Telix Pharmaceuticals (ASX:TLX) has delivered a significant advance in its global precision medicine strategy, announcing positive topline results from a pivotal Phase 3 registration study of TLX591-CDx (ILLUCCIX) in Chinese patients with prostate cancer.
The study confirmed that PSMA-PET imaging with TLX591-CDx in Chinese patients performs consistently with clinical experience observed in other regions, reinforcing the product’s role as a globally scalable diagnostic standard. The trial met its primary endpoint of patient-level positive predictive value (PPV) for detecting prostate cancer recurrence following surgery or radiation therapy, delivering an overall PPV of 94.8 per cent across 140 patients.
The performance of TLX591-CDx remained strong even at very low baseline prostate-specific antigen (PSA) levels, a setting where conventional imaging often fails. The study demonstrated high PPV across all PSA strata and metastatic sites, including the prostate bed, lymph nodes, bone, and extra-pelvic soft tissue, confirming its broad clinical applicability.
Beyond diagnostic accuracy, the trial underscored the clinical impact of PSMA-PET imaging in real-world decision-making. More than two-thirds of patients (67.2 per cent) experienced a change in their treatment plan following imaging with TLX591-CDx, highlighting the technology’s ability to directly influence patient management and optimise therapeutic strategy in cases of biochemical recurrence.
The China Phase 3 study was conducted in collaboration with Telix’s strategic partner Grand Pharmaceutical Group, reflecting a long-term commercial and regulatory alignment in the Greater China region. With prostate cancer diagnoses in China exceeding 134,000 cases annually and rising by approximately 6 per cent per year, the market opportunity is expanding rapidly, particularly as government policy supports the broader deployment of PET/CT infrastructure nationwide.
Dr David Cade, Telix’s Group Chief Medical Officer, described the outcome as a decisive validation of the product. He said the results exceeded the performance threshold agreed with Chinese regulators and demonstrated robust performance across metastatic locations and low-PSA disease, enabling Telix and its partner to proceed confidently toward regulatory submission.
The Illuccix China milestone sits alongside progress across Telix’s broader diagnostic portfolio. The company confirmed it is finalising resubmission of the New Drug Application for TLX101-CDx (PIXCLARA), its PET imaging agent for glioma, following constructive engagement with the U.S. Food and Drug Administration. An approved Expanded Access Program remains active, reflecting continued clinical demand.
Telix has also reported alignment with the FDA on remediation steps for TLX250-CDx (ZIRCAIX), its PET imaging candidate for clear cell renal cell carcinoma, after a Type A meeting focused on manufacturing and comparability issues. Further regulatory interactions are scheduled, positioning the program for potential re-engagement following completion of additional data requirements.