Second Complete Response in ACCENT Pancreatic Cancer Trial
ABN 16 165 160 841
ASX RELEASE
19 June 2025
SECOND COMPLETE RESPONSE RECORDED IN ACCENT PANCREATIC CANCER TRIAL
HIGHLIGHTS
•
A second confirmed complete response has been recorded in the ACCENT trial
•
In advanced pancreatic cancer a complete response is extremely rare
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The ACCENT trial is evaluating the Company’s best-in-class FAK inhibitor narmafotinib in
combination with chemotherapy in advanced pancreatic cancer
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is
pleased to announce further data from the ongoing ACCENT trial investigating the Company’s best-inclass FAK inhibitor narmafotinib in advanced pancreatic cancer. 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 week 1 of a separate patient who achieved a pathological CR in the trial.
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. 2
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 overexpressed 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
1
2
ASX Release 16 Jun 2025
New England Journal of Medicine 2013; 369: 1691 – 703
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
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.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
About Amplia Therapeutics Limited
Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal
Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the
field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic
and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic
pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on Twitter
(@ampliatx) and LinkedIn.
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