Radiopharm's RAD101 PET Imaging Hits Primary Endpoint in Phase 2b Brain Metastases Trial, Data Selected for SNO26 Late-Breaker
核心洞察
Interim Phase 2b data show 18F-RAD101 (搜索) PET achieved 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint in suspected recurrent brain metastases (搜索).
Among 14 patients with evaluable six-month follow-up or biopsy data, RAD101 demonstrated preliminary 86% sensitivity for identifying recurrent disease, a secondary objective.
The findings were selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26), November 12-15, 2026, in Philadelphia.
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) announced that positive interim data from its U.S. Phase 2b imaging trial (NCT06777433) of 18F-RAD101 (搜索) in participants with suspected recurrent brain metastases (搜索) from solid tumors has been selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26), taking place November 12-15, 2026, in Philadelphia.
The interim analysis showed 93% concordance between RAD101 PET and MRI across all evaluable lesions, meeting the trial's primary endpoint. The results also demonstrated substantial and selective tumor uptake of RAD101, with PET images confirming metabolic activity in lesions where MRI findings were equivocal. Among 14 patients with evaluable six-month follow-up and/or biopsy data, RAD101 showed preliminary 86% sensitivity, representing a strong positive trend on a secondary objective. Sensitivity measures an imaging test's ability to correctly identify patients with disease.
"Having these data selected for a late-breaking oral presentation at SNO26 is a meaningful recognition of the potential clinical importance of RAD101," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The neuro-oncology community understands better than anyone the challenges associated with distinguishing active brain metastases (搜索) from treatment effects using current imaging approaches. Knowing whether metastatic disease is present can fundamentally alter a patient's treatment path and prognosis. We believe these data underscore RAD101's potential to address a significant unmet need by helping physicians make more informed decisions and potentially changing the course of disease management for patients with suspected recurrent brain metastases."
Trial Design and Endpoints
The U.S. multi-center, open-label, single-arm Phase 2b trial is assessing the diagnostic performance of 18F-RAD101 (搜索) in 30 evaluable individuals with suspected recurrent brain metastases (搜索) from solid tumors of different origins. The primary objective is concordance between 18F-RAD101 PET-positive lesions and equivocal lesions seen on conventional gadolinium-enhanced MRI in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints are the sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases.
The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial. Radiopharm expects to meet with the FDA on October 1, 2026, to align on the Phase 3 pivotal trial protocol.
Mechanism and Prior Evidence
RAD101 is a novel imaging small molecule that selectively binds to fatty acid synthase (搜索) (FASN), a multi-enzyme protein that catalyzes de-novo fatty acid synthesis and is overexpressed in cerebral metastases from solid tumors. Targeting FASN activity may allow for more accurate detection of cancer cells in the central nervous system, representing a clinically relevant method for imaging brain metastases (搜索).
Positive data from Imperial College of London (搜索)'s Phase 2a imaging trial of 18F-RAD101 (搜索) in patients with brain metastases (搜索) — including both SRS pre-treated and treatment-naive patients — showed significant tumor uptake that was independent of the tumor of origin. That study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall survival, warranting larger studies.
Regulatory and Manufacturing Status
RAD101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases (搜索) originating from solid tumors of different origin, including leptomeningeal disease (搜索). Radiopharm also recently announced a partnership with Siemens Healthineers (搜索), which will manufacture and distribute doses of 18F-labeled RAD101 to support the company's upcoming Phase 3 pivotal trial in the U.S.
Unmet Need and Market Context
In the U.S. alone, more than 300,000 patients are diagnosed annually with cerebral metastases, and the incidence of intracranial metastatic disease (IMD) continues to increase — in part due to improvements in systemic therapy resulting in more durable control of tumors outside the central nervous system. Contrast-enhanced MRI (CE-MRI) is the preferred method for imaging IMD but has limitations, particularly in follow-up surveillance scans intended to optimize patient care.
According to the company, brain metastases (搜索) imaging represents a total addressable market of approximately $600 million, and there are currently no approved PET products specifically for brain metastases imaging.
Radiopharm Theranostics is a clinical-stage radiotherapeutics company developing a platform of radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Its pipeline spans peptides, small molecules and monoclonal antibodies for use in cancer, with a clinical program that includes one Phase 2 and five Phase 1 trials across solid tumor cancers including lung, breast, prostate and brain.