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.
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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
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