Core Insights - The company Yongda Pharmaceutical (00512) has reported positive topline results from a Phase III clinical trial of its innovative radiolabeled drug conjugate (RDC) TLX591-CDx (Illuccix, gallium Ga68PSMA-11) for diagnosing prostate cancer in China, successfully meeting its primary clinical endpoint [1] - The RDC product TLX591 for treating prostate cancer has also been approved to join an international multicenter Phase III clinical study, indicating a strong potential for both products to provide more precise and effective diagnostic and treatment options for prostate cancer patients in China [1] Summary by Sections Clinical Trial Results - The study is a single-arm, open-label Phase III clinical trial involving over 100 patients with biochemical recurrence of prostate cancer, utilizing TLX591-CDx along with PET/CT or PET/MRI imaging to assess diagnostic efficacy and safety in the Chinese population [2] - The topline results indicate that the overall positive predictive value (PPV) of TLX591-CDx for detecting tumors is 94.8% (confidence interval: 85.9%-98.2%) [2] - For tumors recurring in the prostate bed and metastasizing to soft tissues, lymph nodes, and organs (non-bone metastasis), the PPV is 100.0%; for tumors recurring outside the prostate bed in pelvic regions (including lymph nodes), the PPV is 94.7%; and for bone metastasis, the PPV is 87.0% [2] PSA Level Group Analysis - The trial categorized participants based on baseline prostate-specific antigen (PSA) levels, showing high PPV across all groups, with PPV exceeding 90% even in the subgroup with very low PSA levels [3] - This suggests that TLX591-CDx PET imaging has significant clinical implications for the early diagnosis of suspected biochemical recurrence in prostate cancer patients [2][3] Impact on Clinical Decision-Making - More than two-thirds (67.2%) of patients had their treatment plans adjusted following PET imaging with TLX591-CDx, indicating its important role in clinical decision-making and the potential to optimize treatment strategies for suspected biochemical recurrence of prostate cancer [3]
远大医药用于诊断前列腺癌的创新在研放射性核素偶联药物TLX591-CDx中国 III 期临床研究成功达到主要临床终点