Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has announced positive results from the diagnostic Phase 2 DISCO study with 64Cu-SARTATE in patients with known or suspected neuroendocrine tumours (NETs).
DISCO is a 'Diagnostic Imaging Study of 64COpper-SARTATE Using PET on Patients with Known or Suspected Neuroendocrine Tumours'.
The study assessed the performance of Clarity’s SARTATE imaging product as a potential new method for diagnosing and managing NETs.
DISCO recruited participants with Gastroenteropancreatic NETs (GEP-NETs) across four sites in Australia, comparing the diagnostic performance of 64Cu-SARTATE PET at an average of 4 hours and approximately 20 hours post-administration to the current standard of care.
Participants were required to have undergone a pre-study 68Ga-DOTATATE PET/CT scan within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE as part of their routine clinical care.
The study was initially designed to enrol up to 63 patients, based on the anticipated lesion-level discordance rate between 64Cu-SARTATE and 68Ga-DOTATATE PET. Following a pre-planned early analysis of the data collected during the study, the sample size was adjusted to 45 patients, allowing for an earlier enrolment completion. Study participants were dosed with 200 MBq of 64Cu-SARTATE.
Clarity said the results indicate that lesion detection by 64Cu-SARTATE substantially outperformed that of 68Ga-DOTATATE. 64Cu-SARTATE detected 393 to 488 lesions, and 68Ga-DOTATATE identified 186 to 265 lesions among 45 participants across the readers.
Clarity executive chairperson Dr Alan Taylor said, “We are very excited about the initial topline data from the DISCO trial as 64Cu-SARTATE was confirmed to be safe and very effective in detecting NET lesions in patients with known or suspected disease. The DISCO trial demonstrates a significant advantage of our diagnostic over 68Ga-DOTATATE."
Dr Taylor continued, “We look forward to sharing additional data readouts from the trial and presenting the results at future international medical conferences. We plan to rapidly progress discussions with the FDA to initiate a diagnostic registrational Phase III study, as a first key step in expanding SARTATE into the theranostic field of NETs, as well as other SSTR2-expressing cancers, with the copper-64/copper-67 pair. If the findings from the DISCO trial are substantiated in a registrational Phase III study and lead to regulatory approval by the US FDA, 64Cu-SARTATE may play an important role in improving diagnostic accuracy, lesion detection and staging of patients with NETs. These factors could improve clinical decision-making and treatment outcomes, potentially positioning 64CuSARTATE as a best-in-class agent for the diagnosis of NETs.”