OncoSil Medical’s PANCOSIL Phase 1-2 study reveals promising safety and feasibility for a novel CT-guided pancreatic cancer therapy, with survival outcomes exceeding historical benchmarks.
- First CT-guided percutaneous OncoSil™ delivery for pancreatic cancer
- 90% technical success rate with manageable serious adverse events
- Median overall survival of 20.6 months versus historical 13 months
- Plans for expanded regulatory approvals in FY26
- Engagement of interventional radiologists to broaden clinical adoption
A New Frontier in Pancreatic Cancer Treatment
OncoSil Medical Limited (ASX – OSL) has announced encouraging preliminary results from its PANCOSIL Phase 1-2 investigator-initiated study, marking a significant step forward in the treatment of locally advanced pancreatic cancer (LAPC). The study, presented at the prestigious CIRSE 2025 Congress in Barcelona, demonstrates that OncoSil™ can be safely and effectively delivered via a novel CT-guided percutaneous injection directly into pancreatic tumors.
This approach is pioneering in its use of minimally invasive image guidance to implant radioactive microparticles, offering a targeted radiation dose that spares surrounding healthy tissue. The technical success rate of 90% underscores the procedure’s reliability, while the safety profile, with only 10% of patients experiencing serious adverse device events, all of which were manageable, provides reassurance for wider clinical application.
Survival Outcomes That Outperform Expectations
Perhaps most compelling is the median overall survival of 20.6 months observed in the study cohort, a notable improvement over the approximate 13-month survival typically seen in LAPC patients. While the sample size of 20 patients is modest, these early efficacy signals suggest that OncoSil™’s targeted radionuclide therapy could meaningfully extend patient lives beyond current standards of care.
Three patients exhibited partial tumor responses beyond what chemotherapy alone would achieve, hinting at the potential for OncoSil™ to enhance existing treatment regimens. The study’s design, involving patients who had undergone at least two months of systemic chemotherapy before implantation, reflects a real-world clinical pathway that could facilitate integration into practice.
Strategic Expansion and Regulatory Ambitions
Building on these promising results, OncoSil is targeting additional regulatory approvals in the second half of fiscal year 2026, focusing initially on label expansion within the European Union. This regulatory push aligns with the company’s strategy to broaden its clinical base by engaging interventional radiologists, specialists adept at minimally invasive procedures, thereby enhancing adoption and accessibility of the therapy worldwide.
CEO Nigel Lange highlighted the significance of enabling interventional radiologists to deliver OncoSil™ with precision and consistency, a move expected to accelerate integration into multidisciplinary oncology care. This shift could transform treatment paradigms for pancreatic cancer, a disease notorious for its late diagnosis and poor prognosis.
Looking Ahead
While the PANCOSIL study’s preliminary nature and limited patient numbers warrant cautious optimism, the data provide a compelling foundation for further investigation and regulatory progress. Additional safety, feasibility, and survival data are anticipated, which will be critical to validating these early findings and supporting broader clinical use.
OncoSil’s innovative approach, combining targeted radiation with minimally invasive delivery, positions it at the forefront of interventional oncology. As the company advances through regulatory milestones and expands its clinical footprint, the pancreatic cancer treatment landscape may be on the cusp of meaningful change.
Bottom Line?
OncoSil’s promising PANCOSIL results set the stage for regulatory advances and wider clinical adoption, but longer-term data will be key to confirming its transformative potential.
Questions in the middle?
- Will expanded regulatory approvals in FY26 accelerate OncoSil’s market penetration?
- How will interventional radiologists’ involvement impact clinical adoption rates?
- What additional safety and efficacy data will emerge from longer-term follow-up?