Data for the combination of peralolep and atezolizumab exceeds previous controlled trials with an objective response rate of 37.5%, including complete responses.
SAN DIEGO and CALGARY, Alberta, Nov. 9, 2023 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), an oncology-focused clinical-stage immunotherapy company, today announced that gave a presentation on intermediate therapeutic drugs. Results from the phase 1/2 GOBLET trial evaluating the combination of peraorep and atezolizumab in second-line patients with unresectable squamous cell carcinoma of the anal canal (SCCA) by Dirk Arnold, MD, director of the Asklepios Oncology Center in Hamburg. He is the principal investigator of the GOBLET trial and gave an oral presentation at the 2nd International Multidisciplinary Conference on Anal Cancer (IMACC) 2023 held in Rome, Italy.
“The positive interim data from the anal cancer cohort of the Phase 2 GOBLET trial presented today at the IMACC meeting is very exciting for our company and for the potential of peroleop in gastrointestinal cancers. “The results exceeded historical control results in our cohort and similar patient populations1-7,” said Matt Coffey, Ph.D., President and CEO of Oncolytics. “This is the third indication in the GOBLET trial to consecutively meet success criteria, and the fourth indication for the combination of perolep and atezolizumab presented positive data, highlighting the clinical potential of this combination. We are particularly pleased to see further validation of the benefits of this drug and the initiation of clinical trials.”Additionally, another complete response has been confirmed in an indication where checkpoint inhibitor therapy alone has historically had limited success. This is a good sign that Peraorep may work synergistically with multiple immunotherapies in multiple tumor types. ”
Dr. Arnold said, “Current treatment options for SCCA are poor and no standard of care has been defined for patients who have progressed after first-line therapy. Oncolytic therapy continues to improve clinical data showing consistent positive results with the combination of perolep and perolep. “We are developing a solid outline of this.” “Checkpoint inhibitor atezolizumab. We are particularly pleased with the encouraging data presented today because they show that perolep may be a new effective treatment option for patients with advanced SCCA. .”
Summary of interim data and findings from the SCCA arm of the Phase 1/2 GOBLET study:
tumor response: Interim objective response rate based on 1 patient with complete response (continued at 12 months) and 2 patients with partial response (1 patient at 8 weeks, 1 patient continuing at 16 weeks) (ORR) was 37.5%.
safety: No safety signals observed, consistent with previously reported cohort in the GOBLET study
“We are very pleased with the positive data from SCCA patients presented at IMACC. These results are in line with similar This represents an almost 3-fold improvement compared to data from studies 1-7, which further supports Peraleorep’s ability to generate effective immune responses and improve objective response rates.” said Thomas Heinemann, M.D., Lytix’s chief medical officer. “These data, combined with positive data on pancreatic and colorectal cancers, will help define and prioritize registration pathways for perolep in gastrointestinal cancers.”
GOBLET study SCCA patient overview:
Patients in the SCCA cohort presented at IMACC 2023 received second-line (2L) or later treatment with peralolep in combination with atezolizumab. The first phase of the study will enroll 10 patients, with 8 patients evaluable based on the data cut-off date of October 23, 2023. To meet Simon’s two-step success criterion, she needs at least 2 of the first 10 enrolled patients to respond.
References
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Ott et al Annal Oncology (2017)/NCT02054806
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Morris et al., The Lancet (2017)/NCT02314169
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Lao et al Annal Oncology (2020)/NCT03597295
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Marabelle et al Lancet Oncology (2022)/NCT02628067
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Sarah Ronaldi (2021) J. Immu Cancer/NCT03944252
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Kim et al., BMC Cancer.2020 April 25;20(1):352.
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Sheila Rao (Frontier Oncor) 2022
Lecture information
A poster titled “Goblet: Phase 1/2 multi-indication study in advanced gastrointestinal cancer treated with perolep and atezolizumab – preliminary safety and efficacy results in second-line and beyond unresectable anal cancer” was presented at IMACC earlier today, and a copy of the poster can be found on the GOBLET media page on the Oncolytics website. Please click here.
