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CNS tumours

2484 - Epidermal Growth Factor Receptor (EGFR) Amplification Rates Observed in Screening Patients for Randomized Clinical Trials in Glioblastoma

Date

08 Sep 2017

Session

CNS tumours

Topics

Translational Research;  Prostate Cancer;  Central Nervous System Malignancies

Presenters

Martin van den Bent

Citation

Annals of Oncology (2017) 28 (suppl_5): v109-v121. 10.1093/annonc/mdx366

Authors

M.J. van den Bent1, L.A. Roberts-Rapp2, P. Ansell2, J. Lee3, J. Looman2, E. Bain2, C. Ocampo2, K.D. Holen2, E.J. Gomez2, A.B. Lassman4

Author affiliations

  • 1 Neuro-oncology, Erasmus MC Daniel den Hoed Cancer Center, 3075 EA - Rotterdam/NL
  • 2 Oncology, AbbVie Inc, North Chicago/US
  • 3 Oncology, Abbott Molecular Inc, Des Plaines/US
  • 4 Department Of Neurology And Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York/US
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Abstract 2484

Background

EGFR is a key oncogenic target for the treatment of glioblastoma. EGFR amplification is detected in ∼50% of tumors. Depatuxizumab mafodotin (depatux-m), formerly called ABT-414, is a tumor-specific antibody-drug conjugate that preferentially targets tumors with EGFR amplification. Herein, we report the frequency of EGFR amplification in 2 large-scale glioblastoma clinical trials of depatux-m.

Methods

Assays for EGFR abnormalities were performed centrally in 2077 (as of May 1, 2017) glioblastomas during screening for 2 randomized glioblastoma trials with depatux-m: INTELLANCE 1 (NCT02573324) for newly diagnosed patients (n = 1001), and INTELLANCE 2 (NCT02343406) for recurrent disease (n = 1076). EGFR amplification, required for eligibility in both trials, was determined by fluorescence in situ hybridization and defined as at least 2 copies in at least 15% of cells. EGFRvIII data will be reported at the meeting.

Results

The frequency of EGFR amplification was ∼50% (Table), similar to published rates. Higher rates were observed in patients from the Americas/Europe (53–57%) than from Asia (34%).Table:

327O Pooled Screening Results: INTELLANCE 1 (phase II/III, newly diagnosed) and INTELLANCE 2 (phase II, recurrent)

World RegionNot AmplifiedEGFR AmplifiedTotal PatientsPositive, %
Africa54944.4
Americas21323845152.8
Asia1326920134.3
Europe518672119056.5
Middle East19214052.5
Oceania1068018643.0
Total9931084207752.2

Conclusions

This study represents the first report of lower EGFR amplification rates in patients from Asia with glioblastoma to our knowledge. This observation requires further study.

Clinical trial identification

INTELLANCE 1: NCT02573324 INTELLANCE 2: NCT02343406

Legal entity responsible for the study

AbbVie Inc.

Funding

AbbVie Inc.

Disclosure

M.J. van den Bent: Honoraria from Roche, AbbVie, Celldex, Novocure, Merck Ag, Cavion, Actelion, Bristol-Myers Squibb, Blue Earth Diagnostics. Research funding from AbbVie and Roche. L.A. Roberts-Rapp, P. Ansell, J. Looman, E. Bain, C. Ocampo, K.D. Holen, E.J. Gomez: AbbVie employee and may own stock. J. Lee: Abbott employee (companion diagnostic partner). A.B. Lassman: Honoraria and/or travel support from Kadmon, AbbVie, Sapience Therapeutics, Novocure, AstraZeneca, Genentech, Bioclinica. Research funding from multiple companies including AbbVie.

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