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OncoSil Medica Limited (ASX:OSL)

OncoSil Medical (ASX:OSL) Positive Preliminary Results from the PANCOSIL Phase 1-2 Study

OncoSil Medical Limited (ASX:OSL)

Key Highlights:

  • PANCOSIL is the first in the world study administering OncoSil™ via direct injection through the skin (percutaneous) under CT-imaging guidance for treatment of locally advanced pancreatic cancer (LAPC)
  • Preliminary results from the PANCOSIL Investigator Initiated Study presented at the CIRSE 2025 Congress demonstrate it is both safe and feasible to deliver OncoSil™ by CT-guided percutaneous administration
  • 10% of patients experienced a Grade 3 serious adverse device events (one possibly device related) (safety outcome) with the procedure resulting in a 90% technical success rate (feasibility) 
  • Median overall survival from diagnosis was 20.6 months, comparing favourably with LAPC survival rates of approximately 13 months
  • Company is targeting additional regulatory approvals in the second half of FY26

Interactive Investor Webinar with Mr Nigel Lange (CEO/MD) at 10.30am AEST today - details below

Sydney, Australia – 18 September 2025: Pancreatic cancer treatment device company OncoSil Medical Limited (ASX:OSL) (“OncoSil” or “the Company”) is pleased to announce that the preliminary results of the PANCOSIL Investigator Initiated Study reveal that it is safe and feasible to deliver OncoSil™ by CT-guided percutaneous administration. The PANCOSIL trial results were presented by Dr. Danielle Vos from Amsterdam University Medical Center (Amsterdam UMC) in the Netherlands at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2025 Congress, held 13-17 September 2025 in Barcelona, Spain.

PANCOSIL Study Preliminary Results Reveal Multiple Key Outcomes

  • Safety: No procedure-related mortality was observed. Two (10%) of the 20 patients experienced Grade 3 Serious Adverse Device Effects (SADEs) by Common Terminology Criteria for Adverse Events (CTCAE) ii within 90 days; one procedure-related and one possibly device-related. Both patients recovered. There were no other procedure- or device-related events. The events were consistent with expectations for this patient population.
  • Feasibility: The technical success rate was 90%, demonstrating reliable and reproducible delivery of OncoSil™ via the percutaneous approach. The investigators concluded that it is feasible to perform implantation with patients’ conscious, thereby reducing the length of the procedure and postprocedure recovery.
  • Efficacy signals: Three (15%) patients demonstrated a partial response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) criteria compared to the tumour size prior to implantation and hence in addition to response from chemotherapy alone. Median overall survival (OS) was 20.6 months from diagnosis, comparing favourably to historical outcomes for LAPC OS of approximately 13 months.
  • Baseline Characteristics: A total of 20 patients were enrolled in the study, with each receiving a single dose of the OncoSil™ resulting in 100 Gy of radiation over 81 days (same treatment regimen as prior OncoSil™ studies). The median age of the patients was 62 years, with 11 males and 9 females participating.

The study investigators anticipate further analysis and results to follow including additional safety and adverse event data after 90 days, procedure and feasibility metrics and further survival data, which may form part of a future medical conference presentation and/or a scientific publication as determined by the study investigators given PANCOSIL was an investigator-initiated study. As a result of the PANCOSIL study, OncoSil is targeting further regulatory approvals in the second half of FY26 which relate to this innovative CT-guided percutaneous administration approach, which has the potential to transform the delivery of OncoSil™ therapy—offering treatment centres worldwide more flexibility with respect to local expertise and practice. The Company will initially seek a label expansion through a centralised process within the European Union and country specific approvals where required.

OncoSil is broadening its base of treating clinicians by engaging Interventional Radiologists (IRs), whose expertise in delivering minimally invasive oncology treatments, which is a high growth segment of the overall oncology market. In addition, this strategy strengthens multidisciplinary collaboration with Medical Oncologists and Surgeons, which the Company expects to increase adoption and integration into clinical practice over time.

PANCOSIL is an open-label, single-arm Phase 1–2 feasibility investigator-initiated study by Amsterdam UMC. The study is evaluating the safety and feasibility of CT-guided percutaneous radionuclide therapy using the OncoSil™ device in patients with non-progressive locally advanced pancreatic cancer (LAPC). The patients in the study had a median longest tumour diameter of 41mm and were implanted with OncoSil™ following a minimum 2 months of standard of care systemic chemotherapy.

Prof. Martijn Meijerink, Interventional Oncologist at Amsterdam UMC, said:

“The PANCOSIL study shows that percutaneous CT-guided implantation of the OncoSil™ device is safe and feasible, while offering encouraging signals of clinical benefit. This approach enables interventional radiologists to deliver the treatment with precision and reproducibility. In our view, this represents an important step towards making radionuclide therapy more widely available for patients with locally advanced pancreatic cancer, subject to regulatory approval.”

Nigel Lange, CEO & Managing Director of OncoSil Medical, said:

"We are greatly encouraged by the preliminary results of the PANCOSIL trial, in which the investigators concluded that OncoSil™ can be safely and effectively delivered using a percutaneous CT-guided approach. Importantly, this enables interventional radiologists to administer the treatment with precision and consistency, significantly expanding the potential reach of OncoSil™. These findings strengthen our clinical evidence base and mark another step forward in our mission to transform outcomes for patients with locally advanced pancreatic cancer."

Investor webinar

OncoSil Medical will be hosting an investor webinar at 10.30AM AEST today, where the Company’s CEO & Managing Director Nigel Lange will discuss the significance of the preliminary results for the PANCOSIL trial and recent progress in delivering other growth initiatives. Investors wanting to register to attend this webinar can use the following link:

https://us02web.zoom.us/webinar/register/WN_6xxWjGNfTtavhJgszhcvAg


About us:

About OncoSil Medical
OncoSil Medical Limited (ASX:OSL) has developed a cancer treatment device, the OncoSil™ brachytherapy device, which is a critical component of a revolutionary brachytherapy treatment for locally advanced unresectable pancreatic cancer. This type of cancer is the 12th most common cancer in men and the 11th most common cancer in women across the globe, with some 500,000 new cases of pancreatic cancer detected every year. With pancreatic cancer typically diagnosed at a later stage, it has a poor prognosis for longterm survival.

The OncoSil™ device delivers a targeted intratumoural placement of Phosphorous-32 (32P) in the treatment of locally advanced unresectable pancreatic cancer. This occurs via injection directly into a patient’s pancreatic tumours under endoscopic ultrasound guidance and takes place in combination with gemcitabine-based chemotherapy. 

The OncoSil™ device that has already received breakthrough device designation in the European Union, United Kingdom and United States for the treatment of locally advanced unresectable pancreatic cancer in combination with chemotherapy. CE Marking has additionally been granted for the OncoSil™ device, which can be marketed in the European Union, United Kingdom.

While clinical trials involving the OncoSil™ device continue to occur, the Company is simultaneously moving to commercialise this unique medical technology. It is currently approved for sale in 30+ countries including European Union, United Kingdom, Türkiye and Israel, with initial commercial pancreatic cancer treatments using the device already undertaken in Spain, Italy and Israel.

To learn more, please visit: www.oncosil.com


Contact details:

For further information, please contact:

OncoSil Medical Limited 
Nigel Lange
CEO & Managing Director
[email protected]
+49 16096424981

Company Secretary
Mr. Tim Luscombe
Joint Company Secretary
[email protected]
+61 429 707 079

Mr. David Wood
Joint Company Secretary
[email protected]
+61 408 393 670

Investor Relations
The Capital Network 
Julia Maguire
+61 2 7257 7338
[email protected]