Telix Pharmaceuticals Ltd (ASX:TLX) has delivered an update on its precision medicine portfolio. The company is a Melbourne-based biopharmaceutical company developing and commercialising radiopharmaceutical therapies and diagnostic imaging technologies. It operates internationally, with activities across the United States, United Kingdom, Brazil, Canada, Europe and Japan, and is advancing a pipeline of clinical and commercial-stage assets targeting oncology and rare diseases.
Telix’s lead imaging product, Illuccix, a gallium-68 PSMA-PET agent, has received regulatory approval in multiple global markets, while Gozellix has been approved by the US Food and Drug Administration. The broader portfolio includes TLX101-CDx, a PET imaging candidate for glioma, and TLX250-CDx, a PET imaging agent under development for clear cell renal cell carcinoma. Neither TLX101-CDx nor TLX250-CDx has yet received marketing approval in any jurisdiction.
Illuccix China Phase 3 Registration Study
Telix reported positive top-line results from a Phase 3 registration study of TLX591-CDx (Illuccix) in Chinese patients with biochemical recurrence of prostate cancer following surgery or radiation therapy.
The 140-patient, prospective, multicentre study achieved a patient-level positive predictive value (PPV) of 94.8% for tumour detection, meeting the primary endpoint and supporting plans for a near-term New Drug Application submission in China with local commercial partner Grand Pharmaceutical Group.
The study demonstrated consistent performance across a range of prostate-specific antigen (PSA) levels, including very low PSA values, highlighting the sensitivity of PSMA-PET imaging in early recurrent disease.
At a regional level, PPV reached 100% in the prostate bed and in extra-pelvic soft tissue, lymph node and organ metastases, while PPV was 94.7% in pelvic regions outside the prostate bed and 87.0% in bone metastases. Imaging results also influenced clinical decision-making, with more than two-thirds of patients experiencing a change in their treatment plan following scanning.
“This is an outstanding result. The primary endpoint of the study was met decisively, with the positive predictive value significantly 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,” Dr. David N. Cade, Group chief medical officer said.
In China, more than 134,000 men were diagnosed with prostate cancer in 2022, with case numbers rising by about 6% a year. Expanding access to nuclear medicine is also supporting growth in imaging capacity, with the installed base of PET/CT scanners forecast to exceed 1,600 by the end of 2025, up from 133 in 2010.
TLX101-CDx advances toward FDA resubmission
Progress continued on TLX101-CDx (Pixclara), a PET imaging agent for glioma, with work underway to finalise a New Drug Application resubmission to the US Food and Drug Administration.
The resubmission follows detailed engagement with the FDA on additional clinical data requirements and a revised statistical analysis plan. A further update is expected once the application has been filed and formally accepted, while the Expanded Access Program for TLX101-CDx remains active.
TLX250-CDx regulatory discussions continue
For TLX250-CDx (Zircaix), a PET imaging candidate for clear cell renal cell carcinoma, discussions with the FDA have focused on addressing chemistry, manufacturing and controls issues identified in a Complete Response Letter.
A recent Type A meeting resulted in alignment on remediation steps, with a further meeting scheduled to review plans for additional data to demonstrate comparability between clinical trial material and scaled-up commercial manufacturing. The Expanded Access Program for TLX250-CDx continues as regulatory work progresses.