Amplia Therapeutics (ASX: ATX) has released updated clinical data from its ACCENT trial, showing improved response rates and extended survival in advanced pancreatic cancer patients. The results follow an independent centralised analysis using RECIST 1.1 criteria, replacing earlier site-based assessments.
Independent Review Lifts Complete Response Count
The updated dataset confirms five complete responses among 64 patients receiving narmafotinib with chemotherapy. This equates to a 7.8% complete response rate, materially higher than historical benchmarks.
The independent review identified four additional complete responses not previously classified. A complete response requires the disappearance of measurable tumours for at least two months without new lesions.
An additional partial response was also confirmed. This lifts the overall objective response rate to 35.9% across the study cohort.
Survival Data Tracks Above Standard Therapy
Median overall survival reached 11.1 months, based on data cut through mid-March 2026. This compares to approximately 8.5 months reported in the MPACT trial for chemotherapy alone.
The survival outcome aligns with results from the NAPOLI-3 study, which supported regulatory approval of the NALIRIFOX regimen. Importantly, no additional toxicity burden was observed with narmafotinib.
Benchmarking Against Established Trials
Data presented in the table on page 2 show clear differentiation versus historical studies. Complete response rates in comparator trials ranged between 0.2% and 0.3%, well below the ACCENT outcome.
Objective response rates remain broadly comparable to leading regimens. However, the higher complete response rate stands out within first-line pancreatic cancer studies.
Trial Context and Ongoing Monitoring
The ACCENT trial is a Phase 1b/2a study combining narmafotinib with gemcitabine and Abraxane. It includes patients across multiple sites in Australia and South Korea.
Four patients remain on treatment. One patient is approaching 24 months on study, indicating extended durability in select cases.
The trial is expected to complete in the third quarter of 2026. Amplia plans to present expanded data at the American Association for Cancer Research conference in April.
Strategic Relevance of the Data
Pancreatic cancer remains one of the most aggressive malignancies with limited first-line treatment options. Improvements in complete response rates are rare in this setting.
The data suggest narmafotinib may enhance chemotherapy efficacy without increasing adverse effects. This positions the drug for further development in combination regimens.
CEO Dr Chris Burns said, “These latest data from the ACCENT trial clearly demonstrate the significant clinical benefit of narmafotinib.”
