ASCO Conference Abstract
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
24 May 2024
ASCO CONFERENCE ABSTRACT
HIGHLIGHTS
•
Data from our Phase 1b ACCENT trial in pancreatic cancer included in online abstracts for the
American Society of Clinical Oncology annual meeting
•
The data summary further highlights the tolerability for narmafotinib observed in advanced
pancreatic patients and the preliminary signs of activity observed
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”) is
pleased to announce that data from the ACCENT trial of narmafotinib in advanced pancreatic cancer
patients has been accepted and published in the online abstracts for the annual meeting of the
American Society of Clinical Oncology (ASCO). The ASCO meeting, to be held in Chicago from May 31
– June 4, is the largest and most significant oncology conference held annually and is attended by
practising oncologists and related healthcare providers, pharma and biotech representatives,
academics, and patient advocacy groups.
The ACCENT trial is the Company’s lead clinical program, exploring the activity of our best-in-class FAK
inhibitor narmafotinib, in combination with standard-of-care chemotherapy, in advanced pancreatic
cancer patients. The Phase 1b stage of the trial was completed in October 2023 and the Phase 2a stage
of the trial in currently underway. Clinical data from the Phase 1b portion of the Accent Trial was
reported by the Company it its announcement dated 30 October 2023 1. Fourteen patients were
enrolled in the Phase 1b trial and we recently reported that 19 patients have already been enrolled in
the Phase 2a portion of the trial.
The abstract (available here) outlines the design of the trial and includes key data obtained to date
from the fourteen patients in the Phase 1b stage of the trial. In particular we note that 9 of 14 patients
stayed on trial for more than 5 months; 6 of 14 patients recorded a partial response as best response;
and a dose of 400 mg was identified as the dose for the Phase 2a stage of the trial. Narmafotinib has
been shown to be generally safe and well tolerated, with fatigue (Grade 3 or below) in more than one
participant identified as the main adverse event related to narmafotinib.
Amplia’s CEO Dr Chris Burns commented: “To have clinical data from our ACCENT trial accepted and
published in the ASCO meeting abstracts helps raise the profile of narmafotinib, and the clinical data
obtained to date, to the broader oncology community. This improves visibility of the program to
potential commercial partners, as well as to oncologists working in pancreatic cancer.”
About the ACCENT Trial
The protocol for 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’.
ASX Announcement, 30 October 2023 - Amplia Reports Promising Clinical Data from Phase 1B Portion of the
Accent Trial in Pancreatic Cancer
1
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b)
determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability,
pharmacokinetics, pharmacodynamics and preliminary efficacy of narmafotinib when dosed in
combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.
This second stage (Phase 2a), of the trial currently underway will assess efficacy of narmafotinib in
combination with gemcitabine and Abraxane, along with continued assessment of safety and
tolerability. 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).
More information about the ACCENT trial, including a list of participating sites, can be found via the
Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.
The Company will provide further updates on the trial as recruitment proceeds.
This ASX announcement was approved and authorised for release by the Board.
- End -
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
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
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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