Amplia Reports Improved Responses & Survival in ACCENT trial
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
23 MARCH 2026
ASX RELEASE
AMPLIA THERAPEUTICS REPORTS FOUR ADDITIONAL COMPLETE RESPONSES AND IMPROVED
OVERALL SURVIVAL DATA IN ACCENT PANCREATIC CANCER TRIAL
HIGHLIGHTS
• Formal centralised and independent analysis of the clinical response data from the ACCENT trial
has been undertaken and updated analysis provided to the Company
• The data confirm that five (5) patients have achieved a complete response (CR) in the Phase 1b/2a
trial of narmafotinib combined with chemotherapy resulting in an unprecedented rate of CRs of
7.8% (5/64)
• A median Overall Survival of 11.1 months has also been determined which is a 2 month
improvement compared to chemotherapy alone, with no additional toxicity burden
• The Company has been chosen to present trial data at the prestigious annual meeting of the
American Association of Cancer Research (AACR) being held in April 2026 in San Diego, CA, USA
Melbourne, Australia: Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the
“Company”), announces mature data from the ongoing ACCENT clinical trial in advanced pancreatic
cancer in which theCompany’s lead drugnarmafotinib is combined with chemotherapy showing amedian
overall survival of 11.1 months, and five complete responses recorded to date.
Expert central reading of the clinical data by a contracted independent laboratory has reclassified some
of the response data, identifying an additional four (4) confirmed complete responses (CRs). This brings
the total CR’s for all patients in the ACCENT trial receiving a 400 mg dose of narmafotinib to five (5),
resulting in a CR rate of 7.8% (5/64) which is unprecedented in this indication. Notably, this does not
include the pathological complete response (pCR) recorded in the ACCENT trial, announced in June 2025.
A confirmed CR means that CT scans have confirmed the disappearance of measurable tumours and
metastases for two months or more, without the appearance of new lesions.
An additional confirmed partial response (PR) has also been identified, resulting in an updated Objective
Response Rate (ORR) of 35.9% (23/64) for all patients in both stages of the 1b/2a ACCENT trial on a 400
mg dose of narmafotinib. As of 15 March 2026, four (4) patients remain on study, with one patient
approaching 24 months on trial.
Up until the independent analysis, all clinical response data reported to the market has been based on
analysis by the clinical investigator at each trial site.The Company has alwaysplanned for an independent
data analysis to occur toward the conclusion of the trial, and with the anticipated completion in Q3 2026
this analysis was recently initiated. The expert and independent ‘central read’ laboratory has used the
standardized and internationally recognized RECIST 1.1 criteria for measuring how a patient’s cancer
responds to treatment.
Importantly,analysis of overall survival data (with a data cut-off of mid-March), indicates a median Overall
Survival (mOS) of 11.1 months. This is an approximate two-month improvement when compared to
clinical studies of the gemcitabine-Abraxane® chemotherapy alone, including the MPACT study1
, which
established this standard-of-care for advanced pancreatic cancer and against which ACCENT is
benchmarked.
Combined, these data compare very favourably to published data for the gemcitabine-Abraxane
chemotherapy alone from both the historical MPACT trial1
and the recent NAPOLI 3 trial2
(see table).
Particularly noteworthy is that the mOS data from the ACCENT trial is identical to that obtained for the
combination chemotherapy regimen NALIRIFOX in NAPOLI 3, and which resulted in its subsequent
approval by the US FDA.
ACCENT Trial (P1b/2a)
(Narmafotinib +
Gemcitabine/Abraxane)
(n = 64)
MPACT Trial
(Gemcitabine/
Abraxane)
(n = 431)1
NAPOLI 3
(Gemcitabine/
Abraxane)
(n = 387)2
Complete Response
(CR)
7.8% 0.2% 0.3%
Objective Response
Rate (ORR)
35.9% 23% 36.2%
Median Overall
Survival (mOS)
11.1 8.5 9.2
Narmafotinib continues to be well tolerated by patients with the adverse effect profile of the narmafotinib-
chemotherapy combination similar to chemotherapy alone.
The Company has been selected to present its trial data, along with additional ACCENT data derived from
further analysis of the independently read data, at the annual meeting of the American Association of
Cancer Research (AACR) meeting to be held April 17-22 in San Diego, California.
Dr Chris Burns, CEO and Managing Director of Amplia, commented on the latest results: “These latest
data from the ACCENT trial clearly demonstrate the significant clinical benefit of narmafotinib. The
unprecedented 7.8% rate of CR's in the first line setting provides new hope for patients with this very
aggressive cancer and provides further strong support for the benefit that narmafotinib can bring when
combined with other treatment modalities. We look forward to presenting a detailed analysis of the
ACCENT trial at the forthcoming AACR conference.”
WEBINAR
A webinar discussing these results will be held on Tuesday 24 March 2026, 9:30am AEDT (Monday 23
March, 6:30pm EST). The webinar can be accessed by this link: https://ampliatx.com/webinars/pegkve-
amplia-therapeutics-shareholder-webinar .
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
Media Contact:
Tom Trezona, H^CK Acting MD
tom@hck.digital
+61 411 235 692
1
New England Journal of Medicine 2011, 364, 1817-1825
2
The Lancet 2023, 402(10409), 1272-1281
U.S. Contact:
Robert Giordano
rjgiordano@ggrouplifesciences.com
+1 917 327 3938
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 tumours.
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 sites in Australia and the
US, 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, 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 ObjectiveResponse 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 canbefound via the ACCENT trial site, the Amplia Therapeutics
website and at ClinicalTrials.gov under the identifier NCT05355298.
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