Glossary
Complete response: all detectable signs of cancer have disappeared after treatment.
Intravesically: means within the bladder; specifically refers to the administration of a medication or treatment directly into the bladder via a catheter.
News
Article
Cretostimogene Has Durable Response in BCG-Unresponsive Bladder Cancer
Key Takeaways
- Cretostimogene monotherapy achieves a 75.5% complete response rate in high-risk, BCG-unresponsive non-muscle invasive bladder cancer patients.
- The treatment maintains a 46% complete response at 12 months, with no severe side effects or close contact precautions needed.
Cretostimogene treatment shows best-in-class durability of response for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ
Cretostimogene shows best-in-class durability of response for BCG-unresponsive NMIBC with CIS: © pikovit - stock.adobe.com.
Treatment with cretostimogene monotherapy continues to demonstrate best-in-class durability of response and consistent safety and efficacy in patients with high-risk, Bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer with carcinoma in situ, according to a news release from CG Oncology, Inc.
In a presentation of data given at the 40th Annual European Association of Urology Congress in Madrid, Spain, treatment with cretostimogene therapy was shown to lead to a complete response at any time in 83 out of 110 patients (75.5%) enrolled in cohort C of the phase 3 BOND-003 trial.
“Cretostimogene’s strong safety and efficacy profile, combined with its best-in-class durability, address an unmet need for my [patients with non-muscle invasive bladder cancer],” Dr. Trinity J. Bivalacqua, a professor of Urology and Oncology at the Perelman Center for Advanced Medicine, University of Pennsylvania, said in the news release. “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 [Food and Drug Administration (FDA)].”
As of the data cutoff on Jan. 20, 2025, 46% of patients maintained a complete response at 12 months, with 30 confirmed responses at 24 months. The data continue to mature, and the median duration of response has not yet been reached but exceeds 28 months. No close contact precautions are required following cretostimogene treatment.
More Information on the Phase 3 BOND-003 Trial
Researchers found that cretostimogene levels peaked immediately after being introduced into the bladder and remained in the area for approximately four to five days, according to data presented at the European Association of Urology Congress. Because the treatment is delivered directly into the bladder, the body does not produce significant levels of anti-drug antibodies that could interfere with its effectiveness. Additionally, there was no detectable presence of the drug in the bloodstream, meaning that patients do not need to follow special precautions regarding close contact with others after treatment. These findings support the current dosing schedule.
The treatment was well tolerated, according to the news release, with no grade 3 (severe) or higher treatment-related side effects or deaths reported. Any side effects that did occur in patients typically had symptoms resolve within a day. No patients had to stop treatment due to side effects, and 97.3% completed their full course of therapy, indicating strong patient adherence.
The most commonly reported side effects, occurring in at least 10% of patients, included bladder spasms, frequent urination, urgent need to urinate, painful urination and blood in the urine.
“We are highly encouraged by the latest BOND-003 results, the largest study to date in [patients with] BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, and cretostimogene’s potential to significantly impact the future of bladder cancer care. We are grateful to the patients and providers who participated in our study, advancing research and offering hope to those seeking bladder-sparing options,” Ambaw Bellete, president and chief operating officer of CG Oncology, concluded in the press release.
What is Cretostimogene?
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate which is being investigated in the phase 3 BOND-003 clinical trial for patients with high-risk non-muscle invasive bladder cancer who are unresponsive to BCG therapy. This agent is also being investigated as a monotherapy in patients with intermediate-risk non-muscle invasive bladder cancer in the phase 3 PIVOT-006 clinical trial.
Moreover, cretostimogene is being investigated in combination with Opdivo (nivolumab) for the treatment of muscle invasive bladder cancer in an investigator-sponsored clinical trial, according to the press release.
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