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Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer

Year: 2025

Type: article

Abstract: PURPOSE: Data from the CT-P16 3.1 study demonstrated equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) for the primary endpoint of objective response rate (ORR) during induction treatment in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). We now present long-term findings. METHODS: ) and carboplatin (area under the curve 6.0) for 4-6 cycles during the induction period. Patients with controlled disease entered the maintenance period, continuing with CT-P16 or EU-bevacizumab as monotherapy until disease progression/intolerable toxicity. They were then followed up every 9 weeks until death or end of study. Outcomes were evaluated ≤3 years after the last patient enrollment. RESULTS: Of 689 patients receiving CT-P16 (N = 342) or EU-bevacizumab (N = 347), 499 (72.4 %) completed the induction period (CT-P16, n = 258 [75.4 %]; EU-bevacizumab, n = 241 [69.5 %]), 466 (67.6 %) initiated the maintenance period (CT-P16, n = 239 [69.9 %]; EU-bevacizumab, n = 227 [65.4 %]), and 389 (56.5 %) entered follow-up (CT-P16, n = 190 [55.6 %]; EU-bevacizumab, n = 199 [57.3 %]). Whole study ORRs were similar for CT-P16 (45.61 % [95 % confidence interval 40.34-50.89]) and EU-bevacizumab (46.11 % [95 % confidence interval 40.86-51.35]). Response duration, time to progression, progression-free survival, and overall survival were similar. No new safety signals were detected. CONCLUSIONS: Long-term results of the CT-P16 3.1 study confirm equivalent efficacy of CT-P16 and EU-bevacizumab in patients with metastatic or recurrent non-squamous NSCLC. TRIAL REGISTRATION NUMBER: NCT03676192. MICRO ABSTRACT: Equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) was demonstrated in a phase 3 study of patients with metastatic or recurrent non-squamous NSCLC. Long-term findings in 689 patients confirmed equivalent efficacy of CT-P16 and EU-bevacizumab; objective response rates were 45.6 % and 46.1 %, respectively. Response duration, time to progression, progression-free survival, and overall survival were also similar.

Source: Cancer Treatment and Research Communications

DOI: 10.1016/j.ctarc.2025.100970