu Y, Zhao Y, Zheng Q, Chen J, Pan Z, Zhang Y, Lian W, Jiang B, Qiu B, Zhang G, Zhang H, Chen Y, Chen Y, Duan H, Li M, Liu S, Ma L, Pan H, Yuan X, Yuan X, Zheng Y, Gao E, Zhao L, Wang S, Wu C
- Issue date: 2021 Sep
- First-line pemetrexed/carboplatin or cisplatin/bevacizumab compared with paclitaxel/carboplatin/bevacizumab in patients with advanced non-squamous non-small cell lung cancer with wild-type driver genes: A real-world study in China.
- Authors: Chang Q, Zhang Y, Xu J, Zhong R, Qiang H, Zhang B, Han B, Qian J, Chu T
- Issue date: 2019 May