On April 15, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that the first patient has been treated in the Phase II DISCO trial (Diagnostic Imaging Study of Copper-64 SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors) (Press release, Clarity Pharmaceuticals, APR 15, 2021, View Source [SID1234578042]).
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The DISCO trial (NCT04438304)1 is assessing the performance of 64Cu-SARTATE imaging agent in participants with known or suspected gastroenteropancreatic (GEP) NETs as a potential new way to help diagnose NETs. It is a Phase II study in 63 patients across 3 sites in Australia that compares the diagnostic performance of 64Cu-SARTATE at 4 and 20 hours to the current standard of care 68Ga-DOTATATE at 1 hour.
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, are a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system. The most common site of primary NETs is the gastrointestinal tract (GI) (about 60% of all cases), followed by the bronchopulmonary tree (27%). Less frequent sites are the pancreas, biliary tract, liver, ovaries and testes.2 In 2020, the National Cancer Institute (NCI) estimated a prevalence close to 300,000 individuals who had a NET diagnosis and are currently alive in the U.S. Only 15% are survivors of 1 or less years from diagnosis.
A delay in diagnosis or misdiagnosis of NETs is common, such that most NET patients have metastatic disease by the time a diagnosis is confirmed.3 About 30-75% of NETs patients have distant metastases at the time of diagnosis according to the US and European cancer registries.
Clarity’s Executive Chairman, Dr Alan Taylor, commented: "There is a clear unmet need in the diagnosis of NETs with the frightening proportion of people currently being diagnosed when the cancer has already spread in their bodies, limiting treatment options and negatively affecting prognosis.
"Our 64Cu-SARTATE first-in-human diagnostic trial in NETs has demonstrated promising results in the safety and potential effectiveness of the product as a new way to detect neuroendocrine cancers (Hicks, R. et al. 2018)4. The study showed that the longer 12.7 hour half-life of Cu-64, combined with the stability of our proprietary SAR chelator which does not leak copper over time, proved to be advantageous in identifying additional tumour burden as it allows clinicians to have the flexibility to image patients at later time points than products based on Ga-68 or copper-based products that employ inferior chelators," said Dr Taylor.
The longer half-life of Cu-64 also enables product supply benefits. In the DISCO trial, clinical sites across Australia will be supplied 64Cu-SARTATE from a central radiopharmacy. In contrast, Ga-68 based products have to be synthesised on site and require the clinical sites to have local radiopharmacies.
"Our team is very excited to progress the development of 64Cu-SARTATE for NET patients to expand the patient population for SARTATE from neuroblastoma in children. We are also looking forward to capitalising on the many benefits of the "perfect pairing" of Cu-64 and Cu-67 for imaging, therapy, manufacture and logistics in the development of all of our pipeline products with the ultimate goal of improving treatment outcomes for children and adults with cancer," commented Dr Taylor.
Reference List
A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors, <View Source>
Modlin, E. et al. 2010, "Gastrointestinal neuroendocrine (carcinoid) tumours: current diagnosis and management", The Medical Journal of Australia, <View Source>
Basuroy, R. et al. 2018, "Delays and routes to diagnosis of neuroendocrine tumours", BMC Cancer, <View Source>
Hicks, R. et al. 2018, "First-in-human trial of 64Cu-SARTATE PET imaging of patients with neuroendocrine tumours demonstrates high tumor uptake and retention, potentially allowing prospective dosimetry for peptide receptor radionuclide therapy", The Journal of Nuclear Medicine, <View Source>