cretostimogene grenadenorepvec (CG0070) / Kissei, CG Oncology - LARVOL DELTA

CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates (GlobeNewswire) - "Anticipated Upcoming Milestones: (i) PIVOT-006 (intermediate-risk NMIBC): Phase 3 enrollment completion in 3Q'25; (ii) Initiation of BLA submission in 4Q'25 for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease; (iii) BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS): Topline data from the Phase 3 clinical trial of cretostimogene monotherapy in 4Q'25; (iv) CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1): Topline data from the Phase 2 clinical trial of cretostimogene monotherapy in 4Q'25; (v) CORE-008 Cohort CX (HR BCG-exposed NMIBC): Topline data from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26."

Clinical data • Enrollment status • FDA filing • Bladder Cancer

BOND-003: Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (clinicaltrials.gov) - P3 | N=190 | Active, not recruiting | Sponsor: CG Oncology, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Emerging bladder-sparing treatments for high risk non-muscle invasive bladder cancer. (PubMed, Bladder Cancer) - "Emerging BSTs include immune checkpoint inhibitors like pembrolizumab and novel agents such as nadofaragene firadenovec and nogapendekin alfa inbakicept (IL-15)...Gene therapies and targeted agents like CG0070 and EG-70 are also gaining traction for their innovative mechanisms...Despite advancements, challenges remain in balancing efficacy, safety, and cost-effectiveness within diverse healthcare settings. This narrative review highlights the evolving landscape of BSTs for HR-NMIBC, emphasising the need for robust clinical evidence to refine patient selection and optimise outcomes."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

Updates to CORE-008: A phase 2 multi-arm, multi-cohort study to evaluate intravesical cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer. (ASCO 2025) - P2 | "Cohort CX, recently added, will evaluate safety and High-Grade Event-Free Survival (HG-EFS) of cretostimogene in combination with intravesical gemcitabine, either concurrent (Arm 1) or sequential (Arm 2) in BCG-exposed and BCG-unresponsive patients. All cohorts are open for enrollment. Cohort B has received collaborative support from the Society of Urologic Oncology-Clinical Trials Consortium (SUO-CTC)."

Clinical • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

CG Oncology Reports First Quarter 2025 Financial Results and Provides Business Updates (GlobeNewswire) - "Anticipated Next Milestones in the Second Half of 2025: Initiation of BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease; PIVOT-006 (intermediate-risk NMIBC): Phase 3 enrollment completion; BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS): Topline data from the Phase 3 clinical trial of cretostimogene monotherapy; CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1): Topline data from the Phase 2 clinical trial of cretostimogene monotherapy."

FDA filing • P2 data • P3 data: top line • Trial status • Bladder Cancer

CORE-008: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: CG Oncology, Inc. | N=200 ➔ 325

Enrollment change • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Current State of Bladder Preservation in High Grade Non-Muscle Invasive Bladder Cancer and Localized Muscle Invasive Bladder Cancer. (PubMed, Curr Oncol Rep) - "Approved novel therapies, including systemic pembrolizumab and intravesical agents such as nadofaragene, nogapendekin alfa inbakicept, and cretostimogene grenadenorepvec, have shown promising results for BCG-unresponsive NMIBC patients. Promising novel therapies, such as immunotherapy, recombinant intravesical therapies, and antibody-drug conjugates are emerging as potential alternatives. These therapies aim to achieve good oncological outcomes while maintaining quality of life, providing an alternative to the decades long standard of care."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

AUA 2025: PIVOT-006: A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec Versus Surveillance for the Treatment of Intermediate-Risk NMIBC (UroToday) - "The 2025 AUA annual meeting featured a bladder cancer clinical trials in progress session and a presentation by Dr. Max Kates discussing 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 (NMIBC)....Patients (~n = 364) will be randomized 1:1 to receive intravesical cretostimogene (Cohort 1) adjuvant to TURBT or surveillance (Cohort 2). Participants in Cohort 2 will be eligible to receive intravesical cretostimogene if recurrence with intermediate risk NMIBC is noted....First enrollments were in January 2024 and is ahead of the expected enrollment period. PIVOT-006 anticipates completing enrollment in late 2025-early 2026."

