AbbVie has announced that safety and preliminary efficacy data from a Phase 1 study of ABT-414—an investigational antibody drug conjugate (ADC) for epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM)—shown no dose-limiting toxicities and frequent, reversible ocular toxicities.
Additionally, an estimated 30% (n=44) of patients treated with ABT-414 as monotherapy were progression free at six months [95% CI=17, 44] (secondary endpoint). These results, from an expansion cohort of one arm (Arm C) of a three-arm open-label study, were at the 52(nd) Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA).
As of January 7, 2016, the most common serious adverse event (>1 patient) (n=48) was seizure (8%). Additionally, Best Response Assessment in Neuro-Oncology (RANO) Criteria, an assessment of tumour response used in GBM, identified two partial responses, 18 patients with stable disease, and 24 with progressive disease, for a total of 44 patients with complete data.
Martin van den Bent, head of Neuro-Oncology Unit, Erasmus MC Cancer Institute, the Netherlands, and lead investigator of the study, says, “These data are important as they demonstrate the potential of ABT-414 and underscore the need for further investigation in glioblastoma.”