OncoSil Medical (ASX: OSL) has reported OncoSil Türkiye Clinical Results showing 83% of patients treated with its OncoSil™ device achieved surgical resection at Ankara Bilkent City Hospital. The early commercial-use data, derived from six patients treated with the device alongside FOLFIRINOX chemotherapy, marks the first substantive clinical evidence from Türkiye’s adoption of the pancreatic cancer treatment technology.
Post-treatment analysis of the six patients revealed one Complete Response (16.6%), four Partial Responses (66.6%), and one case of Stable Disease (16.6%). Critically, five of the six patients (83%) subsequently underwent successful surgical resection with curative intent. This data emerged from clinical practice rather than a controlled trial environment, providing real-world validation of the device’s efficacy.
Ankara Bilkent City Hospital represents a high-volume pancreatic cancer treatment centre, having performed over 500 pancreatic surgeries between February 2019 and December 2024. The facility stands among the first centres in Türkiye to adopt the OncoSil™ device in routine clinical practice, positioning it as a reference site for the technology’s commercial deployment.
The 83% resection rate achieved with OncoSil™ plus FOLFIRINOX substantially exceeds published benchmarks for standard chemotherapy regimens alone. This early commercial experience signals the device’s potential to materially alter treatment pathways for patients with locally advanced pancreatic cancer, a diagnosis that typically carries limited therapeutic options.
Why surgical resection matters in pancreatic cancer treatment
Locally advanced pancreatic cancer (LAPC) refers to tumours that have grown to involve major blood vessels near the pancreas, rendering them technically unresectable at diagnosis. Most patients presenting with LAPC cannot undergo immediate surgery due to the risk of incomplete tumour removal or damage to critical vascular structures. The standard approach involves chemotherapy to shrink the tumour, with the hope of later converting the patient to a surgical candidate.
Surgical resection with curative intent represents the primary pathway to meaningfully extended survival in pancreatic cancer. Patients who achieve resection following chemotherapy demonstrate significantly higher median overall survival compared with those who remain unresectable. Published data shows resected patients survive a median 35.3 months versus 16.3 months for non-resected patients, a difference that reaches statistical significance (p < 0.001).
Pancreatic cancer ranks as the 12th most common cancer in men and the 11th most common cancer in women globally, with approximately 500,000 new cases detected annually. The disease generally presents at a late stage, contributing to its poor prognosis. The five-year survival rate remains below 10% across most health systems, largely because the majority of patients never become eligible for surgical resection.
The ability to convert initially unresectable patients into surgical candidates therefore represents the core clinical value proposition for OncoSil™. The device delivers targeted radiation directly into the tumour through Phosphorous-32 microparticles, enabling healthcare professionals to administer a greater radiation dose than external beam radiotherapy while sparing surrounding critical organs. When combined with systemic chemotherapy, this localised approach aims to achieve sufficient tumour reduction to permit curative surgery.
Historical resection rates comparison
The 83% resection rate reported from Ankara Bilkent City Hospital materially exceeds published benchmarks for standard chemotherapy regimens in locally advanced pancreatic cancer. Literature supports a resection rate of approximately 15% for LAPC patients receiving first-line Gemcitabine plus Nab-Paclitaxel (Gem-Nab), while FOLFIRINOX chemotherapy achieves resection rates of approximately 26% (13% without radiotherapy).
OncoSil’s own 2022 PANCO clinical trial reported a 24% overall resection rate, with 80% of patients in that study receiving Gem-Nab rather than FOLFIRINOX. The Türkiye clinical experience, using FOLFIRINOX as the backbone chemotherapy, demonstrates a threefold improvement over that earlier trial data and more than triples the expected outcome for FOLFIRINOX monotherapy.
| Treatment Approach | Resection Rate |
|---|---|
| OncoSil + FOLFIRINOX (Türkiye) | 83% |
| FOLFIRINOX alone | ~26% |
| FOLFIRINOX without radiotherapy | ~13% |
| Gem-Nab alone | ~15% |
| OncoSil (PANCO trial, 2022) | 24% |
The magnitude of improvement versus historical benchmarks strengthens the commercial case for adoption across treatment centres. While the sample size remains small at six patients, the consistency of response (five of six achieving resection) suggests the effect may be reproducible. Further real-world data from ongoing commercial use will determine whether these early results represent a sustained clinical benefit.
