OncoSil Medical has achieved Last Patient, Last Visit (LPLV) in the TRIPP-FFX clinical trial, marking the completion of all patient treatments and follow-up assessments in its pivotal clinical study. The trial recruited 88 patients across 15 clinical sites in Europe and Australia, evaluating the OncoSil™ device for treating unresectable locally advanced pancreatic cancer (LAPC).
This operational milestone transitions the company from clinical execution to data analysis and regulatory engagement. Patient recruitment was completed in July 2025, with the final follow-up assessments now complete. The OncoSil™ device delivers targeted radiation therapy directly into pancreatic tumours using Phosphorous-32 microparticles, offering a localised treatment approach for patients with limited therapeutic options.
The completion of LPLV clears the path for database lock and statistical analysis in accordance with the trial protocol. The company expects to present trial results in the first half of calendar year 2026 (1H CY26).
What the TRIPP-FFX trial is evaluating
The TRIPP-FFX study is a prospective, multi-centre, non-comparative randomised trial assessing the OncoSil™ device when used in addition to FOLFIRINOX chemotherapy. FOLFIRINOX represents a widely adopted standard-of-care chemotherapy regimen in Europe for LAPC patients, meaning physicians already prescribe this combination in routine clinical practice.
The trial endpoints include:
- Primary endpoints: Safety and Tolerability, Local Disease Control Rate (LDCR) at 16 weeks
- Secondary endpoints: Local Progression-Free Survival (LPFS), Progression-Free Survival (PFS), Overall Survival (OS), and other efficacy measures
The trial design evaluates whether adding the OncoSil™ device to existing chemotherapy protocols can improve outcomes for patients with unresectable locally advanced pancreatic cancer. This real-world treatment combination reflects how oncologists currently manage LAPC, making the data directly applicable to established clinical pathways.
Near-term catalysts and regulatory pathway
OncoSil Medical (ASX: OSL) has outlined a defined timeline of milestones that investors can track through 2026:
| Milestone | Expected Timing | Significance |
|---|---|---|
| Database lock & statistical analysis | 1H CY26 | Final data cleaning complete |
| Trial results presentation | 1H CY26 | Clinical data readout |
| Regulatory submission (CE Mark extension) | 2H CY26 | Adds FOLFIRINOX to product label |
| Long-term OS data collection | Ongoing | Trial continues for survival tracking |
The regulatory submission aims to extend OncoSil’s existing CE Mark by adding FOLFIRINOX as an additional chemotherapy option. This extension would be processed through a change notification to the British Standards Institute, the regulatory body responsible for the company’s CE Marking. If approved, the label expansion would formally recognise the OncoSil™ device’s use in addition to FOLFIRINOX within the approved indication.
The extension of the product label is subject to regulatory review and approval. Long-term overall survival data collection will continue beyond the primary analysis, providing additional evidence on treatment durability.
What CE Mark extension means for commercial reach
OncoSil™ already holds CE Marking approval, providing marketing authorisation in both the EU and the UK. The device is currently approved for sale in 30+ countries, including the European Union, United Kingdom, Turkey, and Israel. Commercial treatments using the device have already been performed in Spain, Italy, Austria, Germany, Greece, Turkey, Portugal, Israel, and the UK.
A successful label extension would give physicians greater flexibility to integrate OncoSil™ into established treatment pathways, reflecting real-world clinical practice and addressing an area of high unmet medical need. Currently, oncologists must consider whether their preferred chemotherapy protocol aligns with the device’s approved label. Adding FOLFIRINOX removes this practical barrier, as it represents a widely adopted standard-of-care regimen across European markets.
This regulatory pathway builds on the company’s existing commercial infrastructure rather than requiring market re-entry. The device is designated as a breakthrough device in both Europe and the United States, reflecting regulatory recognition of its novel approach to treating pancreatic cancer.
Building the clinical evidence base for LAPC
The TRIPP-FFX trial completion represents the conclusion of a major clinical investment phase for the company. OncoSil Medical has now completed two significant studies targeting unresectable locally advanced pancreatic cancer:
- TRIPP-FFX: Company-sponsored trial evaluating OncoSil™ in addition to FOLFIRINOX
- PANCOSIL: Investigator-initiated study adding to clinical evidence base
- Combined data package: Supports regulatory and commercial strategy for label expansion
With the completion of both the PANCOSIL Investigator-Initiated Study and the TRIPP-FFX trial, the company transitions focus toward regulatory engagement, label expansion opportunities, and broader commercial execution, subject to regulatory approvals. This represents a shift from capital-intensive clinical development to monetising the investment through regulatory milestones and commercial rollout.
The clinical programme positions OncoSil Medical to pursue label extension based on a substantial body of clinical evidence. The company can now allocate resources toward regulatory submissions and commercial activities rather than ongoing trial operations.
CEO commentary
“Achieving Last Patient, Last Visit in the TRIPP-FFX study represents an important operational milestone for the Company. The trial has been designed to generate clinical data evaluating the use of OncoSil™ in addition to FOLFIRINOX, which is intended to support future regulatory extensions of the product label. We thank the investigators, clinical teams, and patients for their contribution and now look forward to progressing through database lock and data analysis in accordance with the trial protocol,” said Nigel Lange, CEO & Managing Director of OncoSil Medical.
The investment case for OncoSil at this stage
The completion of LPLV in the TRIPP-FFX trial de-risks the clinical execution component of the investment thesis. Investors now have visibility to a defined catalyst timeline through 2026, with trial results expected in 1H CY26 and regulatory submission planned for 2H CY26.
Pancreatic cancer is the 12th most common cancer in men and the 11th most common cancer in women globally, with 500,000 new cases detected annually. The disease is generally diagnosed at a later stage, resulting in poor prognosis for long-term survival and representing significant unmet medical need.
Key thesis elements for investors:
- Clinical trial execution risk eliminated: LPLV complete, all patient treatments and follow-ups finished
- Defined catalyst timeline: Data readout and regulatory submission milestones through 2026
- Existing commercial presence: CE Mark approval and commercial treatments in 30+ countries
- Large addressable market: 500,000 new pancreatic cancer cases annually with high unmet need
- Breakthrough device designation: Recognised in both Europe and United States
The OncoSil™ device’s targeted approach enables healthcare professionals to deliver a greater radiation dose directly into tumours compared to external beam radiotherapy, while sparing surrounding critical organs. This localised treatment modality addresses a therapeutic gap for patients with unresectable disease who cannot undergo surgical resection.
Investors now await the 1H CY26 data readout as the next major catalyst. The trial results will determine whether the addition of OncoSil™ to FOLFIRINOX demonstrates sufficient safety, tolerability, and efficacy to support the regulatory submission and subsequent label extension.
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