Positive ACCENT Trial Topline Data Released
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
6 August 2025
POSITIVE ACCENT TRIAL TOPLINE DATA RELEASED
HIGHLIGHTS
•
Progression Free Survival (PFS) of 7.6 months has been determined with current data which
represents a 2-month improvement over chemotherapy alone (benchmark MPACT study)
•
Days on Trial (DOT) of 202 days is a material improvement on chemotherapy alone (117 days)
•
Objective Response Rate (ORR) currently at 31%, is significantly better compared to
chemotherapy alone (23%), with 17 patients still on study
•
Excellent tolerability profile apparent with adverse events being very similar in type and
occurrence to those observed for chemotherapy alone
•
Disease Control Rate (DCR) of 73% is superior to that observed in the MPACT study (50%)
•
Further patient updates from the ACCENT trial expected in 2H 2025 and mature data expected
in Q1 2026
•
Company accelerating towards potential initiation of pivotal phase 2b/3 trial in 2H 2026
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is
pleased to announce important new interim data from the ongoing ACCENT clinical trial in advanced
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 addition to the 31% ORR previously reported, including a confirmed Complete Response and a
pathological Complete Response 1, topline data, available up to 20 July 2025, has now been analysed.
Key findings are as follows:
1
2
•
The adverse event profile of the narmafotinib combination is very similar to adverse events
previously reported for the chemotherapy combination of gemcitabine and Abraxane, in both
type of event, rate of occurrence and severity. Narmafotinib treatment results in negligible
patient burden in the majority of patients.
•
Durability of response is excellent with, at this time, 7 patients having stayed on trial for >12
months. The mean Days on Trial for evaluable patients is 202 days, substantially better than
the 117 days reported for chemotherapy alone in the benchmark MPACT study 2. At data cutoff 17 patients remained on trial.
•
The interim PFS analysis indicates a median PFS of 7.6 months, two months better than
previously reported for chemotherapy alone. Importantly, this is also superior to the PFS
obtained with the more aggressive, but less well tolerated, FOLFIRINOX chemotherapy.
ASX Release 11 July 2025
New England Journal of Medicine 2013, 369, 1691 – 703
Level 5, 90 William Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
ACCENT Trial
MPACT Trial
NAPOLI 3
PRODIGE Trial
7.6 months
5.5 months
5.6 months
6.4 months
(Narmafotinib/Gemcitabine/
Abraxane)
PFS
(Gemcitabine/
Abraxane)
(Gemcitabine/
Abraxane) 3
(FOLFIRINOX) 4
Amplia CEO and MD Dr Chris Burns commented: “The data from the ACCENT trial of narmafotinib
combined with chemotherapy continues to out-perform chemotherapy alone across a variety of
measures. A PFS of 7.6 months at this interim stage of the trial is a significant improvement on existing
chemotherapy regimens. We will provide further updates on the data as the trial matures.”
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 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 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
3
4
The Lancet 2023, 402(10409), 1272-1281
New England Journal of Medicine 2011, 364, 1817-1825
Media Contact:
H^CK Director, 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 Twitter
(@ampliatx) and LinkedIn.
ACCENT TRIAL TOPLINE DATA
August 2025
ampliatx.com | @ampliatx
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EXECUTIVE SUMMARY
Developing a pipeline of small molecule inhibitors of FAK
Lead drug narmafotinib is best-in-class FAK inhibitor in development
Promising efficacy, durability and tolerability in Phase 2a ACCENT clinical trial in
pancreatic cancer
US trial of narmafotinib in pancreatic cancer to start imminently
FAST-track and Orphan Drug Designation granted from US FDA
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3
METASTATIC PANCREATIC CANCER
Limited treatment options; poor patient outcomes
5Y Survival
Limited Treatment Options
Treatment
3%
Gemcitabine +
Abraxane ®
Median Overall
Survival
5.5 months
8.5 months
6.4 months
11.1 months
Tolerability
(MPACT study)
FOLFIRINOX
(Prodige study)
Highly aggressive with multiple genetic
drivers
Median Progression
Free Survival
Most patients receive
gemcitabine + Abraxane
or FOLFIRINOX
or variations of these †
>50% pancreatic cancer patients
diagnosed with advanced (metastatic,
stage 4) disease at the time of diagnosis
Other regimens
20%
5-FU treatments
2.2%
Gem + Abraxane
46.4%
FOLFIRINOX
18.9%
Gemcitabine
12.4%
MPACT Trial - N Engl J Med. 2013, 369, 1691-703; PRODIGE trial - N Engl J Med. 2011, 364, 1817-1825; † - The Oncologist 2022, 27, 469–475
4
THE AMPLIA ADVANTAGE
Three critical features
Efficacy
Narmafotinib
Tolerability
Durability
5
ACCENT TRIAL IN PANCREATIC CANCER
Phase 1b/2a study in Australia and Korea
Intermittent dosing schedule
OBJECTIVE
narmafotinib
To determine safety and efficacy of narmafotinib
when added to standard of care
in newly diagnosed patients
Gemcitabine +
Abraxane
PRIMARY ENDPOINTS
Safety, Tolerability
ORR (RECIST 1.1)*
ADDITIONAL ENDPOINTS
Duration on Trial
Progression free survival (PFS)
Overall Survival (OS)
Disease Control Rate
* ORR - Objective Response Rate; RECIST - Response Evaluation Criteria in Solid Tumours, Eur J Canc. 2009, 45, 228-247.
