The innovative investigational radiopharmaceutical TLX591-CDx by GRAND PHARMA (00512) for diagnosing prostate cancer has successfully reached the main clinical endpoints in Phase III clinical trials in China.

Grand Pharma (00512) announced that the innovative investigational radioligand conjugate (RDC) drug TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11) used for diagnosing prostate cancer has achieved positive top-line results in a Phase III clinical trial conducted in China, successfully meeting its primary clinical endpoints. In addition, the RDC product TLX591 used for treating prostate cancer has been approved to join an international multicenter Phase III clinical study in China. In the future, the combination of these two products is poised to provide more precise and effective diagnosis and treatment options for prostate cancer patients in China. This study is a single-arm, open-label Phase III clinical study involving over 100 patients with biochemically recurrent prostate cancer who were administered TLX591-CDx and underwent positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance imaging (PET/MRI) scans to evaluate the diagnostic effectiveness of the product as well as its safety and tolerability in the Chinese population. According to the clinical top-line results, the overall positive predictive value (PPV) of TLX591-CDx in detecting tumors reached 94.8% (confidence interval, CI: 85.9%-98.2%). For tumors recurring in the prostate bed and soft tissues, lymph nodes, and organs outside the pelvic area (non-bone metastases), the PPV was 100.0%; for tumors recurring in the pelvic area outside the prostate bed (including lymph nodes), the PPV was 94.7%; for bone metastases, the PPV was 87.0%. Moreover, the trial grouped subjects based on their prostate specific antigen (PSA) baseline levels, and TLX591-CDx demonstrated a high PPV in all groups, even exceeding 90% in subgroups with very low PSA levels, indicating the significant clinical significance of early diagnosis of prostate cancer with suspected biochemical recurrence using TLX591-CDx PET imaging. Furthermore, over two-thirds (67.2%) of patients had adjustments made to their treatment plans after undergoing TLX591-CDx PET imaging, compared to their initial plans at baseline. This demonstrates the significant impact of TLX591-CDx PET imaging on clinical decision-making, optimizing the clinical treatment strategies for prostate cancer patients with suspected biochemical recurrence.