Preliminary Data Suggest Clinical Benefit of Investigational Glioblastoma Drug
MDNA55 prolonged survival in IL4R-positive patients with recurrent glioblastoma in a phase 2b clinical trial.
Preliminary data from a phase 2b clinical trial evaluating the investigational glioblastoma (GBM) treatment MDNA55 showed improved survival in patients with interleukin-4 receptor (IL4R)-positive tumors, according to a Medicenna press release.
IL4R-positive tumors are highly expressed on brain cancers and known to be associated with aggressive disease. Patients with an IL4R profile typically have a worse prognosis than the overall GBM population, including poor long-term survival. MDNA55 is designed to target this biomarker, according to the release.
Data from the MDNA55-05 clinical trial were presented at the 5th Annual Immuno-Oncology 360 Conference held in New York, NY. According to the findings, MDNA55 showed promising signs of clinical benefit.
The trial evaluated MDNA55 in patients with GBM at first or second relapse. In the study, the investigators administered MDNA55 only once directly into the brain tumor using the Convection Enhanced Delivery technique.
IL4R-positive patients who were treated with MDNA55 at the low dose demonstrated an increase in median overall survival of 15.2 months compared with 8.5 months in the ILR4 negative group. Survival rates at 6, 9, and 12 months were 100%, 67%, and 55% versus 73%, 40%, and 30% in the IL4R-positive and -negative groups, respectively. Patients with IL4R-positive tumors also showed a faster time to relapse (10.3 months) following initial diagnosis of GBM compared with patients with low to no expression of IL4R (16.7 months), according to the study.
Median overall survival was 11.8 months, regardless of IL4R expression, following a single treatment with MDNA55 at a low dose. The overall survival rate was 89% at 6 months, 59% at 9 months, and 46% at 12 months.
“These preliminary data showing longer median survival in MDNA55-treated subjects with positive IL4R expression are highly encouraging and could help determine which subjects will receive optimal therapeutic benefit from MDNA55 treatment,” Martin Bexton, MD, head of Clinical Development at Medicenna, said in a statement. “As the second half of our trial continues to enroll at higher doses of MDNA55, we expect to see more data supporting IL4R as an important biomarker and immunotherapeutic target for rGBM and to improve the benefit-risk profile for subjects treated with MDNA55.”
Medicenna anticipates enrollment in the second half of the study, which will evaluate a higher dose of MDNA55, to be completed in the next couple of months with top-line data expected in mid-2019, according to the press release.
Medicenna Presents Promising Clinical Data from Phase 2b Recurrent Glioblastoma Trial of MDNA55 [news release]. Medicenna. https://ir.medicenna.com/2019-02-07-Medicenna-Presents-Promising-Clinical-Data-from-Phase-2b-Recurrent-Glioblastoma-Trial-of-MDNA55/ Accessed February 7, 2019.