Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell

Background MB02 (bevacizumab biosimilar) showed similar structural, functional, and pharmacokinetic properties to reference bevacizumab (Avastin; EU-bevacizumab). Objectives To confirm clinical similarity between MB02 and EU-bevacizumab, a comparability study was undertaken in the first-line treatme...

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Published in:BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2021-07, Vol.35 (4), p.429-444
Main Authors: Trukhin, Dmytro, Poddubskaya, Elena, Andric, Zoran, Makharadze, Tamta, Bellala, Ravi Shankar, Charoentum, Chaiyut, Yañez Ruiz, Eduardo P, Fulop, Andrea, Hyder Ali, Irfhan Ali, Syrigos, Kostas, Katgi, Nuran, Chuken, Yamil Alonso Lopez, Rumyana, Ilieva, Reyes-Igama, Jasmin, Costamilan, Rita De cassia, García, Ana Del Campo, Florez, Amalia, Paravisini, Alexandra, Millan, Susana
Format: Article
Language:English
Subjects:
Adverse events
Bevacizumab
Biological products
Cancer therapies
Carboplatin
Chemotherapy
Clinical trials
Drug dosages
Drug withdrawal
Immunogenicity
Immunotherapy
Lung cancer
Monoclonal antibodies
Non-small cell lung carcinoma
Paclitaxel
Pharmacokinetics
Safety
Small cell lung carcinoma
Structure-function relationships
Targeted cancer therapy
Toxicity
Tumors
Vascular endothelial growth factor
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Summary:Background MB02 (bevacizumab biosimilar) showed similar structural, functional, and pharmacokinetic properties to reference bevacizumab (Avastin; EU-bevacizumab). Objectives To confirm clinical similarity between MB02 and EU-bevacizumab, a comparability study was undertaken in the first-line treatment of stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC). Patients and Methods This multinational, double-blind, randomized, phase III study (STELLA) compared MB02 or EUbevacizumab (15 mg/kg) administered with chemotherapy (paclitaxel 200 mg/m2 and carboplatin AUC6) on Day 1 of every 3-week cycle for 6 cycles (Week 18), followed by MB02/EU-bevacizumab in blinded monotherapy until disease progression, unacceptable toxicity, death, withdrawal of consent or end of study (Week 52). The primary efficacy endpoint was objective response rate (ORR) evaluated by an independent radiological review committee (IRC) at Week 18 (intent-to-treat population). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety and immunogenicity. Results A total of 627 subjects were randomized 1:1 to MB02 (n=315) or EU-bevacizumab (n=312). ORR, assessed by the IRC at Week 18, was comparable in MB02 (40.3%) and EU-bevacizumab (44.6%) groups. ORR risk ratio of 0.910 (90% CI 0.780 to 1.060; 95% CI 0.758 to 1.092) and ORR risk difference of -4.02 (90% CI -10.51 to 2.47; 95% CI -11.76 to 3.71) were within the similarity predefined margins. There were no significant differences between MB02 and EU-bevacizumab groups in median PFS (36.0 vs 37.3 weeks, respectively; HR 1.187; 95% CI 0.98 to 1.44) and median OS (not achieved; HR 1.108; 95% CI: 0.83 to 1.49) at the end of study. The safety profile of MB02 and EU-bevacizumab regarding nature, frequency and severity of the adverse events (AE) was comparable. The most frequent grade >3 investigational-product-related AEs were hypertension and anemia, with a difference between treatment groups of
ISSN:1173-8804
1179-190X