Results of bevacizumab biosimilar compared with RMP for the treatment of metastatic colorectal cancer
| العنوان: | Results of bevacizumab biosimilar compared with RMP for the treatment of metastatic colorectal cancer |
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| المؤلفون: | Pradeep Shah, Igor Bondarenko, Vikas Ostwal, Susana Millan, Sajeed Abdul Rahuman, Fabio Franke, Francisco Javier Fernandez, Yaroslav Shparyk, Camino Huerga, Kathia Cristina Abdalla, Alexandra Paravisini, Suresh Sudalaiandi, Giovanni M. Bariani, Sulabhchandra Bhamare, Yuriy Vinnyk, Antonio Cubillo, Felipe Melo Cruz, Alvaro Romera, Enrique Roca |
| المصدر: | Journal of Clinical Oncology. 35:e14065-e14065 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | 0301 basic medicine, Cancer Research, Bevacizumab, business.industry, Colorectal cancer, Biosimilar, Pharmacology, Multiple dose, medicine.disease, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Oncology, FOLFOX, Pharmacokinetics, 030220 oncology & carcinogenesis, medicine, FOLFIRI, In patient, business, medicine.drug |
| الوصف: | e14065 Background: BEVZ92 has being developed as a proposed biosimilar approved reference medicine product (RMP). BEVZ92 has an identical amino acid sequence and highly similar physicochemical and in vitro functional properties to RMP. The aim of this study was to demonstrate pharmacokinetics (PK) similarity of BEVZ92 to RMP, in combination in combination with FOLFOX or FOLFIRI, as first-line treatment in patients with mCRC (NCT02069704). Methods: PK analysis for multiple dose studies was conducted, as per guidelines, measuring the total exposure area under the concentration-time profile (AUC0-336) at cycle 1, and to the end of the dosing interval at steady-state (AUCss) at cycle 7. PK similarity was achieved if 90% confidence interval (CI) for the test-to-reference ratios of AUC0-336h and AUCss were within 80.00–125.00% bioequivalence acceptance window. Secondary endpoints included other PK parameters, safety profile, immunogenicity and objective response rate (ORR). Results: A total of 142 patients were randomized and treated. Bevacizumab serum concentrations showed a ratio (90% CI) of geometric means for BEVZ92 and RMP were 99.4% (90.5%-109%) and 100% (90.2%–112%) for AUC0-336h and AUCss, respectively. All secondary PK endpoints which include Cmax, Ctrough, Tmax, t1/2, Kel, CL, Vd, and RA-AUC were also similar between the two arms. The ORR was 45% (95% CI, 33% to 57%) for BEVZ92, and 52% (95% CI, 40% to 64%) for RMP. Immunogenicity results showed a low incidence in the anti-drug antibodies de novo development and similar between both arms. Safety profile in terms of nature, frequency and severity was similar to the RMP and according to what is expected given the underlying disease and concurrent use of chemotherapy. Conclusions: These study results confirm the bioequivalence of BEVZ92 and the RMP in a real and common clinical setting, and translates the high similarity demonstrated in the in vitro and in vivo characterization into the clinical outcomes such as efficacy, immunogenicity and safety profile. Clinical trial information: NCT02069704. |
| تدمد: | 1527-7755 0732-183X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::e22f6c8fe26193f1b1ab027861b2b2a5Test https://doi.org/10.1200/jco.2017.35.15_suppl.e14065Test |
| رقم الانضمام: | edsair.doi...........e22f6c8fe26193f1b1ab027861b2b2a5 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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