– The results demonstrate a significant and long-lasting efficacy signal in a very difficult indication
– Higher dose of pelareorep led to 50% median overall survival (mOS) at 24 months and a patient still alive at 42 months, compared to 16.7% mOS at the lowest dose
– Investigator-sponsored trial confirms favorable safety profile of pelareorep
SAN DIEGO and CALGARY, Alta., April 8, 2022 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today 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) with standard chemoradiation 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 signal of efficacy in patients newly diagnosed with GBM and demonstrate the safety and the tolerability of the therapeutic combination studied in this indication.
“These results provide further evidence to suggest that the long-term survival benefits that pelareorep provides to breast cancer patients can be extended to a variety of indications,” said Suzanne runs, MRCP, Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. “I am very encouraged by the two-year survival rate and median overall survival observed in ReoGlio and consider the relative increases these parameters show in the high-dose cohort as a promising sign of the dose-dependent activity of this combination therapy in GBM.The term results are also consistent with the positive progression-free survival data previously reported and confirm the favorable safety profile of pelareorep in this new indication.Together, these results highlight the potential of pelareorep to generate clinical benefits in patients with GBM, which are historically very difficult to treat and in urgent need of new therapies.”
Key data and findings from the AACR poster and corresponding abstract include:
Evaluable patients treated with pelareorep at dose level-2 (3×10ten 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 (1×10ten TCID50) had an mOS of 12.6 months and a 24-month survival rate of 16.7% (n = 6)
For both dose levels, the 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 study treatment combination was found to be 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 presented at the AACR is an extension of earlier data that was presented 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 for all evaluable study patients (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 with an estimated mPFS of 6.1 months (n=6).
Matt CoffeyPh.D., MBA, President and CEO of Oncolytics Biotech Inc. added, “The ReoGlio results reinforce the large body of clinical data demonstrating the potential of pelareorep to address unmet needs across a range of cancers. . We believe they warrant further clinical study, and plan to discuss them with thought leaders and potential partners to identify the best and most effective way forward in the GBM. This strategy will allow us to expand opportunistically the commercial potential of pelareorep while remaining focused on advancing our lead breast cancer program toward a registrational study. We would like to sincerely thank the University of Leeds, Cancer Research UK and The Brain Tumor Charity for designing and funding the ReoGlio trial, and all the patients who took part.
An electronic copy of the presentation and corresponding abstract, titled, Combination of reoviruses (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 phase Ib ReoGlio trial, is available to registered attendees of the AACR Annual Meeting on the meeting website. A copy of the presentation will also be posted on the Posters and Publications Oncolytics website page (LINK) after the conclusion of the meeting.
Details of the online presentation are shown below.
Abstract number: CT569
Session title: OPO.CT01.01 – Phase I clinical trials
The ReoGlio trial was an investigator-sponsored phase 1b, an open-label trial evaluating the combination of pelareorep and GM-CSF, in combination with standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of whom 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. The secondary objectives were to obtain a preliminary evaluation 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 by grants from Cancer Research UK and The Brain Tumor Charity.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously administered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype – turning “cold” tumors into “hot” – through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it progresses to a registration study in metastatic breast cancer. For more information, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are hereinafter collectively referred to as “forward-looking statements”). Forward-looking statements in this press release include statements regarding Oncolytics’ belief in the potential and benefits of pelareorep as a cancer treatment; Oncolytics’ expectations regarding the purpose, design, results and benefits of its current or ongoing clinical trials involving pelareorep; the timing and results of the presentation to be made at the annual meeting of the American Association for Cancer Research; our plans to discuss the results of the ReoGlio study with thought leaders and potential partners to identify the best and most effective potential path to GBM and the expected results of this strategy; our plans to move toward a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief regarding future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement, expectation or conviction will be achieved. These forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the effectiveness of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to research and development of pharmaceutical products, uncertainties related to the regulatory process and general changes in the economic environment. In particular, we may be affected by business interruptions resulting from the COVID-19 coronavirus, including delays and interruptions in operations, manufacturing supply chain, clinical trials and project development, labor shortages, travel and shipping disruptions and closures (including due to government regulatory and preventative measures). It is unknown if and how oncolytics may be affected if the COVID-19 pandemic persists for an extended period. We may incur expenses or delays related to such events beyond our control, which could have a material adverse effect on our business, results of operations and financial condition. Investors are encouraged to consult the quarterly and annual filings of Oncolytics with the securities commissions in Canada and the United States for additional information on the risks and uncertainties associated with forward-looking statements. Investors are cautioned not to place undue reliance on forward-looking statements. The Company undertakes no obligation to update these forward-looking statements, except as required by applicable law.
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