Amplia Therapeutics Reports Four Additional Complete Responses and Improved Overall Survival Data in Accent Pancreatic Cancer Trial

HIGHLIGHTS

• Formal centralized 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, March 23, 2026 (GLOBE NEWSWIRE) -- 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 the Company’s lead drug narmafotinib is combined with chemotherapy showing a median 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 tumors 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 always planned 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 favorably 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.

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 22 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 authorized for release by the Board of Amplia Therapeutics.

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 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, 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), 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 can be found via the ACCENT trial site, the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.

¹ New England Journal of Medicine 2011, 364, 1817-1825

² The Lancet 2023, 402(10409), 1272-1281