Celltrion Reports P-III Trial Results of CT-P16 (biosimilar, bevacizumab) for Non-Squamous Non–Small Cell Lung Cancer
- The P-III trial evaluating CT-P16 vs EU-Approved Avastin (15mg/kg, q3w; ≤ 6 cycles) with paclitaxel (200mg/m2) & carboplatin in 689 patients with metastatic or recurrent non-sq. NSCLC across 164 study sites in 21 countries
- CT-P16 showed an equivalent efficacy & similar PK, safety, and immunogenicity to reference EU-bevacizumab. In the primary efficacy EPs, ORR (42.40% vs 42.07%); CR (0.6% vs 0.9%); PR (41.8% vs 41.2%) while the 2EPs incl. response duration (7.2 vs 6.3mos.), m-TTP, PFS, and OS were also similar
- Patients experienced ≥1 TEAEs (96.2% vs 93%); TEAEs considered to be related to the use of bevacizumab (51.6% vs 50.6%); patients were positive for antidrug Abs (22.6% vs 24.1%) regarding immunogenicity
Ref: Centerforbiosimilar | Image: Celltrion
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