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CG Oncology (NASDAQ: CGON) has announced significant results for cretostimogene grenadenorepvec in treating bladder cancer at the 2025 American Urological Association Annual Meeting. The Phase 3 BOND-003 Cohort C study showed impressive durability with a 24-month complete response rate of 42.3% in high-risk non-muscle invasive bladder cancer (NMIBC) patients.
Key findings include:
- 75.5% complete response rate at any time
- 97.3% of patients remained free from progression to muscle invasive disease at 24 months
- 91.6% of responders remained cystectomy-free at 24 months
- Median duration of response of 28 months (ongoing)
Additionally, Cohort P demonstrated 90.5% high-grade recurrence-free survival at 3 and 9 months. The treatment showed excellent safety with no Grade 3 or greater treatment-related adverse events reported.
CG Oncology (NASDAQ: CGON) ha annunciato risultati significativi per cretostimogene grenadenorepvec nel trattamento del cancro alla vescica durante il Congresso Annuale 2025 dell’American Urological Association. Lo studio di Fase 3 BOND-003 Coorte C ha mostrato un’impressionante durata con un tasso di risposta completa a 24 mesi del 42,3% nei pazienti con carcinoma della vescica non muscolo-invasivo ad alto rischio (NMIBC).
Risultati chiave includono:
- 75,5% di tasso di risposta completa in qualsiasi momento
- 97,3% dei pazienti senza progressione verso malattia muscolo-invasiva a 24 mesi
- 91,6% dei responder senza necessità di cistectomia a 24 mesi
- Durata mediana della risposta di 28 mesi (in corso)
Inoltre, la Coorte P ha dimostrato un 90,5% di sopravvivenza senza recidive di alto grado a 3 e 9 mesi. Il trattamento ha mostrato un’eccellente sicurezza, senza eventi avversi correlati al trattamento di grado 3 o superiore segnalati.
CG Oncology (NASDAQ: CGON) ha anunciado resultados significativos para cretostimogene grenadenorepvec en el tratamiento del cáncer de vejiga en la Reunión Anual 2025 de la American Urological Association. El estudio de Fase 3 BOND-003 Cohorte C mostró una durabilidad impresionante con una tasa de respuesta completa a 24 meses del 42,3% en pacientes con cáncer de vejiga no músculo invasivo de alto riesgo (NMIBC).
Los hallazgos clave incluyen:
- 75,5% de tasa de respuesta completa en cualquier momento
- 97,3% de los pacientes permanecieron libres de progresión a enfermedad músculo invasiva a los 24 meses
- 91,6% de los respondedores permanecieron libres de cistectomía a los 24 meses
- Duración media de la respuesta de 28 meses (en curso)
Además, la Cohorte P demostró una supervivencia libre de recurrencia de alto grado del 90,5% a los 3 y 9 meses. El tratamiento mostró una excelente seguridad, sin eventos adversos relacionados con el tratamiento de grado 3 o mayor reportados.
CG Oncology (NASDAQ: CGON)는 2025년 미국비뇨기과학회 연례회의에서 방광암 치료를 위한 크레토스티모진 그레나데노레프벡의 중요한 결과를 발표했습니다. 3상 BOND-003 코호트 C 연구는 고위험 비근육침윤성 방광암(NMIBC) 환자에서 24개월 완전 반응률 42.3%라는 인상적인 내구성을 보여주었습니다.
주요 결과는 다음과 같습니다:
- 언제든지 75.5% 완전 반응률
- 24개월 시점에 97.3% 환자가 근육 침윤성 질환 진행 없이 유지
- 24개월 시점에 91.6% 반응자들이 방광 절제술 없이 유지
- 반응의 중앙 지속 기간 28개월 (진행 중)
추가로, 코호트 P는 3개월 및 9개월에 90.5%의 고등급 재발 무병 생존율을 보였습니다. 치료는 3등급 이상의 치료 관련 이상반응이 보고되지 않아 우수한 안전성을 나타냈습니다.
CG Oncology (NASDAQ : CGON) a annoncé des résultats significatifs pour le crétostimogène grenadénorépvec dans le traitement du cancer de la vessie lors de la réunion annuelle 2025 de l’American Urological Association. L’étude de phase 3 BOND-003 cohorte C a montré une durabilité impressionnante avec un taux de réponse complète à 24 mois de 42,3% chez les patients atteints de cancer de la vessie non invasif à haut risque (NMIBC).
Les résultats clés incluent :
- Taux de réponse complète de 75,5% à tout moment
- 97,3% des patients sont restés sans progression vers une maladie musculaire invasive à 24 mois
- 91,6% des répondeurs sont restés sans cystectomie à 24 mois
- Durée médiane de la réponse de 28 mois (en cours)
De plus, la cohorte P a démontré une survie sans récidive de haut grade de 90,5% à 3 et 9 mois. Le traitement a montré une excellente sécurité, aucun événement indésirable lié au traitement de grade 3 ou plus n’ayant été rapporté.
