Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Technical Presentation (February 2023)
19 slides from Telix Pharmaceuticals's technical presentation, Feb 21, 2023
Slide 1: Results from phase 3 study of 89Zr-DFO-girentuximab PET/CT in ccRCC
Results from phase 3 study of 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma (ccRCC) ZIRCON study (NCT 03849118 ) Brian M. Shuch, Allan J. Pantuck, Jean-Christophe Bernhard, Michael A. Morris, Viraj Master, Andrew Scott, Charles van Praet, Clement Bailly, Tamer Aksoy, Ro
Slide 2: Legal notice
Legal notice This presentation is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, the United States and the United Kingdom). This presentation contains summary information about Telix Pharmaceuticals Li
Slide 3: Disclosures & disclaimer
Disclosures & disclaimer This study was Presenter (Shuch) disclosures listed below v sponsored by Telix Pharmaceuticals Company Role JNJ, Telix, BMS, Genetech, Merck, Veracyte Consulting 89Zr-DFO-girentuximab is not currently approved in any jurisdiction Merck Speaking SWOG, Hope Foundation, DOD, KC
Slide 4: Background
Background Background Unmet medical need in the non-invasive diagnosis There is need for accurate, and characterization of ccRCC in patients noninvasive methods for pre-treatment risk Anatomic imaging cannot Renal mass biopsy is invasive, stratification to help guide reliably distinguish between per
Slide 5: Carbonic anhydrase IX (CAIX) in ccRCC
Carbonic anhydrase IX (CAIX) in ccRCC CAIX upregulation may lead to:1 • Acidification of extracellular pH • Loss of cellular adhesion CAIX is a cell surface, Normoxia: von Hippel-Lindau (VHL) protein • Increased tumor cell migration transmembrane binds to HIF-1a and leads to degradation1 protein ind
Slide 6: CAIX detection with 89Zr-DFO-girentuximab
CAIX detection with 89Zr-DFO-girentuximab Antibody-based PET imaging agent targeting CAIX 89Zr-DFO-girentuximab in CAIX Girentuximab Payload: 89Zr expressing tumors • IgG1 kappa light chain chimeric • Positron emitter • Previous studies show monoclonal antibody • T1/2 3.3 days feasibility imaging CA
Slide 7: ZIRCON study design
ZIRCON study design Eligibility Single indeterminate renal mass ≤7 cm (cT1) in diameter v on CT or MRI suspicious for ccRCC 89Zr-girentuximab administration Initial sample size: n=252 Day 0 Adapted size: n=300 Scheduled for surgical removal Abdominal PET/CT imaginga Performed 5 ± 2 days Blinded cent
Slide 8: Global study participation
Global study participation 300 subjects enrolled between Aug 2019-Aug 2022 | 36 sites | 9 countries v v v Europe | 17 sites North America | 13 sites Australia | 6 sites 8
Slide 9: Patient disposition
Patient disposition 371 Early withdrawal v 8.3% 25 patients Screened Safety reason / Reason for adverse event (2) v early withdrawal 332 Enrolled v Other (12) Lost to follow-up (6) Safety analysis set*, n (%) | 300 (100) Withdrawal of consent (5) Full analysis set**, n (%) | 284 (94.7) * All patient
Slide 10: Population demographics
Population demographics Safety analysis set Evaluable surgical samples Patient characteristic Total (N = 300) Lesion characteristic Total (N = 288) Age, years Lesion median size, range (cm) 3.7 (0.9-7.7) Median (range) 62 (27-87) cT1a (≤ 4 cm) lesions, n (%) 179 (62%) Mean ± SD 61 ± 12 cT1b lesions,
Slide 11: ccRCC - slightly more frequent in larger lesions
ccRCC - slightly more frequent in larger lesions cT1a lesions (≤4 cm), N = 179 cT1b lesions (>4 to ≤7 cm), N = 109 Other Renal Lesions Other Renal Lesions N = 32 (29%) N = 63 (35%) ccRCC ccRCC N = 116 (65%) N = 77 (71%) * All patients who received 89Zr-DFO-girentuximab ** All patients with evaluable
Slide 12: Co-primary endpoints (Full Analysis Set, N = 284)
Co-primary endpoints (Full Analysis Set, N = 284) Sensitivity and specificity thresholds exceeded by all 3 independent readers* Overall % Reader 1 Reader 2 Reader 3 (95% CI) Sensitivity, % 84.13 85.19 87.30 85.5 (79.8, 89.8) Lowest bounds, Wilson 95% CI 78.24 79.42 81.80 Specificity, % 88.42 88.42 8
Slide 13: Key secondary endpoints: cT1a (≤4 cm) Cohort
Key secondary endpoints: cT1a (≤4 cm ) Cohort Sensitivity and specificity thresholds exceeded by all 3 independent readers (FAS) Overall % Reader 1 Reader 2 Reader 3 (95% CI) Sensitivity, % 84.05 86.17 86.17 85.5 Lowest bounds, Wilson 95% CI 75.33 77.76 77.76 (77, 91.2) Specificity, % 90.74 90.74 87
Slide 14: ZIRCON study confirms prior safety and tolerability profile
ZIRCON study confirms prior safety and tolerability profile Very few AEs considered possible or related to 89Zr-DFO-girentuximab Most AEs were mild; only 18 patients (6%) had a ≥ Grade 3 TEAE AE pattern consistent with post-surgical complications related to the nephrectomy No unexpected safety signa
Slide 15: ZIRCON clinical case in a complex cyst
ZIRCON clinical case in a complex cyst Potential support for clinical decision making MRI axial PET axial Fused PET/ CT coronal Diagnostic challenge: Clinical management: • 42 yr male • 89Zr-girentuximab PET scan clearly • Surgery - radical nephrectomy • 3.1 cm (cT1a) left positive→ ccRCC highly lik
Slide 16: ZIRCON clinical case in a 1 cm mass
ZIRCON clinical case in a 1 cm mass Potential support for clinical decision making MRI axial PET axial Fused PET/ CT coronal Diagnostic challenge: Clinical management: • 57 yr male with 1 cm lesion found • 89Zr-DFO-girentuximab PET clearly • Partial nephrectomy incidentally in right kidney positive→
Slide 17: Summary of ZIRCON results
Summary of ZIRCON results Summary of ZIRCON results89 ZIRCON Phase III pivotal study with Zr-DFO-girentuximab has met its primary endpoint, exceeding the sensitivity and specificity targets The study met its key secondary endpoint of sensitivity and specificity in small masses (cT1a ≤4cm) The favora
Slide 18: Summary of ZIRCON results
Summary of ZIRCON results Summary of ZIRCON results 89 These positive results suggest that Zr-DFO-girentuximab improves identification of primary ccRCC compared to cross-sectional imaging 89Zr-DFO-girentuximab has the potential to improve management by aiding risk stratification, selecting appropria
Slide 19: Thank you for your attention!
Thank you for your attention! We would like to acknowledge the invaluable contributions from participating patients, sites, and partners MSKCC Cabrini Hospital Austin Health Peter MacCallum Cancer Centre City of Hope Macquarie University Urology San Antonio CHRU de Nancy – Hôpitaux Jewish General Ho
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