Telix Pharmaceuticals (ASX:TLX) announced positive top-line results from its Phase 3 study of TLX591-CDx (Illuccix) in Chinese patients with prostate cancer.
Conducted with Grand Pharmaceutical Group, the study met its primary endpoint, showing a patient-level positive predictive value of 94.8% for detecting tumors in patients with biochemical recurrence after prostatectomy or radiation therapy.
High PPV was observed across metastatic sites and low baseline PSA levels, with region-level PPV reaching 100% in the prostate bed and extra-pelvic soft tissue.
Over two-thirds of patients experienced changes in their treatment plans based on TLX591-CDx imaging. Telix and Grand Pharma plan to submit a New Drug Application in China in the near term.
In the US, Telix is finalising the NDA resubmission for TLX101-CDx (Pixclara), a PET imaging agent for glioma.
Following collaborative FDA interactions and a Type A meeting to address a prior complete response letter, resubmission is expected shortly. The Expanded Access Program remains active.
Telix also advanced discussions on TLX250-CDx (Zircaix) for clear cell renal cell carcinoma. A recent Type A FDA meeting addressed manufacturing deficiencies identified in its BLA CRL, and an additional meeting is scheduled in January to review comparability data. The EAP for TLX250-CDx continues.
Dr. David N. Cade, Telix Group Chief Medical Officer, said, "The Illuccix China data exceed regulatory thresholds and demonstrate the clinical value of PSMA-PET imaging in guiding treatment strategies."