Telix Pharmaceuticals Poised for China Expansion with Positive illuccix Trial Data
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Melbourne, Australia – Telix Pharmaceuticals Ltd (ASX:TLX) announced promising results from a Phase 3 trial of its prostate cancer imaging agent, illuccix, paving the way for a New Drug Application (NDA) in China – a rapidly growing market for nuclear medicine. The company is also making progress with its glioma and renal cell carcinoma programs in the United States.
Illuccix Demonstrates High Accuracy in Chinese Prostate Cancer Patients
The pivotal Phase 3 registration study, evaluating TLX591-CDx (Illuccix) in 140 Chinese patients with biochemical recurrence of prostate cancer, achieved a remarkable patient-level positive predictive value (PPV) of 94.8% for tumor detection. This key finding successfully met the primary endpoint and supports the planned submission of an NDA to Chinese regulatory authorities in collaboration with local partner Grand Pharmaceutical group.
The study highlighted the sensitivity of PSMA-PET imaging even in patients with very low levels of prostate-specific antigen (PSA), a crucial factor in early detection of recurrent disease. Regional analysis revealed PPV reaching 100% in the prostate bed and in distant metastases affecting soft tissue, lymph nodes, and organs. PPV was also high in pelvic regions (94.7%) and bone metastases (87.0%). Importantly, imaging results prompted changes in treatment plans for over two-thirds of the patients scanned.
“This is an outstanding result,” stated a senior official at Telix. “The primary endpoint of the study was met decisively, with the positive predictive value considerably exceeding the performance threshold agreed with the Chinese regulator. Importantly, the high PPV was consistent even in patients with very low PSA values, and across differing metastatic locations, demonstrating broad clinical applicability. These compelling data will enable Telix and our partner Grand Pharma to submit a New Drug Application for Illuccix in China, a strategically important market.”
The potential impact in China is important, with over 134,000 men diagnosed with prostate cancer in 2022, and incidence rates increasing by approximately 6% annually. furthermore, the country is experiencing rapid growth in its nuclear medicine infrastructure, with the number of PET/CT scanners projected to exceed 1,600 by the end of 2025, a substantial increase from the 133 scanners available in 2010.
Advancing Glioma and Renal Cell Carcinoma Programs in the US
Beyond the promising developments in China, Telix continues to progress its pipeline in the United States.Work is underway to finalize a resubmission of the NDA for TLX101-CDx (Pixclara), a PET imaging agent for glioma, a type of brain cancer. This resubmission follows constructive engagement with the US Food and Drug Governance (FDA) regarding additional clinical data requirements and a revised statistical analysis plan. The Expanded Access Program for TLX101-CDx remains active, providing continued access for eligible patients.
For TLX250-CDx (Zircaix), a PET imaging candidate for clear cell renal cell carcinoma, discussions with the FDA are focused on resolving chemistry, manufacturing, and controls (CMC) issues identified in a Complete Response Letter.A recent Type A meeting resulted in a clear path forward, with a follow-up meeting scheduled to review plans for additional data demonstrating consistency between clinical trial material and scaled-up commercial manufacturing.The Expanded Access Program for TLX250-CDx also remains open to patients while regulatory processes continue.
Telix Pharmaceuticals is strategically positioned to capitalize on the growing demand for precision medicine solutions in both established and emerging markets, with a robust pipeline and a commitment to innovation in radiopharmaceutical imaging and therapy.