28 Day cycle
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ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
Progression Free Survival (PFS) data
All ACCENT patients @ 400 mg (n = 64)
Currently determined at 7.6 months substantially better than chemotherapy alone
(5.5 months)
Improvement over FOLFIRINOX chemotherapy
(6.4 months)
PFS
ACCENT Trial
MPACT Trial
PRODIGE Trial
(Narmafotinib/Gemcitabine/Abraxane)
(Gemcitabine/Abraxane)
(FOLFIRINOX)
7.6 months
5.5 months
6.4 months
PFS data calculation included patients from Phase 1b dosed with narmafotinib (400 mg) and all patients in Phase 2a. Interim data based on data cut-off 20 Jul 2025.
7
ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
Includes:
1 confirmed Complete Response (CR)
1 pathological Complete Response (pCR)
Indicating narmafotinib + chemotherapy is
superior to chemotherapy alone
7 patients on study > 1 year
Mean DoT = 201 days
Individual Patients
17 confirmed responses observed to
date
At data cut-off (20 Jul 2025):
17 patients remain on study
Data for 6 patients at 6 months yet to
be collected
Interim data based on data cut-off 20 Jul 2025. Only evaluable patients shown. Responses are investigator read. DoT - Duration on Trial, PR - Partial Response; SD - Stable Disease, PD - Progressive Disease.
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ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
Excellent response rate observed
1 confirmed Complete Response
16 confirmed Partial Responses
Incl. 1 patient determined to be a pathological Complete
Response
Objective response rate (ORR) of 31%
Disease control rate (DCR) of 73%
*
Individual Patients
Interim data based on data cut-off Jul 20, 2025. Responses are investigator read
* Pathological Complete Response
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ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
Excellent response rate observed
1 confirmed Complete Response
16 confirmed Partial Responses
Incl. 1 patient determined to be a pathological Complete
Response
Objective response rate (ORR) of 31%
Disease control rate (DCR) of 73%
*
Individual Patients
Interim data based on data cut-off Jul 20, 2025. Responses are investigator read. NE - Non-evaluable
ACCENT Trial
MPACT Trial
(Narmafotinib/Gemcitabine/Abraxane)
(Gemcitabine/Abraxane)
CR
2%
0.2%
PR
29%
23%
SD
42%
27%
PD
16%
20%
NE
11%
30%
ORR
31%
23%
DCR
73%
50%
DOT
202 days
117 days
* Pathological Complete Response
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ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
Excellent tolerability observed to date
Narmafotinib treatment results in negligible extra patient burden
Adverse Events (Grade 3 or above)
Adverse Event (AE) Grade ≥ 3
Narmafotinib +Gem/Abr
(ACCENT; N=55)
Gem/Abr
(MPACT; N=421)
Gem/Abr
(NAPOLI 3; N=379)
FOLFIRINOX
(PRODIGE; N=171)
NALIRIFOX
(NAPOLI 3; N=370)
Neutropenia
38.2%
38%
39%
46%
24%
Anemia
9.1%
13%
18%
8%
11%
Diarrhea
5.5%
6%
5%
13%
20%
Peripheral neuropathy
3.6%
17%
6%
9%
3%
Vomiting
3.6%
NR
2%
15%
7%
Febrile Neutropenia
5.5%
3%
NR
5%
NR
Thrombocytopenia
NR
13%
NR
9%
NR
Fatigue
NR
17%
5%
24%
6%
Hypokalemia
NR
NR
4%
NR
15%
Nausea
3.6%
NR
3%
NR
12%
ACCENT and MPACT trials have very similar inclusion criteria and trial designs however no head-to-head clinical trial has been conducted. Differences exist between ACCENT and other trials in design, inclusion criteria
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and patient demographics. NR - Not Reached. NAPOLI 3 Trial - The Lancet 2023, 402(10409),1272-1281
ACCENT TRIAL SUMMARY
On track to achieve trial goals
Superior Efficacy
For full 55 patient cohort
1 CR
16 PR (incl. 1 pCR)
Improved PFS over Gemcitabine
+ Abraxane, and FOLFIRINOX
Improved Durability
7 patients on trial for >12
months
Deep and sustained response
for a subset of patients
Biomarker discovery to be
initiated
Demonstrated
Tolerability
Excellent tolerability profile
Minimal additional burden on
the patients above standard of
care
No evidence or likelihood of
drug-drug interactions
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FUTURE OPPORTUNITIES
FAK inhibition will enhance multiple therapeutic strategies
Narmafotinib
(FAK inhibition)
CHEMOTHERAPY
IMMUNOTHERAPIES
Clinical and preclinical data incl.
