Drug intelligence / Profile preview

IBI305 + carboplatin + paclitaxel

Development stage
Unknown
Lead developer
Innovent Biologics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

The drug combination IBI305 + carboplatin + paclitaxel is a therapeutic regimen used primarily in the treatment of non-small cell lung cancer (NSCLC). IBI305 is a bevacizumab biosimilar developed by Innovent Biologics in China. ## Composition and Mechanism This combination therapy consists of: 1. **IBI305** - A bevacizumab biosimilar that targets vascular endothelial growth factor (VEGF), inhibiting angiogenesis and tumor blood vessel formation[5][7] 2. **Carboplatin** - A platinum-based chemotherapy agent that forms DNA adducts, preventing DNA replication and transcription 3. **Paclitaxel** - A taxane chemotherapy agent that stabilizes microtubules, preventing cell division The combination works through multiple mechanisms: IBI305 targets the tumor vasculature, while carboplatin and paclitaxel directly attack cancer cells through different cytotoxic mechanisms[7]. ## Clinical Development This combination has been extensively studied in clinical trials, particularly for non-squamous NSCLC. A pivotal phase 3 trial compared IBI305 + carboplatin + paclitaxel with reference bevacizumab + carboplatin + paclitaxel in 450 patients with advanced non-squamous NSCLC[5][6][7]. In this double-blind study, patients received up to 6 cycles of IBI305 or reference bevacizumab (15 mg/kg) combined with carboplatin (AUC 6) and paclitaxel (175 mg/m²), followed by maintenance therapy with IBI305 or bevacizumab (7.5 mg/kg) at 3-week intervals[7]. ## Efficacy Results The combination demonstrated clinical equivalence to the reference bevacizumab combination: - Objective response rate (ORR): 44.3% for IBI305 vs 46.4% for bevacizumab (risk ratio: 0.95, 90% CI: 0.803-1.135)[6][7] - Disease control rate (DCR): 90.5% for IBI305 vs 87.7% for bevacizumab[7] - Median progression-free survival (PFS): 7.64 months for IBI305 vs 7.77 months for bevacizumab (p=0.9987)[7] - Median duration of response (DOR): 7.3 months for IBI305 vs 6.9 months for bevacizumab (p=0.559)[7] These results confirmed the therapeutic similarity between IBI305 and reference bevacizumab when used in this combination regimen. ## Safety Profile The safety profile of IBI305 + carboplatin + paclitaxel was consistent with the known adverse event profile of bevacizumab + carboplatin + paclitaxel. Treatment-emergent adverse events were well balanced between treatment arms[6]. Immunogenicity was low, with only 0.5% of patients in the IBI305 arm developing binding antibodies compared to 0% in the bevacizumab arm. No patients tested positive for neutralizing antibodies[6]. This combination represents an important treatment option for patients with advanced NSCLC in China, where lung cancer has the highest incidence among all cancers[5].

Brand names
Avastin (for reference bevacizumab, of which IBI305 is a biosimilar)Taxol (for paclitaxel)Paraplatin (for carboplatin)
Other names
bevacizumab biosimilar + paclitaxel + carboplatin
02

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