CG Oncology (NASDAQ: CGON) hat bedeutende Ergebnisse für Cretostimogene Grenadenorepvec bei der Behandlung von Blasenkrebs auf dem Jahreskongress 2025 der American Urological Association vorgestellt. Die Phase-3-Studie BOND-003 Kohorte C zeigte eine beeindruckende Dauerhaftigkeit mit einer 24-Monats-Komplettansprechrate von 42,3% bei Patienten mit Hochrisiko-nicht-muskelinvasivem Blasenkrebs (NMIBC).
Wichtige Ergebnisse umfassen:
- 75,5% Komplettansprechrate zu jedem Zeitpunkt
- 97,3% der Patienten blieben 24 Monate ohne Progression zur muskelinvasiven Erkrankung
- 91,6% der Ansprechenden blieben 24 Monate ohne Zystektomie
- Medianes Ansprechdauer von 28 Monaten (laufend)
Zusätzlich zeigte Kohorte P eine 90,5% hochgradige rezidivfreie Überlebensrate bei 3 und 9 Monaten. Die Behandlung zeigte eine ausgezeichnete Sicherheit, es wurden keine behandlungsbedingten Nebenwirkungen Grad 3 oder höher berichtet.
Positive
- Strong efficacy with 42.3% complete response rate at 24 months
- Excellent safety profile with no Grade 3 or greater adverse events
- High patient compliance rate of 97.3%
- Promising 90.5% recurrence-free survival in Cohort P
- 97.3% of patients remained free from progression to muscle invasive disease
Negative
- Complete response rate decreases from 50.7% at 12 months to 42.3% at 24 months
Insights
Cretostimogene shows exceptional 42.3% 24-month complete response in BCG-unresponsive bladder cancer with unprecedented safety profile and durability.
The Phase 3 BOND-003 data for cretostimogene grenadenorepvec represents a potential breakthrough in treating BCG-unresponsive high-risk NMIBC. The 42.3% 24-month complete response rate by K-M estimation demonstrates remarkable durability in this challenging population. Most striking is that 97.3% of patients remained free from progression to muscle-invasive disease at 24 months—critical since progression typically necessitates radical cystectomy.
The median 28-month duration of response (still ongoing) significantly exceeds what we typically see with other therapies in this space. The safety profile is unprecedented—zero Grade 3+ treatment-related adverse events in a heavily pretreated population (median 12 prior BCG doses). The 97.3% treatment completion rate indicates exceptional tolerability rare in oncology therapeutics.
Cohort P’s data showing 90.5% high-grade recurrence-free survival at both 3 and 9 months suggests efficacy across different NMIBC subtypes (Ta/T1 without CIS). This broadens cretostimogene’s potential utility beyond CIS-containing disease.
With 110 efficacy-evaluable patients, this represents the largest study in this patient population. The dual mechanism of action appears to effectively address both CIS and papillary lesions, positioning cretostimogene as a potential backbone therapy across multiple NMIBC presentations where treatment options remain
CG Oncology’s Phase 3 data shows best-in-disease efficacy and safety for cretostimogene, substantially elevating its commercial prospects.
These Phase 3 BOND-003 results materially enhance CG Oncology’s clinical and commercial profile. The 42.3% 24-month complete response rate demonstrates superior durability in BCG-unresponsive NMIBC—a notoriously difficult-to-treat indication. Most compelling is the 91.6% cystectomy-free rate among responders at 24 months, representing substantial clinical value as bladder preservation significantly impacts quality of life.
The exemplary safety profile—with zero Grade 3+ treatment-related adverse events and one-day median resolution time for adverse events—positions cretostimogene favorably against existing therapeutic options. The 97.3% treatment completion rate indicates exceptional patient adherence, a critical factor for commercial success.
The efficacy extension to Cohort P (Ta/T1 disease without CIS) with 90.5% high-grade recurrence-free survival at 9 months broadens the potential addressable market. With 110 patients, this is the largest study in this patient population to date, providing robust evidence for regulatory consideration.
These results validate cretostimogene’s unique dual mechanism of action in addressing high-risk NMIBC. The data strengthens CG Oncology’s position in the bladder cancer space and supports the company’s strategic positioning of cretostimogene as a potential backbone therapy for bladder cancer treatment.
