CT-P16 (bevacizumab biosimilar, anti-VEGF) matches reference bevacizumab in nsNSCLC

From a South Korean biopharma company, Celltrion’s CT-P16 is a bevacizumab biosimilar (anti-VEGF-A mAb). In a randomized, double-blind, global, multicenter Phase 3 first-line study for metastatic/recurrent non-squamous NSCLC (NCT03676192), patients received paclitaxel 200 mg/m² + carboplatin AUC6 plus CT-P16 or EU-bevacizumab 15 mg/kg q3w for 4–6 cycles, then maintenance bevacizumab; 689 patients were treated. Whole-study ORR was 45.61% vs 46.11%, and response duration, time-to-progression, PFS, and OS were similar with no new safety signals—consistent with historical paclitaxel/carboplatin+bevacizumab benchmarks (ORR 35%, mPFS 6.2 mo, mOS 12.3 mo) and acknowledging that modern chemo-IO (pembrolizumab+pemetrexed/platinum) improves survival over chemo alone (HR 0.56; PFS ~9 mo).