Ann: SABRE topline results, page-2

SABRE topline results: 64Cu-SAR-Bombesin is effective in detecting prostate cancer recurrence in patients with negative SOC imaging
Highlights
• Topline data from Clarity’s diagnostic Phase II trial, SABRE, showed that 64Cu-SAR-Bombesin was safe, well tolerated and effective at detecting prostate cancer in patients with biochemical recurrence (BCR) who are negative or equivocal on standard-of-care (SOC) scans, including prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET).
• SAR-Bombesin targets the gastrin-releasing peptide receptor (GRPR), a promising pan-cancer target expressed in a number of indications, including prostate cancer. Unlike PSMA-targeted agents, 64CuSAR-Bombesin may be particularly valuable for imagining prostate cancer with known biological heterogeneity, which prostate cancer is known to be.
• The trial enrolled 53 patients. 64Cu-SAR-Bombesin identified lesions in approximately 35% and 28% of participants on same-day and next-day imaging, respectively (average across readers). Forty-nine lesions in total were identified on 64Cu-SAR-Bombesin PET/computed tomography (CT) scans (average across readers and imaging days).
• The participant-level correct detection rate (CDR) was 14.9% (95% confidence interval [CI]: 6.2, 28.3) on same-day imaging and ranged from 4.3% to 14.9% (95% CI: 0.5-28.3) on next-day imaging across the readers. Region-level positive predictive value (PPV) ranged from 22.6% to 47.1% (95% CI: 9.672.2) on same-day imaging and from 22.2% to 37.5% (95% CI: 2.8-61.7) on next-day imaging. The CDR and PPV results were substantially impacted by the large number of lesions that were detected, but unable to be verified by biopsies (not clinically feasible in many cases) and by the low sensitivity of follow-up SOC imaging.
• Despite biopsy not being SOC for this patient population, approximately 16% of patients who were positive on 64Cu-SAR-Bombesin PET/CT were biopsied in the SABRE study. All lesions assessed by histopathology were positive for prostate cancer, indicating a 100% true-positive rate among those biopsied lesions.
• As an example, in one participant, 64Cu-SAR-Bombesin PET/CT detected multiple lesions, two of which were confirmed as prostate cancer by biopsy. No lesions were detected on a prior SOC screening 18FDCFPyL PSMA PET/CT scan, and on a follow-up 18F-DCFPyL PET/CT scan conducted approximately 11 weeks later only one bone lesion was detected. A follow-up CT scan conducted approximately 3 months after the 64Cu-SAR-Bombesin scans confirmed the presence of multiple cancerous lesions.
• Only two participants had adverse events (AEs) related to 64Cu-SAR-Bombesin, with all being mild (Grade 1) and resolving within 2 days of onset. • Based on these positive results, Clarity has commenced discussions with key medical experts to determine the most effective pathway for registration of 64Cu-SAR-Bombesin and to explore its development in a range of large oncology indications with high unmet needs.