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, April 22, 2026 (GLOBE NEWSWIRE) — 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, “These extremely promising clinical responses 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 | Media Contact: Tom Trezona, H^CK Acting MD tom@hck.digital +61 411 235 692
U.S. Media: |
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.
