ADDITIONAL RESPONSES IN ACCENT PANCREATIC CANCER TRIAL
Released
Released
Announcement PDF
ABN 16 165 160 841
+61 (0) 3 9123 1140 | info@ampliatx.com
Level 5, 90 William Street, Melbourne VIC 3000 Australia
www.ampliatx.com
09 OCTOBER 2025
ASX RELEASE
AMPLIA THERAPEUTICS REPORTS ADDITIONAL RESPONSES IN ACCENT PANCREATIC CANCER TRIAL
HIGHLIGHTS
• An updated data analysis of the trial of narmafotinib in combination with chemotherapy to 25
September 2025 is presented
• An additional confirmed partial response and unconfirmed partial response have been recorded bringing
the Objective Response Rate to 33%, notably superior to 23% recorded for chemotherapy alone
• The mean Duration on Trial, a measure of the effectiveness of the drug combination halting cancer
progression, is 219 days, substantially better than chemotherapy alone
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), referred to as “Amplia” or “the Company”,
is pleased to announce an update from the ongoing ACCENT clinical trial, which is investigating the
company’s leading FAK inhibitor, narmafotinib, in combination with the chemotherapies gemcitabine and
Abraxane®
for the treatment of advanced pancreatic cancer. The trial is being conducted across sites in
Australia and Korea.
LATEST TRIAL DATA AND KEY FINDINGS
An additional confirmed partial response and an unconfirmed partial response have been recorded as part
of the data analysis from the ACCENT Trial following the data cut off on 25 Sept 2025. These new findings
bring the Objective Response Rate (ORR) to 33%, a notable improvement over the 23% response rate
previously observed with chemotherapy alone1
. The objective response rate measures only the partial and
complete responses that have been confirmed by an additional scan after 2 months. When all confirmed
and unconfirmed responses are taken together, the response rate is 42%.
The mean duration on trial—a key indicator of the drug combination’s ability to halt cancer progression—
is 219 days, which is substantially longer than the duration typically achieved with chemotherapy alone.
Notably, seven patients have remained on the study for at least 12 months, and two patients have
continued for more than 18 months. These results are consistent with previously reported data2
showing a
median Progression Free Survival (mPFS) of 7.6 months, representing a two-month improvement compared
to chemotherapy alone. There are currently nine (9) patients on study.
1
New England Journal of Medicine 2013, 369, 1691 – 703
2
ASX Announcement 6 August 2025
TOLERABILITY AND SAFETY
Narmafotinib continues to demonstrate good tolerability in the ACCENT trial, with most adverse events
being mild to moderate. Importantly, there has been no apparent increase in the severity of chemotherapy-
related side effects when narmafotinib is included in the treatment regimen.
CEO COMMENTARY
Dr Chris Burns, CEO and Managing Director of Amplia, commented on the latest results: “These latest data
from the ACCENT trial continue to support our belief that narmafotinib enhances the response to
chemotherapy by improving efficacy and durability, whilst being well tolerated in this patient group. Further
trial updates will be provided in the coming months, with overall survival (OS) data planned for release in
Q1 2026.”
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
Investor Contact (US):
Robert Giordano
GGroup Life Sciences
rjgiordano@ggrouplifesciences.com
Media Contact:
Haley Chartres
haley@hck.digital
+61 423 139 163
About Amplia Therapeutics Limited
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 X (@ampliatx) and
LinkedIn.
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. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in
combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced
pancreatic cancer. The trial has already achieved its desired outcome in achieving a response rate of 31%,
superior to chemotherapy alone and an interim PFS of 7.6 months has been reported. A second trial –
AMPLICITY – has recently opened and is being run under an IND at sites in Australia and the US, investigating
the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer
patients.
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 ObjectiveResponse Rate (ORR) and safety and tolerability, with
secondary endpoints including Progression Free Survival (PFS), Overall Survival (OS) and Duration on
Trial (DOT).
The trial is being conducted at seven sites in Australia and five sites in South Korea.
More information about the ACCENT trial canbefound via the ACCENT trial site, the Amplia Therapeutics
website and at ClinicalTrials.gov under the identifier NCT05355298.
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