Interim Data From Accent Pancreatic Cancer Trial
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
30 October 2024
INTERIM DATA FROM ACCENT PANCREATIC CANCER TRIAL SUPPORTS CONTINUATION OF TRIAL
HIGHLIGHTS
•
Data analysis up to 27 September 2024 from the ongoing ACCENT trial of narmafotinib in
combination with chemotherapy has been undertaken
•
Fifteen patients of the 26 enrolled in the study remain on trial with six (6) confirmed PRs having
been recorded along with four (4) unconfirmed PRs and five (5) SDs
•
The median duration on trial is longer than for comparative trials of chemotherapy alone
•
The ACCENT trial has resumed recruitment for the final cohort of 24 patients and as of 24
October 2024, 3 patients have been recruited
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is
pleased to report the interim data analysis from the Company’s Phase 2a clinical trial investigating
narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial). The trial is
investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the
standard-of-care chemotherapy regimen of gemcitabine and Abraxane®. Data cut-off for the interim
analysis is 27 September 2024.
As previously reported by the Company, narmafotinib continues to be generally well tolerated by
patients with no dose reductions. In addition, six (6) patients recorded confirmed partial responses
(PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions,
with no new tumour lesions, sustained for two or more months.
Further details regarding the responses observed by trial participants are summarised below and
presented in the attached slides:
• 6 patients have recorded unconfirmed PRs, 4 of which are awaiting confirmation whilst 2 have
subsequently recorded progressive disease (PD)
• 8 patients recorded sustained stable disease (SD), with 5 of these patients remaining on study
• 3 patients recorded PD as best response, while 3 other participants were considered ineligible
or withdrew from the trial
• Of the 24 evaluable patients, 19 have recorded a decrease in tumour size as best response at
any scan
• Median duration on trial at data cut-off is 136 days, which compares favourably with historical
data for chemotherapy alone of 117 days
• Preliminary analysis indicates patients have a faster response to therapy in terms of tumour
reduction, compared to historical data for chemotherapy alone
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs
obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of
patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled
as of 24 October 2024.
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
Amplia CEO and MD Dr Chris Burns commented: “We continue to be excited by the data coming from
the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved
ones for their involvement in the study. Further trial updates will be provided to the market in due
course. "
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 and other cancers, 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. The drug has successfully completed a healthy volunteer
study, and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of
narmafotinib and the chemotherapies gemcitabine and Abraxane® is being assessed for safety,
tolerability and efficacy.
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 ACCENT trial explores the use of narmafotinib in combination with standard-of-care
chemotherapy of gemcitabine and Abraxane® in first-line patients with advanced pancreatic cancer.
The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed
in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding
regular chemotherapy infusion, as safe and well tolerated.
This second stage (Phase 2a), of the trial is designed to assess drug efficacy in combination with
gemcitabine and Abraxane. 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). Safety and tolerability will continue to be assessed.
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.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
About Amplia Therapeutics Limited
Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
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), Threads (@ampliatx) and LinkedIn.
ACCENT Trial Interim Data
30 October 2024
ampliatx.com | @ampliatx
1
ACCENT TRIAL DESIGN
An open-label trial of narmafotinib in combination with gemcitabine and
Abraxane® in first-line patients with advanced pancreatic cancer
Trial Read-outs:
Phase 1b: Primary endpoint – Safety and Tolerability; Secondary endpoint – PK and preliminary efficacy
Phase 2a: Primary endpoint – Objective Response Rate; Secondary endpoint – Duration on Trial
Dose
Selected
Phase 1b
(Australia)
Phase 2a
(Australia and South Korea)
26 patients
14 patients
Interim
Analysis
≥6 PR
Phase 2a (cont)
(Australia and South Korea)
24 patients
400 mg*
200 mg
100 mg
COMPLETED
RECRUITED
UNDERWAY
*Dose selected for Phase 2
2
ACCENT PHASE 2a Preliminary Data
Data cut-off 27 September 2024
Narmafotinib continues to be generally well tolerated in this patient group with no
dose reductions
6 confi rmed PRs observed at 4 month timepoint by 23 September 2024
• >30% reduction in tumour lesion size sustained over 2 months
• No new lesions
Developing data-set sufficiently positive, compared to historical data, to continue
trial and complete recruitment of 50 patients
3
ACCENT PHASE 2a Preliminary Data
Duration on Trial*
High-level data as of 27 September
2024*
• 15 patients remain on study
• 6 confirmed PRs (= PR sustained over 2
or more months)
• 4 PRs yet to be confirmed
• 7 SDs for 2 or more months
• 8 patients whose disease has
progressed
• 3 patients that have withdrawn or were
considered ineligible for assessment
Individual patients
Trial is ongoing - dataset is developing
Days on trial
*Based on data available in trial database on Sep 27; responses are investigator read; analysis may change as data matures.
PR = Partial response, SD = Stable Disease
4
ACCENT PHASE 2a Preliminary Data
Collated data of ‘best response’ at any
Best Response (evaluable patients)*
scan indicates promising activity
• 19 patients have recorded a decrease in
tumour size
• 12 patients have recorded a decrease in
tumour size >30%
Partial Response
Stable Disease
Progressive Disease
*Based on data available in trial database on Sep 27; responses are investigator read; analysis may change as data matures.
5
ACCENT PHASE 2a Preliminary Data
Comparison with historical gemcitabine/
Abraxane data indicates promising
response trends, noting
Response
ACCENT Phase 2a
Historical
Part A*
MPACT Trial
Best Response
Response**
Classification
(n=26)
Complete Response (CR)
0 (0%)
<1%
Partial Response (PR)
12 (46%)†
23%
Stable Disease (SD)
8 (31%)
27%
Progressive Disease (PD)
3 (12%)
20%
Not evaluable (NE)
3 (12%)‡
30%
Median Duration on Treatment
136 days
117 days
• Different data-set sizes
• ACCENT trial still ongoing – 15 patients remain
on trial
Best Overall
*_Based on data available in trial database on Sep 27; responses are investigator read; analysis may change as data matures.
** Confirmed data from MPACT trial (independent review); NEJM 2013: 369; 1691-1703
† Partial response as best response includes 6 confirmed PRs, 4 unconfirmed PRs, 2 PRs that converted to PD
‡ Includes one patient who withdrew
(n=431)
6
ACCENT PHASE 2a Preliminary Data
Comparison with historical gemcitabine/
with narmafotinib leads to:
• Faster response
• Longer/sustained response
Historical gemcitabine/Abraxane data ‡
Pancreatic lesions
ACCENT Phase 2a Response over time (all lesions)*
Mean % Change from Baseline ± 95% CI
(all target lesions)
Abraxane data suggests combination
Metastatic lesions
Time on trial (weeks)
0
8
Time on trial (weeks)
16
‡ Pancreas 2017: 46; 203
*Based on data available in trial database on Sep 27; responses are investigator read; analysis may change as data matures.
7
Chris Burns PhD GAICD
CEO and MD
chris@ampliatx.com
Amplia Therapeutics Limited
ABN 16 165 160 841
ASX: ATX
info@ampliatx.com
ampliatx.com
8
Share your feedback
Discover