Highlights

  • Amplia Therapeutics launched the first stage of a registration-enabling Phase 2b study for narmafotinib in pancreatic cancer.
  • The study will assess a new daily dosing schedule of narmafotinib alongside gemcitabine and Abraxane.
  • The trial design was developed in alignment with feedback from the U.S. FDA.
  • Patient enrolment is expected to begin by Q4 2026 across multiple Australian sites.
  • Previous ACCENT trial data showed a 36% response rate and median overall survival of 11.1 months.
  • Shares of Amplia Therapeutics closed flat on 19 May 2026 despite the clinical development update.

Amplia Therapeutics Ltd (ASX:ATX) announced the launch of the first stage of a new Phase 2b study evaluating narmafotinib in advanced pancreatic cancer, marking another step in the Company’s effort to progress the therapy toward a potential registrational pathway. Despite the clinical development update and the Company outlining plans aligned with U.S. Food and Drug Administration (FDA) feedback, shares of Amplia Therapeutics closed flat at AUD 0.14 on 19 May 2026.

While the stock remained unchanged during the session, Amplia Therapeutics shares are still approximately 180% higher over the past year. The latest announcement appeared to reinforce the Company’s focus on advancing narmafotinib through later-stage clinical development in an area where treatment Options remain limited.

New Phase 2b Study Designed to Support Registrational Pathway

The newly announced Phase 2b study is intended to form the first stage and foundation of a future registrational study for narmafotinib in pancreatic cancer. According to the Company, the study design has been developed in line with regulatory feedback received from the FDA.

The trial will investigate a new daily dosing regimen of narmafotinib in combination with standard chemotherapy agents gemcitabine and Abraxane in patients with newly diagnosed advanced pancreatic cancer.

Amplia stated that previous studies involving narmafotinib had utilised an intermittent dosing schedule. The Company now plans to evaluate whether daily dosing could further improve therapeutic activity while maintaining tolerability.

The initial stage of the study will enrol 12 patients across two dosing cohorts, with each cohort comprising six patients. Both groups will receive narmafotinib alongside standard chemotherapy administered according to conventional treatment schedules.

The Company noted that the study will examine safety, tolerability, pharmacokinetics and efficacy. Additional exploratory endpoints will include assessment of disease biomarkers and fibrosis, which is considered an important indicator of focal adhesion kinase (FAK) activity.

Patient recruitment is expected to commence in the fourth quarter of 2026 across three to four Australian clinical sites. Amplia anticipates that initial safety, tolerability and pharmacokinetic assessments for the 12 enrolled patients will be completed during the second quarter of 2027.

Narmafotinib Continues to Build on Earlier Trial Results

The Phase 2b study follows earlier data generated from Amplia’s ACCENT trial involving narmafotinib in advanced pancreatic cancer.

According to the Company, the ACCENT trial achieved a response rate of 36%, which Amplia stated was superior to chemotherapy treatment alone. The trial also reported a median overall survival of 11.1 months.

Narmafotinib is being developed as a highly selective inhibitor of focal adhesion kinase, or FAK, a protein increasingly associated with cancer progression and fibrosis in solid tumours.

The Company stated that narmafotinib has also received Orphan Drug designation and Fast Track Designation from the FDA for pancreatic cancer treatment, highlighting the ongoing unmet need for improved therapies in the disease area.

Pancreatic cancer remains one of the more difficult cancers to treat effectively, with survival outcomes often remaining limited despite existing chemotherapy combinations. Amplia’s latest study is intended to further assess whether narmafotinib can improve outcomes when combined with established treatment regimens.

Company Shifts Resources Following AMPLICITY Recruitment Wind-Down

Amplia also stated that the new Phase 2b study was able to move forward more quickly due to the redeployment of resources from the Company’s AMPLICITY trial.

This included the use of available drug product and operational resources following the wind-down of patient recruitment in that study.

The Company indicated that integrating this additional Phase 2b component into the broader development pathway may help strengthen future regulatory submissions to the FDA.

Chief Executive Officer and Managing Director Dr Chris Burns said narmafotinib had so far demonstrated no significant additional tolerability burden when combined with chemotherapy.

He also noted that the Company had observed encouraging efficacy signals related to tumour response and survival outcomes using intermittent dosing schedules, which supported the rationale for evaluating daily dosing in the new study.

According to management, the Company expects that the inclusion of this Phase 2b component could contribute positively to the overall registrational package planned for future FDA discussions.

FAK Inhibition Continues to Attract Interest in Cancer Research

Amplia Therapeutics focuses on developing therapies targeting focal adhesion kinase, commonly referred to as FAK.

FAK is increasingly being explored as a therapeutic target in oncology because of its role in tumour growth, fibrosis, metastasis and resistance to treatment. The protein is often overexpressed in cancers such as pancreatic and ovarian cancer.

The Company’s pipeline includes therapies targeting fibrotic cancers as well as chronic diseases linked to fibrosis pathways.

Narmafotinib remains Amplia’s lead clinical asset and is positioned by the Company as a best-in-class FAK inhibitor. Preclinical research has shown encouraging activity across a range of solid tumour models, according to the announcement.

The Company continues to investigate the therapy in combination with established chemotherapy regimens in advanced pancreatic cancer settings.

In addition to the ACCENT study, Amplia has also been running the AMPLICITY trial in Australia, evaluating narmafotinib alongside the chemotherapy combination FOLFIRINOX in advanced pancreatic cancer patients.

Regulatory Alignment Seen as Important Step Forward

One of the more notable elements of the latest update was the Company’s emphasis on alignment with FDA guidance in designing the new Phase 2b study.

The registrational focus of the trial potentially represents a transition toward later-stage development planning for narmafotinib.

Regulatory pathways are particularly important in pancreatic cancer due to the high unmet medical need associated with the disease and the limited number of effective treatment options available for patients with advanced-stage diagnoses.

The FDA’s orphan drug and fast track designations for narmafotinib may also support more streamlined engagement with regulators as the program progresses.

Amplia stated that it intends to continue discussions with regulatory authorities as data from the new study becomes available.

Pancreatic Cancer Remains a Challenging Treatment Area

Pancreatic cancer is considered one of the more aggressive cancer types globally, with many patients diagnosed at advanced stages where treatment options are limited.

Current first-line therapies such as gemcitabine with Abraxane or FOLFIRINOX can provide clinical benefit for some patients, although long-term outcomes often remain challenging.

Companies developing therapies targeting new biological pathways, including FAK inhibition, continue to attract interest due to the need for additional treatment approaches.

Amplia’s focus on fibrosis-related tumour biology may differentiate narmafotinib from some traditional treatment strategies, particularly if future studies demonstrate improved efficacy outcomes when used alongside chemotherapy.

With enrolment expected later this year, investors are likely to continue monitoring how the Company progresses the registration-enabling study and whether additional data further supports narmafotinib’s development pathway.