Amplia Therapeutics (ASX: ATX) has reported significant improvements in response and survival rates from its ACCENT trial for narmafotinib in advanced pancreatic cancer.
In centrally reviewed RECIST 1.1 response data from its ACCENT Phase 1b/2a trial, the confirmed complete response (CR) rate in patients receiving 400 mg of narmafotinib has increased to 7.8%.
The objective response rate (ORR) for all 64 patients in stages 1b/2a on the 400 mg dose now stands at 35.9%.
These results show an improvement when compared to historical gemcitabine/Abraxane benchmarks, where the MPACT trial reported an ORR of 23%.
Improved Median Overall Survival
Further positive data comes from the median overall survival (mOS) figures. As of the mid-March data cut-off, mOS has improved to 11.1 months.
This represents an approximate two-month improvement over historical gemcitabine/Abraxane benchmarks, which recorded 8.5 months in the MPACT study and 9.2 months in the NAPOLI 3 trial.
Notably, this 11.1 months mOS figure matches that reported for NALIRIFOX in the NAPOLI 3 trial.
The company also confirmed that four patients remain on the study, with one patient approaching 24 months on trial.
The safety profile of narmafotinib in combination with chemotherapy was also highlighted.
The combination therapy was reportedly well-tolerated, with the adverse effect profile similar to chemotherapy alone, with no additional toxicity burden noted.
San Diego Presentation
Looking ahead, Amplia is set to present its ACCENT trial data at the AACR conference in San Diego between 17 and 22 April 2026.
A webinar will discuss the results on 24 March 2026 (AEDT).
Previously, the US FDA provided positive feedback to Amplia on narmafotinib's dose optimisation strategy for a planned Phase 2b/3 registration-enabling pancreatic cancer trial.
The full protocol is expected for FDA review in H1 2026.
Outlook for Narmafotinib
Amplia Therapeutics' latest ACCENT trial results present a compelling case for narmafotinib in advanced pancreatic cancer, showing significant efficacy improvements in response and survival rates without added toxicity.
While these findings are promising and support continued development, investors remain mindful of the trial's single-arm design and reliance on historical benchmarks, alongside inherent clinical and funding risks.
"The unprecedented 7.8% rate of CR 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," chief executive officer Dr Chris Burns said.
"We look forward to presenting a detailed analysis of the ACCENT trial at the forthcoming AACR conference.”
