Oncolytics Advances Pelareorep Development in KRAS-Mutant Colorectal Cancer
Oncolytics announced clinical and translational findings supporting the development of pelareorep in second-line metastatic colorectal cancer, specifically in patients with KRAS-mutant, microsatellite-stable disease. This represents one of the most difficult-to-treat and least responsive subgroups within colorectal cancer. In a previously completed clinical study evaluating pelareorep in combination with standard-of-care therapy, 33% of KRAS-mutant MSS patients achieved an objective response, compared to the well-established historical objective response rate of approximately 6%-11% for Avastin + Folfiri in second-line mCRC. In that same study, patients receiving the pelareorep, bevacizumab, and Folfiri treatment regimen more than doubled progression-free survival and overall survival compared to those receiving bevacizumab and Folfiri. In addition to the clinical activity, a separate translational analysis of paired tumor biopsies revealed that treatment with pelareorep led to a notable increase in KRAS-mutant-specific T-cell populations, indicating that pelareorep may directly enhance anti-tumor immune recognition in this genetically defined subgroup. These findings provide strong biological support for pursuing pelareorep as a precision immunotherapy capable of addressing a patient population that rarely benefits from checkpoint inhibitors or other immunotherapies. A complete analysis of the translational data will be presented at an upcoming medical meeting. Together, the clinical and mechanistic data support advancing pelareorep into a controlled study in second-line KRAS-mutant MSS mCRC, which the company expects to initiate following consultation with key opinion leaders and regulatory authorities. The planned study is intended to confirm pelareorep's potential to significantly outperform the current standard-of-care in a controlled setting and establish a new treatment paradigm for KRAS-mutant colorectal cancer. By sponsoring the study instead of pursuing an investigator-sponsored trial, Oncolytics will be able to provide an appropriate level of analytical rigor to support regulatory submissions that could lead to an approval in this indication. Additionally, the company will have full control over data from the study and will be able to update investors, potential partners, and other stakeholders at its discretion. This change reflects the company's heightened interest in and focus on mCRC and pelareorep's potential as a platform gastrointestinal immunotherapeutic agent.
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Oncolytics Biotech Strengthens Leadership Amid Oncology Market Surge
- Executive Appointments: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Clinical Data Breakthrough: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, tripling the historical response rate of 6-11%, demonstrating significant efficacy in this difficult-to-treat population.
- FDA Alignment Success: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this challenging therapeutic area, further solidifying its market position.
- Strategic Expansion: The company has also expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, aiming to accelerate clinical development across multiple indications and enhance overall R&D capabilities.
Oncolytics Biotech Strengthens Leadership to Advance Clinical Programs
- Leadership Enhancement: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate, indicating its potential in difficult-to-treat patient populations.
- FDA Designation Approval: Oncolytics secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the initiation of the only immunotherapy registration trial planned for this challenging area, further solidifying its market position.
- Advisory Board Expansion: The company has expanded its Scientific Advisory Board by adding globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, laying the groundwork for accelerated clinical development across multiple indications.
