First Patient Dosed in Pivotal Phase III Study of TLX591-CDx (Illuccix®) for Prostate Cancer Imaging in Chinese Patients

Melbourne (Australia) | 11 August 2023

Telix today announces that a first patient has been dosed in China in the pivotal Phase III registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11),[1] for the imaging of prostate cancer using positron emission tomography (PET).

The Phase III Illuccix China study ( ID: NCT05847348) is a prospective, open-label, single-arm, multicenter study in Chinese patients with biochemically recurrent (BCR) prostate cancer that is intended to bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA). The study – a collaboration with Telix’s strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma) – is required to establish that the diagnostic utility of TLX591-CDx is equivalent in Chinese and Western populations. This study will enrol up to 110 patients with BCR prostate cancer, and data will support a future marketing authorisation application for TLX591-CDx in China.

Dr Shams UL Arifeen, Regional Medical Director, Telix Asia Pacific said, “We are pleased to have commenced this study, which brings advanced PSMA-PET imaging[2] one step closer for Chinese men with prostate cancer. With our strategic collaborator in the region, Grand Pharma, we would like to express our gratitude to Dr Yong He, principal investigator at Zhongnan Hospital of Wuhan University as well as his clinical research team, and the patients who will contribute to this important study.”

About Prostate Cancer in China

The Asia Pacific region comprises approximately one third of the world’s male population and includes many nations whose populations are ageing or increasingly adopting a more affluent, “Western-style” lifestyle, the two main demographic trends driving increasing cancer incidence rates. Consequently, the incidence of prostate cancer is increasing in many parts of the region.

In China, 115,000 men are diagnosed with prostate cancer each year, increasing by approximately 6% each year.[3] In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is forecast to reach 1,240 by the end of 2023, compared with 133 in 2010.[4]

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[1] For regulatory reasons, Telix refers to its 68Ga-PSMA-11 kit as Illuccix in markets where it has received regulatory approval, and TLX591-CDx when referring to its use in both approved and unapproved markets. Registrations vary country to country. Always refer to local labelling.

[2] Imaging of prostate-specific membrane antigen with positron emission tomography.

[3] Ye Dingwei et al. Lancet Oncology, 2022.

[4] Goetz Partners research 2020.