The way we think about treating brain cancers is being quietly revolutionized, buried beneath recent headline-grabbing announcements pertaining to COVID-19. A series of discoveries and breakthroughs in oncology, especially those targeting glioblastoma—the most common and aggressive form of brain cancer in adults. Over the span of just a month, researchers in Canada, the USA, and Israel have announced breakthrough discoveries that could upend the field for years to come. While projections for the Global Brain Tumor Therapeutics Market are expected to hit $3.4 billion by the end 2025, the pharma sector is answering the call with their own studies for proprietary treatments, including companies such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Northwest Biotherapeutics, Inc. (OTC:NWBO), Inovio Pharmaceuticals, Inc. (NASDAQ:INO), Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), and Sanofi (NASDAQ:SNY).
Positive results were just announced by Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) for the ReoGlio phase 1b trial for the treatment of glioblastoma multiforme (GBM)—being designed, managed and funded by the University of Leeds, Cancer Research UK, and The Brain Tumor Charity.
Featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting, Oncolytics Biotech announced that the latest ReoGlio results show a compelling signal of efficacy and demonstrate the safety and tolerability of a therapy involving the developer’s flagship platform as part of a combination therapy in newly diagnosed GBM patients.
The trial has been launched to evaluate the combination of Oncolytics’ proprietary oncolytic virus platform, pelareorep, with granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide (aka “Temodar”) to treat GBM.
"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 Dr. Thomas Heineman, 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."
Key data and conclusions from the presentation included:
- 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
The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance.
Oncolytics Biotech’s (NASDAQ:ONCY) (TSX:ONC) pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.
Results from another trial were released in November, behind the ReoGlio announcement from a partnership involving both Inovio Pharmaceuticals, Inc. (NASDAQ:INO), Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) that also is targeting the most common and aggressive form of brain cancer.
Back in May, results for the combination of Inovio’s INO-5401 with PD-1 Inhibitor Libtayo (cemiplimab) demonstrated 85% of newly diagnosed GBM patients were alive 12 months following treatment. Updated results involving overall survival at 18 months (OS18) were released at the same 2020 Society of Neuro-Oncology Annual Meeting as the Oncolytics Biotech announcement.
The progress for the Inovio treatment along with Sanofi/Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) has finally culminated with the collaboration picking up Libtayo’s third FDA drug approval, the latest being for lung cancer.
Another set of clinical data to be released is set to come from Northwest Biotherapeutics, Inc. (OTC:NWBO).
It appears that the long wait for results will soon be over, as the company’s 14-year-long phase 3 clinical trial to evaluate its one and only immunotherapy candidate, DCVax-L, as a treatment for glioblastoma, concludes.
DCVax-L has been in phase 3 clinical trials since December 2006, studying the efficacy of DCVax-L as an experimental immunotherapy that seeks to stimulate patients’ own immune systems to fight cancer growth.
A key trial endpoint requires at least 233 patient deaths out of a total of 331 participants enrolled to calculate a survival benefit for DCVax-L, if any. The company completed its study on July 24, and the most recent update came in late October 2020.
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