CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months
CG Oncology (NASDAQ: CGON) has reported impressive updated data from its BOND-003 Cohort C trial for cretostimogene, showing a 41.8% complete response (CR) rate at 24 months in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG treatment.
The study demonstrated remarkable durability with 90% of 12-month responders remaining disease-free at 24 months. Among 110 heavily pretreated patients, 96.6% remained free from progression to muscle invasive disease at 24 months. The treatment showed excellent tolerability with no Grade 3 or greater treatment-related adverse events.
The company plans to initiate its BLA submission for cretostimogene in Q4 2025, positioning it as a potential breakthrough bladder-sparing therapeutic option.
CG Oncology (NASDAQ: CGON) ha comunicato dati aggiornati molto solidi dal trial BOND-003 Coorte C per cretostimogene, mostrando un tasso di risposta completa (CR) del 41,8% a 24 mesi in pazienti con carcinoma vescicale non muscolo-invasivo (NMIBC) ad alto rischio non responsivo al trattamento con BCG.
Lo studio ha evidenziato una notevole durabilità, con il 90% dei responder a 12 mesi ancora liberi da malattia a 24 mesi. Tra 110 pazienti fortemente pretrattati, il 96,6% è rimasto libero da progressione verso malattia muscolo-invasiva a 24 mesi. Il trattamento è risultato ben tollerato, senza eventi avversi correlati di grado 3 o superiore.
L’azienda prevede di avviare la sottomissione della BLA per cretostimogene nel quarto trimestre 2025, collocandolo come possibile opzione terapeutica innovativa che preserva la vescica.
CG Oncology (NASDAQ: CGON) ha informado datos actualizados muy sólidos de su ensayo BOND-003 Cohorte C para cretostimogene, mostrando una tasa de respuesta completa (CR) del 41,8% a 24 meses en pacientes con cáncer de vejiga no músculo-invasivo (NMIBC) de alto riesgo no responsive al tratamiento con BCG.
El estudio demostró una durabilidad notable, con el 90% de los respondedores a 12 meses permaneciendo libres de enfermedad a 24 meses. Entre 110 pacientes fuertemente pretratados, el 96,6% permaneció libre de progresión a enfermedad músculo-invasiva a 24 meses. El tratamiento mostró una excelente tolerabilidad sin eventos adversos relacionados de grado 3 o superior.
La compañía planea iniciar la presentación de la BLA para cretostimogene en el cuarto trimestre de 2025, posicionándolo como una posible opción terapéutica innovadora que preserva la vejiga.
CG Oncology (NASDAQ: CGON)는 크레토스티모진(crelostimogene)에 대한 BOND-003 코호트 C 시험의 업데이트된 유의미한 데이터를 보고했으며, BCG 치료에 반응하지 않는 고위험 비근육침습성 방광암(NMIBC) 환자에서 24개월 시점에 41.8%의 완전관해(CR)율을 보였습니다.
연구는 뛰어난 지속성을 입증했으며, 12개월 반응자 중 90%가 24개월 시점에도 무병 상태를 유지했습니다. 광범위한 전처치 경험이 있는 110명 중 96.6%가 24개월 시점에 근육침습성 질환으로의 진행 없이 지냈습니다. 치료는 매우 양호한 내약성을 보였고, 관련된 3등급 이상 이상반응은 보고되지 않았습니다.
회사는 크레토스티모진에 대한 BLA 제출을 2025년 4분기에 시작할 계획이며, 방광을 보존하는 획기적 치료 옵션으로 자리매김할 가능성이 있습니다.
CG Oncology (NASDAQ: CGON) a communiqué des données actualisées impressionnantes de la cohorte C de l’essai BOND-003 pour le crétostimogène, montrant un taux de réponse complète (RC) de 41,8 % à 24 mois chez des patients atteints d’un cancer de la vessie non invasif musculairement (NMIBC) à haut risque, ne répondant pas au traitement par BCG.
L’étude a mis en évidence une durabilité remarquable : 90 % des répondants à 12 mois restaient indemnes de maladie à 24 mois. Parmi 110 patients fortement prétraités, 96,6 % sont restés sans progression vers une maladie musculairement invasive à 24 mois. Le traitement a été très bien toléré, sans événements indésirables liés au traitement de grade 3 ou plus.
L’entreprise prévoit de lancer son dossier BLA pour le crétostimogène au quatrième trimestre 2025, le positionnant comme une option thérapeutique novatrice susceptible de permettre la conservation de la vessie.
CG Oncology (NASDAQ: CGON) hat beeindruckende aktualisierte Daten aus der BOND-003 Kohorte C für Cretostimogene berichtet und zeigt eine vollständige Ansprechrate (CR) von 41,8% nach 24 Monaten bei Patienten mit hochrisikoreichem, nicht muskelinvasivem Blasenkarzinom (NMIBC), die nicht auf BCG angesprochen haben.
