Evidence map›Paper›PMID 34264503›Full record

Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2021

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).

Konstantinos Syrigos, Istvan Abert, Zoran Andric, Igor N Bondarenko, Mikhail Dvorkin, Kristina Galic, Rinat Galiulin, Vladimer Kuchava, Virote Sriuranpong, Dmytro Trukhin and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02810457 (A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients With Advanced/Recurrent Non Squamous NSCLC in Combination of Paclitaxel and Carboplatin), which is not on this map. Cited by 14 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 5 pooled it
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02810457 phase3completednot on this map

A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients With Advanced/Recurrent Non Squamous NSCLC in Combination of Paclitaxel and Carboplatin

TypeinterventionalSponsorCentus Biotherapeutics LimitedRan2016 to 2022Enrolled731ConditionsCarcinoma, Non-Small-Cell LungArmsFKB238 (bevacizumab), Avastin (bevacizumab), Paclitaxel, Carboplatin
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 5 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Pooled it
  4. Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Pooled it
  5. Pooled it
  6. Trial
  7. Article
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  13. Review
  14. FKB238: A Bevacizumab Biosimilar.Clinical drug investigation · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 7 countries.

Konstantinos SyrigosGeneral Hospital of Chest Diseases of Athens "Sotiria", Athens, Greece.
Istvan AbertMátrai Gyógyintézet-Bronchológia, Heves, Hungary.
Zoran AndricClinical Hospital Center Bezanijska Kosa, Belgrade, Serbia.
Igor N BondarenkoKomunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4, Dnipropetrovsk, Ukraine.
Mikhail DvorkinClinical Oncological Dispensary, Budget Healthcare Institution of Omsk Region, Omsk, Russian Federation.
Kristina GalicUniversity Clinical Hospital, Mostar, Bosnia and Herzegovina.
Rinat GaliulinClinical Oncological Dispensary, Omsk, Russian Federation.
Vladimer KuchavaICO-Institute of Clinical Oncology-Hospital, Tbilisi, Georgia.
Virote SriuranpongDivision of Medical Oncology, Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Dmytro TrukhinOdeskyi oblasnyi onkolohichnyi dyspanser, Odesa, Ukraine.
Edvard ZhavridState Institution N.N. Alexandrov Republican Scientific, Minsk Region, Belarus.
Dongyue FuAstraZeneca Inc, Gaithersburg, MD, USA.
Laurent M KassalowAstraZeneca Inc, Gaithersburg, MD, USA.
Stephanie JonesPharmora Solutions, Dorset, UK.
Zahid BashirTranscrip Partners, Reading, UK. zahid.bashir@transcrip-partners.com.
AVANA Investigators
AstraZeneca (United States) · USBudgetary Healthcare Institution of Omsk Region Regional Clinical Hospital · RUBudgetary Health Care Institution of the Omsk Region "Clinical Oncology Center" · RUInstitute of Clinical Research · USKing Chulalongkorn Memorial Hospital · THPlethora Solutions (United Kingdom) · GBSotiria General Hospital · GRUniversity Clinical Hospital Mostar · BAUniversity Hospital Medical Center Bezanijska kosa · RS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBevacizumab is an antiangiogenic recombinant humanized monoclonal antibody that inhibits tumor growth. FKB238, a bevacizumab biosimilar, has analytical pharmacokinetic and safety profiles similar to those of bevacizumab.

objectiveThis phase III trial (NCT02810457) compared the efficacy and safety of FKB238 with that of bevacizumab in patients with advanced/recurrent non-squamous non-small-cell lung cancer (non-sq-NSCLC).

methodsThis global, multicenter, double-blind, parallel, randomized, comparative clinical trial enrolled and randomized patients with advanced/recurrent non-sq-NSCLC to receive intravenous infusions of either FKB238 15 mg/kg or bevacizumab 15 mg/kg. All patients received intravenous infusions of paclitaxel 200 mg/m

resultsThe ORR for the intent-to-treat (ITT) population (N = 731) was 51.6% in the FKB238 arm (N = 364) and 53.7% in the bevacizumab arm (N = 367). The FKB238:bevacizumab ORR ratio (ITT population) was 0.96 (90% confidence interval [CI] 0.86-1.08), and the difference in ORR (per-protocol set) between FKB238 and bevacizumab was - 0.02 (95% CI - 0.09 to 0.06). Both CIs fell within the prespecified equivalence margins. Estimated median PFS was 7.72 and 7.62 months in the FKB238 and bevacizumab arms, respectively (hazard ratio 0.97; 95% CI 0.82-1.16). Treatment-emergent adverse events (TEAEs) were reported for 94.2% and 95.1% of patients in the FKB238 and bevacizumab arms, respectively. Grade 3 or higher TEAEs were reported for 53.6% and 55.5% of patients in the FKB238 and bevacizumab arms, respectively. Serious TEAEs were reported for 25.1% and 26.0% of patients treated with FKB238 and bevacizumab, respectively.

conclusionsEfficacy equivalence was demonstrated between the two drugs, and safety profiles were similar. There were no meaningful differences in efficacy and safety between FKB238 or bevacizumab in patients with non-sq-NSCLC. TRIAL REGISTRATION NUMBER: NCT02810457.

Indexed as

Biosimilar PharmaceuticalsCarcinoma, Non-Small-Cell LungLung NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinHumansNeoplasm Recurrence, LocalPaclitaxelTreatment OutcomeBevacizumabBiosimilar PharmaceuticalsCarboplatinPaclitaxel

Identifiers

PMID34264503
PMCPMC8295151
OpenAlexW3180050323

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.