Updated BOND-003 data support durability of cretostimogene grenadenorepvec in NMIBC

Updated data from cohort C of the BOND-003 trial (NCT04452591) show consistent efficacy and favorable tolerability with cretostimogene grenadenorepvec in patients with high-risk BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), CG Oncology announced in a news release.¹

Specifically, as of a data cutoff of January 20, 2025, 12 additional patients in cohort C remained in complete response (CR) at 24 months. This translates to a 24-month CR rate of 41.8%, with a durable CR achieved in 46 of 110 patients. Of those who achieved a CR at 12 months, 90% remained in CR at the 24-month time point.

According to CG Oncology, these findings “reaffirm the best-in-disease durability that the company announced at the American Urological Association Annual Meeting in April 2025.”

“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,” Trinity J. Bivalacqua, MD, PhD, of Penn Medicine in Philadelphia, Pennsylvania, said in the news release.¹ “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 demonstrate that if a patient is a responder at 12 months, there is a 90% 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 updated data are set to be presented at the New England Section of the American Urological Association’s 94th annual meeting in Boston, Massachusetts.²

In total, cohort C of the BOND-003 trial enrolled 112 patients with histologically confirmed high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without Ta or T1 disease. Patients enrolled in the study were highly pretreated, with a median of 12 prior BCG doses and an upper limit as high as 66.

For the study, patients received 6 weekly induction doses followed by maintenance. Reinduction was permitted. The primary end point was CR rate at any time.

At a median follow-up of 22.3 months, the CR rate at any time point was 75.5% (83 of 110; 95% CI, 66.3%-83.2%). The estimated 12- and 24-month duration of response (DOR) rates were 64.1% and 58.3%, respectively. The median DOR is 28 months (95% CI, 14.3-not estimable) and is ongoing.

A total of 28 patients underwent reinduction, after which 50% had CR. Of these, 64.3% (9 of 14) remained in a durable CR.

According to the authors, “Complete responses are consistent across patient subgroups, including those who received prior intervening therapy, re-induction, or presented with higher-risk phenotypes such as CIS+HGT1.”

Overall, treatment was well tolerated, with 97.3% of patients (107 of 110) completing all protocol-defined treatments. At 24 months, 96.6% of patients remained free from T2 or higher progression during the treatment phase. Additionally, at 24 months, the cystectomy-free rate was 84.5%.

The safety profile for cretostimogene also remained consistent with previous reports.

No grade 3 or higher treatment-related adverse events (TRAEs), treatment-related discontinuations, or deaths were reported. The median time to resolution of TRAEs was 1 day. The most common TRAEs (≥ 10%) included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

Overall, the authors wrote, “The consistent and compelling outcomes with intravesical cretostimogene for the treatment of [high-risk BCG-unresponsive] NMIBC with CIS compare favorably and offer distinct advantages to existing therapies.”

“The data from our phase 3 BOND-003 cohort C registrational trial underscore cretostimogene’s potential to become a breakthrough backbone treatment for bladder cancer patients,” Ambaw Bellete, president and chief operating officer at CG Oncology, concluded in the news release.¹ “We are eager to bring this innovative treatment to a broad range of NMIBC patients, and we are making great strides toward that goal as we prepare to initiate our BLA [biologics license application] submission for cretostimogene in our initial indication for the treatment of patients with HR [high-risk] NMIBC unresponsive to BCG in the fourth quarter of this year.”

REFERENCES

1. 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. News release. CG Oncology Inc. September 5, 2025. Accessed September 5, 2025. https://www.globenewswire.com/news-release/2025/09/05/3145193/0/en/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.html

2. Tyson M, Uchio EM, Nam JK, et al. Encore durability results from BOND-003 cohort C- phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. Abstract presented at: New England Section of the American Urological Association 94th Annual Meeting; September 4-6, 2025; Boston, MA. Abstract 58.