– Robust 24-month complete response rate of 42.3% by K-M for cretostimogene monotherapy in BOND-003 Cohort C –
– 58.3% of patients showed durable complete responses by K-M at 24 months –
– 97.3% of all treated patients remained free from progression to MIBC at 24 months–
– 91.6% of responders remained cystectomy-free at 24 months –
– No Grade 3 or greater treatment-related adverse events or deaths reported –
– Strong initial Cohort P data reported 90.5% high-grade recurrence-free survival at 3 and 9 months by K-M –
– Company will host a conference call and webcast at 8 a.m. EDT on Monday, April 28, 2025 –
IRVINE, Calif., April 26, 2025 (GLOBE NEWSWIRE) — CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that cretostimogene grenadenorepvec monotherapy data was presented at the Practice-Changing, Paradigm-Shifting Clinical Trials in Urology Plenary Session at the 2025 American Urological Association (AUA) Annual Meeting, in Las Vegas, Nevada.
The Phase 3 BOND-003 Cohort C study is in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. 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.
| BOND-003 Cohort C | CR Rate, % (95% CI) |
CR by K-M estimate, % (95% CI) |
DOR by K-M estimate, % (95% CI) |
| 12-month | 46.4% (36.9, 56.1)1 | 50.7% (40.9, 59.8) | 64.1% (52.4, 73.7) |
| 24-month | 33.7% (24.8, 43.8)2 | 42.3% (32.7, 51.6) | 58.3% (46.3, 68.5) |
1 CR rate observed in 51 out of 110 patients
2 CR rate observed in 34 out of 101 evaluable patients, pending 9 ongoing CRs yet to reach 24-month assessment
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.
“We continue to see strong safety and efficacy, as well as best-in-disease durability and tolerability, with cretostimogene at the 24-month mark, in a high-risk, heavily pretreated NMIBC patient population,” said Gary D. Steinberg, M.D., Professor, Department of Urology at Rush University Medical Center. “Now, we have Cohort P data demonstrating cretostimogene also has activity and efficacy in BCG-unresponsive patients with Ta/T1 lesions. This body of evidence demonstrates the power of cretostimogene’s unique dual mechanism of action, its potential to treat different tumor types across high-risk NMIBC, positioning it as a potential breakthrough, backbone therapy in bladder cancer treatment.”
A total of 110 highly pretreated patients are efficacy evaluable in the BOND-003 Cohort C study, which makes it the largest study in this patient population to date. These patients received a median of 12 prior BCG doses, some as high as 66. Prior intervening therapy also included intravesical chemotherapy (41.1%) and systemic immunotherapy (6.3%). Despite their highly pretreated conditions, patients tolerated cretostimogene treatment well. There were no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. Patients who experienced TRAEs of any grade had a median resolution time of one day. No treatment-related discontinuation of cretostimogene was observed. 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.
“The compelling efficacy, durability, freedom from progression to muscle-invasive disease, and tolerability of cretostimogene offer potential, distinct advantages over existing therapies for the treatment of high-risk BCG-unresponsive NMIBC,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “Ongoing investigations of this promising monotherapy, as well as future combinations, have the potential to address a considerable unmet need for bladder cancer patients. This suggests that, if approved, cretostimogene will represent an important advancement for people suffering with bladder cancer, and we are working diligently to bring it forward to patients.”
Investor Conference Call
CG Oncology will host a conference call and webcast at 8 a.m. EDT on Monday, April 28, 2025. Individuals can access the webcast via the link on the company’s Investor Relations website https://ir.cgoncology.com. An archive will be available following the completion of the call.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients, its potential to have best-in-disease durability and tolerability, and that cretostimogene offers distinct advantages over existing therapies for the treatment of HR BCG-UR NMIBC. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: additional patient data related to cretostimogene that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; potential delays in the commencement, enrollment and completion of clinical trials; competitive developments with respect to current and other investigational NMIBC treatments may adversely affect the commercial opportunity of cretostimogene; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
(508) 654-2277
sarah.connors@cgoncology.com
Investor Relations
Chau Cheng
Vice President, Investor Relations, CG Oncology
(949) 342-8939
chau.cheng@cgoncology.com
FAQ
What are the key efficacy results of CGON’s cretostimogene in the BOND-003 Cohort C trial?
The trial showed a 42.3% complete response rate at 24 months, with 97.3% of patients remaining free from progression to muscle invasive disease and a median duration of response of 28 months.
How safe is CGON’s cretostimogene treatment for bladder cancer patients?
The treatment demonstrated excellent safety with no Grade 3 or greater treatment-related adverse events or deaths reported. Common side effects included bladder spasm, pollakiuria, and dysuria.
What are the Cohort P results for CGON’s cretostimogene in bladder cancer?
Cohort P showed 90.5% high-grade recurrence-free survival at both 3 and 9 months in BCG-unresponsive Ta/T1 disease patients.
How many patients completed the full treatment course with CGON’s cretostimogene?
97.3% of patients completed all expected treatments, demonstrating strong patient adherence and compliance.
