Amplia Eyes Second Cancer Indication as FAK Inhibitor Enters Ovarian Trial
Amplia partners with ANZGOG to investigate narmafotinib in ovarian cancer
Amplia Therapeutics (ASX: ATX) has entered into an agreement with the Australia New Zealand Gynaecological Oncology Group (ANZGOG) to conduct a clinical study evaluating narmafotinib in ovarian cancer. The investigator-initiated trial, known as the PRROSE trial, will be led by Dr Gwo Yaw Ho of Monash Health and Monash University, with ANZGOG serving as sponsor and coordinator across major hospitals in Australia and New Zealand. The study will enrol approximately 15–20 patients with high-grade serous ovarian cancer (HGSOC) who demonstrate poor response to upfront platinum-based chemotherapy prior to planned interval debulking surgery.
The trial will assess narmafotinib in combination with carboplatin and paclitaxel, the standard-of-care chemotherapy regimen. This marks the second oncology indication for Amplia’s lead asset, expanding the addressable market for narmafotinib beyond its existing pancreatic cancer development programme.
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Why ovarian cancer represents a compelling target for FAK inhibition
Focal Adhesion Kinase (FAK) is a protein involved in cell signalling that promotes tumour growth and spread. Ovarian cancer typically shows higher levels of FAK expression and has a fibrous tumour nature, making it a major target for FAK inhibition therapy, according to the announcement.
Approximately one in five ovarian cancer patients do not respond adequately to initial chemotherapy, limiting their ability to undergo surgery and contributing to poor clinical outcomes. The PRROSE trial is designed to address this significant unmet medical need by assessing whether adding narmafotinib can increase the proportion of patients eligible for successful surgical resection.
The biological rationale for targeting FAK in ovarian cancer, combined with the study’s focus on patients with limited existing treatment options, positions the trial to potentially deliver meaningful clinical benefit in a population where standard-of-care approaches frequently fall short.
Study design and endpoints
The primary objective of the PRROSE trial is to evaluate the safety of narmafotinib combined with standard-of-care chemotherapy in this patient population. As a secondary exploration, the study will assess the potential to improve post-surgical outcomes by increasing surgical eligibility. An extensive tissue and blood biomarker collection component has been incorporated to characterise narmafotinib’s mechanism of action across tumour types.
| Parameter | Detail |
|---|---|
| Trial name | PRROSE |
| Lead investigator | Dr Gwo Yaw Ho |
| Sponsor/Coordinator | ANZGOG |
| Target enrolment | ~15–20 patients |
| Patient population | HGSOC with poor response to platinum-based chemotherapy |
Management commentary
Dr Chris Burns, CEO and Managing Director
“We are very pleased to be collaborating with ANZGOG and Dr Ho on this promising study. Based on the compelling biological rationale for the potential of FAK inhibitors in ovarian cancer, a clinical program in this indication is clearly warranted. Patients with ovarian cancer who do not respond to initial chemotherapy have very limited treatment options and this study will provide an opportunity to assess whether narmafotinib can improve outcomes for these patients. This trial also represents an important step in broadening the clinical utility of our FAK inhibitor program.”
Narmafotinib’s progress in pancreatic cancer provides foundation
Narmafotinib is currently undergoing clinical development in pancreatic cancer, where it has shown promising efficacy combined with good tolerability. The ACCENT trial, evaluating narmafotinib combined with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer, has already achieved its desired outcome by reaching a response rate of 31%, superior to chemotherapy alone. An interim progression-free survival (PFS) of 7.6 months has been reported.
A second trial, AMPLICITY, is being conducted at sites in Australia investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. The drug is described as a highly potent and selective FAK inhibitor.
Existing clinical data in pancreatic cancer de-risks the ovarian cancer study by demonstrating narmafotinib’s safety and efficacy profile in fibrotic tumour settings, where FAK plays a significant role in disease progression and therapeutic resistance.
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What this means for investors
The PRROSE trial positions narmafotinib for potential expansion into a second oncology indication, broadening Amplia’s pipeline beyond pancreatic cancer. The investigator-initiated structure, sponsored by ANZGOG, reduces Amplia’s direct trial costs whilst maintaining the ability to generate clinically meaningful data. The biomarker collection component adds strategic value by informing mechanism of action understanding across tumour types, potentially supporting future development decisions in additional fibrotic cancer settings.
Key investment takeaways include:
- Second oncology indication for lead asset narmafotinib
- Investigator-initiated trial structure limits direct cost burden
- Biomarker data will inform broader development strategy
- Addresses patient population with significant unmet medical need
The trial aligns with Amplia’s broader development focus on fibrotic cancers where FAK expression and activity contribute to poor treatment outcomes. ANZGOG’s established capability in designing and delivering rigorous clinical trials across Australia and New Zealand provides a credible platform for assessing narmafotinib’s potential in this patient population.
Could Narmafotinib Expand Amplia’s Addressable Market Beyond Pancreatic Cancer?
The PRROSE trial marks a strategic expansion of Amplia’s lead FAK inhibitor into ovarian cancer, targeting patients with limited treatment options and high unmet medical need. ANZGOG’s sponsorship reduces trial costs whilst enabling clinically meaningful data collection across a second fibrotic cancer indication.
To explore Amplia’s full development pipeline and assess how narmafotinib’s progress in multiple oncology indications may impact the company’s commercial trajectory, visit the Amplia investor centre. Access detailed trial updates, biomarker strategies, and management commentary on the broader FAK inhibitor programme.