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Penny Taylor
Clinical-stage biotech Amplia Therapeutics has finalised plans for its PRROSE phase two ovarian cancer study, clearing a key preparatory hurdle and opening a second cancer front for its leading drug candidate narmafotinib.
The move takes the drug beyond Amplia’s established pancreatic cancer program, where narmafotinib has already been tested alongside standard chemotherapy and generated encouraging clinical data.
Narmafotinib is Amplia’s highly potent and selective Focal Adhesion Kinase (FAK) inhibitor – a drug designed to block the activity of FAK, a protein that can help cancer cells grow, survive and resist treatment. Amplia says FAK can be found at high levels in ovarian cancer and often contributes to the creation of dense, scar-like fibrotic tissue that forms around some tumours.
By blocking FAK, the company aims to weaken or even break down that biological fortress, giving chemotherapy a cleaner shot at getting in and doing its job.
‘This is an important study for a patient population who currently have limited treatment options.’
Amplia Therapeutics chief executive officer and managing director Dr Chris Burns
After pairing narmafotinib with established chemotherapy in pancreatic cancer and producing encouraging results, Amplia is now taking the same approach into ovarian cancer, where it says FAK can also help drive tumour growth and treatment resistance.
First announced in May, the PRROSE study will test the strategy by adding narmafotinib to the standard-of-care ovarian cancer chemotherapy combination of carboplatin and paclitaxel. The study will target women with high-grade serous ovarian cancer who have responded poorly to initial platinum-based chemotherapy and are preparing for surgery to remove as much of the tumour as possible.
The idea is to combine two lines of attack: carboplatin and paclitaxel provide the established chemotherapy backbone, while narmafotinib targets FAK. The study’s main purposes are to assess the combination’s safety and explore whether it can increase the proportion of patients eligible for successful surgical resection.
Amplia says almost one in five ovarian cancer patients don’t respond adequately to initial chemotherapy, contributing to poor clinical outcomes and underlining the unmet medical need narmafotinib is designed to address.
Working with the Australia New Zealand Gynaecological Oncology Group (ANZGOG), Amplia has spent the past three months finalising the PRROSE design. ANZGOG will sponsor and coordinate the study through its regional gynaecological oncology network of more than 1650 members.
Amplia Therapeutics lead investigator Dr Gwo Yaw Ho said: “Completion of the study protocol enables us to move towards evaluating this promising therapeutic approach in patients with high-grade serous ovarian cancer who are at increased risk of poor outcomes.”
With the trial plans now nailed down, ANZGOG and Amplia will seek ethics and site approvals. Once cleared, selected trial sites across Australia and New Zealand will open, with about 26 patients expected to be recruited before the end of 2026.
Narmafotinib already has clinical runs on the board in pancreatic cancer. Amplia’s Phase 1b/2a ACCENT trial in patients receiving their first treatment for advanced pancreatic cancer recorded a 36 per cent response rate, meaning more than one in three patients saw their tumours shrink by a set amount. Median overall survival was 11.1 months. The study paired narmafotinib with the established chemotherapy combination gemcitabine and Abraxane.
Earlier company data also showed a 7.8 per cent complete response rate, which is historically rare in pancreatic cancer. Amplia has since launched a phase 2b study to test a daily dose of narmafotinib with the same treatment combination.
Amplia’s pancreatic experience has given the company a clinical blueprint for combining narmafotinib with chemotherapy as it takes the same underlying strategy into ovarian cancer. The company said Sydney’s Garvan Institute has also backed the approach with early laboratory research showing a similar reduction in tumour fibrosis and enhanced anti-tumour activity when narmafotinib was combined with chemotherapy.
Amplia is also testing whether narmafotinib’s potential can stretch beyond pancreatic and ovarian cancer. It has teamed with pharmaceutical giant Eli Lilly to evaluate the drug alongside olomorasib in a phase 1b/2b trial for advanced non-small cell lung cancer. Olomorasib targets a mutated protein called KRAS G12C that can drive cancer growth. Amplia says blocking FAK with narmafotinib could also help shut down a pathway cancer cells use to resist KRAS-targeted treatments.
With its PRROSE study heading towards recruitment, Amplia is armed with a 13-kilogram batch of narmafotinib from its commercial-scale manufacturing run and a big pharma collaboration in its back pocket, as it builds a multi-front platform for its lead drug across hard-to-treat cancers.
Is your ASX-listed company doing something interesting? Contact: mattbirney@bullsnbears.com.au
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