Die Studie belegte eine bemerkenswerte Dauerhaftigkeit: 90% der 12‑Monate-Ansprecher blieben auch nach 24 Monaten krankheitsfrei. Bei 110 stark vorbehandelten Patienten blieb 96,6% frei von Progression in Richtung muskelinvasiver Erkrankung nach 24 Monaten. Die Behandlung war sehr gut verträglich, es traten keine therapiebedingten Nebenwirkungen Grad 3 oder höher auf.
Das Unternehmen plant, die BLA-Einreichung für Cretostimogene im vierten Quartal 2025 zu starten und positioniert das Mittel als potenzielle bahnbrechende, blasenerhaltende Therapieoption.
- Strong 41.8% complete response rate at 24 months in high-risk NMIBC patients
- 90% of 12-month responders maintained disease-free status at 24 months
- 96.6% of patients remained free from progression to muscle invasive disease
- Excellent safety profile with no Grade 3 or greater treatment-related adverse events
- High treatment compliance with 97.3% of patients completing all expected treatments
- Median duration of response of 28 months and still ongoing
- 41.1% of patients required prior intravesical chemotherapy
- 6.3% of patients needed systemic immunotherapy before treatment
Insights
CG Oncology's cretostimogene shows remarkable 41.8% complete response rate at 24 months for BCG-unresponsive bladder cancer with excellent safety profile.
The updated BOND-003 Cohort C data for cretostimogene demonstrates exceptional durability in high-risk non-muscle invasive bladder cancer (NMIBC) patients who failed BCG therapy. The 41.8% complete response rate at 24 months (46/110 patients) represents potentially best-in-class efficacy for this difficult-to-treat population.
What's particularly impressive is the 90% retention of response from the 12-month to 24-month timepoint, suggesting that early responders maintain benefit long-term. The 28-month median duration of response is still ongoing, indicating the potential for even longer-term disease control.
From a clinical perspective, the 96.6% freedom from progression to muscle-invasive disease at 24 months is remarkable. Without effective therapy, approximately 30% of these patients would typically progress within 1-2 years, often requiring radical cystectomy (complete bladder removal) with significant impact on quality of life.
The safety profile is equally compelling - no Grade 3+ treatment-related adverse events, no treatment-related discontinuations, and 97.3% treatment completion rate. The rapid resolution of side effects (median 1 day) and mostly mild, localized bladder symptoms (spasm, frequent urination, urgency) suggest excellent tolerability.
This data is particularly meaningful given the heavily pretreated population (median 12 prior BCG doses, some up to 66 doses) and prior therapy with intravesical chemotherapy (41.1%) and systemic immunotherapy (6.3%). For context, current FDA-approved options for BCG-unresponsive NMIBC show complete response rates of only 20-30% at 12 months with significant drop-offs thereafter.
With the planned BLA submission in Q4 2025, cretostimogene appears positioned to potentially become a new standard of care for BCG-unresponsive NMIBC, offering a bladder-sparing alternative to radical cystectomy with meaningful durability.
- Robust 24-month complete response (CR) rate of
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- Safety profile remains consistent -
IRVINE, Calif., Sept. 05, 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 updated data on BOND-003 Cohort C showing 12 additional patients with high risk non-muscle invasive bladder cancer (HR NMIBC) were in complete response (CR) at 24 months. The robust 24-month complete response landmark rate of
“Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG,” said Trinity J. Bivalacqua, MD, PhD. “In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results. The latest data from the BOND-003 Cohort C study demonstrates that if a patient is a responder at 12 months, there is a 90 percent chance they will remain in response at 24 months. This is unprecedented in the high-risk, heavily pretreated NMIBC patient population and very meaningful for those battling this difficult disease.”
“The data from our Phase 3 BOND-003 Cohort C registrational trial underscores cretostimogene’s potential to become a breakthrough backbone treatment for bladder cancer patients,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology. “We are eager to bring this innovative treatment to a broad range of NMIBC patients, and we are making great strides towards that goal as we prepare to initiate our BLA submission for cretostimogene in our initial indication for the treatment of patients with HR NMIBC unresponsive to BCG in the fourth quarter of this year.”
The Phase 3 BOND-003 Cohort C study is in patients with high-risk NMIBC unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. The study reported
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 (
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, as supplemented in Part II, Item 1A, “Risk Factors” of our quarterly report on Form 10-Q for the quarter ended June 30, 2025, 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
sarah.connors@cgoncology.com
Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
megan.knight@cgoncology.com
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