Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — ASCO Genitourinary Cancers Symposium 2024
8 slides from Cg Oncology's conference presentation, 2024
Slide 1: PIVOT-006 Phase 3 Study of Cretostimogene vs Observation in Intermediate Risk NMIBC (Poster)
#437554 PIVOT-006: A Phase 3, Randomized Study of Cretostimogene TPS715 Grenadenorepvec versus Observation for the Treatment of Intermediate Risk NMIBC Following TURBT Robert S. Svatek, MD, MSCI,1 Trinity J. Bivalacqua MD, PhD,2 Kirk A. Keegan, MD, MPH,3 and Siamak Daneshmand, MD 4 1University of Te
Slide 2: PIVOT-006: A Phase 3, Randomized Study of Adjuvant Cretostimogene vs Observation
PIVOT-006: A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk NMIBC Following TURBT Abstract TPS715 Robert S. Svatek, MD, MSCI Global PI, PIVOT-006 Professor, Department of Urology UT Health San Antonio, TX Robert S. Svate
Slide 3: What is Cretostimogene Grenadenorepvec?
What is Cretostimogene Grenadenorepvec? • Conditionally replicating adenovirus o Highly immunogenic o Encodes GM-CSF o Insertion of human E2F-1 promoter • Binds to Coxsackie Adenovirus Receptor (CAR) o Robust expression in all stages of bladder cancer • Viral replication results in tumor lysis in Rb
Slide 4: Significant Unmet Need with High Prevalence of Intermediate-Risk NMIBC in the U.S.
Significant Unmet Need with High Prevalence of Intermediate- Risk NMIBC in the U.S. NMIBC Prevalence NMIBC in U.S. 1 Risk Stratification Intermediate Risk NMIBC • High Recurrence; 50-70%2 Low-Risk • Low Progression; < 5% 2 ~30% High-Risk • Common2 ~40% • Costly3 • Chronic4 All BC • Risk of Anesthesi
Slide 5: NCCN Guidelines: Management per NMIBC Risk Group
National Celene Cancer Network® Comprehensive NCCN Guidelines Version 2.2023 Non-Muscle Invasive Bladder Cancer NCCN Guideli Table of Content! Di MANAGEMENT PER NMIBC RISK GROUP AUA RISK GROUP (SEE BL-2) Low Intermediate > Very-high-risk Bacillus features? Calmette- Guérin ao No very-high- High (BCG
Slide 6: PIVOT-006 Trial Design: Adjuvant Cretostimogene vs TURBT Alone
PIVOT-008 Phase 3 Adjuvant Cretostimogene vs TURBT Alone for IR-NMIBC Up to 426 Two arms, lVe cretostimogene after TURBT vs TURBT Open label Cretostimogene Induction and RFS, RFS at 12-month and 24-month, PFS, & Safety Biomarkers and PROs Maintenance 1:1 Key Entry Criteria Randomization + IR-NMIBC S
Slide 7: PIVOT-006 Design, Regimen and Assessment Schedule
PIVOT-006 Phase 3 Adjuvant Cretostimogene vs TURBT Alone for IR-NMIBC N = Up to 426 Design: Two arms, IVe cretostimogene after TURBT vs TURBT Trial Type: Open label Regimen: Cretostimogene Induction and Endpoints: RFS, RFS at 12-month and 24-month, PFS, & Safety Exploratory: Biomarkers and PROs Main
Slide 8: SUO-CTC and BCAN Support of PIVOT-006
SUO-CTC and BCAN Support- PIVOT-006 Over 90 North American Sites PIVOT-006, SU@ Society of Urologic Oncology < c Hinical Trials Consortium, Ime. ASCO Genitourinary Cancers Symposium
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