On June 19, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported further data from the ongoing ACCENT trial investigating the Company’s best-in-class FAK inhibitor narmafotinib in advanced pancreatic cancer (Press release, Amplia Therapeutics, JUN 19, 2025, View Source [SID1234653983]). A second patient of the 55 patients enrolled in the trial has recorded a confirmed complete response (CR). This finding follows the announcement earlier this week1 of a separate patient who achieved a pathological CR in the trial.
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A confirmed complete response is a formal designation of response where there is a complete disappearance of all tumour lesions that is maintained for >2 months. This is a rare outcome in advanced pancreatic cancer where the disease has spread to other parts of the body. For example, the seminal study demonstrating efficacy of the chemotherapies gemcitabine and Abraxane in advanced pancreatic cancer reported only one (1) CR out of 431 patients.
Amplia CEO and MD Dr Chris Burns commented: "To see a second complete response in the ACCENT trial is really wonderful news, particularly given how rare these are observed in advanced pancreatic cancer. Along with the pathological CR announced earlier in the week, this outcome further demonstrates the promising activity narmafotinib, on top of standard-of-care, is showing in pancreatic cancer."
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies.
About the ACCENT Trial
The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.
The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.
The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.
The trial is being conducted at seven sites in Australia and five sites in South Korea.
More information about the ACCENT trial can be found via the ACCENT trial site, the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.