A total of 110 patients with Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer have been enrolled in a phase 3 study evaluating cretostimogene grenadenorepvec.
Non-Muscular Invasive Bladder Cancer: © PRB ARTS - www.stock.adobe.com
Trial Name: A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)
ClinicalTrials.gov Identifier: NCT04452591
Sponsor: CG Oncology, Inc.
Recruitment Contact: JoAnn Horn, 516-456-1415, joann.horn@CGoncology.com
Completion Date: July 31, 2025
The phase 3 BOND-003 study (NCT04452591) evaluating cretostimogene grenadenorepvec (formerly, CG0070) has completed enrollment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG), according to CG Oncology, Inc.1
Cretostimogene grenadenorepvec is a serotype 5 adenovirus which was made to express GM-CSF. The agent can replicate in cells with mutated or deficient retinoblastoma, and leads to response rates of approximately 45% in patients with recurrent NMIBC after receiving BCG.2
This single-arm, phase 3 BOND-003 study was developed to assess and confirm the clinical activity of cretostimogene grenadenorepvec in this patient population.
"As a patient advocacy organization, it is exciting to see new treatments get closer to being available to bladder cancer patients with BCG-unresponsive disease, who have so few options available. Many will only have the option of bladder removal, which is not always available due to other health concerns," said Andrea-Maddox Smith, chief executive officer, Bladder Cancer Advocacy Network, in a press release.1 "We have consistently advocated for increased funding for research and encouraged patients to seek out appropriate trials."
The open-label, single-arm, phase 3 BOND-003 study enrolled 110 patients with BCG-unresponsive, high-risk NMIBC across North America and the Asia-Pacific regions.3
Patients are eligible for enrollment if aged 18 years and older with an ECOG performance status of 0 to 2 and pathologically confirmed persistent or recurrent carcinoma in situ alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. Patients are also required to have received prior adequate BCG therapy, adequate organ function, and be ineligible for radical cystectomy or refusal of radical cystectomy.
Excluded from the trial will be patients with muscle invasive or locally advanced or metastatic bladder cancer with a known upper tract or prostatic urethra malignancy and an active autoimmune disease. If patients have systemic anti-cancer therapy, including investigational agents, within 4 weeks of baseline or have received prior treatment with adenovirus-based cancer therapy, they will also be excluded from the study. Patients who are immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant and those with clinically significant or active cardiac disease will not be eligible for the study.
Once enrolled, patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease will be given cretostimogene grenadenorepvec will be administered intravesically after a sequence of bladder washes with 5% DDM and normal saline.
Treatment with cretostimogene grenadenorepvec will be administered to patients weekly for 6 weeks. Patients with persistent high-grade disease at week 13 will then be given another cycle of 6 weekly treatments. If a patient has a complete response with no disease present at week 13, the patient will then receive 3 weekly treatments. At week 25, patients will receive 3 weekly treatments every 12 weeks through week 49. This will then be followed every 24 weeks.
The primary end point of the study is complete response (CR) at any time, and secondary end points consist of CR at 12 months, duration of response, progression-free survival, cystectomy-free survival, and safety.
"We would like to thank all those who partnered with us to complete this study, especially patients, care givers, physicians and health care teams in the United States and globally who helped us reach this important milestone," said Arthur Kuan, chief executive officer of CG Oncology, in the press release.1 "We are intensely focused on developing bladder-sparing therapeutics and are actively engaged in making cretostimogene available to patients as soon as possible."
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