ACCENT Trial Mature Data Presented at AACR Conference
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
22 April 2026
ASX RELEASE
ACCENT TRIAL MATURE DATA PRESENTED AT INTERNATIONAL CONFERENCE
HIGHLIGHTS
• Mature data from Amplia’s ACCENT trial in pancreatic cancer is being presented at the prestigious
American Association of Cancer Research (AACR) annual meeting
• The ACCENT trial investigates the combination of narmafotinib with standard-of-care chemotherapy
• The data presented includes additional analysis of the promising efficacy and survival data reported last
month
MELBOURNE, AUSTRALIA: Amplia Therapeutics limited (ASX:ATX | OTCQB:INNMF), (“Amplia” or the
“Company”) announces that an oral presentation highlighting mature data from the Company’s ACCENT
trial in metastatic pancreatic cancer is being delivered today at the annual meeting of the AACR. The
presentation includes more detailed analysis of the recently reported data from the ACCENT study, which
is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-
care chemotherapy.
The presentation is included as part of a mini-symposium entitled Advances in Precision Oncology being held
in the San Diego Convention Center, San Diego USA, and will be delivered by Amplia’s Director of
Translational Biology, Dr Terrie-Anne Cock, at 3:44 pm local time. A copy of the slides is included with this
announcement.
The key points from the presentation are:
• Narmafotinib displays a manageable toxicity profile, with no significant tolerability burden over
chemotherapy alone
• Independent (central) reading of data identified 5 confirmed Complete Responses (CR’s) from 64
patients, an 8% CR rate compared to a 0.2% rate for chemotherapy alone
• A response rate of 36% is observed (23 of 64 patients); 42% if unconfirmed responses included
• A Disease Control Rate (DCR) of 70% was determined, compared to 50% for chemotherapy alone
• Median overall survival (mOS) was found to be 11.1 months, while median progression-free
survival (mPFS) was 7.7 months, both showing improvements of over two months compared to
chemotherapy alone
• A trend to improved Overall Survival is observed when comparing Stable Disease, Partial
Response and Complete Response patients
• The combined efficacy data is superior to chemotherapy alone across all measures despite the
intermittent narmafotinib dosing schedule employed (12 days of each 28 day treatment cycle)
• Subsequent trials will employ a daily dosing regimen of narmafotinib given the tolerability
observed to date, which may lead to improved responses
Dr Chris Burns, CEO and Managing Director of Amplia, commented: “We are excited to present this mature
ACCENT data at the AACR annual meeting. Being able to present the extremely promising clinical responses
to colleagues and peers at one of the world’s most prestigious oncology conferences allows us to
demonstrate the potential narmafotinib has in the treatment of this terrible disease. We are now focused
on building on this promising data with additional clinical studies, including a pivotal study based on the
ACCENT trial, as well as combination studies with the exciting new class of drugs called kRAS inhibitors.”
This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
U.S. Contact:
Robert Giordano
rjgiordano@ggrouplifesciences.com
+1 917 327 3938
Media Contact:
Tom Trezona, H^CK Acting MD
tom@hck.digital
+61 411 235 692
U.S. Media:
media@ampliatx.com
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 tumors. 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 two sites in Australia, 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, Multicenter, 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) and Overall Survival (OS).
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.
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
Terrie-Anne Cock PhD
Amplia Therapeutics
Australia
ASX:ATX | OTCQB:INNMF
FOCAL ADHESION KINASE INHIBITION IN CANCER
FAK enzyme overactive in pancreatic cancer
Modified from Journal for
ImmunoTherapy of Cancer (2017) 5:17
FAK levels are elevated in pancreatic cancer
• Correlate with worse patient outcomes
FAK is a cellular stress-buffer that sustains
tumor survival especially under therapeutic
stress
FAK overactivity in both cancer cells and
fibroblasts
• Causes fibrosis and immune suppression
• Tumor growth
• Metastasis
• Treatment resistance
2
NARMAFOTINIB
A Potent and Selective FAK Inhibitor
Drug-like small molecule
• Highly potent and highly selective FAKi
• Pharmacokinetic (PK) profile supports oral once-a-
day dosing (t½ ~20 h)
• Dose-proportional PK
• Patient population not limited by genetics
Safe to combine with other medicines
• Low risk of significant drug-drug interactions (CYPs:
IC50 > 20 μM)
• Ability to combine with a broad range of standard of
care therapies
Evidence of FAK target engagement preclinically and
in the clinic
3
ACCENT TRIAL IN PANCREATIC CANCER
Phase 1b/2a study in Australia and Korea
* ORR - Objective Response Rate; RECIST - Response Evaluation Criteria in Solid Tumours, Eur J
Canc. 2009, 45, 228-247.
OBJECTIVE
• To determine safety and efficacy of narmafotinib in combination with gemcitabine and nab-
paclitaxel (Gem/nab-P)
• Patients with newly diagnosed metastatic disease
PRIMARY ENDPOINTS
• Safety, Tolerability
• ORR (RECIST 1.1)*
ADDITIONAL ENDPOINTS
• Progression free survival (PFS)
• Overall Survival (OS)
• Disease Control Rate (DCR)
4
ACCENT TRIAL IN PANCREATIC CANCER
Phase 1b/2a study in Australia and Korea
7 days priming prior to
Gem/nab-P on Cycle 1 Day 1
4 days of dosing prior to
each Gem/nab-P thereafter
12 days out of 28-day cycle
43% coverage after cycle 1
5
ACCENT TRIAL IN PANCREATIC CANCER
Phase 1b/2a study in Australia and Korea
Part A: Dose escalation to selectdose for
Part B
• 3 patients at 100 mg
• 3 patients at 200 mg
• 9 patients at 400 mg
Part B: Single arm, non-blinded Simon
2-Stage design
• 55 patients at 400 mg
Total of 64 patients at 400 mg
Demographics
All 400 mg patients
Patient # (total study) 64
Geographic area (%)
Australia (52%) /
Korea (48%)
Female (%) 32 (50%)
Age median (min-max) 63y (37 – 87)
ECOG PS 0 21 (33%)
ECOG PS 1 43 (67%)
Ethnic background
Caucasian 28 (44%)
Asian 34 (53%)
Australian Aborigine /
Torres Strait Islander
1 (1.6%)
Unknown 1 (1.6%)
6
Abstract data
• Investigator read
• Requested in real time to assess
patient progress
• RECIST 1.1 analysis standard in
clinical trials NOT standard in
clinical practice
ACCENT TRIAL IN PANCREATIC CANCER
RECIST 1.1 analysis ACCENT
Data presented today
• Independent review
(central read) performed by
specialist global contract
organization
• Two independent experts
• Blinded to investigator
assessment and blinded to
patient clinical data
7
ACCENT TRIAL IN PANCREATIC CANCER
Narmafotinib treatment results in negligible extra patient burden
PIVOTAL STUDY
Adverse Event (AE)
Grade ≥ 3
Narmafotinib
+Gem/nab-P
(ACCENT N=64)
Gem/nab-P
(MPACT; N=421)
Gem/nab-P
(NAPOLI 3;
N=379)
Neutropenia 39% 38% 39%
Anemia 17.2% 13% 18%
Diarrhea 6.3% 6% 5%
Peripheral neuropathy 6.3% 17% 6%
Vomiting 3.1% NR 2%
Febrile Neutropenia 4.7% 3% NR
Thrombocytopenia 3.1% 13% NR
Fatigue NR 17% 5%
Hypokalemia NR NR 4%
Nausea 4.7% NR 3%
NR: not reached; Common generally refers to TRAEs in ≥ 5% of patients (%); For ACCENT: Peripheral Neuropathy includes events of both Peripheral Sensory
Neuropathy and Neuropathy Sensory; Neutropenia includes events of both Neutropenia and Neutrophil Count Decreased; Thrombocytopenia includes events of both
Thrombocytopenia and Platelet Count Decreased; Not all pivotal trials reported on all AE’s or used fully consistent terminology; Differences exist between trial designs,
subject characteristics and other factors, and caution should be exercised when comparing data across studies: MPACT Von Hoff et al., N Engl J Med. 2013 and
NAPOLI Wainberg et al., Lancet 2023. Interim data based on safety data cut-off 20 Jan 2026.
8
ACCENT TRIAL IN PANCREATIC CANCER
Narmafotinib treatment results in negligible extra patient burden
Abbreviations; N = number of participants.
Interim data based on safety data cut-off 20 Jan 2026
Narmafotinib-related TEAEs in were mostly gastrointestinal events
predominately mild to moderate
Narmafotinib Related Adverse Events
Any grade ( ≥ 5%)
Narmafotinib 400 mg
(N=64) N (%)
Nausea 19 (29.7)
Vomiting 13 (20.3)
Diarrhea 12 (18.8)
Gastroesophageal reflux disease 7 (10.9)
Fatigue 7 (10.9)
9
ACCENT TRIAL IN PANCREATIC CANCER
Exceptional complete response rate
ACCENT Trial
(Narmafotinib/
Gem/nab-P) (N=64)
MPACT Trial
(Gem/nab-P)
CR 5 (8%) 0.2%
PR 18 (28%) 23%
SD 22 (34%) 27%
PD 6 (9%) 20%
NE 13 (20%) 30%
ORR 36% 23%
DCR 70% 50%
Excellent response rate observed
• 5 confirmed Complete Responses (CR)
• 18 confirmed Partial Responses (PR);
Incl. 1 patient with pathological
Complete Response (pCR)
• Confirmed objective response rate
(ORR) of 36%. Unconfirmed objective
response rate 42%
• Disease control rate (DCR) of 70%
• 12 patients on trial >12 months*
• 4 patients are still on study
Interim data based on central read data cut-off 17 March 2026. All responses were confirmed, and efficacy was assessed
using an intention-to-treat analysis in accordance with RECIST criteria. NE - Non-evaluable. N = number of participants.
