Phase 3 trial of oncolytic immunotherapy in NMIBC hits enrollment goal

The recruitment target has been met for the phase 3 BOND-003 trial (NCT04452591) exploring cretostimogene grenadenorepvec (formerly CG0070) in patients with high-risk BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), according to CG Oncology, the developer of the oncolytic immunotherapy.¹

To enroll on the trial, patients must have pathologically confirmed high risk NMIBC (World Health Organization tumor grading system) that is unresponsive to BCG treatment, an ECOG performance status of 0 to 2, and not be eligible for or refuse to receive a radical cystectomy.

The single-arm monotherapy study has enrolled 110 patients at clinical sites across North America and the Asia-Pacific regions.

After a sequence of bladder washes with 5% DDM and normal saline, all patients in the trial will receive cretostimogene grenadenorepvec intravesically.² The oncoloytic immunotherapy will be administered beginning with a weekly induction regimen for 6 weeks. This will be followed by 3 weekly maintenance instillations at months 3, 6, 9, 12, and 18. Patients who continue to have high-grade disease at 3 months are eligible to receive a re-induction regimen of 6 weeks of weekly cretostimogene grenadenorepvec.

"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," Arthur Kuan, chief executive officer, CG Oncology, stated in a 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."

To enroll on the trial, patients must have pathologically confirmed high risk NMIBC (World Health Organization tumor grading system) that is unresponsive to BCG treatment, an ECOG performance status of 0 to 2, and not be eligible for or refuse to receive a radical cystectomy.

Patients are not eligible for study enrollment if they have muscle invasive (stage ≥T2), locally advanced (stage T3/T4; any lymph node involvement), or metastatic bladder cancer. Enrollment is also prohibited to those who have known upper tract or prostatic urethra malignancy, or those who have received any FDA-approved or investigational anticancer therapies ≤4 weeks from baseline.

The primary end point of the trial is the rate of complete responses achieved at any time on study. Secondary end points include the complete response rate at 12 months, duration of response, progression-free survival, cystectomy-free survival, and safety.

The estimated primary completion date of the trial is January 31, 2024.

"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," Andrea-Maddox Smith, chief executive officer, Bladder Cancer Advocacy Network (BCAN), stated in a press release.¹ "We have consistently advocated for increased funding for research and encouraged patients to seek out appropriate trials."

References

1. CG Oncology Completes Patient Enrollment in BOND-003 Phase 3 Monotherapy Study with Cretostimogene Grenadenorepvec in BCG-Unresponsive High-Risk NMIBC. Published online July 24, 2023. Accessed July 26, 2023. https://cgoncology.com/bond-003-study-of-cretostimogene-grenadenorepvec-in-nmibc-completes-enrollment/

2. National Institutes of Health US National Library of Medicine ClinicalTrials.gov. Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (BOND-003). First posted June 30, 2020. Last update posted May 12, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04452591