Amplia and ANZGOG Launch PRROSE Trial Targeting Resistant Ovarian Cancer

New Clinical Trial Tackles Chemotherapy Resistance in Ovarian Cancer

Amplia Therapeutics (ASX:ATX) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) have teamed up to launch the PRROSE trial, a clinical study investigating narmafotinib in combination with standard chemotherapy for ovarian cancer patients who fail to respond to platinum-based treatment. This subgroup, which represents about 20% of ovarian cancer cases, faces poor prognosis and limited treatment options.

The trial will enrol 15–20 patients with high-grade serous ovarian cancer (HGSOC) who exhibit inadequate response to upfront platinum chemotherapy prior to interval debulking surgery. The primary goal is to assess the safety profile of combining narmafotinib with carboplatin and paclitaxel, the current chemotherapy standard. Additionally, the study will explore whether adding Amplia's FAK inhibitor can increase the number of patients eligible for successful surgical resection, potentially improving clinical outcomes.

Narmafotinib’s Expanding Role Beyond Pancreatic Cancer

Narmafotinib, Amplia’s lead drug, is a potent and selective inhibitor of focal adhesion kinase (FAK), a protein overexpressed in several solid tumours including pancreatic and ovarian cancers. The drug has shown promising efficacy and tolerability in pancreatic cancer trials, such as the ACCENT study, where it demonstrated survival gains and multiple complete responses. The PRROSE trial represents an important step in broadening narmafotinib’s clinical applications into fibrotic cancers like ovarian cancer, where FAK expression and tumour fibrosis are typically high.

Amplia’s CEO, Dr Chris Burns, highlighted the compelling biological rationale for FAK inhibition in ovarian cancer and the urgent need for new therapies in chemotherapy-resistant patients. This trial also marks a strategic collaboration with ANZGOG, which brings a robust clinical trials network spanning Australia and New Zealand, led by Dr Gwo Yaw Ho of Monash Health and Monash University.

Biomarker Analysis to Illuminate Mechanism of Action

Beyond safety and surgical eligibility, the PRROSE trial will collect extensive tissue and blood biomarkers to deepen understanding of narmafotinib’s mechanism of action in ovarian cancer. This biomarker data could inform future patient selection and combination strategies, potentially accelerating clinical development. ANZGOG’s experience in delivering rigorous, practice-changing research across gynaecological cancers underpins the study’s design and execution.

Given Amplia’s recent progress in pancreatic cancer, including a GMP manufacturing scale-up and positive regulatory feedback, this ovarian cancer program could diversify the company’s clinical pipeline and address a significant unmet medical need. The trial’s relatively small enrolment reflects its early-stage, exploratory nature, with outcomes likely to influence subsequent development decisions.