Slide 1: Trial in Progress: PIVOT-006 Phase 3 Adjuvant Cretostimogene vs Surveillance in IR-NMIBC
Trial in Progress: PIVOT-006- A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec Versus Surveillance for the Treatment of Intermediate-Risk NMIBC For individual reference only. The information accessed through this QR code is intended solely for individual Max Kates
Slide 2: Disclosures
Disclosures • Consulting/Advisory Boards: Urogen, Aura, Merck, ImmunityBio, CAPSMedical, Janssen, Merck, Pfizer, BMS, Protara • Honorarium: UroToday, UrologyTimes, AUA, Kaplan, BCAN • Clinical Trial Funding: Urogen, Seagen/Pfizer, CG Oncology, Fidia, Merck, Ferring, Aura • Study Chair for EA8212
Slide 3: Cretostimogene Selectively Targets Rb-E2F Pathway Altered Cancers
Cretostimogene Selectively Targets Rb-E2F Pathway Altered Cancers • Oncolytic immunotherapy with dual MOA – Viral replication results in tumor lysis – Stimulation of immune response • Conditionally replicating, highly immunogenic adenovirus – Under regulation of the human E2F-1 promoter – Encodes GM
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 Intermediate- ~30% Risk • Low Progression; < 5%2 ~30% • Common2 All BC • Costly3 NMIBC (75%) High-Risk
Slide 5: Management of Intermediate-Risk NMIBC
Management of Intermediate-Risk NMIBC 4/25/2025 5
Slide 6: Experience with TURBT with Surveillance in NMIBC
Experience with TURBT with Surveillance in NMIBC 63% Freedom from Subsequent TURBT at 1 Year Contieri R., et al. Eur Urol Suppl 2024;85 (S1): S1717 6 4/25/2025
Slide 7: Intermediate-Risk NMIBC Study Considerations
Intermediate-Risk NMIBC Study Considerations • IR-NMIBC is a challenging disease state – Disease is heterogenous – Guidelines recommendations are mixed; Limited adjuvant options • PIVOT-006 is one of the first adjuvant, RCTs in IR-NMIBC • Surveillance as a comparator offers advantages – Reflects tru
Slide 8: Phase 3 Adjuvant Cretostimogene vs Surveillance for Intermediate-Risk NMIBC
Phase 3 Adjuvant Cretostimogene vs Surveillance for Intermediate-Risk NMIBC N = Up to 364 Regimen*: IVE cretostimogene Induction (Weekly x 6) & Trial Type: Phase 3 1- yr Maintenance following TURBT Exploratory: Biomarkers, PROs, Design: Open-label, RCT Endpoints: RFS (primary), RFS at 12-month and 2
Slide 9: Exclusion Criteria
Exclusion Criteria • Current or prior evidence of HR-NMIBC defined as: o HG T1 o HG Ta > 3 cm that is recurrent or multifocal o Any carcinoma in situ (CIS) o Any variant histology o Any HG prostatic urethral involvement o Any LVI o Any BCG treatment failure in HG patient • LR-NMIBC o A LG solitary,
Slide 10: Efficacy Assessments
Efficacy Assessments • Efficacy Assessments • Recurrence Free Assessment - Visit, cystoscopy, biopsy for cause, cytology - Without recurrence or o Q3mo, first 2 years progression in the bladder o Q6mo, 3rd year - Upper tract or prostatic urethra - Imaging o Q12mo - Mapping biopsy/imaging for isolate
Slide 11: Strong Enrollment Momentum on PIVOT-006
Strong Enrollment Momentum on PIVOT-006 • SUO-CTC trial • Diverse representation across LUGPA & Academic sites • First enrollments January 2024 • Ahead of expected enrollment period • Anticipate completing enrollment late 2025-early 2026 4/25/2025 11
Slide 12: Acknowledgements
Acknowledgements All Bladder Cancer Patients and Their Families The Study Coordinators and Nurses Key Collaborators CG Oncology Shelly Basye Robert Svatek, UTHSA, TX Jee-Hyun Kim Trinity Bivalacqua, Univ of Penn, PA Kristen Scholz Neal Shore, CURC, SC Maira Ansari Gautam Jayram, Urology Associates,
Slide 13: Thank You
Thank You For individual reference only. The information accessed through this QR code is intended solely for individual reference and should not be altered, modified, or reproduced in any way.