Positive Data Strong Recruitment in Pancreatic Cancer Trial
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
11 December 2024
POSITIVE NEW DATA AND STRONG RECRUITMENT IN PANCREATIC CANCER TRIAL
HIGHLIGHTS
•
Data analysis up to 6 December 2024 from the ongoing ACCENT trial of narmafotinib in
combination with chemotherapy has been undertaken
•
Nine (9) patients have now recorded a confirmed Partial Response
•
A substantial improvement in patient time on trial, compared to historical data for standardof-care alone, is apparent
•
Recruitment for the final cohort of 24 patients is ahead of schedule
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is
pleased to report updated data from Company’s ongoing Phase 2a clinical trial. This trial is investigating
the Company’s FAK inhibitor narmafotinib in combination with standard-of-care chemotherapy of
gemcitabine and Abraxane® in the treatment of advanced pancreatic cancer (the ACCENT trial). This
latest data analysis was conducted up to 6 December 2024 and expands on the previous interim data
release 1 which covered data up to 27 September 2024.
Nine (9) confirmed partial responses (PRs) have now been recorded from the initial 26 patient cohort
of the Phase 2a trial. This represents an objective response rate of ~35%, significantly better than the
23% reported for the historical trial 2 being used as the benchmark for this study. A confirmed PR is
recorded when there is at least a 30% decrease in the overall size of tumour lesions sustained for two
or more months, with no new tumour lesions apparent.
Importantly, the median duration on trial for the 26 patients is currently 172 days which is a 47%
improvement over the historical data of 117 days. The duration on trial is a measure of how effective
the treatment is in inhibiting disease progression, as patients with progressive disease must leave the
trial. Currently 11 patients from the initial 26 enrolled remain on trial.
Narmafotinib continues to be generally well tolerated by patients and no patients have withdrawn
from study due to issues from narmafotinib.
The Company is now recruiting the second cohort of patients for the Phase 2a study to bring the total
number of evaluable patients for the trial to 50. At this time 12 new patients have enrolled on the trial
since reopening recruitment in October.
Amplia CEO and MD Dr Chris Burns commented: “Adding narmafotinib to the standard-of-care
treatment continues to show promise in comparison to the historical data for standard-of-care alone.
We’ve recruited over 75% of the trial at this time, and with ongoing positive support from clinicians
involved in the study, we are well on track to fully recruit the trial by end of Q1 2025. In addition, we
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ASX Release 30 October 2024
New Engl. J. Med. 2013, vol 369, 1691-1703.
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
have been reassured by our clinical team in Korea that the recent political situation in the country is
not impacting the trial sites located there in terms of recruitment and ongoing support of patients."
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 and other cancers, 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. The drug has successfully completed a healthy volunteer
study, and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of
narmafotinib and the chemotherapies gemcitabine and Abraxane® is being assessed for safety,
tolerability and efficacy.
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 ACCENT trial explores the use of narmafotinib in combination with standard-of-care
chemotherapy of gemcitabine and Abraxane® in first-line patients with advanced pancreatic cancer.
The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed
in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding
regular chemotherapy infusion, as safe and well tolerated.
This second stage (Phase 2a), of the trial is designed to assess drug 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.
More information about the ACCENT trial, including a list of participating sites can be found via the
ACCENT website, the Amplia Therapeutics website, and at ClinicalTrials.gov under the identifier
NCT05355298.
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), Threads (@ampliatx) and LinkedIn.
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