* Patients continued on trial based on investigator read RECIST results
10
ACCENT TRIAL IN PANCREATIC CANCER
Enhanced depth of response
-100
-90
-80
-70
-60
-50
-40
-30
-20
-10
0
10
20
30
Best
change
from
baseline
(%)
(target
lesions)
Progressive Disease
Stable Disease
Complete Response
Partial Response
Pathological Complete Response
Individual patients
Interim data based on central read data cut-off 17 March 2026. All responses were confirmed, and efficacy was assessed
using an intention-to-treat analysis in accordance with RECIST criteria. Non-evaluable not shown
Average tumor volume reduction of ~69% (PR and CR)
Patient still on study
11
ACCENT TRIAL IN PANCREATIC CANCER
Early and sustained deep tumor shrinkage
0 60 120 180 240 300 360 420 480 540 600
-100
-80
-60
-40
-20
0
20
40
60
Time to scan (from day -8)
Target
lesion:
change
from
baseline
(%)
Interim data based on central read data cut-off 17 March 2026. All responses were confirmed, and efficacy was assessed
using an intention-to-treat analysis in accordance with RECIST criteria. Non-evaluable not shown
Key for overall response
Black = PD
Grey = SD
Blue = PR
Orange = pCR
Purple = CR
Open circles = patient still on study
12
Median Progression Free Survival (mPFS)
• Currently determined at 7.7 months -
substantially better than Gem/nab-P
chemotherapy alone (5.5 months)
• Improvement over FOLFIRINOX chemotherapy
(6.4 months)
ACCENT TRIAL IN PANCREATIC CANCER
Improved PFS over chemotherapy alone
ACCENT Trial
(Narmafotinib
+ Gem/nab-P)
MPACT Trial
(Gem/nab-P)
PRODIGE Trial
(FOLFIRINOX)
mPFS 7.7 months 5.5 months 6.4 months
Interim data based on central read data cut-off 17 March 2026
0 2 4 6 8 10 12 14 16 18 20 22 24
0
10
20
30
40
50
60
70
80
90
100
Months
Progression
free
survival
(%)
13
Median Overall Survival (mOS) data
• Currently determined at 11.1 months -
substantially better than Gem/nab-P
chemotherapy alone (8.5-9.2 months)
• Comparable to FOLFIRINOX chemotherapy
(11.1 months)
ACCENT TRIAL IN PANCREATIC CANCER
Improved overall survival – sustained response
Interim data based on central read data cut-off 17 March 2026
0 2 4 6 8 10 12 14 16 18 20 22 24
0
10
20
30
40
50
60
70
80
90
100
Months
Overall
survival
(%)
ACCENT Trial
(Narmafotinib +
Gem/nab-P)
MPACT Trial
(Gem/nab-P)
NAPOLI Trial
(Gem/nab-P)
mOS 11.1 months 8.5 months 9.2 months
14
Median Overall Survival (mOS) data
• Currently determined at 11.1 months -
substantially better than Gem/nab-P
chemotherapy alone (8.5-9.2 months)
• Comparable to FOLFIRINOX chemotherapy
(11.1 months)
ACCENT TRIAL IN PANCREATIC CANCER
Improved overall survival – sustained response
Interim data based on central read data cut-off 17 March 2026
0 6 12 18 24
CR
PR
SD
PD
Overall survival (months)
White circles indicate patients known
to be alive at recent follow up
ACCENT Trial
(Narmafotinib +
Gem/nab-P)
MPACT Trial
(Gem/nab-P)
NAPOLI Trial
(Gem/nab-P)
mOS 11.1 months 8.5 months 9.2 months
15
ACCENT TRIAL IN PANCREATIC CANCER
Summary
Deep and fast
response
Durable and sustained
response
Demonstrated
tolerability
64 patients 400 mg
• 5 CR
• 18 PR (incl. 1 pCR)
Improved PFS (7.7 mo)
over Gem/nab-P and
FOLFIRINOX
12 patients on trial
>12 months
Improved OS (11.1 mo) over
Gem/nab-P
Deep and sustained
response for many patients
Good tolerability profile
Minimal additional burden
on patients above standard
of care
In ACCENT, narmafotinib is dosed intermittently,
subsequent studies including pivotal trials will utilise
daily dosing, which may further enhance efficacy
16
Co-authors: S. Ananda, C. Lee, N. Pavlakis, J. Park, J. Kim, D.
Lau, L. Lipton, A. Nagrial, W. Lee, H. Chan, D. Oh, W. Joubert, S.
Kinkel, N. Kruger, C. Mulder, J. Lickliter, C. Burns
We thank all investigators and site staff involved in the
ACCENT trial
We gratefully acknowledge the patients, their families and
loved ones, whose participation in clinical research makes
these advances possible
ACKNOWLEDGMENTS
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