cretostimogene grenadenorepvec (CG0070)

MP-10.01 Diffusion-Weighted Magnetic Resonance Imaging for Assessment of Tumor Response in Muscle-Invasive Bladder Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Prospective StudyAbbas Basiri, Iran, Islamic Rep. MP-10.02 Divergent Experiences of Bladder Cancer Patients: A Focus on Advanced and Metastatic Disease StagesAlex Filicevas, Belgium MP-10.03 Evolution of a Rapid, Simple Urine Test for Detecting Volatile Organic Compound (VOC) in Urine by a High Performance Portable Device (NABIL) for Detection of Urinary Bladder CarcinomaSaurav Karmakar, India MP-10.04 Intraoperative ICG Fluorescence as a Method of Prevention of Postoperative Strictures of Uretero-Ileoanastomoses During Robot-Assisted Radical CystectomyValentin Pavlov, Russian Federation MP-10.05 Intravesical Gemcitabine and Docetaxel in Patients with High Risk NMIBC: Our ExperienceDeepak Krishnappa, India MP-10.06 On Block Robot-Assisted Radical Cystectomy: New Method for Bladder CancerValentin Pavlov, Russian Federation MP-10.07 Oncological Outcomes with the 80mg Dose of the Moscow Strain of Intravesical BCG for Non-Muscle Invasive Bladder Cancer: Implications for Global ShortageAmandeep Arora, India MP-10.08 Outcome of Robot-Assisted Radical Cystectomy with Intracorporeal Creation of Heterotopic NeocystisValentin Pavlov, Russian Federation MP-10.09 Proposed Novel Surveillance Schedule Using Cx Monitor for Patients on Annual Bladder Cancer SurveillanceArjun Guduguntla, Australia MP-10.10 Quality of Primary TURBTs for Non-Muscle Invasive Bladder Cancer PatientsSaurabh Verma, United Kingdom MP-10.11 TAR-200 in Patients with Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results from the SunRISe-1 StudyAndrea Necchi, United States MP-10.12 Timeline Analysis of Muscle Invasive Bladder Cancer PatientsSaurabh Verma, United Kingdom MP-10.13 Transurethral Resection of Bladder Tumour (TURBT) Operative Notes: How to Improve Their QualitySaurabh Verma, United Kingdom MP-10.14 Trial in Progress: PIVOT-006- A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer Following Transurethral Resection of Bladder TumorRobert Svatek, United States MP-10.15 URO17® Urine Test For Bladder Cancer - Meta AnalysisNikhil Vasdev, United Kingdom MP-10.16 Usefulness of UF-5000 Automatic Screening System in Urothelial Carcinoma DiagnosisTadahiko Kikugawa, Japan MP-10.17 Validation of Novel ddPCR Bladder Cancer DNA Mutation Panels in Liquid BiopsiesAntara Karmakar, Australia

P2, N=50, Recruiting, CG Oncology, Inc. | Not yet recruiting --> Recruiting

P2, N=35, Completed, CG Oncology, Inc. | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> May 2024

P2, N=50, Not yet recruiting, CG Oncology, Inc.

The bi-specific siRNA strategy, encapsulated in an adenovirus, could be a promising tool to augment cancer treatment efficacy and overcome conventional therapy limitations associated with "undruggability." Hence, we propose that dual targeting of mTOR and STAT3 is an advantageous strategy for intravesical therapy using adenoviruses.

P=N/A, N=0, Available, CG Oncology, Inc.

P3, N=190, Recruiting, CG Oncology, Inc. | N=110 --> 190 | Trial completion date: Jul 2025 --> Dec 2029 | Trial primary completion date: Jan 2024 --> Dec 2027

P1, N=20, Recruiting, H. Lee Moffitt Cancer Center and Research Institute

P3, N=426, Recruiting, CG Oncology, Inc. | Not yet recruiting --> Recruiting

Exploratory outcome measures include patient-reported quality of life, biomarker analyses, coxsackie adenovirus receptor and E2F promoter expression, neutralizing antibodies, and markers of immunogenicity. Clinical trial information: Pending.

P3, N=426, Not yet recruiting, CG Oncology, Inc.

As a self-replicating biologic, it shares many characteristics with intravesical BCG but has other unique features. Herein, we detail recommended standardized protocols for bladder infusion of CG0070 for the treatment of bladder cancer and provide many useful tips for trouble shooting.

This initial data on the efficacy and safety of CG0070 plus pembrolizumab for the treatment of BCG unresponsive NMIBC is encouraging. Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference.

P1, N=21, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=30 --> 21 | Trial completion date: Nov 2023 --> Mar 2025 | Trial primary completion date: Nov 2023 --> Mar 2025

P1, N=30, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023

Conclusions : The combination of CG0070 and pembrolizumab has been well tolerated with encouraging early efficacy data. An update on this ongoing trial will be provided at the time of presentation.

The study is currently enrolling. An update on trial enrollment and preliminary data will be provided at the time of presentation.

Study enrollment globally is ongoing.

Study enrollment across the US and Asia Pacific regions is planned to be completed over the next 24 m. An update on trial enrollment and preliminary data will be presented at the time of presentation. Funding: N/A

P1, N=30, Recruiting, H. Lee Moffitt Cancer Center and Research Institute