Trial status • Bladder Cancer

AUA 2025: Updates to the CORE-008 Trial Protocol: A Phase 2 Multi-Arm, Multi-Cohort Study to Evaluate Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk Non-Muscle Invasive Bladder Cancer (UroToday) - "Dr. Trinity Bivalacqua presented updates to the trial protocol of CORE-008, a phase II multi-arm, multi-cohort trial evaluating intravesical cretostimogene grenadenorepvec in high-risk, non-muscle invasive bladder cancer (NMIBC) patients....CORE-008 is a phase II, multi-arm, multi-cohort trial to further evaluate the efficacy and safety of cretostimogene in patients with HR NMIBC, as defined by the AUA guidelines. Two cohorts are specific for cretostimogene monotherapy: Cohort A (BCG-naive) includes patients who have not received prior BCG. Cohort B (BCG-exposed) consists of patients who have received prior BCG and recurred at the initial clinical evaluation at a delayed time point."

Clinical protocol • Bladder Cancer

UPDATES TO THE CORE-008 TRIAL PROTOCOL: A PHASE 2 MULTI-ARM, MULTI-COHORT STUDY TO EVALUATE INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - P2 | "Cohort CX, recently added to the study, will evaluate safety and HG-EFS of cretostimogene in combination with intravesical gemcitabine, either concurrent (Arm 1) or sequential (Arm 2) in BCG-exposed and BCG-unresponsive patients. All cohorts in the CORE-008 study are currently open for recruitment, with approximately one-third of patients already enrolled in Cohort A at the time of abstract submission. Cohort B has received collaborative support from the Society of Urologic Oncology-Clinical Trials Consortium (SUO-CTC)."

Clinical • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

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 (AUA 2025) - P3 | "90+ clinical sites have been selected. Enrollment for PIVOT-006 is ongoing, with approximately one-third of patients already recruited at the time of abstract submission."

Clinical • IO biomarker • P3 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

TRIAL IN PROGRESS: BOND-003 COHORT P- A MULTI-NATIONAL, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR THE TREATMENT OF HIGH-RISK, PAPILLARY ONLY, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - "35+ clinical sites have been selected in the United States and Japan. The study has surpassed 50% enrollment, with interim results expected at the end of 2025."

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2): FINAL RESULTS: BOND-003 COHORT C- PHASE 3, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR HIGH-RISK BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU (AUA 2025) - "The compelling efficacy, durability, freedom from progression, and tolerability of cretostimogene offer distinct advantages over existing therapies for the treatment of HR BCG-UR NMIBC. Ongoing investigations of this promising monotherapy, as well as future combinations, have the potential to address a considerable unmet need for bladder cancer patients."

Clinical • IO biomarker • P3 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

CG Oncology Announces Best-in-Disease Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec at the American Urological Association Annual Meeting (GlobeNewswire) - P3 | N=190 | BOND-003 (NCT04452591) | Sponsor: CG Oncology, Inc. | "The study reported 75.5% complete response (CR) at any time, with 34 confirmed CRs at 24 months and 9 patients pending their 24-month assessment as of the cutoff date of March 14, 2025. The 12- and 24-month CR rates are 50.7% and 42.3% by K-M estimation, respectively. Median duration of response (DOR) is 28 months and is ongoing. Notably, 97.3% of patients were free from progression to muscle invasive disease at 24 months....Additionally, Cohort P, which is in patients with BCG-unresponsive Ta/T1 disease without CIS, showed an estimated 90.5% (95% CI: 77.9, 100.0) high-grade recurrence-free survival at 3 and 9 months in 24 treated patients. A well-tolerated safety profile was observed, consistent with the data in Cohort C."

P3 data • Bladder Cancer

CG Oncology to Host Conference Call and Webcast on BOND-003 Data on Monday, April 28, 2025 (GlobeNewswire) - "CG Oncology, Inc...today announced it will host a conference call and live webcast at 8:00 am ET on April 28, 2025, to discuss results from the Phase 3 BOND-003 trial of cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) to be presented on April 26, 2025, at a Plenary Session at the American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada."

P3 data • Bladder Cancer • Genito-urinary Cancer

Translational Correlates using Urinary Genomic Disease Burden to Assess Cretostimogene Grenadenorepvec: Updated Analysis from the BOND-003 and CORE-001 Trials (AUA 2025) - "Longitudinal reduction in uGDB is associated with favorable response to cretostimogene and a reduced risk of recurrence. These data may inform future clinical trial designs and lend further insights into the use of cretostimogene monotherapy, as well as rational combinations, in a risk-adapted treatment paradigm tailored to baseline and evolving tumor risk."

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2 • TERT • TP53

Trial in Progress: BOND-003 Cohort P- A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (EAU 2025) - No abstract available

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

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 (EAU 2025) - No abstract available

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

CG Oncology Reports 2024 Year End Financial Results and Provides Business Updates (GlobeNewswire) - "CORE-008 Cohort A (HR BCG-naïve NMIBC): Topline data from the Phase 2 clinical trial of cretostimogene monotherapy anticipated in the second half of 2025. CORE-008 Cohort B (HR BCG-exposed NMIBC) and CX (HR BCG-exposed NMIBC): Initiation anticipated in the first half of 2025."

P2 data • Trial status • Bladder Cancer

CG Oncology Reports 2024 Year End Financial Results and Provides Business Updates (GlobeNewswire) - "Anticipated Milestones: Initiation of BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease anticipated in the second half of 2025. BOND-003 Cohort C (HR BCG-unresponsive NMIBC with CIS and with or without Ta/T1 disease): Final data from the Phase 3 clinical trial of cretostimogene monotherapy to be presented at the 120th American Urological Association Annual Meeting. BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS): Topline data from the Phase 3 clinical trial of cretostimogene monotherapy anticipated in the second half of 2025."

FDA filing • P3 data • P3 data: top line • Bladder Cancer

CORE-008: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: CG Oncology, Inc. | N=50 ➔ 200

Enrollment change • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SES AUA 2025: Encore Results: BOND-003 Cohort C – A Phase 3, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for BCG-Unresponsive High-Risk NMIBC with CIS (UroToday) - P3 | N=190 | BOND-003 (NCT04452591) | Sponsor: CG Oncology, Inc. | "The 2025 SESAUA annual meeting featured a bladder cancer session and a presentation by Dr. Shreyas Josh discussing encore results of BOND-003 cohort C, a phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for BCG-unresponsive high risk non-muscle invasive bladder cancer with CIS....Currently, among 110 evaluable patients, the overall complete response rate is 74.5% at any time (95% CI 65.4-82.4%). The 12 month landmark complete response rate is 46% (95% CI 36.9-56.1%), with a 24 month complete response rate by Kaplan-Meier estimate of 41% (95% CI 30.4-50.8). Overall, 97.3% were free from progression to muscle invasive bladder cancer at 12 months, 90.0% were cystectomy free at 12 months, there was consistency of complete response rate across all patient subgroups, and all complete responses were centrally confirmed."

P3 data • Bladder Cancer

CG Oncology to Participate in the 40th Annual European Association of Urology Congress with a Series of Key Presentations and Updates (GlobeNewswire) - "CG Oncology, Inc...announced that a late-breaking abstract on BOND-003 Cohort C, as well as three posters highlighting cretostimogene grenadenorepvec, will be presented at the 40th Annual European Association of Urology (EAU) Congress taking place in Madrid, Spain, from March 21-24, 2025."

Clinical data • Late-breaking abstract • P3 data • Bladder Cancer

Expanded access program of cretostimogene grenadenorepvec in patients with non-muscle invasive bladder cancer unresponsive to bacillus Calmette-Guerin. (ASCO-GU 2025) - P | "A broad cross-section of geographically and socioeconomically diverse clinical sites have been identified. The study is open and actively recruiting."

Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CSF2

CORE-008: A phase 2, multi-arm, multi-cohort, open-label study to evaluate intravesical cretostimogene grenadenorepvec in participants with high-risk non-muscle invasive bladder cancer. (ASCO-GU 2025) - P2 | "Additional HR NMIBC cohorts are under development. Multiple clinical sites have been identified and Cohort B has received collaborative support from the Society of Urologic Oncology-Clinical Trials Consortium."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CSF2