ACCENT Data Presented at 2026 ASCO GI Cancer Symposium
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
9 JANUARY 2026
ASX RELEASE
ACCENT DATA PRESENTED AT 2026 ASCO GASTROINTESTINAL CANCER SYMPOSIUM
HIGHLIGHTS
• Results from the Phase 2a ACCENT trial in pancreatic cancer have been presented at the specialist
conference ASCO Gastrointestinal Cancer Symposium
• Updated data analysis continues to show that Narmafotinib combination compares favourably with
gemcitabine and Abraxane combination alone.
Melbourne, Australia: Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the
“Company”), is pleased to announce that interim data from the ongoing ACCENT trial in metastatic
pancreatic cancer was showcased in a poster presentation on Friday 9 January (US time) at the
American Society for Clinical Oncology: Gastrointestinal Cancer Symposium (ASCO GI) by Chief
Medical Officer, Dr Jason Lickliter. The ACCENT trial is Amplia’s lead clinical program, assessing the
efficacy of the company’s leading FAK inhibitor, narmafotinib, in combination with standard
chemotherapy, for patients with advanced pancreatic cancer.
The poster shares data that highlight both the effectiveness and safety of narmafotinib, showing
promise for improving treatment results in patients with pancreatic cancer. Key points from the
poster are:
• The updated progression-free survival (PFS) is 7.7 months, compared to 5.5 months for
Gemcitabine and Abraxane alone1
• The overall response rate (ORR) is 35%; this increases to 42% when including unconfirmed
responses
• Narmafotinib continues to be well tolerated by patients with the adverse effect profile of the
narmafotinib – chemotherapy combination similar to chemotherapy alone
A copy of the poster is included with this announcement.
Dr Chris Burns, CEO of Amplia, commented, "We are pleased to present our research findings to
clinicians and scientists at this conference, one of the world’s premier pancreatic cancer meetings.
Presenting at ASCO GI positions Amplia among leading biotechnology and pharmaceutical
companies internationally and underscores the company's exciting progress in the development of
narmafotinib in pancreatic cancer."
1
New England Journal of Medicine 2013, 369, 1691 – 703
The company wishes to thank all investigators, collaborators, and patients involved in these studies.
This ASX announcement was approved and authorised 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:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
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 primary endpoint in achieving a confirmed response
rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone.
An interim median PFS of 7.6 months has also been reported. A second trial – AMPLICITY – has recently
opened and is being run under an IND at sites in Australia and the US, investigating the combination of
narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.
Narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel as first-line treatment for patients with metastatic pancreatic cancer
(ACCENT Trial): Phase 2a results
Nick Pavlakis1, Sumitra Ananda2, Howard Chan3, Marion Harris4, Warren Joubert5, Jin Won Kim6, Choong-kun Lee7, Woo-Jin Lee8, Lara Lipton9, Adnan Nagrial10, Do-Youn Oh11, Joon Oh Park12, Terrie-Anne Cock13, Sarah Kinkel13, Nicole Kruger13, Christopher J. Burns13, Jason Lickliter13.
1GenesisCare, Sydney Australia; 2Epworth Cancer Services Clinical Institute Melbourne, Australia; 3Calvary Mater Hospital, Newcastle, Australia; 4Monash Medical Centre Melbourne, Australia; 5Greenslopes Oncology Brisbane, Australia; 6Seoul National University Hospital, Bundang, Korea; 7Yonsei University Health System, Seoul, Korea; 8National Cancer Center, Seoul, Korea;
9Sunshine Hospital, Melbourne, Australia; 10Westmead Cancer Care Centre, Sydney Australia; 11Seoul National University Hospital, Seoul, Korea; 12Samsung Medical Center, Seoul, Korea; 13Amplia Therapeutics, Melbourne, Australia.
Narmafotinib (AMP945) is a potent, selective and orally bioavailable
inhibitor of focal adhesion kinase (FAK).
FAK is a non-receptor tyrosine kinase that acts through key signaling
pathways to mediate communication between cells and their
environment to regulate normal cellular stress responses1.
Aberrant FAK signaling has been implicated in cancer progression via
its role in tumor growth, migration and chemoresistance, as well as
immunosuppression and tumor fibrosis2-4.
FAK is frequently overexpressed in a variety of cancers, including
pancreatic cancer (PCa)4, a highly fibrotic and aggressive malignancy
with a poor 5-year survival rate5, in which high FAK expression
correlates with poor prognosis6,7.
Narmafotinib
7. Jiang H, et al. Nat Med. 2016;22(8):851-860.
8.Von Hoff DD, et al. N Engl J Med. 2013 Oct 31;369(18):1691-703
9.Wainberg , et al. Lancet. 2023 Oct 7;402(10409):1272-1281.
1.Lim ST, et al. Mol Cell. 2008 Jan 18;29(1):9-22.
2. Sulzmaier FJ, et al. Nat Rev Cancer. 2014 Sep;14(9):598-610.
3. Dawson JC, et al. Nat Rev Cancer. 2021 May;21(5):313-324.
4. Zhang Z, et al. Front Cell Dev Biol. 2022 Nov 2;10:1040311.
5. Siegel RL, et al. Cancer statistics, 2023. CA Cancer J Clin 2023; 73, 17-48.
6. Zaghdoudi S, et al. EMBO Mol Med. 2020;12(11):e12010.
ACCENT Trial Phase 2a results
Narmafotinib combined with Gem/NabP was associated with
manageable toxicity and the P2a study met its primary efficacy
endpoint.
