Radiopharm Theranostics (RAD) Study result summary

Study background and objectives

• Phase II-B trial of RAD101 targets brain metastases where standard MRI is suboptimal, aiming to improve diagnostic clarity and patient management.

• RAD101 is a PET imaging agent targeting fatty acid synthase (FASN), a pathway exploited by cancer cells in the brain and overexpressed in many solid tumors.

• The study addresses a high unmet need, as MRI struggles to distinguish tumor recurrence from radiation necrosis post-treatment.

• The trial is a collaboration with Imperial College London, building on positive phase I and II-A data.

• The U.S. multicenter, open-label, single-arm Phase 2b trial evaluates 18F-RAD101 in patients with recurrent brain metastases from various solid tumors.

Interim results and clinical findings

• 90% of patients in the Phase II-B trial achieved concordance between RAD101 PET imaging and MRI, meeting the primary endpoint.

• PET imaging with RAD101 provided clear identification of viable tumor tissue, even when MRI results were equivocal.

• Biopsy confirmation in select cases validated PET findings as true positives.

• Early six-month follow-up and biopsy data from five patients indicate a positive trend for sensitivity and specificity, supporting secondary objectives.

• Two patients with small cerebellar lesions showed no PET activity, suggesting possible MRI false positives.

Clinical impact and expert perspectives

• RAD101 PET-CT offers significant value in post-treatment scenarios, especially where MRI is inconclusive.

• PET imaging can prevent unnecessary treatments and enable timely intervention for recurrent disease.

• High concordance between PET and MRI supports the use of PET as an adjunct, not a replacement, to MRI.

• Experts highlight the potential for RAD101 to change clinical decision-making and improve patient outcomes.

• The technology is positioned to fill a major gap in brain metastasis management.