Gelareh Zadeh, M.D., Ph.D., FRCS(C), FAANS, professor and dan chair of Neurosurgery at the University of Toronto, head of the Division of Neurosurgery at Toronto Western Hospital, and president of Society-of-Neuro-Oncology at the University of Toronto and Toronto Western Hospital discusses the SNO 2020 abstract - DNAtrix Announces Positive Data from Phase 2 CAPTIVE (KEYNOTE-192) Study with DNX-2401 in Patients with Recurrent Glioblastoma Highlighted in an Oral Late-Breaking Presentation During Society for Neuro-oncology (SNO) Annual Meeting.
HOUSTON, TX-November 9, 2020-DNAtrix, a pharmaceutical company developing virus-driven cancer immunotherapies, today announced that median overall survival of 12.5 months was demonstrated in Phase 2 CAPTIVE trial examining treatment with DNX-2401 (tasadenoturev) and pembrolizumab in patients with recurrent glioblastoma (GBM). DNX-2401 is immunotherapy focused on adenovirus designed to selectively destroy tumor cells and initiate a robust anti-tumor immune response.
The Phase 2 multicenter CAPTIVE study tested DNX-2401 in conjunction with pembrolizumab, an anti-PD-1 antibody, in 49 patients with GBM during the first or second recurrence of the disease. In the study, a single dose of DNX-2401 followed by infusions of 200 mg of pembrolizumab every three weeks was administered to patients. Seven cycles are the median duration of treatment with pembrolizumab. Increasing doses of DNX-2401 were evaluated in the first part of the study and the highest dose evaluated was selected for advancement into the dose-expansion phase of the study.
The median overall survival was 12.5 months for patients treated with full-dose DNX-2401 and pembrolizumab (n=42), and the survival rate was 20.2% at 18 months. Four patients continue to be followed for survival, all of whom have survived more than 23 months. Verified responses were received in five patients (11.9 percent), including two permanent continuous full responses and three partial responses. It has not met the median period of response. Headache, fatigue, and brain edema, which were primarily mild to moderate and manageable, were the most frequently recorded adverse events. At a late-breaking session during SNO's 25th Annual Science Meeting and Education Day, detailed findings were presented.