TRIPP-FFX Results Presented at ESMO GI 2026 Reinforce Safety and Encouraging Clinical Outcomes

by | Jul 6, 2026 | News

News

Monday, Jul 06

TRIPP-FFX Results Presented at ESMO GI 2026 Reinforce Safety and Encouraging Clinical Outcomes

Doctor with pancreas outline

Sydney, Australia – 6 July 2026: OncoSil Medical Limited (ASX: OSL) (“OncoSil Medical” or “the Company”), a medical device company focused on localised treatments for patients with unresectable locally advanced pancreatic cancer (LAPC), is pleased to announce that updated results from the TRIPP-FFX clinical study, including a new, Per Protocol (PP) analysis, were presented as a Rapid Oral Presentation at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2026 (ESMO GI 2026), held in Munich, Germany. The presentation was delivered by Michele Milella, Professor of Medical Oncology at the University of Verona, Italy and co-principal investigator of the study.

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

“Presenting the TRIPP-FFX results at ESMO GI 2026 represents an important milestone for OncoSil Medical and provides the opportunity to share our data with one of the world’s leading audiences of gastrointestinal oncology specialists. Importantly, the presentation included new, Per Protocol analysis, which demonstrated a median overall survival of 21.3 months together with encouraging efficacy outcomes across multiple clinically meaningful secondary endpoints. This new analysis further strengthens the clinical evidence supporting the use of the OncoSil™ device alongside FOLFIRINOX in patients with unresectable LAPC.

The continued demonstration of a manageable safety profile with no new safety signals, together with the encouraging efficacy outcomes presented at ESMO GI, further strengthens our confidence as we progress our planned Change Notification submission to expand the OncoSil™ device label to include FOLFIRINOX, subject to regulatory approval.”

The presentation included updated analysis of the Phase II TRIPP-FFX study evaluating the addition of the OncoSil™ device to standard-of-care FOLFIRINOX chemotherapy in patients with unresectable locally advanced pancreatic cancer (LAPC). In addition to confirming the previously announced findings that the study met both co-primary endpoints of safety/tolerability and local disease control rate (LDCR) at 16 weeks, the presentation included a new, Per Protocol analysis.

Per Protocol analysis evaluates outcomes in patients who completed treatment according to the study protocol, providing an assessment of treatment efficacy under the intended conditions of use. When considered alongside the primary intention-to-treat analysis, the Per Protocol results offer complementary evidence that can strengthen confidence in the consistency and robustness of the observed treatment effect.

The Per Protocol analysis demonstrated encouraging efficacy outcomes, including median overall survival of 21.3 months (95% Confidence Interval [CI] 13.8–not calculable [nc]) in patients treated with OncoSil™ device plus FOLFIRINOX. The updated analysis continued to demonstrate encouraging efficacy across multiple secondary endpoints while confirming a manageable safety profile with no new safety signals identified.

Safety

The safety profile remained consistent with the previously announced results, with no new safety signals identified.

  • The study continued to meet its co-primary safety endpoint, confirming that adverse events following the addition of OncoSil™ device to FOLFIRINOX were limited and manageable.

Efficacy

Previously announced Intent-to-Treat (ITT) results

The updated analysis confirmed the previously reported efficacy outcomes, including:

  • Local Disease Control Rate (LDCR) at 16 weeks: 82.2% (95% CI 67.9–92.0) in the OncoSil™ device + FOLFIRINOX arm, exceeding the predefined efficacy threshold
  • Median overall survival: 18.2 months (95% CI 13.8–nc)
  • Median local progression-free survival: 12.8 months (95% CI 7.8–nc)
  • Median progression-free survival: 12.1 months (95% CI 7.8–15.1)
  • Median tumour volume reduction: 57.0% in the FOLFIRINOX arm, 72.1% in the OncoSil™ device + FOLFIRINOX arm

New, Per Protocol (PP) analysis

For the first time, the ESMO GI presentation reported PP analysis, demonstrating encouraging outcomes among patients who completed treatment according to protocol.

  • Local Disease Control Rate at 16 weeks: 85.4% (95% CI 70.8–94.4) in FOLFIRINOX arm, 85.0% (95% CI 70.2–94.3%) in the OncoSil™ device + FOLFIRINOX arm
  • Median overall survival: 15.6 months (95% CI 10.2–21.0) in FOLFIRINOX arm, 21.3 months (95% CI 13.8-nc)
  • Median local progression-free survival: 9.9 months (95% CI 7.8–nc) in FOLFIRINOX arm, 12.8 months (95% CI 11.2–nc) in the OncoSil™ device + FOLFIRINOX arm
  • Median progression-free survival: 9.9 months (95% CI 7.5–nc) in FOLFIRINOX arm, 12.1 months (95% CI 7.8–15.1) in the OncoSil™ device + FOLFIRINOX arm
  • Best overall response was Partial Response in 36.6% & 60.0%, Stable Disease in 53.7% & 30.0% and Progressive Disease in 9.8% & 10.0% in the FOLFIRINOX and FOLFIRINOX + OncoSil™ device arms, respectively
  • Median tumour volume reduction: 55.9% in FOLFIRINOX arm, 72.2% in the OncoSil™ device + FOLFIRINOX arm
  • Surgical resection rate: 7.3%, with 33% achieving R0 resection in the FOLFIRINOX arm, 12.5%, with 60% of these achieving R0 resection in the OncoSil™ device + FOLFIRINOX arm.

The investigators concluded that TRIPP-FFX successfully met its co-primary endpoints, demonstrating manageable toxicities and local disease control exceeding 80% at 16 weeks following the addition of OncoSil™ device to FOLFIRINOX chemotherapy. The updated analysis presented at ESMO GI, including previously unreported Per Protocol results, demonstrated encouraging efficacy outcomes, with median overall survival of 21.3 months in the OncoSil™ device plus FOLFIRINOX arm. Secondary efficacy endpoints were generally in line with the best outcomes reported in recent studies of locally advanced pancreatic cancer and numerically favoured the OncoSil™ device plus FOLFIRINOX arm across objective response rate, local progression-free survival, progression-free survival, overall survival and R0 resection rates. The safety profile remained manageable, with no new safety signals identified, further supporting the growing body of clinical evidence for the use of OncoSil™ device in combination with standard-of-care FOLFIRINOX chemotherapy in patients with unresectable locally advanced pancreatic cancer.