ACCENT study
Preclinical data
RADIOTHERAPY
KRAS INHIBITORS
Published data
Preclinical data, incl.
collaboration
ANTIBODY DRUG
CONJUGATES
Published data
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AMPLICITY TRIAL in mPDAC
Phase 1b/2a study in the US and Australia
OBJECTIVE
To determine safety and efficacy of narmafotinib
when added to FOLFIRINOX in newly diagnosed
patients
To identify recommended phase 2 dose (RP2D)
Moving from intermittent to daily dosing
narmafotinib
FOLFIRINOX
PRIMARY ENDPOINTS
Safety, Tolerability
RP2D
ADDITIONAL ENDPOINTS
ORR (RECIST v1.1)
Duration of Response
Progression free survival (PFS)
Overall Survival (OS)
Disease Control Rate
14 Day cycle
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NARMAFOTINIB: A POTENT AND
SELECTIVE FAK INHIBITOR
FAK enzyme overactive in pancreatic cancer
Benefits of FAK Inhibition
FAK levels are elevated in pancreatic cancer
Correlate with worse patient outcome
Anti-proliferative
Reduces cells’ ability
to proliferate
and migrate
Synergy with
chemotherapies
Enhances activity of
drugs and other
therapies
FAK inhibition blocks processes that support:
Tumour growth
Metastasis
Treatment resistance
Demonstrated efficacy in preclinical models
of human pancreatic cancer
FAK - Focal Adhesion Kinase
Tumour (blue - cancer cells;
green- fibroblasts; purple, grey
and yellow - suppressive
immune cells)
Anti-fibrotic
Reduces scar-tissue in
TME, improving
permeability to drugs
Immunomodulatory
Improves immune cell
reactivity to tumour cells
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NARMAFOTINIB: A POTENT AND
SELECTIVE FAK INHIBITOR
Best-in-class profile
Convenient to take
Once a day oral dosing by capsule
Storage at room temperature
Safe to combine with other medicines
No evidence of drug-drug interactions
Evidence of FAK target engagement preclinically
and in the clinic
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UPCOMING MILESTONES
Q3 2025
ACCENT top-line data
Q4 2025
Q1 2026
Q2 2026
ACCENT further patient
ACCENT mature data
ACCENT trial completion
updates
(including OS)
possible
ACCENT request FDA type
C meeting - Phase 2b/3
AMPLICITY first trial data
AMPLICITY complete
AMPLICITY further
dose escalation
patient updates
FDA meeting and minutes
ACCENT trial pathway
dosed (part A)
ACCENT further patient
begins
IIT data updates (kRAS and Ovarian)
Initiate kRAS combination
Initiate IIT in ovarian
IIT
cancer
IIT funding outcome(s)
updates
ACCENT full data release
AMPLICITY 2-dose comparison trial
pivotal trial design
AMPLICITY first patient
2H 2026
ACCENT Phase 2b/3 trial planning
finalised
EU regulatory response
Drug product scale-up
Possible EU regulatory
filings
ACCENT Phase 2b/3 trial
protocol finalised
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THANK YOU
Chris Burns PhD GAICD FAHMS
CEO and MD
Rhiannon Jones PhD GAICD
COO
chris@ampliatx.com
rhiannon@ampliatx.com
Amplia Therapeutics Limited
ASX: ATX
info@ampliatx.com
ampliatx.com
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