Amplia Therapeutics Ltd (ASX:ATX, OTCQB:INNMF)'s ACCENT trial has reached an important milestone after an independent central review confirmed five complete responses in patients treated with narmafotinib alongside gemcitabine and Abraxane in first-line advanced pancreatic cancer.
The company said the updated result from the 64-patient Phase 1b/2a study represents a complete response rate of 7.8%, which it believes is unprecedented in this setting.
That matters because pancreatic cancer remains one of the hardest cancers to treat, with limited progress in frontline therapy and generally poor survival outcomes. A complete response means measurable tumours and metastases were no longer detectable on scans for at least 2 months, with no new lesions identified.
For Amplia, the milestone strengthens the clinical case around narmafotinib by shifting the ACCENT study beyond a standard tumour shrinkage story to evidence that a subset of patients may have achieved full radiological clearance of disease.
“These latest data from the ACCENT trial clearly demonstrate the significant clinical benefit of narmafotinib. The unprecedented 7.8% rate of CR's in the first line setting provides new hope for patients with this very aggressive cancer and provides further strong support for the benefit that narmafotinib can bring when combined with other treatment modalities. We look forward to presenting a detailed analysis of the ACCENT trial at the forthcoming AACR conference,” Dr Chris Burns, CEO and managing director of Amplia said.
Independent review sharpens efficacy signal
The update follows a formal independent review of trial imaging using RECIST 1.1 criteria, which reclassified four additional patients as confirmed complete responders.
Amplia also reported median overall survival of 11.1 months based on data to 15 March 2026, compared with 8.5 months in the historical MPACT study of gemcitabine and Abraxane alone. The company said the result is also in line with the 11.1-month median overall survival reported for the NALIRIFOX regimen in the NAPOLI 3 trial.
Updated objective response rate in ACCENT was 35.9%, compared with 23% in MPACT and 36.2% in NAPOLI 3.
Just as importantly, Amplia said narmafotinib continues to be well tolerated, with an adverse event profile consistent with chemotherapy alone. That gives added weight to the efficacy signal, as any treatment gain in pancreatic cancer is more meaningful if it does not come with a materially heavier side-effect burden.
The result gives Amplia a stronger platform as it advances narmafotinib and builds its case for the drug as a potential addition to standard-of-care chemotherapy in advanced pancreatic cancer.
The company is due to present more detailed ACCENT data at the American Association of Cancer Research annual meeting in April 2026, with four patients still on study as of mid-March and 1 patient nearing 24 months on trial.