DNAtrix Therapeutics presented safety and efficacy data from the fully enrolled Phase 2 CAPTIVE / KEYNOTE-192 study of DNX-2401 (tasadenoturev), DNAtrix’s oncolytic adenovirus, followed by pembrolizumab for patients with recurrent glioblastoma. The data demonstrate that the therapy elicits durable clinical activity and has a favorable safety profile. These results were presented at the Society for Neuro-Oncology (SNO) Annual Meeting held from November 22-24, 2019 in Phoenix, Arizona.
CAPTIVE/KEYNOTE-192 is an open label study designed to evaluate a single intratumoral injection of DNX-2401 (tasadenoturev) followed by standard dosing with pembrolizumab every three weeks to determine the safety and efficacy in patients with recurrent glioblastoma. A total of 48 patients with recurrent glioblastoma were treated at 15 participating clinical sites with the regimen of DNX-2401, followed by pembrolizumab. The majority of patients experienced clinical benefit following treatment, including durable complete and partial responses. Interim median overall survival for patients is currently 12.3 months. In addition, the interim safety analysis demonstrates that the therapy has a positive benefit-risk profile, there were no unanticipated adverse events and patients remained on pembrolizumab for a median of 5.5 months with a maximum of 34 cycles.
About DNX-2401 (Tasadenoturev)
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and kill cancer cells to elicit an immune response. DNX-2401 has been granted PRIME and Orphan designation by the EMA, and Fast Track and Orphan designation by the FDA.