Encouraging Updated Data from Pancreatic Cancer Trial
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
27 March 2025
ENCOURAGING UPDATED DATA FROM PANCREATIC CANCER TRIAL
HIGHLIGHTS
•
Encouraging updated data from the ongoing ACCENT trial, evaluating narmafotinib with
chemotherapy for advanced pancreatic cancer
•
13 Confirmed partial responses have been observed to date
•
Narmafotinib in combination with chemotherapy demonstrates good tolerability, with adverse
event profiles similar to chemotherapy alone
•
Additional ACCENT trial data has been accepted for presentation at the American Association
of Cancer Research Annual Meeting in April
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is
pleased to report updated data from the Company’s ongoing Phase 2a clinical trial. The ACCENT trial
is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standardof-care chemotherapy in the treatment of advanced pancreatic cancer. This latest data analysis
includes all reported data up to 12 March 2025 and builds on the previous interim data release 1 which
covered data up to 6 December 2024.
Recruitment for the Phase 2a trial began in January 2024 and was completed ahead of schedule in
January this year. A total of 55 advanced pancreatic patients have enrolled in the study at the trial sites
in Australia and Korea. The trial is fully enrolled and as of 12 March 2025, 29 patients remain on study.
The primary endpoint for the study is the objective response rate where data for the narmafotinib +
chemotherapy combination is compared against historical data for chemotherapy treatment alone. At
this time, 13 confirmed partial responses (PRs) have been observed (defined as a >30% reduction in
tumour size sustained over two months with no new lesions apparent), noting that tumour shrinkage
assessments for the majority of patients enrolled since December are yet to be undertaken. An
outcome of 15 PR’s or more, by the end of the study, would indicate the narmafotinib combination
performs better than chemotherapy alone. The drug continues to be well tolerated by patients with
the rate and type of adverse events for the narmafotinib combination being very similar to that
reported for chemotherapy alone.
Further data from the ACCENT trial has been accepted for presentation at the annual meeting of
American Association of Cancer Research to be held next month in Chicago. The poster, Narmafotinib
(AMP945) in combination with gemcitabine and nab-paclitaxel in first-line patients with advanced
pancreatic cancer (ACCENT trial) a Phase 1b 2a study: Interim analysis Part B, will be presented on
Monday 28 April at 2pm (US CDT), and will be released to the market on that date.
Amplia CEO and MD Dr Chris Burns commented: “Data from the ACCENT trial continues to be
extremely positive, with promising efficacy and good tolerability observed to date, and with tumour
responses still being measured for the patients remaining on study. Our scheduled presentation of
additional data at AACR, one of the world’s premier cancer meetings, allows us to engage with
1
ASX Release 11 December 2024
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
clinicians and scientists about the considerable potential narmafotinib is demonstrating in the
treatment of 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
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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