Amplia Therapeutics (ASX:ATX) has delivered an update on its clinical progress, announcing an additional confirmed partial tumour response in its ACCENT trial and presenting new data to investors that reinforce the potential of its FAK inhibitor narmafotinib (AMP945) in metastatic pancreatic cancer.
The latest confirmed response lifts the trial’s objective response rate (ORR) to 35 per cent, with 19 of 55 patients experiencing a complete or partial response to treatment, a result that compares favourably with the 23 per cent ORR documented in the benchmark MPACT study of gemcitabine and nab-paclitaxel alone.
Amplia CEO Dr Chris Burns unveiled the updated data during a presentation to the Life Sciences Virtual Investor Forum.
The ACCENT trial, conducted across Australia and Korea, is evaluating narmafotinib in combination with standard chemotherapy in newly diagnosed metastatic pancreatic cancer.
Pancreatic cancer remains one of the deadliest solid tumours, with limited treatment options and poor long-term survival. The disease’s aggressiveness, high metastatic burden, and frequent resistance to therapy underline the need for novel therapeutic strategies.
FAK, an enzyme overexpressed in pancreatic cancer, contributes to tumour growth, fibrosis, immune suppression, metastasis and treatment resistance. By blocking FAK activity in tumour and stromal cells, narmafotinib is designed to make the tumour microenvironment more permeable to chemotherapy, improve immune responsiveness and limit tumour spread. Preclinical and early clinical data show the drug is potent, orally administered once daily, stable at room temperature and compatible with other medicines.
Interim data show a median progression-free survival of 7.6 months, substantially exceeding the 5.5 months recorded in the MPACT trial and also outperforming FOLFIRINOX, the other major first-line regimen. Patients have tolerated the combination well, with Grade 3 or higher adverse events similar to those with chemotherapy alone, or in some cases, lower.
The company emphasised that narmafotinib’s emerging profile reflects a rare convergence of efficacy, durability and tolerability. Amplia said its effect on tumour fibrosis and immune modulation also opens opportunities for combination strategies with immunotherapies, KRAS inhibitors, antibody-drug conjugates and radiotherapy.
Amplia is now advancing a second clinical program, the AMPLICITY trial, investigating narmafotinib with FOLFIRINOX under a U.S. clinical trial protocol. The study includes sites in both Australia and the United States, with dose escalation underway and dose-expansion cohorts to follow. Over the next two years, Amplia expects a steady sequence of milestones, including the completion of recruitment, additional response-rate updates, mature data cuts, and the initiation of a Phase 2b/3 study.