Cretostimogene Grenadenorepvec Data Continues to Demonstrate Best-in-Class Durability of Response as well as Consistent and Compelling Safety and Efficacy
CG Oncology (NASDAQ: CGON) announced compelling Phase 3 study results for cretostimogene, showing significant efficacy in treating high-risk BCG-unresponsive non-muscle invasive bladder cancer. The BOND-003 study demonstrated that 75.5% of patients (83 out of 110) achieved complete response, with 46% maintaining response at 12 months and 30 confirmed responses at 24 months.
The median duration of response exceeds 28 months and is still ongoing. Notably, translational data revealed that post-treatment close contact precautions are unnecessary, as the treatment remains localized with no systemic exposure. The safety profile was favorable with no Grade 3 or greater treatment-related adverse events, and 97.3% of patients completed all expected treatments.
Common treatment-related adverse events included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria, with a median resolution time of one day.
CG Oncology (NASDAQ: CGON) ha annunciato risultati significativi dello studio di Fase 3 per cretostimogene, mostrando un'efficacia notevole nel trattamento del carcinoma della vescica non muscolare invasivo, ad alto rischio e non responsivo alla BCG. Lo studio BOND-003 ha dimostrato che il 75,5% dei pazienti (83 su 110) ha ottenuto una risposta completa, con il 46% che ha mantenuto la risposta a 12 mesi e 30 risposte confermate a 24 mesi.
La durata mediana della risposta supera i 28 mesi ed è ancora in corso. È importante notare che i dati traslazionali hanno rivelato che le precauzioni di contatto stretto post-trattamento non sono necessarie, poiché il trattamento rimane localizzato senza esposizione sistemica. Il profilo di sicurezza è stato favorevole, con nessun evento avverso correlato al trattamento di grado 3 o superiore, e il 97,3% dei pazienti ha completato tutti i trattamenti previsti.
Gli eventi avversi comuni correlati al trattamento includevano spasmo della vescica, pollachiuria, urgenza minzionale, disuria e ematuria, con un tempo mediano di risoluzione di un giorno.
CG Oncology (NASDAQ: CGON) anunció resultados contundentes del estudio de Fase 3 para cretostimogene, mostrando una eficacia significativa en el tratamiento del cáncer de vejiga no muscular invasivo, de alto riesgo y no respondedor a BCG. El estudio BOND-003 demostró que el 75.5% de los pacientes (83 de 110) logró una respuesta completa, con el 46% manteniendo la respuesta a los 12 meses y 30 respuestas confirmadas a los 24 meses.
La duración mediana de la respuesta supera los 28 meses y aún está en curso. Notablemente, los datos traslacionales revelaron que las precauciones de contacto cercano después del tratamiento son innecesarias, ya que el tratamiento se mantiene localizado sin exposición sistémica. El perfil de seguridad fue favorable, con ningún evento adverso relacionado con el tratamiento de grado 3 o superior, y el 97.3% de los pacientes completaron todos los tratamientos esperados.
Los eventos adversos comunes relacionados con el tratamiento incluyeron espasmo vesical, pollakiuria, urgencia miccional, disuria y hematuria, con un tiempo de resolución mediano de un día.
CG Oncology (NASDAQ: CGON)는 cretostimogene에 대한 3상 연구 결과를 발표하였으며, BCG에 반응하지 않는 고위험 비근육 침습성 방광암 치료에서 상당한 효능을 보여주었습니다. BOND-003 연구에서는 환자의 75.5% (110명 중 83명)이 완전한 반응을 달성했으며, 46%가 12개월 동안 반응을 유지하였고 24개월 동안 30건의 확인된 반응이 있었습니다.
반응의 중앙 지속 시간은 28개월을 초과하며 여전히 진행 중입니다. 주목할 만한 것은, 치료 후 밀접 접촉 예방 조치가 필요 없다는 것이 밝혀졌으며, 치료가 국소적으로 유지되고 전신 노출이 없다는 것입니다. 안전성 프로필은 유리했으며, 3등급 이상의 치료 관련 부작용은 없었습니다, 97.3%의 환자가 모든 예상 치료를 완료했습니다.
치료 관련 일반적인 부작용으로는 방광 경련, 빈뇨, 배뇨 긴급성, 배뇨통 및 혈뇨가 있으며, 중앙 해결 시간은 하루입니다.
CG Oncology (NASDAQ: CGON) a annoncé des résultats convaincants d'une étude de Phase 3 pour le cretostimogene, montrant une efficacité significative dans le traitement du cancer de la vessie non musclé invasif, à haut risque et non réactif à la BCG. L'étude BOND-003 a démontré que 75,5% des patients (83 sur 110) ont obtenu une réponse complète, avec 46% maintenant la réponse à 12 mois et 30 réponses confirmées à 24 mois.
La durée médiane de la réponse dépasse 28 mois et est toujours en cours. Il est à noter que les données translationnelles ont révélé que les précautions de contact rapproché après le traitement ne sont pas nécessaires, car le traitement reste localisé sans exposition systémique. Le profil de sécurité était favorable avec aucun événement indésirable lié au traitement de grade 3 ou supérieur, et 97,3% des patients ont terminé tous les traitements prévus.
Les événements indésirables courants liés au traitement comprenaient des spasmes vésicaux, de la pollakiurie, une urgence mictionnelle, de la dysurie et de l'hématurie, avec un temps médian de résolution d'un jour.
