KEY TAKEAWAYS
- A phase III study of CT-P16 vs EU-bevacizumab in metastatic or recurrent nsNSCLC patients.
- The primary aim was to determine the equivalent effectiveness of CT-P16 and EU-bevacizumab.
- Randomization of patients to receive either CT-P16 or EU-bevacizumab every three weeks for a maximum of six cycles. Induction therapy with paclitaxel and carboplatin was also administered.
- The observed response rate for CT-P16 and EU-bevacizumab was within the predefined equivalence margins, indicating equivalent efficacy.
- Safety profiles of the two treatments were comparable, with similar pharmacokinetics and immunogenicity.
- CT-P16 and EU-bevacizumab are bioequivalent and have equivalent efficacy in patients with nsNSCLC.
This phase III study aimed to determine the comparative effectiveness of CT-P16 and the European Union-endorsed reference bevacizumab (EU-bevacizumab) in individuals diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) through a double-blind, multicenter, parallel-group approach. Randomization was conducted among patients diagnosed with stage IV or recurrent non-squamous non-small cell lung cancer. These patients were assigned to receive either CT-P16 or EU-bevacizumab in a 1:1 ratio. The administration of both drugs was done every three weeks at a 15 mg/kg dose for a maximum of six cycles. Paclitaxel and carboplatin were also administered as induction therapy, with a dose of 200 mg/m2 and an area under the curve of 6.0, respectively, for 4-6 cycles. Patients who achieved disease control following induction therapy were administered maintenance therapy with either CT-P16 or EU-bevacizumab. The main outcome measure was the objective response rate (ORR) observed during the induction phase. The evaluations encompassed time-to-event analyses, pharmacokinetics, safety, and immunogenicity. The findings obtained following a one-year follow-up are being presented.
A total of 689 patients were subjected to randomization, with 342 receiving CT-P16 and 347 receiving EU-bevacizumab. The observed response rate (ORR) for CT-P16 and EU-bevacizumab was 42.40% (95% confidence interval [CI] 37.16-47.64) and 42.07% (95% CI 36.88-47.27), respectively. The observed risk difference (0.40 [95% CI – 7.02 to 7.83]) and risk ratio (1.0136 [90% CI 0.8767-1.1719]) for the overall response rate (ORR) were found to be within the predefined equivalence margins (- 12.5 to + 12.5%, and 0.7368 to 1.3572, respectively). This indicates that CT-P16 and EU-bevacizumab are equivalent. The treatment groups exhibited no significant differences between the median response duration, time to progression, progression-free survival, and overall survival. The safety profiles exhibited comparable results, with 96.2% of patients receiving CT-P16 and 93.0% receiving EU-bevacizumab experiencing treatment-emergent adverse events. The pharmacokinetics and immunogenicity exhibited no significant difference among the groups. The bioequivalence of CT-P16 and EU-bevacizumab has been supported by similar pharmacokinetics, safety, and immunogenicity, indicating equivalent efficacy in patients with nsNSCLC.
Source:https://pubmed.ncbi.nlm.nih.gov/36169807/
Clinical Trail: https://clinicaltrials.gov/ct2/show/NCT03676192
Verschraegen C, Andric Z, Moiseenko F, Makharadze T, Shevnya S, Oleksiienko A, Yañez Ruiz E, Kim S, Ahn K, Park T, Park S, Ju H, Ohe Y. Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial. BioDrugs. 2022 Nov;36(6):749-760. doi: 10.1007/s40259-022-00552-8. Epub 2022 Sep 28. PMID: 36169807; PMCID: PMC9649513.
