Oncolytics Biotech advances pancreatic cancer study following regulatory approval

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Oncolytics Biotech has achieved a critical milestone in its efforts to transform treatment, with Germany’s (PEI) granting regulatory approval for the progression of its GOBLET study. This decision permits full enrollment for Cohort 5, which is testing the innovative oncolytic immunotherapy pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab (Tecentriq), for newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients.

The study’s advancement follows a thorough safety evaluation by an independent Data Safety Monitoring Board (DSMB), which recommended the trial proceed after early results indicated a tolerable safety profile. The approval clears the way for up to 30 patients to join this phase of the trial, offering hope for a disease that remains one of the most challenging to treat effectively.

What Makes Pelareorep a Promising Pancreatic Cancer Treatment?

Pancreatic , particularly its metastatic form, has long been associated with poor survival rates due to limited treatment options and late-stage diagnoses. Oncolytics Biotech’s pelareorep, a novel intravenously delivered immunotherapy, represents a new frontier in cancer treatment by leveraging the body’s immune response to combat tumors.

Pelareorep works by inducing an inflamed tumor phenotype, effectively turning “cold” tumors—those that evade immune detection—into “hot” tumors, which are more vulnerable to immune attacks. According to Oncolytics Biotech’s Chief Medical Officer, Thomas Heineman, the agent has already demonstrated encouraging tumor response rates in earlier phases of the GOBLET study. He noted that Cohort 5 broadens the scope of evaluation by pairing pelareorep with mFOLFIRINOX, a widely utilized chemotherapy regimen, to address a larger subset of pancreatic cancer patients.

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Insights into the GOBLET Study’s Design

The GOBLET study, short for Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1, is a robust Phase 1/2 trial exploring pelareorep’s efficacy across advanced and metastatic gastrointestinal cancers. Managed by AIO-Studien-gGmbH in Germany, the study spans five treatment arms, including Cohort 5, which specifically targets newly diagnosed metastatic PDAC patients.

Each arm of the study involves a two-stage design. Stage 1 evaluates safety and objective response rates in small cohorts of patients, while Stage 2 expands enrollment for treatments that meet the predefined success criteria. In Cohort 5, patients receive pelareorep in combination with mFOLFIRINOX, with one arm including atezolizumab, an anti-PD-L1 immune checkpoint inhibitor. This design allows researchers to assess both safety and potential synergies between pelareorep and other treatments.

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Blood and tumor samples collected during the trial will also undergo translational analysis, offering insights into biomarkers that may predict patient outcomes or response to therapy.

Expert Perspectives on Innovative Cancer Therapy

Dr. Heineman emphasized that pelareorep’s unique mechanism of action could fundamentally change the landscape for pancreatic cancer patients. By activating both innate and adaptive immune responses, the therapy enhances the effectiveness of existing treatments and potentially improves patient survival.

The study’s early success is a positive indicator, and upcoming presentations at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium will provide further details on safety data, with initial efficacy results expected later this year. Experts believe these findings could pave the way for registrational studies, positioning pelareorep as a cornerstone in the future of pancreatic cancer treatment.

Broader Implications for Cancer Immunotherapy

Beyond pancreatic cancer, pelareorep has shown potential in treating other malignancies, including metastatic breast cancer, where it has demonstrated synergistic effects when combined with approved oncology therapies. With Fast Track designation from the U.S. Food and Drug Administration () for both metastatic breast and pancreatic cancers, Oncolytics Biotech is accelerating its clinical trials to bring this transformative therapy to market.

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By addressing critical unmet needs in oncology, pelareorep exemplifies the potential of immunotherapies to improve survival rates and quality of life for patients facing aggressive cancers. The GOBLET study’s results could serve as a benchmark for future research and development in this promising field.

The Future of Pancreatic Cancer Treatment

The PEI’s approval of Cohort 5 enrollment marks a pivotal step in advancing pelareorep as a viable treatment for metastatic PDAC. As the GOBLET study progresses, researchers remain optimistic about its potential to provide a lifeline for patients with limited options. With safety data already meeting expectations and efficacy results on the horizon, pelareorep could redefine standards of care for pancreatic cancer and beyond.


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