ZIRABEV® Data

ZIRABEV® DEMONSTRATED EQUIVALENT EFFICACY VS REFERENCE BEVACIZUMAB2,3

Study design

  • Study design: A Phase 3, randomised, double-blind study of ZIRABEV or Bevacizumab-EU in combination with paclitaxel and carboplatin for the first-line treatment of treatment-naïve patients with advanced non-squamous NSCLC. Primary endpoint: ORR by Week 19, confirmed by Week 25.2,3
  • Similarity between ZIRABEV and Reference Bevacizumab is indicated by the 95% CI for the risk ratio,* which fell within the prespecified equivalence margin2,3

Secondary Endpoint:

  • There were no statistically significant or clinically meaningful differences between ZIRABEV and Bevacizumab-EU for all of the secondary efficacy endpoints (progression-free survival, overall survival, and duration of response)2,3

zirabev

 

In patients with non-squamous NSCLC, ZIRABEV and Reference Bevacizumab had comparable ORRs3 

comparable_orr

Secondary endpoint: No significant difference in 55-week progression-free survival rate and 55-week overall survival rate2 

progression free survival

overall survival

Abbreviations: CI=confidence interval. HR=hazard ratio. ITT=intention to treat. NSCLC=non-small cell lung cancer. PFS=progression free survival. ORR=overall response rate. OS=overall survival.

aEstimated from the Kaplan-Meier curve, calculated from the product limit method. bBased on the Brookmeyer and Crowley method. cThis is a 2-sided P value from log-rank test stratified by smoking, sex, and region. dBased on the Cox proportional hazards model stratified by smoking, sex, and region.

 

 

References:

1. ZIRABEV® (bevacizumab) summary of product characteristics.
2. Data on file. Full Clinical Study Report. Protocol B7391003. Pfizer Inc. New York, NY. Data as of 2018.
3. Reinmuth N, Bryl M, Bondarenko I, et al. BioDrugs. 2019;33(5):555-570.
4. Melosky B et al Future Oncol 2018;14(24):2507-2520.

PP-BIO-IRL-0130. Preparation Date: April 2021.