Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced positive results from ReoGlio, an investigator-sponsored, phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM). The results, which were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting, show a compelling signal of efficacy and demonstrate the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients.
"The ReoGlio trial results add to a robust set of clinical data supporting the safety, tolerability, and efficacy of pelareorep in a broad range of indications," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "The median progression-free survival (PFS) of approximately eight months is encouraging in this challenging indication, particularly considering the improved median PFS correlated with the dose of pelareorep administered. Together, these results drive momentum to develop pelareorep across a spectrum of cancer indications."
The podium presentation, Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: ReoGlio phase I trial results, was given by Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. Key data and conclusions from the presentation include:
- Evaluable patients treated at pelareorep dose level-2 (3x1010 TCID50) had an estimated median PFS of 9.4 months (n=6; 95% CI: 4.2-10.6)
- Evaluable patients treated at pelareorep dose level-1 (1x1010 TCID50) had an estimated median PFS of 6.1 months (n=6; 95% CI: 4.9-9.2)
- The estimated median PFS of all evaluable patients, regardless of pelareorep dose level, was 7.8 months (n=12; 95% CI: 4.9-9.7)
- Pelareorep, in addition to GM-CSF, standard chemoradiotherapy, and adjuvant temozolomide, was safe and well-tolerated
Oncolytics remains focused on the clinical advancement of pelareorep and will continue evaluating new commercial opportunities for pelareorep, while prioritizing the current programs and achieving the expected milestones for those in breast, gastrointestinal, and hematological malignancies. Oncolytics thanks the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing, managing, and funding the ReoGlio trial.