About the goblet
Goblet (Ggastrointestinal tract○Explore Treatment Com rsBInfection with oncolytic reovirus peLAruEOrep andTThe i-PD-L1) study is a Phase 1/2 multi-indication study in advanced or metastatic gastrointestinal tumors. The study was carried out in 12 centers in Germany and managed by AIO-Studien-gGmbH. The study’s co-primary endpoints are objective response rate (ORR) and safety assessed at week 16. Important secondary and exploratory endpoints include additional efficacy assessments and assessment of potential biomarkers (T cell clonality and CEACAM6). The study will employ Simon’s two-stage design, with Stage 1 consisting of four treatment groups, with a total of approximately 55 patients expected to be enrolled.
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Peralolep in combination with atezolizumab, gemcitabine, and nab-paclitaxel for patients with first-line advanced/metastatic pancreatic cancer (n=12).
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Peraleorep in combination with atezolizumab for first-line MSI (microsatellite instability) highly metastatic colorectal cancer patients (n=19).
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Pelaolep in combination with atezolizumab and TAS-102 in patients with third-line metastatic colorectal cancer (n=14).and
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Combination therapy of peraleolep and atezolizumab for patients with second-line unresectable advanced anal cancer (n=10).
Cohorts that demonstrate an ORR above a prespecified threshold in Stage 1 are advanced to Stage 2, where additional patients can be enrolled.
About AIO
AIO-Studien-gGmbH (AIO) Internal Oncology Working Group Within the German Cancer Society (DKG). AIO operates with a not-for-profit purpose of advancing science and research with an emphasis in medical oncology. Since its inception, AIO has established itself as a successful sponsor and research management company nationally and internationally.
About Oncolytics Biotech Co., Ltd.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously administered immunotherapy. Peraleorep showed promising results in a phase 2 study in breast and pancreatic cancer. It acts by inducing anti-cancer immune responses, promoting an inflamed tumor phenotype through innate and adaptive immune responses, transforming “cold” tumors into “hot” and causing a variety of treatment.
Pelaolep has demonstrated synergy with multiple approved oncology treatments. Oncolytics is currently moving forward with registration studies in metastatic breast and pancreatic cancer, and is conducting and planning clinical trials in combination with perolep in solid tumors and hematologic malignancies. See below for more information. www.oncolyticsbiotech.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act 1934 and as amendments and forward-looking information under applicable Canadian securities laws (such Forward-looking statements and forward-looking information are collectively referred to as “forward-looking statements”). (hereinafter referred to as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ beliefs regarding the potential, mechanism of action, and benefits of perolep as a cancer treatment. Our established goals and objectives. And we plan to move forward with registration studies for metastatic breast cancer and pancreatic cancer. In forward-looking statements in which Oncolytics expresses expectations or beliefs regarding future results, such expectations or beliefs are expressed in good faith and believed to have a reasonable basis; There is no guarantee that any expectation or belief will be certain. It will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties that could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, but are not limited to, the availability of funding and resources to pursue research and development projects, the effectiveness of Peraleorep as a cancer treatment, the success and timely completion of clinical studies and trials, and These include Oncolytics’ ability to successfully commercialize. uncertainties associated with pharmaceutical research and development, uncertainties associated with regulatory processes and general changes in the economic environment; In particular, we are experiencing delays and disruptions to our operations, manufacturing supply chain, clinical trials and project development, workforce shortages, travel and transportation disruptions, and closures (including due to government actions) resulting from COVID-19. may be affected by business interruption. Regulations and Precautions). It is unclear whether and how oncolytic therapy will be affected if the COVID-19 pandemic continues for an extended period of time. We may incur costs and delays related to such events that are beyond our control, which could have a material adverse effect on our business, results of operations and financial condition. Investors should refer to Oncolytics’ quarterly and annual reports filed with the Canadian and U.S. securities commissions for additional information regarding the risks and uncertainties associated with forward-looking statements. Investors are cautioned not to place undue reliance on forward-looking statements. We undertake no obligation to update these forward-looking statements, except as required by applicable law.
SOURCE Oncolytics Biotech® Inc.