Core Insights - Telix Pharmaceuticals Limited announced positive top-line results from its Phase 3 registration study of TLX591-CDx (Illuccix®) for prostate cancer imaging in Chinese patients, achieving a patient-level positive predictive value (PPV) of 94.8% for tumor detection [2][3][6] Group 1: Study Results - The Illuccix China trial met its primary endpoint, confirming that TLX591-CDx PSMA-PET imaging is effective in detecting tumors in patients with biochemical recurrence of prostate cancer [2][3] - The study involved 140 patients and demonstrated a region-level PPV of 100.0% in the prostate bed and extra-pelvic soft tissue, with varying PPV rates in other regions [3][4] - More than two-thirds (67.2%) of patients had a change in their treatment plan due to TLX591-CDx PSMA-PET imaging, indicating its significant impact on clinical decision-making [5] Group 2: Future Plans - The positive results from the Phase 3 study provide a basis for Telix and Grand Pharma to submit a New Drug Application (NDA) for Illuccix in China, a strategically important market [6][7] - Telix is also finalizing its NDA resubmission for TLX101-CDx (Pixclara®) and has had productive interactions with the FDA regarding additional clinical data [9][10] - For TLX250-CDx (Zircaix®), Telix has reached alignment with the FDA on addressing deficiencies identified in a previous Complete Response Letter [11][12] Group 3: Market Context - In China, over 134,000 men were diagnosed with prostate cancer in 2022, with an annual increase of approximately 6% [6] - The number of PET/CT cameras installed in China is projected to exceed 1,600 by the end of 2025, a significant increase from 133 in 2010 [8]
Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions