Melbourne (Australia) and Indianapolis, IN (U.S.A.) | 13 February 2025

Telix today announces presentations featuring the Company’s late-stage and next generation therapeutic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2025) to be held in San Francisco, CA (US) from 13 – 15 February 2025.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, “Telix will feature in four presentations at this year’s ASCO GU, which showcase the depth and differentiation of our therapeutic urologic pipeline, alongside our industry-leading precision medicine portfolio. For the first time at a medical congress, preliminary data will be presented from the CUPID study of TLX592, which was successful in demonstrating clinical proof-of-concept of Telix’s alpha therapy candidate for prostate cancer[1]”.

ProstACT GLOBAL, the first Phase 3 trial to evaluate Telix’s lead rADC[2] therapy candidate, TLX591, in patients with PSMA[3]-positive mCRPC[4] who have progressed while receiving a prior androgen receptor pathway inhibitor (ARPI) drug, is actively dosing patients in the United States and the Asia Pacific region and will be highlighted during a ‘Trials In Progress’ presentation.

In kidney cancer, Principal Investigators of the STARLITE-1 and -2 investigator-initiated trials will provide an update on design and status of these trials in progress. These groundbreaking studies are investigating Telix’s therapeutic candidate TLX250 in combination with immunotherapy in treatment-naïve and late-stage patients, respectively. TLX250 is positioned to be the first carbonic anhydrase IX (CAIX)- targeting rADC to market and is progressing toward a pivotal trial in clear cell renal cell carcinoma (ccRCC).

ASCO GU 2025 presentation details are listed below: 

Title:  A Phase 3 Study of 177Lu-rosoptamab Tetraxetan Plus Standard of Care vs. Standard of Care Alone in Patients with Metastatic Castration-Resistant Prostate Cancer

ClinicalTrials.gov ID: NCT06520345

Date and Time: February 13, 2025 | 11:25 AM – 12:45 PM (PST)

Presenter: Oliver Sartor, MD, Mayo Clinic

Type: Trials in Progress Poster Session

Location: Level 1, West Hall | On Demand

Abstract: TPS303

Poster Bd: M22

Title: CUPID (64Cu-TLX592 Phase 1 PK, Biodistribution & Dosimetry): A Proof-of-Concept Study of TLX592 Targeted Alpha Therapy in Prostate Cancer

ClinicalTrials.gov ID: NCT04726033

Date and Time: February 13, 2025 | 11:25 AM – 12:45 PM (PST)

Presenter: David N. Cade, MD, Telix Pharmaceuticals

Type: Poster Session

Location: Level 1, West Hall | On Demand

Abstract: 177

Poster Bd: E16

Title: STARLITE-2: Phase 2 Study of Nivolumab plus 177Lutetium-labeled Anti–Carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (177Lu-girentuximab, TLX250) in Patients with Advanced ccRCC

ClinicalTrials.gov ID: NCT05239533

Date and Time: February 15, 2025 | 7:10 AM – 8:10 AM (PST)

Presenter: Darren Feldman, MD, Memorial Sloan Kettering Cancer Center

Type: Trials in Progress Poster Session

Location: Level 1, West Hall | On Demand

Abstract: TPS608

Poster Bd: K9

Title: STARLITE-1: Phase 1b/2 Study of Combination 177Lu Girentuximab (TLX250) Plus Cabozantinib and Nivolumab in Treatment Naive Patients with Advanced ccRCC

ClinicalTrials.gov ID: NCT05663710

Date and Time: February 15, 2025 | 7:10 AM – 8:10 AM (PST)

Presenter: Eric Jonasch, MD, The University of Texas, MD Anderson Cancer Center

Type: Trials in Progress Poster Session

Location: Level 1, West Hall | On Demand

Abstract: TPS614

Poster Bd: K15

Read the full media release here

[1] Telix ASX disclosure 21 May 2024.

[2] Radio antibody-drug conjugate.

[3] Prostate-specific membrane antigen.

[4] Metastatic castrate-resistant prostate cancer.

TLX591, TLX592 and TLX250 have not received marketing authorization in any jurisdiction and are for investigational use only.