Amplia Therapeutics (ASX: ATX) has reported a rare and potentially game-changing result from its ACCENT trial, with one patient achieving a pathological complete response (pCR) to treatment for advanced pancreatic cancer.
The Melbourne-based biotech is testing its FAK inhibitor, narmafotinib, in combination with the standard chemotherapies gemcitabine and Abraxane®.
The patient’s tumours — both in the pancreas and liver — were surgically removed and found to contain no live cancer cells, a result classified as pCR.
This outcome is exceptionally rare in metastatic pancreatic cancer, a disease with a notoriously poor prognosis and limited treatment breakthroughs.
While pCRs occur in roughly 5% of patients with locally advanced (non-metastatic) disease following neoadjuvant chemotherapy, they are almost unheard of in metastatic cases.
Amplia’s results suggest narmafotinib may enhance the efficacy of existing chemotherapy regimens in a meaningful way.
The ACCENT trial is a Phase 1b/2a study running across sites in Australia and South Korea. It aims to evaluate the safety and efficacy of narmafotinib, a best-in-class FAK (Focal Adhesion Kinase) inhibitor, which targets a protein overexpressed in pancreatic tumours.
The drug has already received fast-track designation from the US FDA, underscoring its potential to address a critical unmet need.
Amplia CEO Dr Chris Burns called the results “wonderful news”.
Dr Burns commented: “We are extremely excited to learn that a patient from our study has achieved a pathological complete response. This is wonderful news for the patient and the clinical team involved. We firmly believe this outcome further demonstrates the promising activity narmafotinib, on top of standard-of-care, is showing in the treatment of advanced pancreatic cancer.”
While a single pCR doesn’t constitute statistical significance, it offers a strong signal in a cancer type where median survival is often measured in months, not years.
For investors, the result adds momentum to Amplia’s clinical narrative and could support future regulatory engagement or partnership discussions. Shares in the company surged following the announcement, reflecting market enthusiasm for a rare bright spot in pancreatic cancer drug development. Further data from the trial will be closely watched as Amplia builds its case.
At the time of writing, the stock price of Amplia Therapeutics Ltd was $0.069, up 0.0030 (4.55%) today. It has a market cap of around $25.06 million.