Amplia has initiated (Q2 2025) a Phase 1b/2a study to investigate
narmafotinib in combination with modified FOLFIRINOX in
pancreatic cancer patients (AMP945-PC-202)
Jason Lickliter, Amplia Therapeutics
Email: jason@ampliatx.com
Website: www.ampliatx.com
Narmafotinib is safe and well tolerated in
combination with Gem/NabP
ACCENT Study Overview
Progression Free Survival (PFS)
• PFS determined using all ACCENT patients on
400mg narmafotinib (Part A and Part B)
• Median PFS 7.7 months
• Compares favourably with Gem/NabP alone (5.5
months)8 and FOLFIRINOX (6.4 months)9
All ACCENT patients @
400mg (n = 64)
PIVOTAL STUDY
Narmafotinib
+Gem/NabP
(ACCENT N=55)
Gem/
NabP
(8MPACT; N=421)
Gem/
NabP
(9NAPOLI 3; N=379)
Adverse Event (AE)
Grade ≥ 3
Neutropenia 38.2% 38% 39%
Anemia 9.1% 13% 18%
Diarrhea 5.5% 6% 5%
Peripheral neuropathy 3.6% 17% 6%
Vomiting 3.6% NR 2%
Febrile Neutropenia 5.5% 3% NR
Thrombocytopenia NR 13% NR
Fatigue NR 17% 5%
Hypokalemia NR NR 4%
Nausea 3.6% NR 3%
NR: not reported
Narmafotinib-related AEs in ≥ 5%
of patients, n (%)
Severity of Treatment-
Related AEs
Any grade
n (%)
Grade ≥ 3
n (%)
Nausea 16 (29.1) 2 (3.6)
Diarrhea 9 (16.4) 2 (3.6)
Vomiting 8 (14.5) 1 (1.8)
Fatigue 6 (10.9) 0
Gastroesophageal reflux
disease
4 (7.3) 0
Constipation 3 (5.5) 0
ACCENT trial (NCT05355298):
Phase 1b/2a, open label study of the pharmacokinetics, safety and
efficacy of narmafotinib in combination with gemcitabine and nab-
paclitaxel as first-line therapy in patients with metastatic pancreatic
cancer.
Part A (Phase 1b): Narmafotinib dose escalation (100, 200 and 400
mg) was completed, and the recommended phase 2 dose (400mg)
was identified.
Part B (Phase 2a): Gem (1000 mg/m2) and NabP (125 mg/m2) were
given on days 1, 8 and 15 of a conventional 28-day cycle. Patients
also received narmafotinib (400 mg, p.o. mane) priming on days -8 to
-2 of cycle 1 and then combined as 4-day pulses beginning on days 3,
10 and 24 of each 28-day chemotherapy cycle.
The primary endpoint was investigator assessed objective response
rate (ORR) by RECIST v1.1. Key secondary endpoints included
adverse events (AEs, using NCI CTCAEv5.0), progression free survival
(PFS) and overall survival (OS).
The preliminary results presented here include safety (cut-off 20th July 2025) and efficacy data (cut-off
25th Sept 2025).
Only 2 patients
(3.6%) had
narmafotinib
withdrawn due to
a related AE.
Toxicity was
overall similar to
that reported for
chemotherapy
alone.
Tumor imaging assessments
were conducted every 2
months and evaluated using
RECIST 1.1.
All patients planned for the
ACCENT Phase 2a study were
recruited between 16th Jan
2024 and 17th Feb 2025 in
Australia and South Korea.
Demographics
Patient # (total study) 55
Geographic area (%)
Australia (44%) /
Korea (56%)
Female (%) 49%
Age median (min-max) 64 (37 - 87)
ECOG PS 0 17 (31%)
ECOG PS 1 38 (69%)
Ethnic background
Caucasian 21 (38%)
Asian 33 (60%)
Australian Aborigine /
Torres Strait Islander
1 (2%)
Arrow indicates patients still on trial. pCR indicates pathological complete response. Only patients with a valid post-
baseline RECIST assessment scan are shown.
Partial response (PR) ≤-30%
Unconfirmed partial response indicated by light blue
PD SD PR CR pCR
Partial response (PR) ≤-30%
Progressive disease (PD) ≥20%
Encouraging antitumor activity
with rapid and sustained tumor reduction
19 confirmed responses observed to date: including,
1 confirmed complete response and 1 pathological
complete response
7 patients on study > 1 year: range: 21 – 548 days,
with 9 patients still on trial
ACCENT Trial*
(n) %
8MPACT Trial
CR (1) 2% 0.2%
PR (18) 33% 23%
SD (23) 42% 27%
PD (7) 13% 20%
NE (6) 11% 30%
ORR (CR+PR)† (19) 35% 23%
DCR (CR+PR+SD) (42) 76% 50%
*Numbers calculated on the ITT population of n=55
† Unconfirmed ORR: (23) 42%
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