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Telix Pharmaceuticals Limited: Detailed Results from Telix's ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU

Trial met primary and secondary endpoints and confirmed favourable safety and tolerability profile, indicating TLX250-CDx has the potential to become a new clinical standard in the identification ....

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Detailed Results from Telix's ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU

Trial met primary and secondary endpoints and confirmed favourable safety and tolerability profile, indicating TLX250-CDx has the potential to become a new clinical standard in the identification and characterisation of clear cell renal cell carcinoma (ccRCC): Primary endpoint met: Sensitivity of 84% and specificity of 84% in all three readers (86% / 87% overall) Considerably exceeds confirmatory trial sensitivity and specificity success targets Key secondary endpoints met, achieving 85% sensitivity and 89% specificity in small renal masses (cT1a 4cm) Full data set: 93% positive predictive value; 75% negative predictive value; 86% accuracy (secondary endpoints) cT1a masses:93% positive predictive value; 78% negative predictive value; 87% accuracy Case study presented on a 1cm mass, demonstrating potential for clinical decision making with renal masses 2cm Favourable safety and tolerability profile of TLX250-CDx also confirmed MELBOURNE, Australia, Feb. 20, 2023 /PRNewswire/ Telix Phar ....

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Detailed Results from Telix's ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU

Trial met primary and secondary endpoints and confirmed favourable safety and tolerability profile, indicating TLX250-CDx has the potential to become a new. ....

United States , United Kingdom , Los Angeles , Kyahn Williamson , Colin Hayward , Peter Mulders , Brian Shuch , European Association Of Urology , Telix Pharmaceuticals , American Society Of Clinical Oncology , Drug Administration , Institute Of Urologic Oncology Los Angeles , Telix Group , Australian Securities Exchange , Australian Therapeutic Goods Administration , Kidney Cancer Program , Corporate Communications , Telix Pharmaceuticals Limited , Health Canada , Associate Professor Brian Shuch , Urologic Oncology , Principal Investigator , American Society , Clinical Oncology , Cancers Symposium , Prof Brian Shuch ,

Detailed Results from Telix's ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU

Trial met primary and secondary endpoints and confirmed favourable safety and tolerability profile, indicating TLX250-CDx has the potential to become a new. ....

United States , United Kingdom , Los Angeles , Kyahn Williamson , Colin Hayward , Peter Mulders , Brian Shuch , European Association Of Urology , Telix Pharmaceuticals , American Society Of Clinical Oncology , Drug Administration , Institute Of Urologic Oncology Los Angeles , Telix Group , Australian Securities Exchange , Australian Therapeutic Goods Administration , Kidney Cancer Program , Corporate Communications , Telix Pharmaceuticals Limited , Health Canada , Associate Professor Brian Shuch , Urologic Oncology , Principal Investigator , American Society , Clinical Oncology , Cancers Symposium , Prof Brian Shuch ,

Telix Announces Positive Topline Results of ZIRCON Phase III Kidney Cancer Imaging Study

Summary of Study Outcomes ZIRCON Phase III study of Telix's investigational imaging agent TLX250-CDx in clear cell renal cell carcinoma (ccRCC) has met all of its primary and secondary endpoints The study delivered co-primary endpoints of 86% sensitivity and 87% specificity and 93% positive predictive value (secondary endpoint) considerably exceeding sensitivity and specificity targets These ground-breaking results indicate that TLX250-CDx has the potential to become a new clinical standard in the diagnosis of ccRCC and deliver an unmet medical need for a non-invasive diagnostic tool in this disease setting Based on these positive results, Telix will progress towards a Biologics License Application (BLA) filing with the U.S. Food and Drug Administration (FDA) and worldwide regulatory filings in key commercial jurisdictions MELBOURNE, Australia, Nov. 7, 2022 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces highly positive top-line results fr ....

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