Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.
- 64Cu-SAR-bisPSMA outperforms standard PSMA PET imaging in lesion detection
- Next-day imaging significantly increases lesion visibility and alters patient management
- 67Cu-SAR-bisPSMA therapy leads to undetectable disease in metastatic prostate cancer cases
- Data supports ongoing Phase III trials and potential commercialisation
- Real-world and clinical trial evidence underpin product’s clinical impact
Top-Rated Presentation Highlights Diagnostic Edge
Clarity Pharmaceuticals (ASX:CU6) is set to spotlight its pioneering prostate cancer imaging and therapeutic agents at the European Association of Nuclear Medicine (EANM) Annual Congress 2026 in Vienna. The highlight is a top-rated oral presentation of the Co-PSMA trial led by Prof Louise Emmett at St Vincent’s Hospital, Sydney, which demonstrated that 64Cu-SAR-bisPSMA significantly outperforms the current standard-of-care (SOC) 68Ga-PSMA-11 PET/CT in detecting biochemical recurrence (BCR) of prostate cancer.
The trial showed a near threefold increase in mean lesions detected per patient (1.26 vs. 0.48), a 2.6 times higher total lesion count (63 vs. 24), and a true positive rate more than doubling to 71% compared to 29% with SOC imaging. Moreover, 78% of participants had positive scans with 64Cu-SAR-bisPSMA versus just 36% with the standard agent, underscoring its diagnostic superiority.
Next-Day Imaging Uncovers Hidden Lesions, Alters Treatment
Real-world case reports will also be presented, including three patients with BCR who had negative results on standard PSMA PET/CT scans using advanced Siemens Biograph Vision Quadra technology but tested positive with 64Cu-SAR-bisPSMA. Notably, next-day imaging (24 hours post-injection) revealed more than twice the number of lesions compared to same-day imaging, with additional sites detected in the prostate bed and lymph nodes.
One patient, Steve Hunter, who accessed the imaging under compassionate use, credited the scans with enabling targeted radiotherapy that deferred androgen deprivation therapy (ADT) for over three years, sparing him from its significant side effects while maintaining PSA control. This case highlights the agent’s potential to transform patient management and quality of life.
Therapeutic Promise from 67Cu-SAR-bisPSMA in Advanced Prostate Cancer
The therapeutic arm of Clarity’s pipeline, 67Cu-SAR-bisPSMA, will be featured through case reports from the Phase I/IIa SECuRE trial involving metastatic castration-resistant prostate cancer (mCRPC) patients. Two participants achieved undetectable PSA levels and no detectable disease on follow-up imaging after receiving three to four cycles of treatment.
Participant A saw a 95.7% PSA decline within four weeks and remained disease-free at 33 weeks post-treatment, while Participant B experienced a 94.2% PSA drop and complete radiological response after two cycles. Both tolerated the therapy well, with only mild and transient side effects reported.
Building a Robust Clinical and Real-World Evidence Base
Dr Alan Taylor, Clarity’s Executive Chairperson, emphasised the significance of these findings in the context of the company’s broader clinical program. The Co-PSMA data, already published in European Urology and presented at the European Association of Urology, adds to a growing body of evidence from approximately 700-800 patients dosed with 64Cu-SAR-bisPSMA across various geographies and imaging platforms.
This extensive dataset supports ongoing registrational Phase III trials and real-world access programs in Australia and the US, reinforcing the product’s potential to reshape diagnostic and therapeutic pathways in prostate cancer. Clarity’s commitment extends beyond diagnostics, with 67Cu-SAR-bisPSMA representing a key asset to address unmet needs in mCRPC treatment.
Commercial and Clinical Implications
The presentations at EANM 2026 come amid Clarity’s progress in securing manufacturing capacity and supply agreements in the US, positioning the company for potential market entry pending regulatory approvals. The promising clinical data, combined with patient testimonials and real-world impact, underscore the potential for SAR-bisPSMA to become a significant player in the prostate cancer theranostics landscape.
While 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA remain unregistered products with safety and efficacy yet to be assessed by regulatory bodies such as the FDA and TGA, the accumulating evidence signals meaningful advancement in the field. The company’s ambitious goal to transition from Australian innovation to a blockbuster product hinges on continued trial success and regulatory milestones.
Bottom Line?
Clarity’s expanding clinical evidence and patient impact stories position SAR-bisPSMA as a potential game-changer in prostate cancer care, but regulatory approval and broader commercial uptake remain pivotal next steps.
Questions in the middle?
- Will ongoing Phase III trials confirm SAR-bisPSMA’s diagnostic and therapeutic advantages at scale?
- How will regulatory agencies respond to the emerging clinical data on these unregistered products?
- What are the commercial prospects and competitive dynamics for SAR-bisPSMA in global prostate cancer markets?