Amplia Therapeutics (ASX:ATX) and the Australia New Zealand Gynaecological Oncology Group have launched a new investigator-initiated clinical study to test the FAK inhibitor narmafotinib in combination with standard chemotherapy for patients with high-grade serous ovarian cancer who respond poorly to first-line platinum-based treatment.
The trial called PRROSE will enrol roughly 15 to 20 patients across the ANZGOG network and will assess the safety of narmafotinib given with carboplatin and paclitaxel while exploring whether the drug can increase the proportion of patients who become eligible for successful interval debulking surgery. The protocol includes an extensive collection of tissue and blood biomarkers to better characterise narmafotinib’s mechanism of action.
Amplia frames ovarian cancer as a strong target for FAK inhibition because of typically higher FAK expression and the fibrous nature of tumours, and points to encouraging activity already observed in pancreatic cancer trials where narmafotinib has shown tolerability and improved response rates.
The PRROSE study aims to address the roughly one in five ovarian cancer patients who do not respond adequately to upfront chemotherapy and therefore face limited surgical and clinical options.
Dr Chris Burns, CEO and Managing Director of Amplia, said, “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.”
Lead investigator Dr Gwo Yaw Ho of Monash Health and Monash University said, “This study reflects the strength of ANZGOG’s collaborative clinical trials network and its ability to bring together leading clinical investigators to address areas of high unmet need in gynaecological cancers. This trial builds on ANZGOG’s established capability to design and deliver rigorous, potentially practice-changing clinical research across Australia and New Zealand. The study is underpinned by a commitment to translating promising scientific approaches, such as Amplia’s, into well-conducted clinical trials that can generate meaningful evidence to inform future treatment options for women with ovarian cancer.”