COMPARISON OF THE EFFECT OF A BIOSIMILAR BEVACIZUMAB WITH THE INNOVATORS’ BEVACIZUMAB IN THE TREATMENT OF NON-SMALL-CELL LUNG CANCER
Journal Title: European Journal of Biomedical and Pharmaceutical Sciences - Year 2019, Vol 6, Issue 2
Abstract
Aim: The role of bevacizumab in combination with carboplatin/paclitaxel chemotherapy has been established in patients with non-small-cell lung cancer (NSCLC). This trial was designed to compare the effect of the Zydus biosimilar bevacizumab with the reference bevacizumab in patients with NSCLC. Methods: A multicentre, prospective, randomized, open-label, active controlled study was carried out on 248 subjects with advanced, unresectable, recurrent or metastatic NSCLC at 28 sites across India. Subjects were randomized in a 2:1 ratio to receive intravenous infusion of 15 mg/kg of test or reference bevacizumab, plus paclitaxel 175 mg/m2 and carboplatin (AUC 5 mg/mL×min) every 3 weeks for 6 cycles. Overall response rate (ORR) after 6 cycles was assessed by using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Pharmacokinetics, safety and tolerability, and immunogenicity were also assessed. Results: The ORR was 60.82% responders in the Zydus bevacizumab and 58.82% responders in the reference bevacizumab and the 90% confidence interval (CI) for the difference of ORR fell within the ±20% equivalence margin (-11.96, 15.97). The pharmacokinetic assessment of the Ln-transformed bevacizumab after Cycle-1 data showed the 90% CI for the ratio of the test to reference geometric least square mean fell within the 80.00-125.00% limits for Cmax (87.99%; 120.41%) and AUC0-t (90.70%; 122.03%). The incidence of immunogenicity was marginally lower in the test group as compared to the reference group (72.16% vs. 76.47%). Conclusion: The results demonstrated biosimilarity between Zydus and reference bevacizumab with respect to efficacy, tolerability and safety in the patients with NSCLC.
Authors and Affiliations
Dr. Deven Parmar
Keywords
Related Articles
- EP ID EP670320
- DOI -
- Views 133
- Downloads 0
NEEDLE FREE INJECTION TECHNOLOGY
The Needle-free injection (NFI) systems are novel ways to introduce various medicines Needle free injection technology was developed to reduce the number of needle stick accidents and associated problems. It is an extrem...
THE OCCUPATIONAL RISK FACTORS FOR CANCER: A SURVEY AMONG THE ARTISANS IN THE CITY OF FEZ (MOROCCO)
Cancer is the second leading cause of mortality in Morocco. Data on occupational exposure related to cancer are still lacking. The objective of this study was to determine the frequency and the significance of the exposu...
HYPOGLYCEMIC AND ANTIDIABETIC ACTIVITIES OF AQUEOUS EXTRACT OF PSEUDOLACHNOSTYLIS MAPROUNEIFOLIA VAR. MAPROUNEIFOLIA PAX (EUPHORBIACEAE) STEM BARK IN EXPERIMENTAL WISTAR RATS
The present scientific work was designed to investigate potential hypoglycaemic and antidiabetic activities of aqueous extract of Pseudolachnostylis maprouneifoilia var. maprouneifolia stem bark and its soluble fractions...
EVALUATION OF ANTIASTHMATIC ACTIVITY OF FERONIA ELEPHANTUM BARK LINN
Feronia Elephantum Syn-LimoniaAcidissima L Kingdom Plantae Division Embryophyta Subdivision Angiospermae Class Dicotyledoneae Subclass Archichlamydeae Order Plantae Family Rutaceae Genus Feronia Species Feroniaelephantum...
FORMULATION DEVELOPMENT OF OXYCODONE HCL SOFT GELATIN CAPSULES
The objective of this work is to develop simple, elegant, liquid-filled immediate release soft gelatin capsules containing Oxycodone HCl intended for the management of moderate to severe pain in patients who require trea...