远大医药(00512)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

Core Viewpoint - The innovative radiolabeled drug conjugate TLX591-CDx for diagnosing prostate cancer has achieved positive top-line results in a Phase III clinical trial in China, successfully meeting its primary clinical endpoint, indicating potential for more precise and effective diagnostic solutions for prostate cancer patients in China [1]. Group 1: Clinical Trial Results - The Phase III clinical study was a single-arm, open-label trial involving over 100 patients with biochemical recurrence of prostate cancer, utilizing TLX591-CDx for diagnostic imaging through PET/CT or PET/MRI to assess diagnostic efficacy and safety in the Chinese population [2]. - TLX591-CDx demonstrated an overall positive predictive value (PPV) of 94.8% (confidence interval: 85.9%-98.2%) for detecting tumors, with a PPV of 100.0% for tumors recurring in the prostate bed and metastasizing to soft tissues, lymph nodes, and organs (non-bone metastases) [2]. Group 2: Subgroup Analysis - The PPV for tumors recurring in pelvic regions outside the prostate bed (including lymph nodes) was 94.7%, while for bone metastases, the PPV was 87.0% [2]. - TLX591-CDx showed high PPV across all subgroups based on baseline prostate-specific antigen (PSA) levels, with PPV exceeding 90% even in the subgroup with extremely low PSA levels [2][3]. Group 3: Clinical Decision Impact - More than two-thirds (67.2%) of patients had their treatment plans adjusted following PET imaging with TLX591-CDx, indicating its significant impact on clinical decision-making and optimization of treatment strategies for suspected biochemical recurrence of prostate cancer [3].