Highlights

  • Amplia Therapeutics announced a new ovarian cancer clinical study in Partnership with ANZGOG.
  • The PRROSE trial will evaluate narmafotinib alongside standard chemotherapy.
  • The study is expected to enrol approximately 15 to 20 ovarian cancer patients.
  • The trial will focus on safety and potential improvements in post-surgical outcomes.
  • Biomarker analysis will also explore narmafotinib’s mechanism of action.
  • The update expands Amplia’s broader FAK inhibitor development strategy beyond pancreatic cancer.

Amplia Therapeutics Ltd (ASX:ATX) announced a new clinical collaboration with the Australia New Zealand Gynaecological Oncology Group (ANZGOG) to investigate its lead drug candidate narmafotinib in ovarian cancer patients, marking another expansion of the company’s oncology development program.

Despite the favourable clinical update, Amplia shares traded flat at AUD 0.14 during the afternoon session on 8 May 2026. However, the stock remains approximately 170% higher over the past 12 months as investors continue monitoring progress across the company’s broader FAK inhibitor pipeline.

The newly announced study will evaluate narmafotinib in combination with standard chemotherapy in patients with high-grade serous ovarian cancer (HGSOC) who have shown poor response to initial platinum-based chemotherapy treatment.

Management described the collaboration as an important step in broadening the clinical Utility of Amplia’s focal adhesion kinase (FAK) inhibitor platform beyond its current pancreatic cancer focus.

Company Overview

Amplia Therapeutics Ltd is an Australian pharmaceutical company focused on developing focal adhesion kinase (FAK) inhibitors targeting cancer and fibrotic diseases.

The company’s lead drug candidate, narmafotinib (AMP945), is a selective FAK inhibitor currently undergoing clinical evaluation in pancreatic cancer.

Amplia’s research programs target tumour types characterised by fibrosis and elevated FAK expression, including pancreatic and ovarian cancers.

New Ovarian Cancer Study Targets High-Unmet-Need Patient Group

The clinical study, named the PRROSE trial, will be led by Dr Gwo Yaw Ho of Monash Health and Monash University.

The trial will be sponsored and coordinated through ANZGOG, a major gynaecological oncology Clinical Trials network operating across Australia and New Zealand.

According to Amplia, the study is expected to enrol approximately 15 to 20 patients diagnosed with high-grade serous ovarian cancer who have not responded adequately to upfront platinum-based chemotherapy prior to planned interval debulking surgery.

The company stated that around one in five ovarian cancer patients experience insufficient response to initial chemotherapy treatment, limiting their ability to undergo surgery and contributing to less favourable clinical outcomes.

The PRROSE trial has therefore been designed to evaluate whether adding narmafotinib to standard chemotherapy could potentially improve treatment response and increase the proportion of patients eligible for successful surgical intervention.

Focus on Safety and Mechanism of Action

Amplia stated that the primary objective of the trial will be evaluating the safety of combining narmafotinib with standard-of-care chemotherapy agents carboplatin and paclitaxel.

In addition to safety assessment, the study will also investigate post-surgical outcomes and broader treatment response indicators.

Extensive tissue and blood biomarker analysis will also be conducted throughout the trial.

Management indicated that these biomarker studies are expected to provide additional insight into narmafotinib’s mechanism of action and further strengthen the overall clinical data package associated with the drug candidate.

The company noted that ovarian cancer represents an important target for FAK inhibition therapy due to:
• typically elevated FAK expression levels
• the fibrous nature of ovarian tumours
• the role of FAK signalling in tumour progression and treatment resistance

Expanding Beyond Pancreatic Cancer

The latest announcement broadens Amplia’s existing clinical development efforts, which have primarily focused on pancreatic cancer.

Narmafotinib is currently undergoing clinical development in advanced pancreatic cancer through two ongoing studies:
• the ACCENT trial
• the AMPLICITY trial

According to the company, narmafotinib has shown promising efficacy alongside favourable tolerability in pancreatic cancer settings so far.

Amplia disclosed that the ACCENT trial has already achieved its target response rate outcome, reporting:
• a 31% response rate
• progression-free survival (PFS) of 7.6 months on an interim basis

Management stated that these outcomes compared favourably to chemotherapy treatment alone.

The AMPLICITY trial is separately investigating narmafotinib in combination with FOLFIRINOX chemotherapy in advanced pancreatic cancer patients at Australian sites.

The company believes expanding into ovarian cancer may help further validate the broader clinical potential of its FAK inhibitor platform.

Collaboration with ANZGOG Adds Clinical Network Support

Amplia highlighted the significance of partnering with ANZGOG, describing the organisation as a major cooperative clinical trials network spanning leading hospitals and research institutions across Australia and New Zealand.

ANZGOG focuses on advancing clinical research in gynaecological cancers and includes more than 1,650 members working across healthcare, research, academia and cancer support sectors.

Management indicated that the collaboration provides access to established clinical trial infrastructure and specialist oncology expertise.

Amplia CEO and Managing Director Dr Chris Burns stated that the biological rationale supporting FAK inhibition in ovarian cancer made further clinical exploration in the indication a logical progression for the company.

He also noted that patients who Fail to respond to initial chemotherapy currently face limited treatment Options, making the study an important opportunity to explore whether narmafotinib may improve outcomes in this setting.

Investigators Highlight Need for New Treatment Approaches

Lead investigator Dr Gwo Yaw Ho stated that the study reflects ANZGOG’s ability to coordinate collaborative clinical research programs focused on areas of high unmet medical need.

According to Dr Ho, the trial aims to translate promising scientific approaches into rigorously designed clinical research capable of generating meaningful evidence for future treatment strategies in ovarian cancer.

The study is also intended to contribute further understanding around the role of FAK inhibition in difficult-to-treat tumour environments.

Broader Focus on FAK Inhibitors

Amplia continues positioning itself within the growing field of FAK-targeted therapeutics.

FAK, or focal adhesion kinase, is increasingly being explored as a treatment target in several cancer types due to its involvement in:
• tumour growth
• metastasis
• fibrosis
• chemotherapy resistance
• tumour microenvironment signalling

Amplia’s development strategy focuses particularly on fibrotic cancers such as pancreatic and ovarian cancer.

The company also noted that FAK may have potential applications beyond oncology, including chronic diseases such as idiopathic pulmonary fibrosis.

Investors Monitoring Clinical Pipeline Progress

Although Amplia’s share price remained unchanged following the update, investors are likely to continue watching the company’s expanding clinical pipeline and future trial milestones closely.

Key areas of market focus may include:
• patient enrolment progress in the PRROSE study
• future safety and efficacy data
• biomarker findings
• broader expansion opportunities for narmafotinib

Investors are also expected to monitor ongoing outcomes from the company’s pancreatic cancer studies, particularly given previous response rate and progression-free survival results disclosed by the company.

As Amplia broadens the scope of its FAK inhibitor program, future clinical data could play an important role in shaping sentiment around the company’s long-term oncology strategy.