Clarity’s Cu-SARTATE Doubles Lesion Detection in NETs, Phase III Trial Next
Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.
- Cu-SARTATE detected nearly twice as many NET lesions as Ga-DOTATATE
- High lesion-level sensitivity of 93.4% to 95.6% confirmed for Cu-SARTATE
- Well tolerated with no serious adverse events reported
- Phase III registrational trial planned with FDA guidance
- Potential expansion into other SSTR2-expressing cancers beyond NETs
A New Benchmark in NET Imaging
Clarity Pharmaceuticals has unveiled compelling topline results from its Phase II DISCO trial, demonstrating that its radiopharmaceutical Cu-SARTATE is markedly more effective than the current standard-of-care, Ga-DOTATATE, in detecting neuroendocrine tumour (NET) lesions. The trial, conducted across four Australian sites with 45 participants, showed that Cu-SARTATE identified between 393 and 488 lesions, nearly double the 186 to 265 lesions detected by Ga-DOTATATE.
This leap in lesion detection is not just a numerical victory but also a clinical one. Approximately 93.5% of discordant lesions; those detected by only one of the imaging agents; were found exclusively by Cu-SARTATE. Where standard-of-truth verification was available, Cu-SARTATE demonstrated a lesion-level sensitivity between 93.4% and 95.6%, compared to a mere 4.4% to 6.6% for Ga-DOTATATE.
Safety and Patient-Centric Advantages
Safety data from the DISCO trial are encouraging, with only 15.6% of participants experiencing mild, mostly gastrointestinal adverse events related to Cu-SARTATE, and no serious treatment-emergent adverse events reported. The longer half-life of copper-64 used in Cu-SARTATE allows for flexible imaging timepoints up to 24 hours post-injection, a stark contrast to the roughly one-hour half-life of gallium-68 in Ga-DOTATATE. This flexibility supports patient-centric scheduling and potentially improves lesion detection by optimizing the signal-to-noise ratio.
Strategic Implications and Market Potential
Clarity’s Executive Chairperson, Dr Alan Taylor, highlighted the transformative potential of Cu-SARTATE not only for NET diagnosis but also for broader applications in other cancers expressing the SSTR2 receptor, such as certain breast and lung cancers. The US NET diagnostic market alone is estimated at around 100,000 scans annually, expected to grow to 120,000 by 2029. Cu-SARTATE’s superior imaging characteristics and manufacturing advantages position it well to capture significant market share.
With these promising Phase II results, Clarity plans to engage with the US Food and Drug Administration to initiate a registrational Phase III trial. Success in this pivotal study could lead to regulatory approval, establishing Cu-SARTATE as a best-in-class diagnostic tool that enhances clinical decision-making and patient outcomes in NETs and potentially other malignancies.
Looking Ahead
While the DISCO trial results mark a significant milestone, the path to commercialisation and widespread adoption depends on the outcomes of the upcoming Phase III study and regulatory review. Clarity’s next steps will be closely watched by investors and clinicians alike, as the company seeks to redefine standards in cancer imaging and theranostics.
Bottom Line?
Cu-SARTATE’s superior detection and safety profile set the stage for a pivotal Phase III trial that could reshape NET diagnostics.
Questions in the middle?
- Will the Phase III trial confirm Cu-SARTATE’s diagnostic superiority and safety at scale?
- How quickly can Clarity secure FDA approval and commercial partnerships post-Phase III?
- What is the timeline and strategy for expanding Cu-SARTATE into other SSTR2-expressing cancers?
