Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2019
PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02364999 (A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.), which is not on this map. Cited by 30 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 3 randomized, double-blind study of pf- 06439535 plus paclitaxel-carboplatin and bevacizumab plus paclitaxel -carboplatin for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer.
Who cites it
30 citing papers in PubMed, 7 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Clinical Similarity of Biosimilars and Reference Drugs: A Comprehensive Review and New Hope for Public Health in a New Frontier.Current drug research reviews · 2025Pooled it
- Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024Pooled it
- Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China: A Systematic Review and Meta-Analysis.JAMA network open · 2023Pooled it
- Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Pooled it
- Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review.Frontiers in pharmacology · 2023Pooled it
- Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: A Systematic Review and Meta-analysis.JAMA oncology · 2022Pooled it
- Efficacy and Safety of Bevacizumab Biosimilars Compared With Reference Biologics in Advanced Non-small Cell Lung Cancer or Metastatic Colorectal Cancer Patients: A Network Meta-Analysis.Frontiers in pharmacology · 2022Pooled it
- Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study.Advances in therapy · 2024Trial
- Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Trial
- Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial.Cancer communications (London, England) · 2021Trial
- Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC).BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Trial
- Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (AvastinCancer chemotherapy and pharmacology · 2020Trial
- Real-world cost avoidance associated with bevacizumab biosimilar adoption in a tertiary public hospital in Ecuador: a cost-minimization and budget impact analysis.Cost effectiveness and resource allocation : C/E · 2026Article
- Economic evaluation of three domestic bevacizumab biosimilars and the original bevacizumab for treating nonsquamous non-small cell lung cancer in china: a cost-effectiveness analysis.Cost effectiveness and resource allocation : C/E · 2025Article
- Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.Pharmaceutical medicine · 2024Article
- Retrospective analysis of survival and safety of bevacizumab biosimilar and original drug combination chemotherapy in non-small cell lung cancer.Frontiers in oncology · 2024Article
- A descriptive analysis of real-world oncology biosimilar use in Japan.Future oncology (London, England) · 2024Observational
- Development of the Drug Product Formulation of the Bevacizumab Biosimilar PF-06439535 (Bevacizumab-bvzr).Drugs in R&D · 2023Article
- Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials.European journal of hospital pharmacy : science and practice · 2022Article
- An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review.Ophthalmology and therapy · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 7 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPF-06439535 is a bevacizumab biosimilar. We aimed to compare the efficacy and safety of PF-06439535 with that of reference bevacizumab (Avastin
methodsIn this double-blind, parallel-group study, we recruited patients from 159 centers in 27 countries. Participants were randomized 1:1 to receive PF-06439535 plus paclitaxel and carboplatin or bevacizumab-EU plus paclitaxel and carboplatin on day 1 of each 21-day cycle for 4-6 cycles, followed by blinded monotherapy with PF-06439535 or bevacizumab-EU until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study. Randomization was stratified by region, sex, and smoking history. The primary endpoint was objective response rate (ORR) in accordance with RECIST 1.1, based on responses achieved by week 19 and confirmed by week 25.
resultsBetween 21 May 2015 and 14 November 2016, 719 patients were randomized to the PF-06439535 group (n = 358) or the bevacizumab-EU group (n = 361). As of data cutoff for analysis of the primary endpoint (8 May 2017), 45.3% (95% confidence interval [CI] 40.01-50.57) of patients in the PF-06439535 group and 44.6% (95% CI 39.40-49.89) of patients in the bevacizumab-EU group achieved an objective response by week 19 that was confirmed by week 25. The unstratified ORR risk ratio was 1.015 (95% CI 0.863-1.193; 90% CI 0.886-1.163), and the unstratified ORR risk difference was 0.653% (95% CI - 6.608 to 7.908); all three CIs fell within pre-specified equivalence margins. Using final data after study completion (22 December 2017), no notable differences in progression-free survival or overall survival were observed between the groups. The most frequently reported grade 3 or higher treatment-emergent adverse events were hypertension, neutropenia, and anemia. There were no clinically meaningful differences in safety, pharmacokinetics, or immunogenicity across treatment groups.
conclusionAmong patients with advanced non-squamous NSCLC, PF-06439535 demonstrated similarity to bevacizumab-EU in terms of efficacy. Safety profiles for the two treatments were comparable.
trial registrationClinicalTrials.gov, NCT02364999.
fundingPfizer.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.