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

Oncolytic virotherapy: molecular mechanisms, delivery strategies, and translational insights. (PubMed, Crit Rev Oncol Hematol) - "We highlight trials where OVs prime checkpoint response (e.g., DNX-2401→pembrolizumab in recurrent glioblastoma) and where vector design (e.g., TK-deleted vaccinia, CG0070) or payloads (e.g., IFNβ, NIS) drive measurable benefit. We conclude with actionable priorities, patient selection by IFN-pathway competence, receptor-tropism panels, and rational OV-ICI sequencing, to accelerate durable responses."

Journal • Review • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IFNB1

Gene Therapy for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Current Evidence and Future Directions. (PubMed, Cancers (Basel)) - P1/2, P2, P3 | " Nadofaragene firadenovec, a recombinant adenovirus delivering interferon alpha-2b (IFNα2b), is the first FDA-approved gene therapy for BCG-unresponsive NMIBC with carcinoma in situ (CIS)...Cretostimogene grenadenorepvec (CG0070), an oncolytic vector, demonstrated a 47% 6-month CR rate in a phase II study (NCT02365818). Detalimogene voraplasmid (EG-70), a nonviral gene therapy, demonstrated a 47% 6-month CR in a phase I/II study (NCT04752722). Future advances are likely to focus on patient selection, novel vectors, and combination strategies to improve treatment outcomes. Gene therapy represents a significant addition to the bladder cancer treatment landscape by offering bladder-sparing alternatives where conventional therapies are limited."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • Urethral Cancer • Urothelial Cancer • IFNA1

CG Oncology to Present Results on Cretostimogene Grenadenorepvec at the Society of Urologic Oncology (SUO) 26th Annual Meeting (GlobeNewswire) - "...Two late breaking podium presentations on the topline results from BOND-003 Cohort P (BCG-Unresponsive in papillary-only) and first results from CORE-008 Cohort A (BCG-Naïve with carcinoma in situ) as well as three additional posters, will be presented..."

Clinical data • Late-breaking abstract • Bladder Cancer

CONTEMPORARY EXPERIENCE USING GENE THERAPIES FOR NMIBC AT AN ACADEMIC CENTER: OUTCOMES AND SEQUENCING (SUO 2025) - "These are: nadofarogene firadenovec-vncg, cretostimogene grenadenorepvec, and detalimogene voraplasmid...Of these, 5 (24%) were retreated with the same agent and eight (38%) were treated with gemcitabine/docetaxel... In this single-institution experience, intravesical gene therapy offered a bladder-preserving option for patients with BCG-unresponsive NMIBC, including those with high-risk CIS and T1 disease. While high-grade recurrence remained common, treatment with an alternative GT agent offers durable disease control in a subset of patients, with additional salvage possible with the same GT agent or gem/doce in well selected patients. These findings highlight the evolving role of gene therapy in the management of BCG-unresponsive NMIBC and the opportunity for future work to refine sequencing strategies and optimize long-term outcomes."

Gene therapy • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Solid Tumor

CORE-008 COHORT B: EVALUATING INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK, BCG-EXPOSED NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P2 | "Cohort B is now open for enrollment in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). "

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

FIRST RESULTS FROM CORE-008 COHORT A- PHASE 2 STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK BCG-NAÏVE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P2 | "The first results from CORE-008 Cohort A demonstrate that cretostimogene has promising clinical efficacy and safety in patients with high-risk, BCG-naïve NMIBC. These findings support the further evaluation of cretostimogene in the early, HR NMIBC disease continuum. Additional analyses are planned in patients with high-grade BCG-naïve Ta/T1 papillary-only NMIBC, within CORE-008, Cohort A."

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

DESIGN AND IMPLEMENTATION OF A PATIENT-CENTRIC EXPANDED ACCESS PROGRAM WITH CRETOSTIMOGENE GRENADENOREPVEC IN NON-MUSCLE INVASIVE BLADDER CANCER UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (SUO 2025) - P | "The study is actively enrolling, with initial patients treated. "

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

DURABLE 24-MONTH OUTCOMES FROM BOND-003 COHORT C: PHASE 3 STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR HIGH-RISK BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU (SUO 2025) - P3 | "Cretostimogene offers distinct advantages with its efficacy, durability and safety profile for the treatment of HR BCG-UR NMIBC. Ongoing and future investigations of this promising therapy, as monotherapy and in rational combinations, may address the considerable unmet need for patients with bladder cancer."