CG Oncology (NASDAQ: CGON) hat überzeugende Ergebnisse der Phase-3-Studie zu cretostimogene bekannt gegeben, die eine signifikante Wirksamkeit bei der Behandlung von hochriskantem, BCG-unempfindlichem, nicht-muskelinvasivem Blasenkarzinom zeigen. Die BOND-003-Studie zeigte, dass 75,5% der Patienten (83 von 110) eine vollständige Reaktion erzielten, wobei 46% die Reaktion nach 12 Monaten aufrechterhielten und 30 bestätigte Reaktionen nach 24 Monaten vorlagen.
Die mediane Dauer der Reaktion übersteigt 28 Monate und ist weiterhin aktiv. Bemerkenswert ist, dass translationalen Daten zeigten, dass nach der Behandlung keine engen Kontaktvorkehrungen erforderlich sind, da die Behandlung lokal bleibt und keine systemische Exposition besteht. Das Sicherheitsprofil war günstig, mit keinen behandlungsbedingten Nebenwirkungen der Grad 3 oder höher, und 97,3% der Patienten schlossen alle erwarteten Behandlungen ab.
Häufige behandlungsbedingte Nebenwirkungen umfassten Blasenspasmen, Pollakisurie, Dringlichkeit beim Wasserlassen, Dysurie und Hämaturie, mit einer medianen Lösungszeit von einem Tag.
- 75.5% complete response rate in Phase 3 trial
- Exceptional durability with median response exceeding 28 months
- 46% of patients maintaining complete response at 12 months
- 97.3% patient treatment completion rate
- No Grade 3 or greater treatment-related adverse events
- No close contact precautions needed, simplifying treatment protocol
- Common treatment-related adverse events affecting >10% of patients
Insights
The Phase 3 BOND-003 data for cretostimogene grenadenorepvec represents potentially practice-changing results in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. The 75.5% complete response rate at any time is impressive, but what's truly remarkable is the durability – 46% maintaining complete response at 12 months with median duration exceeding 28 months.
From a clinical perspective, these results address a critical treatment gap. BCG-unresponsive patients typically face options, with radical cystectomy (complete bladder removal) often recommended, which significantly impacts quality of life. A bladder-sparing therapy with this efficacy profile would be transformative.
The safety profile deserves particular attention – no Grade 3+ treatment-related adverse events, no treatment discontinuations, and a 97.3% completion rate. This suggests exceptional tolerability comparable to or better than existing options. The most common side effects (bladder spasm, urinary frequency, urgency, pain, and blood in urine) are manageable and expected with bladder instillation therapies.
The translational data showing no systemic exposure has two critical implications: reduced risk of systemic side effects and no need for close contact precautions post-treatment – an important logistical advantage compared to some viral-based therapies that require such precautions. The intravesical delivery reducing anti-drug antibody neutralization is an elegant solution to a common challenge with immunotherapies.
These Phase 3 results significantly strengthen CG Oncology's competitive position in the bladder cancer market. The 75.5% complete response rate positions cretostimogene as potentially best-in-class among bladder-sparing therapies for this indication, with durability metrics exceeding 28 months that surpass many competing approaches.
The addressable market is substantial – approximately 80,000 new bladder cancer cases occur annually in the US, with roughly 20-30% being high-risk non-muscle invasive disease. Of these, about 30-40% eventually become BCG-unresponsive, creating a sizeable target population with treatment options.
Several factors enhance commercial potential: excellent safety profile enabling outpatient administration, no post-treatment contact precautions (unlike some competing viral therapies), and high patient adherence/compliance (97.3%). These attributes should drive strong physician adoption if approved.
Regulatory prospects appear favorable given the robust efficacy, safety, and the fact this represents the "largest study to date" in this specific indication. The FDA has shown willingness to approve bladder cancer therapies based on complete response rate and duration in single-arm trials for this population.
While pricing remains unknown, similar specialty oncology biologics command premium pricing. Given the alternative is often radical cystectomy (with its associated costs and complications), cretostimogene could demonstrate compelling pharmacoeconomic value even at premium pricing, allowing for strong market uptake and revenue potential if approved.
– Latest BOND-003 data show
– Median duration of response exceeds 28 months and is ongoing –
– No close contact precautions needed post cretostimogene treatment –
IRVINE, Calif., March 24, 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 83 out of 110 patients (
“Cretostimogene’s strong safety and efficacy profile, combined with its best-in-class durability, address an unmet need for my non-muscle invasive bladder cancer patients,” said Trinity J. Bivalacqua, M.D., Professor of Urology and Oncology at the Perelman Center for Advanced Medicine, University of Pennsylvania. “Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA.”
Translational data shared at the EAU Congress showed the level of cretostimogene peaked immediately after instillation, which was sustained locally for 4-5 days. Furthermore, intravesical delivery of cretostimogene reduces anti-drug antibody neutralization, thereby preserving therapeutic efficacy. There was no systemic exposure, with cretostimogene levels remaining below the limit of detection, providing evidence that post cretostimogene treatment close contact precautions are not needed. This information supports the current dosing schedule.
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.
“We are highly encouraged by the latest BOND-003 results, the largest study to date in BCG-unresponsive NMIBC with CIS patients, and cretostimogene’s potential to significantly impact the future of bladder cancer care,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “We are grateful to the patients and providers who participated in our study, advancing research and offering hope to those seeking bladder-sparing options.”
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guérin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in patients with intermediate-risk NMIBC. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy 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 and its potential to have a best-in-class durable response and meaningfully improve patient outcomes. 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
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