Understanding Telix, page-1447

Zircaix ... " As big (or bigger) than Illuccix "

how this doesn't get priced in is beyond moi ..... $19.50 Illuccix plus Zircaix $19.50 = Cheap today


"Until now, assessing whether renal masses arecancerous has been difficult and often involves invasive surgery or percutaneous biopsy.This is because standard imaging technology -- either a CT or MRI scan -- cannot reliablydifferentiate between benign or malignant renal lesions or provide information aboutdisease biology.

Key findings of the ZIRCON trial, outlined in the paper, include: -- 89Zr-girentuximab PET/CT imaging accurately detected ccRCC in patients with cT1 IRM (<=7cm), demonstrating a mean sensitivity of 86%, specificity of 87% and positive predictive value of 93% -- 89Zr-girentuximab PET/CT imaging has high diagnostic performance for detection and characterization of small and very small renal masses -- The primary and secondary endpoints were met by all three radiology readers and exceeded pre-specified thresholds. Inter-reader variability indicated robust agreement among the readers and intra-reader variability was 100%, indicating perfect agreement -- No safety concerns associated with the administration of 89Zr-girentuximab were revealed -- Imaging performed 5+/-2 days after administration is sufficient to visualize and assess ccRCC lesions, with the flexible imaging window offering several advantages for patient management -- The non-invasive nature of this technique may be especially beneficial to those at risk of complications from a surgical renal mass biopsy.


Imaging Published in The Lancet Oncology'Highly Accurate': Telix's Phase III ZIRCON Trial for Kidney Cancer Imaging Published inThe Lancet Oncology MELBOURNE, Australia, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited(ASX: TLX, Telix, the Company) today announces that primary results from its Phase IIIZIRCON(1) trial have been published in The Lancet Oncology, reporting that Telix'sfirst-in-class investigational PET(2) agent, TLX250-CDx (Zircaix(R)(3) , (89)Zr-girentuximab), is highly accurate in detecting and characterizing clear cell renalcell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs). In this peer-reviewed manuscript, Professor Brian Shuch (University of California, LosAngeles, UCLA) and colleagues report results from this prospective, open-label,multicentre, Phase III trial in which 300 patients with an IRM <=7cm (cT1) receivedTLX250-CDx. Authors conclude that TLX250-CDx "has a favorable safety profile and is ahighly accurate, non-invasive imaging modality for the detection and characterization ofccRCC, which has the potential to be practice changing." Authors explain that small masses in the kidney are increasingly being detectedincidentally when patients undergo abdominal imaging, often for other health conditions,contributing to "an era of gross overtreatment". Diagnosis and treatment are limited bycurrent imaging techniques, and renal mass biopsy is invasive, which can often lead tocomplications. Up to 30% of patients undergo unnecessary surgery, removing masses thatare later determined to be benign(4) . If confirmed, however, ccRCC is the most commonand aggressive form of kidney cancer, and delays in diagnosis can significantly reducesurvival rates. Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & CarrieMeinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology,and a ZIRCON principal investigator, said, "Until now, assessing whether renal masses arecancerous has been difficult and often involves invasive surgery or percutaneous biopsy.This is because standard imaging technology -- either a CT or MRI scan -- cannot reliablydifferentiate between benign or malignant renal lesions or provide information aboutdisease biology. "The challenges and uncertainty in diagnosing ccRCC underscore a critical unmet needfor a new, non-invasive technique that accurately detects and differentiates ccRCC fromother renal masses in patients, to inform clinical decision making. The ZIRCON trial hasshown that TLX250-CDx is a breakthrough technology that can address this need." TLX250-CDx is a zirconium-89 ((89) Zr) radiolabelled monoclonal antibody that targetscarbonic anhydrase IX (CAIX), a tumor-associated antigen highly expressed in ccRCC.Following successful Phase I and II trials to establish safety and preliminary efficacy,the ZIRCON trial was designed to assess sensitivity and specificity of TLX250-CDx PET/CTimaging to non-invasively detect ccRCC in patients with cT1 IRMs (<=7 cm in diameter) whounderwent nephrectomy, using central histological confirmation as standard of truth. Key findings of the ZIRCON trial, outlined in the paper, include: -- 89Zr-girentuximab PET/CT imaging accurately detected ccRCC in patients with cT1 IRM (<=7cm), demonstrating a mean sensitivity of 86%, specificity of 87% and positive predictive value of 93% -- 89Zr-girentuximab PET/CT imaging has high diagnostic performance for detection and characterization of small and very small renal masses -- The primary and secondary endpoints were met by all three radiology readers and exceeded pre-specified thresholds. Inter-reader variability indicated robust agreement among the readers and intra-reader variability was 100%, indicating perfect agreement -- No safety concerns associated with the administration of 89Zr-girentuximab were revealed -- Imaging performed 5+/-2 days after administration is sufficient to visualize and assess ccRCC lesions, with the flexible imaging window offering several advantages for patient management -- The non-invasive nature of this technique may be especially beneficial to those at risk of complications from a surgical renal mass biopsy. Dr David N. Cade, Chief Medical Officer at Telix said, "The results of the ZIRCON trialmake a compelling case for TLX250-CDx as a breakthrough product for kidney cancerimaging, and validate CAIX as a novel target to accurately identify renal cell carcinoma. "Professor Shuch and his co-investigators, at 36 sites worldwide, found that its highdiagnostic performance, including for very small lesions, may support early and accuratediagnosis, inform patient risk stratification and clinical decision making, and reduceover- and under-treatment. We believe this result will lead to improved patientoutcomes". If approved by the United States (U.S.) Food and Drug Administration (FDA), TLX250-CDxwill be the first and only targeted PET agent specifically for kidney cancer to becommercially available in the U.S. The full paper can be found at:https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00402-9/fulltext About TLX250-CDx (Zircaix(R)(3) ) TLX250-CDx (Zircaix(R)(3) ) is an investigational radiodiagnostic PET agent that isunder development to characterize IRMs as ccRCC or non-ccRCC in a non-invasive manner.Telix's pivotal Phase III ZIRCON trial evaluating TLX250-CDx in 300 patients, of which284 were evaluable, was completed in 2022 and met all primary and secondary endpoints(5). About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercializationof therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telixis headquartered in Melbourne, Australia, with international operations in the UnitedStates, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio ofclinical and commercial stage products that aims to address significant unmet medicalneeds in oncology and rare diseases. Telix is listed on the Australian SecuritiesExchange (ASX: TLX).