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

Initiated BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease (GlobeNewswire) - "...Complete submission expected in 2026."

FDA filing • Bladder Cancer

TOPLINE RESULTS FROM BOND-003 COHORT P- A MULTI-NATIONAL, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR TREATMENT OF HIGH-RISK, PAPILLARY ONLY, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P3 | "Results from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-RFS and a consistent, well-tolerated safety profile. Mature data with longer term follow-up will build upon these promising findings and will inform future treatment approaches with cretostimogene in High-Risk papillary-only BCG-UR NMIBC."

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

Anticipated Upcoming Milestones (GlobeNewswire) - "(i) 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; (ii) CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1): First results from the Phase 2 clinical trial of cretostimogene monotherapy in 4Q’25; (iii) 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 • Bladder Cancer

Ongoing Trial: Bond-003 Cohort P- a Multi-National, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (SIU 2025) - No abstract available

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

Encore Durability Results From 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 (SIU 2025) - No abstract available

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

UC Davis Leads Region’s First Groundbreaking Clinical Trial for Bladder Cancer (Managed Healthcare Executive) - "In September, UC Davis Comprehensive Cancer Center announced it has become the first in the region to offer a pioneering clinical trial targeting intermediate-risk nonmuscle invasive bladder cancer (IR-NMIBC). The study, known as PIVOT-006, is a phase 3 randomized controlled trial that compares the experimental drug cretostimogene against observation, aiming to improve outcomes and preserve the bladder in affected patients."

Trial status • Bladder Cancer

Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer. (PubMed, Cancer Med) - "The treatment landscape for BCG-unresponsive NMIBC is rapidly evolving, with immune checkpoint inhibitors, gene therapies, targeted agents, and advanced drug delivery systems showing promising efficacy. These innovations provide bladder-preserving options for patients ineligible for radical cystectomy. Future directions include biomarker-driven therapy selection, combination regimens, and optimized intravesical delivery platforms to improve long-term outcomes."

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

Gene-mediated therapy for BCG-unresponsive nonmuscle-invasive bladder cancer: mechanisms, clinical evidence, and practical implementation. (PubMed, Curr Opin Urol) - "Gene-mediated therapy is gradually advancing NMIBC care, with expanding indications and potent combinations positing itself to improve bladder preservation and long-term outcomes."

IO biomarker • Journal • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor

INNOVATIONS IN THERAPIES FOR BACILLUS CALMETTE-GUERIN (BCG) FAILURE NON-MUSCLE INVASIVE PATIENTS (PubMed, Harefuah) - "Diverse treatments, both systemic and local, administered directly into the bladder, have been investigated in recent years to mitigate the need for cystectomy. This review article provides an overview of current approved therapeutic options such as combined intravesical chemotherapy with gemcitabine and docetaxel, systemic therapy with pembrolizumab, intravesical therapy with nadofaragene firadenovec, and innovative investigational treatments including TAR-200 drug-releasing supplement therapy and novel viral therapy, cretostimogene grenadenorepvec."

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

Study of CG0070 After Transurethral Resection in Patients With IR NMIBC (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Sep 2027 | Trial primary completion date: Mar 2027 ➔ Sep 2027

Enrollment closed • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

PIVOT-006: A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT (clinicaltrials.gov) - P3 | N=367 | Active, not recruiting | Sponsor: CG Oncology, Inc. | Recruiting ➔ Active, not recruiting

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

Oncolytic virus therapy for nonmuscle-invasive bladder cancer: current status and future directions. (PubMed, Curr Opin Urol) - "Oncolytic virus therapy represents a paradigm shift toward an effective bladder-preserving treatment for BCG-unresponsive NMIBC. With phase 3 data supporting regulatory approval pathways, these therapies are poised to become new standards of care, offering hope for improved outcomes while avoiding radical surgery."

Journal • Bladder Cancer • Genito-urinary Cancer • Herpes Simplex • Infectious Disease • Measles • Oncology • Solid Tumor

CG Oncology Completes Enrollment in PIVOT-006 (GlobeNewswire) - "Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC)."

Enrollment closed • Bladder Cancer

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