TLX591 PROSTATE CANCER
Prostate cancer is a major killer of men and is the most commonly diagnosed cancer in males.
Prostate cancer is the fourth most common cancer worldwide and, in 2020, 1.4 million men were diagnosed with prostate cancer for the first time.
Rates of diagnosis are increasing, yet despite advances in treatments, prostate cancer still accounts for a large number of deaths with more than 375,000 men dying from their disease in 2020.
Telix’s prostate cancer program consists of an investigational diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX591) candidate with the potential to improve the detection and treatment of prostate cancer.
The recently updated National Comprehensive Cancer Network® (NCCN) Guidelines® for prostate cancer now include Ga-68 PSMA-11 PET/CT to be considered as an alternative to standard imaging of bone and soft tissue.
Telix’s prostate cancer imaging investigational product Illuccix® (TLX591-CDx, kit for the preparation of 68Ga-PSMA-11 injection) has been accepted for filing by the U.S. Food and Drug Administration (FDA), and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA). Telix is also progressing marketing authorisation applications for Illuccix® in the European Union and Canada. The ‘cold kit’ format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, ideally suited to the commercial and hospital radiopharmacy setting.
TLX591 (177Lu-DOTA-rosopatamab) is an antibody-based therapeutic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), a well-validated target in prostate cancer.
Current development activity
TLX591 (Therapy) is currently in Phase III clinical trials in Australia and, subject to regulatory approval, further trials are expected to commence in the USA in 2021.
- Tagawa ST, Niaz MJ, Osborne J, et al. Phase 1/2 dose-escalation trial of fractionated dose 177Lu-591 plus 177Lu-PSMA for metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2019 37:7_suppl, TPS339-TPS339.
- Calderoni L, Farolfi A, Cabitza V, Pianori D, Maietti E, Ricci G, et al. Automated synthesis module and sterile cold kit for 68Ga-PSMA-11 do not show differences in PET/CT image quality. [submitted]
- Eiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, et al. Evaluation of hybrid 68Ga-PSMA ligand PET/CT in 248 patients with biochemical recurrence after radical prostatectomy. J Nucl Med. 2015 May;56(5):668-74.
- Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, et al. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer. JAMA Oncol. 2019 Mar. doi: 10.1001/jamaoncol.2019.0096. [Epub ahead of print]
None of Telix’s product pipeline has received marketing authorization in any jurisdiction. Any use of Telix products is on an investigational basis or for use in approved clinical trials.