Biosimilar MB02 as an Alternative to Bevacizumab in Lung Cancer Treatment
The STELLA clinical trial aimed to evaluate the efficacy, safety, and immunogenicity of MB02, a biosimilar to bevacizumab, in patients with advanced non-small cell lung cancer.
Biosimilar MB02
Bevacizumab is a monoclonal antibody against human vascular endothelial growth factor (VEGF). Binding of this antibody prevents the interaction of VEGF with its receptor on the surface of endothelial cells, thereby inhibiting angiogenesis. Bevacizumab is approved for the treatment of advanced non-small cell lung cancer (NSCLC) and other malignancies.
MB02 is a biosimilar to bevacizumab and was approved under the same standards of quality, safety, and efficacy as other biologics. MB02 exhibits comparable binding affinity to all isoforms of VEGF, similar neutralizing capabilities, and the same mechanism of action.
Methods and Study Design
The STELLA clinical trial enrolled 627 patients with newly diagnosed or recurrent non-squamous NSCLC in stage IIIB/IV without surgical treatment options and with at least one unidimensional measurable lesion per RECIST criteria.
Participants were randomized to treatment with either bevacizumab or biosimilar MB02. Both MB02 and bevacizumab were administered by infusion at a dose of 15 mg/kg in combination with chemotherapy (paclitaxel 200 mg/m2 and carboplatin AUC6) every 3 weeks (6 cycles). Subsequently, only the investigational drug (bevacizumab or MB02) was administered every 3 weeks until the end of the study (week 52) or until disease progression, unacceptable toxicity, or patient withdrawal of consent.
The efficacy of the anticancer treatment was assessed using CT and MRI scans.
Results
At week 18, the objective response rate (ORR) to treatment was comparable between MB02 (ORR 40.3%; 95% confidence interval [CI] 34.9–46%) and bevacizumab (ORR 44.6%; 95% CI 39.0–50.3%) in combination with paclitaxel and carboplatin. Progression-free survival (PFS) did not significantly differ between MB02 (36.00 weeks; 95% CI 33.00–36.43) and bevacizumab (37.29 weeks; 95% CI 36.14–45.14). Median overall survival (OS) also did not differ between the groups at the end of the study.
The safety profile of MB02 and bevacizumab in terms of the type, frequency, and severity of adverse events (AEs) was comparable. The most common AEs of severity ≥ 3 associated with the investigational drug were hypertension and anemia (difference between the groups was < 5%). Antibodies against the investigational drugs and neutralizing antibodies were present in both groups at the same rate.
Conclusion
MB02 is as effective as bevacizumab in combination with paclitaxel and carboplatin in patients with advanced NSCLC. Its safety profile and immunogenicity are also comparable.
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Source: Trukhin D., Poddubskaya E., Andric Z. et al. 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). BioDrugs 2021 Jul; 35 (4): 429–444, doi: 10.1007/s40259-021-00483-w.
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