Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
CG Oncology (NASDAQ: CGON) announced topline data from Phase 3 BOND-003 trial for cretostimogene in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients unresponsive to BCG treatment. Key findings show 74.5% of patients (82 out of 110) achieved complete response, with median duration of response exceeding 27 months. The study demonstrated 63.5% of patients maintained response at 12 months and 56.6% at 24 months. Notably, 97.3% of patients remained free from progression to Muscle Invasive Bladder Cancer at 12 months.
The treatment showed favorable safety profile with no Grade 3 or greater treatment-related adverse events, no deaths, and no treatment discontinuations. Common side effects included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.
CG Oncology (NASDAQ: CGON) ha annunciato i dati preliminari del trial di fase 3 BOND-003 per il cretostimogene in pazienti ad alto rischio con cancro della vescica non muscolo-invasivo (NMIBC) che non hanno risposto al trattamento con BCG. I risultati chiave mostrano che il 74,5% dei pazienti (82 su 110) ha ottenuto una risposta completa, con una durata mediana della risposta che supera i 27 mesi. Lo studio ha dimostrato che il 63,5% dei pazienti ha mantenuto la risposta a 12 mesi e il 56,6% a 24 mesi. È importante notare che il 97,3% dei pazienti è rimasto libero da progressione verso il cancro della vescica muscolo-invasivo a 12 mesi.
Il trattamento ha mostrato un profilo di sicurezza favorevole, senza effetti avversi gravi di grado 3 o superiori, senza decessi e senza interruzioni del trattamento. Gli effetti collaterali comuni includevano spasmo vescicale, pollachiuria, urgenza urinaria, disuria e ematuria.
CG Oncology (NASDAQ: CGON) anunció los datos preliminares del ensayo de fase 3 BOND-003 para el cretostimogene en pacientes de alto riesgo con cáncer de vejiga no musculoinvasivo (NMIBC) que no respondieron al tratamiento con BCG. Los hallazgos clave muestran que el 74,5% de los pacientes (82 de 110) logró una respuesta completa, con una duración media de la respuesta que supera los 27 meses. El estudio demostró que el 63,5% de los pacientes mantuvo la respuesta a los 12 meses y el 56,6% a los 24 meses. Notablemente, el 97,3% de los pacientes permanecieron libres de progresión a cáncer de vejiga musculoinvasivo a los 12 meses.
El tratamiento mostró un perfil de seguridad favorable sin eventos adversos relacionados con el tratamiento de grado 3 o mayores, sin muertes y sin interrupciones del tratamiento. Los efectos secundarios comunes incluyeron espasmo vesical, pollakiuria, urgencia miccional, disuria y hematuria.
CG Oncology (NASDAQ: CGON)는 BCG 치료에 반응하지 않는 고위험 비근육 침습성 방광암(NMIBC) 환자를 위한 cretostimogene의 3상 BOND-003 시험에서 주요 데이터를 발표했습니다. 주요 결과에 따르면 74.5%의 환자(110명 중 82명)가 완전한 반응을 보였으며, 반응의 중앙 지속 기간은 27개월을 초과했습니다. 이 연구는 12개월에서 63.5%의 환자가 반응을 유지했으며 24개월에서는 56.6%가 반응을 유지했다고 보여주었습니다. 특히, 12개월 동안 97.3%의 환자가 근육 침습성 방광암으로의 진행 없이 지냈습니다.
치료는 3등급 이상의 치료 관련 부작용이 없었고, 사망자나 치료 중단 사례도 없어서 안전성이 우수함을 보여주었습니다. 일반적인 부작용으로는 방광 경련, 빈뇨, 배뇨 급박감, 배뇨 곤란, 혈뇨가 포함되었습니다.
CG Oncology (NASDAQ: CGON) a annoncé des données préliminaires de l'essai clinique de phase 3 BOND-003 pour le cretostimogene chez des patients à haut risque souffrant de cancer de la vessie non musculo-invasif (NMIBC) qui n'ont pas répondu au traitement par BCG. Les résultats clés montrent que 74,5 % des patients (82 sur 110) ont obtenu une réponse complète, avec une durée médiane de la réponse dépassant 27 mois. L'étude a démontré que 63,5 % des patients ont maintenu leur réponse à 12 mois et 56,6 % à 24 mois. Il est à noter que 97,3 % des patients sont restés exempts de progression vers un cancer de la vessie musculo-invasif à 12 mois.
Le traitement a montré un profil de sécurité favorable, sans événements indésirables liés au traitement de grade 3 ou supérieur, sans décès et sans interruptions de traitement. Les effets secondaires courants comprenaient des spasmes vésicaux, pollakiurie, urgence mictionnelle, dysurie et hématurie.
