Comparison of biosimilar and originator bevacizumab in NSCLC

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Comparison of biosimilar and originator bevacizumab in NSCLC

Biosimilares/Investigación | Posted 14/09/2018 0 Post your comment

A study carried out by international researchers reported results from a comparative clinical study of PF‑06439535, a candidate bevacizumab biosimilar compared to originator bevacizumab, in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

Pfizer started its phase III trial for its bevacizumab biosimilar (PF‑06439535) in lung cancer patients in February 2015 [2]. This ongoing, double-blind, randomized, global clinical trial evaluated the efficacy, safety and immunogenicity of PF‑06439535 vs reference bevacizumab sourced from the European Union (EU) (bevacizumab-EU), in combination with paclitaxel (P) and carboplatin (C), as first-line therapy in patients with advanced non-squamous NSCLC.

Eligible patients were randomized 1:1 to PF‑06439535 or bevacizumab-EU plus P/C on Day 1 of every 3-week cycle followed by PF‑06439535 or bevacizumab-EU blinded monotherapy until disease progression or unacceptable toxicity. The primary objective was to compare objective response rate (ORR) by Week 19 between treatment arms. Secondary objectives included safety, 1 year PFS, 1 year survival rate and immunogenicity.

A total of 719 patients were randomized: PF-06439535 (n = 358) and bevacizumab-EU (n = 361). The majority of patients were male (65%) with a median age of 61 years and newly diagnosed Stage IV NSCLC (76%). For the primary endpoint, relative risk of ORR was 1.015. The 90% confidence interval (CI), 0.886−1.163, was contained within the US Food and Drug Administration (FDA) pre-specified therapeutic equivalence margin of 0.73−1.37. Secondary endpoints further supported similarity between the 2 treatment arms. The incidence of treatment-emergent adverse events (AEs) (all-causality) was similar (PF‑06439535: 96.6%) and (bevacizumab-EU: 96.1%). AE results indicated no clinically meaningful differences between the two arms for arterial thromboembolic event (TE)/venous TE events, bleeding events, hypertension, gastrointestinal perforation and proteinuria.

These data were presented at the American Society of Clinical Oncology’s (ASCO) 2018 Annual Meeting, which was held on 1−5 June 2018 in Chicago, IL, USA.

The authors concluded that ‘in patients with advanced non-squamous NSCLC, PF‑06439535 and bevacizumab-EU showed similar ORR (primary endpoint) PFS, OS, safety and immunogenicity’.

Conflict of interest
The authors of the abstract [1] reported conflict of interest, including having received honoraria from, having worked in a consulting or advisory role for and having received speakers fees or research funding from various pharmaceutical companies. For full details of the authors’ conflict of interest, see the abstract [1].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

References
1. Socinski MA, Von Pawel J, Kasahara K, et al. A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced non-squamous non-small cell lung cancer. American Society of Clinical Oncology (ASCO) 2018 Annual Meeting; 1-5 June 2018; Chicago IL, USA.
2. GaBI Online - Generics and Biosimilars Initiative. Pivotal clinical trials for bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 14]. Available from: www.gabionline.net/Reports/Pivotal-clinical-trials-for-bevacizumab-biosimilars

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.