CEO frames results as validation of commercial strategy
Nigel Lange, Chief Executive Officer and Managing Director of OncoSil Medical, positioned the Türkiye clinical experience as evidence supporting the company’s broader international rollout strategy. The results offer tangible validation of the device’s real-world performance outside controlled trial environments.
CEO Commentary
“Achieving an 83% surgical resection rate in this early commercial experience is an exceptional outcome and highlights the potential of the OncoSil™ device to meaningfully change treatment pathways. Pancreatic cancer patients who are initially deemed unresectable typically have very limited options, with published resection rates remaining relatively low despite advances in chemotherapy. OncoSil™’s outstanding results in this institution strongly support our commercial strategy and reinforces the long-term value proposition for shareholders.”
Nigel Lange, CEO & Managing Director
OncoSil™ has received approval for sale in more than 30 countries, including the European Union, United Kingdom, Türkiye, and Israel. Commercial treatments using the device have been undertaken across nine countries: Spain, Italy, Austria, Germany, Greece, Türkiye, Portugal, Israel, and the UK. The device holds CE Marking approval, providing marketing authorisation in both the EU and UK, and carries breakthrough device designation in both Europe and the United States.
Ankara Bilkent City Hospital’s adoption of OncoSil™ in routine clinical practice demonstrates growing acceptance among high-volume pancreatic cancer centres. The facility’s substantial caseload, exceeding 500 pancreatic surgeries in recent years, provides a credible reference point for other institutions evaluating the technology.
What comes next for OncoSil
OncoSil Medical continues to expand commercial adoption of the OncoSil™ device across international markets while building real-world clinical evidence to support broader use. The company’s forward strategy centres on accumulating clinical data from active commercial settings to strengthen the evidence base for the device’s efficacy and safety profile.
Key strategic elements include:
- Breakthrough device designation in both Europe and the United States, providing potential regulatory advantages for market expansion
- CE Marking approval, enabling continued commercial activity across EU and UK markets
- Real-world evidence generation from ongoing treatments across nine countries to support adoption by additional treatment centres
- Potential US market entry, leveraging breakthrough designation status to facilitate regulatory pathway
The Türkiye clinical experience represents an early data point in this evidence-building strategy. As additional patients receive treatment across the device’s approved markets, the company aims to establish a robust real-world dataset demonstrating consistent clinical outcomes.
Investment thesis: Real-world validation strengthens OncoSil’s commercial case
The OncoSil Türkiye Clinical Results announcement carries significant implications for investors evaluating the company’s commercial trajectory. The 83% resection rate achieved at Ankara Bilkent City Hospital provides tangible evidence that OncoSil can deliver on its core value proposition in commercial settings, addressing a key de-risking milestone.
1. Clinical results from active commercial use demonstrate real-world applicability. Unlike controlled trial environments, commercial clinical practice introduces variability in patient selection, treatment protocols, and institutional expertise. The Türkiye data confirms the device performs effectively outside trial constraints.
2. The 83% resection rate materially exceeds historical benchmarks and OncoSil’s prior trial data. The threefold improvement over FOLFIRINOX monotherapy and the substantial increase versus the company’s own PANCO trial results suggest the combination of OncoSil with FOLFIRINOX specifically may represent an optimal treatment paradigm.
3. Growing international footprint with treatments across nine countries. Commercial adoption continues to expand geographically, with Türkiye joining eight other markets where OncoSil treatments have been performed. Each new market entry provides additional revenue potential and further real-world validation.
4. Breakthrough designation provides potential regulatory advantages for market expansion. The device’s breakthrough status in both Europe and the United States positions the company for accelerated regulatory pathways, particularly relevant for potential US market entry where pancreatic cancer incidence remains high.
The scarcity of effective treatment options in locally advanced pancreatic cancer and OncoSil’s differentiated positioning as a targeted radiation delivery system combined with chemotherapy create a compelling commercial opportunity. Investors should monitor ongoing real-world data accumulation across the device’s approved markets to assess whether the Türkiye results represent a reproducible clinical benefit.
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