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 2018, 1.4 million men were diagnosed with prostate cancer for the first time. Despite advances in treatments, prostate cancer still accounts for a large number of deaths and in 2018 more than 375,000 men died from their disease. Rates of diagnosis are increasing and the highest levels of prostate cancer are found in Europe, the US, Europe, Australia and New Zealand. Telix’s prostate cancer program consists of a companion diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX591) to improve the detection and treatment of prostate cancer.
TLX591-CDx (branded in the United States illumet™) is an imaging radiopharmaceutical for the imaging of metastatic prostate cancer. The product comes in a “cold kit” form for the rapid preparation of 68Ga-PSMA-11 injection and is compatible with the major commercially available 68Ga generators (EZAG, IRE and ITG).
illumet™ is for investigational use only as part of an FDA Investigational New Drug (IND) application, Clinical Trial Application (CTA). illumet™ is not an approved agent in any country.
Current development activity
The TLX591-CDx cold kit is currently being used in research studies under US Investigational New Drug applications by the following institutions:
- Emory University Hospital
- Memorial Sloan Kettering Cancer Center
- Endocyte (US and EU for the VISION trial)
Telix has also partnered with Cardinal Health, UPPI and Pharmalogic in the US for pharmacy preparation and distribution of the TLX591-CDx kit delivered as an investigational product for use in qualified investigator-sponsored clinical trials. The product is also available through a number of distributors around the globe.
TLX591 (177Lu-DOTA-Rosopatamab) is an antibody-based therapeutic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA). PSMA is a well-validated target in prostate cancer.
Current development activity
TLX591 (Therapy) is currently in pre-Phase 3 development with trials planned to start in Australia and the United States late 2019/early 2020 (subject to regulatory approvals).
- 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.