Pathological Complete Response in Pancreatic Cancer Trial
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
16 June 2025
PATHOLOGICAL COMPLETE RESPONSE RECORDED IN PATIENT FROM ACCENT CANCER
TRIAL
HIGHLIGHTS
•
A confirmed pathological complete response has been recorded in the ACCENT trial
•
A pathological complete response (pCR) is extremely rare in patients undergoing treatment for
advanced pancreatic cancer
•
A pCR means that there are no signs of cancer in tissue examined by a pathologist following
surgical removal
•
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 important new data from our 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® in patients with metastatic pancreatic
cancer. A patient from the trial has now recorded a pathological complete response (pCR), an
extremely rare observation in this patient population.
During routine assessment of tumour burden for the patient in question, it was noted that there had
been a significant reduction in the size and number of hepatic metastases (secondary tumours in the
liver) and in the primary tumour in the pancreas. The medical team decided that this enabled them to
change the treatment plan for this patient, and surgery was performed to remove both the secondary
tumours in the liver and the primary tumour in the pancreas. The surgically removed lesions were
subjected to pathological examination and were determined to contain no live tumour tissue. This
outcome is classified as a pCR.
A pCR is very rarely reported in patients with advanced pancreatic cancer, where the disease has
spread to other organs in the body. In patients with locally advanced (i.e. non-metastatic) pancreatic
cancer, however, around 5% of patients do record a pCR in response to treatment with neoadjuvant
chemotherapy (chemotherapy before surgery). 1 In these earlier stage patients, a pCR is associated
with improvements in overall survival.
Amplia CEO and MD Dr Chris Burns commented: “We are extremely excited to learn that a patient
from our study has achieved a pathological complete response. This is wonderful news for the patient
and the clinical team involved. We firmly believe this outcome further demonstrates the promising
activity narmafotinib, on top of standard-of-care, is showing in the treatment of advanced pancreatic
cancer.”
1
JAMA Netw Open 2024;7;(6):e2417625.
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
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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