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Equivalence Study of Bevacizumab Biosimilar in Metastatic Nonsquamous NSCLC

By: Sarah Campen, PharmD
Posted: Wednesday, November 11, 2020

MYL-14020, a proposed bevacizumab biosimilar, appears to be equivalent in efficacy and safety compared with the brand agent Avastin in the first-line treatment of patients with stage IV nonsquamous non–small cell lung cancer (NSCLC), based on a phase III confirmatory study. Mark A. Socinski, MD, of Florida Hospital Advent Cancer Institute, Orlando, and colleagues presented their findings at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 1391P).

In this multicenter, double-blind equivalence study, 671 patients with stage IV metastatic nonsquamous NSCLC were randomly assigned to receive MYL-14020 (n = 337) or Avastin (n = 334). Patients received combination therapy of study treatment with carboplatin plus paclitaxel up to 18 weeks, followed by 24 weeks of monotherapy.

The ratio of overall response rate between the MYL-14020 and Avastin arms was 0.96. At week 42, the median progression-free survival for investigational review was 7.6 months in the MYL-14020 arm and 9.0 months in the Avastin arm (P = .0906); the progression-free survival for investigator assessment was 7.8 months and 7.3 months, respectively (P = .4748). Although the median overall survival was not reached at 42 weeks, the overall survival rate was 70.0% and 75.4% for MYL-14020 and Avastin, respectively (P = .1185).

Safety was comparable between MYL-14020 and Avastin. Serious adverse events occurred in 17.6% versus 16.7%, and treatment-related adverse events led to death in 2.4% versus 1.5% patients, respectively. The incidence of treatment-emergent antidrug antibodies was also comparable.

Disclosure: For full disclosure of the study authors, visit oncologypro.esmo.org.



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