Journal article
Efficacy of depatuxizumab mafodotin (ABT-414) monotherapy in patients with EGFR-amplified, recurrent glioblastoma: results from a multi-center, international study
M van den Bent, HK Gan, AB Lassman, P Kumthekar, R Merrell, N Butowski, Z Lwin, T Mikkelsen, LB Nabors, KP Papadopoulos, M Penas-Prado, J Simes, H Wheeler, T Walbert, AM Scott, E Gomez, HJ Lee, L Roberts-Rapp, H Xiong, E Bain Show all
Cancer Chemotherapy and Pharmacology | SPRINGER | Published : 2017
Abstract
Purpose: Patients with recurrent glioblastoma (rGBM) have a poor prognosis. Epidermal growth factor receptor (EGFR) gene amplification is present in ~ 50% of glioblastomas (GBMs). Depatuxizumab mafodotin (depatux-m), formerly ABT-414, is an antibody–drug conjugate that preferentially binds cells with EGFR amplification, is internalized and releases a potent antimicrotubule agent, monomethyl auristatin F (MMAF). Here we report the safety, pharmacokinetics, and efficacy of depatux-m monotherapy at the recommended Phase 2 dose (RPTD) in patients with EGFR-amplified, rGBM. Methods: M12-356 (NCT01800695) is an open-label study with three escalation and expansion cohorts. Sixty-six patients with E..
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Awarded by AbbVie
Funding Acknowledgements
AbbVie provided financial support for this study (NCT01800695) and participated in the design, study conduct, analysis and interpretation of the data, as well as the writing, review, and approval of the manuscript. All authors were involved in the data gathering, analysis, review, interpretation and manuscript preparation and approval.