- 01FDA agrees Phase 3 RAD101 trial design; 280 patients to enrol.
- 02Trial will assess PET sensitivity and specificity in brain metastases.
- 03RAD101 has FDA Fast Track status; Phase 2b showed 93% MRI concordance.
Radiopharm Theranostics (ASX: RAD) has reached agreement with the US Food and Drug Administration on the design of a pivotal Phase 3 clinical trial to evaluate novel imaging agent RAD101 in patients with indeterminate brain metastases following radiotherapy.
The company expects to enrol 280 patients to the multi-centre trial using a clinical supply of RAD101 radiolabelled with Fluorine-18 under a partnership with Siemens Healthineers, targeting co-primary endpoints of sensitivity and specificity of RAD101 positron emission tomography (PET) against a defined reference standard.
RAD101 is Radiopharm’s novel imaging small molecule designed to selectively bind to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de novo fatty acid synthesis and is overexpressed in brain metastases from solid tumours.
Targeting FASN activity may allow for the more accurate detection of cancer cells in the central nervous system, representing a clinically relevant method for the imaging of brain metastases.
Fast Track Designation
RAD101 was previously granted FDA fast track designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumours of different origin including leptomeningeal disease.
The designation recognises the seriousness of the condition and the unmet medical need for innovative products that can differentiate between tumour recurrence and radiation necrosis or pseudoprogression (defined as an increase in the size of a primary tumour or the appearance of a new lesion followed by tumour regression).
Radiopharm signed a supply agreement in April with German multinational Siemens Healthineers for the manufacture and distribution of doses of Fluorine-18-labelled RAD101 to support the upcoming Phase 3 trial.
Data from a Phase 2b trial of RAD101 demonstrated 93% concordance between magnetic resonance imaging (MRI) and PET scans of brain metastases in patients with suspected recurrence, along with substantial and selective tumour uptake of RAD101 and PET demonstrating tracer uptake in lesions that were equivocal on MRI.
Managing Brain Metastases
Radiopharm chief executive officer Riccardo Canevari said being able to distinguish recurrent tumour from treatment-related necrosis is one of the most important challenges physicians face when managing patients with brain metastases.
“This determination has profound implications for patient care, helping clinicians decide whether a patient requires additional intervention and treatment or can be managed with continued observation and surveillance,” he said.
“Existing imaging modalities often leave uncertainty, creating difficult clinical decisions for physicians and patients however RAD101 has shown the potential to resolve diagnostic uncertainty in lesions that are equivocal on MRI and could potentially offer a clearer assessment of active disease.”
“We are grateful to the FDA for its constructive review of our clinical data and for aligning with us on a single, multi-centre pivotal study design, and look forward to advancing RAD101 to provide physicians and patients with a more reliable tool to guide critical treatment decisions.”
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