CG Oncology (NASDAQ: CGON) gab die vorläufigen Daten aus der Phase-3-Studie BOND-003 für cretostimogene bei Hochrisiko-Patienten mit nicht muskelinvasivem Blasenkrebs (NMIBC) bekannt, die nicht auf eine BCG-Behandlung angesprochen haben. Wichtige Ergebnisse zeigen, dass 74,5% der Patienten (82 von 110) eine vollständige Reaktion erzielten, wobei die mediane Dauer der Reaktion 27 Monate überstieg. Die Studie zeigte, dass 63,5% der Patienten ihre Reaktion nach 12 Monaten aufrechterhielten und 56,6% nach 24 Monaten. Bemerkenswert ist, dass 97,3% der Patienten nach 12 Monaten keine Fortschritte zu muskelinvasivem Blasenkrebs zeigten.
Die Behandlung zeigte ein günstiges Sicherheitsprofil ohne behandlungsbezogene unerwünschte Ereignisse der Grade 3 oder höher, keine Todesfälle und keine Behandlungsunterbrechungen. Häufige Nebenwirkungen umfassten Blasenschnürung, Pollakisurie, Harndrang, Dysurie und Hämaturie.
- 74.5% complete response rate in Phase 3 trial
- Median duration of response exceeds 27 months
- 63.5% of patients maintained response at 12 months
- 97.3% of patients were free from disease progression at 12 months
- 97.3% patient treatment completion rate
- No serious adverse events or treatment discontinuations reported
- None.
Insights
The Phase 3 BOND-003 trial results for cretostimogene represent a significant breakthrough in bladder cancer treatment. The
The
This data represents a significant value driver for CG Oncology, potentially positioning cretostimogene as a first-line therapy for BCG-unresponsive NMIBC. The market opportunity is substantial, with bladder cancer being the 6th most common cancer in the US. The superior efficacy and safety profile could lead to rapid market adoption and premium pricing if approved.
The dual mechanism of action provides a competitive advantage over existing treatments. With no Grade 3+ adverse events and high treatment completion rates, the therapy could become the standard of care, potentially generating significant revenue. The stock is likely to see positive momentum as the company moves toward FDA submission, with the robust Phase 3 data supporting a strong regulatory package.
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– Median duration of response is greater than 27 months and not reached –
– Latest data update continued to show favorable safety and tolerability results –
– Company hosting virtual investor event with lead investigator at 8 am EST today –
IRVINE, Calif., Dec. 05, 2024 (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 topline data from the Phase 3 BOND-003 trial in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) demonstrating
“There continues to be a significant need for new treatment options for patients with bladder cancer,” said Gary D. Steinberg, M.D., Professor, Department of Urology at Rush University Medical Center. “Therefore, I am very encouraged by the latest data from the BOND-003 study, which demonstrates cretostimogene’s compelling efficacy as well as its potential to induce a best-in-class durable response in NMIBC patients, with
There were no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. No treatment-related discontinuation of cretostimogene was observed.
“The BOND-003 monotherapy data underscores our novel investigational oncolytic immunotherapy’s unique product profile, including its dual mechanism of action, which we believe differentiates it from current and investigational NMIBC treatments,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “Based upon the latest data, we are confident that cretostimogene is well positioned to address an unmet need for patients as a potential backbone bladder-sparing therapeutic if approved by the FDA.”
About the BOND-003 Phase 3 Trial
BOND-003 (NCT04452591) is a single-arm, Phase 3, monotherapy clinical trial for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in-situ (CIS) with or without Ta or T1 papillary tumors. The fully enrolled global trial with a total of 112 patients is currently ongoing in North America and the Asia-Pacific region. The primary endpoint of the trial is CR at any time, with DOR measured as a secondary endpoint. The highly pre-treated trial population includes patients with prior intravesical chemotherapy and systemic immunotherapy.
Cretostimogene monotherapy received FDA Fast Track and Breakthrough Therapy Designations in BCG-Unresponsive, high-risk NMIBC patients with CIS in December 2023. On May 3, 2024, CG Oncology presented preliminary data from the Phase 3 BOND-003 trial at the 2024 American Urological Association Annual Meeting.
Investor Conference Call
CG Oncology will host a conference call and live webcast at 8 am EST today, December 5, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the “Investor Relations" section of the company's website at https://ir.cgoncology.com. A webcast replay will be available in the investor relations section on the company's website following the completion of the call.
About Bladder Cancer
More than 83,000 people are estimated to be diagnosed with bladder cancer in 2024. NMIBC is the most common form of bladder cancer, representing approximately
About Cretostimogene Grenadenorepvec
Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 250 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 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
FAQ
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