Telix Reports Positive Phase 3 Results For Illuccix Prostate Cancer Imaging Trial In China

Telix Pharmaceuticals

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(RTTNews) - Telix Pharmaceuticals Limited (TLX, TLX.AX) announced positive top-line results from its Phase 3 registration study of TLX591-CDx (Illuccix, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients. The Illuccix China trial successfully met its primary endpoint of patient-level positive predictive value (PPV) for detecting tumors in patients with biochemical recurrence (BCR) of prostate cancer following prior radical prostatectomy or radiation therapy. The study confirmed that the clinical experience of TLX591-CDx PSMA-PET imaging in Chinese patients is consistent with outcomes observed in patients studied elsewhere.

More than two-thirds (67.2%) of patients experienced a change in their treatment plan as a result of TLX591-CDx PSMA-PET imaging compared with the initial plan at baseline. This demonstrates that PSMA-PET imaging with TLX591-CDx had a significant impact on clinical decision-making in Chinese patients, potentially leading to improved treatment strategies for those with BCR. Final data from the study will be submitted for peer-reviewed publication.

Telix also advised that its New Drug Application (NDA) resubmission for TLX101-CDx (Pixclara, 18F-floretyrosine) to the U.S. Food and Drug Administration (FDA) is progressing well. The company has engaged in collaborative interactions with the FDA regarding additional clinical data and a revised statistical analysis plan. Following a productive Type A meeting to review the basis of the Complete Response Letter (CRL), Telix is finalizing its resubmission package. The company will provide an update once the resubmission has been filed and accepted by the FDA. The approved Expanded Access Program (EAP) for TLX101-CDx remains active, underscoring Telix's commitment to serving patients.

In addition, Telix recently participated in a Type A meeting to discuss the CRL received after review of the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab). Telix believes it has reached alignment with the FDA on addressing deficiencies related to the product's chemistry, manufacturing, and controls (CMC) package, which formed the substantive basis of the CRL. The FDA has granted Telix an additional meeting in January to review its plan for providing the requested data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. Telix will provide a further update following receipt of the official FDA meeting minutes. The approved EAP for TLX250-CDx also remains active, reflecting Telix's ongoing commitment to patient care.

TLX closed at $7.80 on December 19, down $0.01 or 0.13%. But in overnight trading on December 21, the stock rose to $8.00, gaining $0.20 or 2.56%.

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