Oncolytics Biotech announces positive long-term survival data from phase 1b glioblastoma multiforme trial

Oncolytics Biotech Inc. announced positive long-term survival data 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 are the subject of a presentation at the American Association for Cancer Research (AACR) Annual Meeting, show a substantial and durable efficacy signal in newly diagnosed GBM patients and demonstrate the safety and tolerability of the studied treatment combination in this indication. "These results provide further evidence suggesting that the long-term survival benefits pelareorep delivers to breast cancer patients may be extended to a variety of indications," said Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. "I am highly encouraged by the two-year survival rate and median overall survival observed in ReoGlio and view the relative increases these metrics show in the high dose cohort as a promising sign of this therapy combination's dose-dependent activity in GBM. ReoGlio's long-term results are also consistent with the positive progression-free survival data that were previously reported and confirm pelareorep's favourable safety profile in this new indication. Collectively, these findings highlight pelareorep's potential to drive clinical benefit in GBM patients, who are historically very challenging to treat and in urgent need of novel therapies." Key data and conclusions from the AACR poster and corresponding abstract include: Evaluable patients treated with pelareorep at dose level-2 (3x1010 TCID50) had a median overall survival (mOS) of 16.1 months and a 24-month survival rate of 50% (n=6); Evaluable patients treated with pelareorep at dose level-1 (1x1010 TCID50) had a mOS of 12.6 months and a 24-month survival rate of 16.7% (n=6); Across both dose levels, mOS was 13.1 months and the 24-month survival rate was 33% (n=12); One patient treated at dose level-2 remains alive at 42 months; The studied treatment combination was deemed safe and well-tolerated at both dose levels by a Safety Review Committee that included two independent physicians. The long-term follow-up data from the ReoGlio study being presented at AACR are an extension of prior data that were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting (link to PR). These data demonstrated an estimated median progression-free survival (mPFS) of 7.8 months across all evaluable patients in the study (n=12), with those treated at dose level-2 showing an estimated mPFS of 9.4 months (n=6) and those treated at dose level-1 showing an estimated mPFS of 6.1 months (n=6). Matt Coffey, Ph.D., MBA, president and chief executive officer of Oncolytics Biotech Inc. added, "ReoGlio's results strengthen the broad clinical dataset demonstrating pelareorep's potential to address unmet needs across a range of cancers. We believe they warrant additional clinical study, and plan to discuss them with thought leaders and potential partners to identify the best and most efficient potential path forward in GBM. This strategy will allow us to opportunistically expand pelareorep's commercial potential while staying focused on the advancement of our lead breast cancer program to a registrational study. We would like to sincerely thank the University of Leeds, Cancer Research UK, and The Brain Tumour Charity for designing and funding the ReoGlio trial, as well as all of the patients who participated." An electronic copy of the presentation and the corresponding abstract, entitled, Combination of reovirus (pelareorep) and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant chemotherapy (temozolomide) for patients with glioblastoma multiforme (GBM): long term follow up results of the ReoGlio phase Ib trial, is available to registered attendees of the AACR annual meeting on the meeting website. A copy of the presentation will also be posted to the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the meeting. 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. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumour Charity. Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumour phenotype -- turning "cold" tumours "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

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