On July 1, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that an additional confirmed partial response has been recorded in the Company’s ongoing ACCENT clinical trial in pancreatic cancer. The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane (Press release, Amplia Therapeutics, JUL 1, 2025, View Source [SID1234654198]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
This additional confirmed partial response brings the objective response rate to 29%, namely 16 out of 55 patients enrolled in the trial. There are 20 patients still enrolled in the trial.
A confirmed partial response is a formal designation of response where tumour shrinkage >30% is recorded and sustained for two (2) or more months and where no new cancerous lesions have been detected.
Amplia CEO and MD Dr Chris Burns commented: "An additional confirmed PR adds to the promising data already recorded in the ACCENT trial. With 20 patients still on study we are hopeful that further PR’s will be recorded in the future."
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.
The Company will provide further updates on the trial as data is accrued.