Evidence map›Paper›PMID 31747009›Full record

Trial reportNeuro-oncology2020

INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFR amplified glioblastoma.

Martin Van Den Bent, Marica Eoli, Juan Manuel Sepulveda, Marion Smits, Annemiek Walenkamp, Jean-Sebastian Frenel, Enrico Franceschi, Paul M Clement, Olivier Chinot, Filip De Vos and 15 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Neuro-oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02343406 (INTELLANCE-2), which is not on this map. Cited by 130 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 10 pooled it
15.5field-weighted citation impact, top 1% 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.

NCT02343406 phase2completednot on this map

INTELLANCE-2: ABT-414 Alone or ABT-414 Plus Temozolomide Versus Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase 2 Study of the EORTC Brain Tumor Group

TypeinterventionalSponsorAbbVieRan2015 to 2019Enrolled266ConditionsGlioblastomaArmsDepatuxizumab mafodotin, Temozolomide, Lomustine
3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 10 syntheses or guidelines pooled it, 184 citations in OpenAlex.

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  10. Anti-epidermal growth factor receptor therapy for glioblastoma in adults.The Cochrane database of systematic reviews · 2020
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  18. Next-generation therapeutics for glioblastoma: Challenges and future directions.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
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70 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 14 institutions in 8 countries.

Martin Van Den BentBrain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.
Marica EoliDepartment of Neurology, Carlo Besta Institute, Milan, Italy.
Juan Manuel SepulvedaUniversity Hospital 12 October, Madrid, Spain.
Marion SmitsDepartment of Radiology, Erasmus MC, Rotterdam, the Netherlands.
Annemiek WalenkampDepartment of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.
Jean-Sebastian FrenelDepartment of Medical Oncology, René Gauducheau Center for Cancer Care, Nantes, France.
Enrico FranceschiDepartment of Medical Oncology, Local Health Unit Agency/Scientific Institute for Research, Hospitalization, and Healthcare (AUSL/IRCCS) Neurological Sciences, Bologna, Italy.
Paul M ClementDepartment of Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.
Olivier ChinotDepartment of Neuro-Oncology, Institute of Neurophysiopathology, Aix-Marseille University, Marseille, France.
Filip De VosDepartment of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.
Nicolas WhenhamDepartment of Medical Oncology, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
Paul SangheraUniversity Hospitals Birmingham, Birmingham, UK.
Michael WellerDepartment of Neurology, University Hospital Zurich, Zurich, Switzerland.
H J DubbinkDepartment of Pathology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Pim FrenchBrain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.
Jim LoomanAbbvie, Chicago, IL USA.
Jyotirmoy DeyDepartment of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Scott KrauseAbbvie, Chicago, IL USA.
Pete AnsellAbbvie, Chicago, IL USA.
Sarah NuyensEORTC Headquarters, Brussels, Belgium.
Maarten SpruytBrain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.
Joana BrilhanteEORTC Headquarters, Brussels, Belgium.
Corneel CoensEORTC Headquarters, Brussels, Belgium.
Thierry GorliaEORTC Headquarters, Brussels, Belgium.
Vassilis GolfinopoulosEORTC Headquarters, Brussels, Belgium.
European Organisation for Research and Treatment of Cancer · BEErasmus MC Cancer Institute · NLAbbVie (United States) · USErasmus MC · NLAix-Marseille Université · FRFondazione IRCCS Istituto Neurologico Carlo Besta · ITInstitut de Cancérologie de l'Ouest · FRInstitute of Neurological Sciences · ITKU Leuven · BENIHR Surgical Reconstruction and Microbiology Research Centre · GBResearch Institute Hospital 12 de Octubre · ESUniversity Hospital of Zurich · CHUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDepatuxizumab mafodotin (Depatux-M) is a tumor-specific antibody-drug conjugate consisting of an antibody (ABT-806) directed against activated epidermal growth factor receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as a single agent in a randomized controlled phase II trial in recurrent EGFR amplified glioblastoma.

methodsEligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with temozolomide. Patients were randomized to either Depatux-M 1.25 mg/kg every 2 weeks intravenously, or this treatment combined with temozolomide 150-200 mg/m2 day 1-5 every 4 weeks, or either lomustine or temozolomide. The primary endpoint of the study was overall survival.

resultsTwo hundred sixty patients were randomized. In the primary efficacy analysis with 199 events (median follow-up 15.0 mo), the hazard ratio (HR) for the combination arm compared with the control arm was 0.71 (95% CI = 0.50, 1.02; P = 0.062). The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR = 1.04, 95% CI = 0.73, 1.48; P = 0.83). The most frequent toxicity in Depatux-M treated patients was a reversible corneal epitheliopathy, occurring as grades 3-4 adverse events in 25-30% of patients. In the long-term follow-up analysis with median follow-up of 28.7 months, the HR for the comparison of the combination arm versus the control arm was 0.66 (95% CI = 0.48, 0.93).

conclusionThis trial suggests a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing well after the end of first-line adjuvant temozolomide treatment. (NCT02343406).

Indexed as

Brain NeoplasmsGlioblastomaAntibodies, Monoclonal, HumanizedAntineoplastic Agents, AlkylatingErbB ReceptorsHumansLomustineTemozolomideAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Alkylatingdepatuxizumab mafodotinEGFR protein, humanErbB ReceptorsLomustineTemozolomideAntibody drug conjugatedepatux-mEGFRglioblastomarecurrent

Identifiers

PMID31747009
PMCPMC7229258
OpenAlexW2990424668

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.