Recent Updates
Immunotherapy Shows Promise in Sparing Cystectomy for High-Risk BCG-Unresponsive NMIBC
In BOND-003, cretostimogene showed durable responses and high cystectomy-free survival in high-risk BCG-unresponsive NMIBC.
The phase 3 BOND-003 trial has demonstrated that cretostimogene grenadenorepvec, an innovative oncolytic immunotherapy, provides a bladder-sparing solution for patients with high-risk (HR), BCG-unresponsive non–muscle-invasive bladder cancer (NMBIC) with carcinoma in situ (CIS). This patient population, which has few effective, well-tolerated treatment options, may benefit from the dual mechanisms of action of cretostimogene: direct cancer cell lysis and amplification of antitumor immune responses via the GM-CSF transgene.
In the study, 112 patients received 6 weekly induction doses of cretostimogene, followed by maintenance cycles over 3 years. At a median follow-up of 25.8 months, the therapy achieved a complete response rate of 75.5%, with durable responses extending to 27.9 months. By 24 months, cystectomy-free survival was an impressive 81.3%, and 96.6% of patients remained free from progression to muscle-invasive disease (≥T2). Among those who underwent cystectomy due to recurrence or progression, 83.3% had non–muscle-invasive disease or no cancer at all (pT0), preserving the potential for less aggressive management.
Safety was another highlight of the trial, with no grade ≥3 treatment-related adverse events reported. This favorable profile makes cretostimogene an attractive option for patients who may otherwise face the significant physical and emotional challenges of radical cystectomy.
For oncology teams, these findings underscore the potential of cretostimogene as a transformative therapy for HR BCG-unresponsive NMIBC, particularly for patients with CIS. By reducing the need for radical surgery and offering durable responses, this treatment expands options for bladder preservation while maintaining a manageable safety profile.
As investigations into cretostimogene continue, this innovative therapy may play a key role in addressing the unmet needs of NMIBC patients, offering hope for effective, bladder-sparing outcomes.
Reference
Steinberg GD, Li R, Joshi S, et al. Cystectomy-free survival following cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ: results from the phase 3 BOND-003 trial (Cohort C). J Clin Oncol. 2026 Mar 2. Epub ahead of print.
The phase 3 BOND-003 trial has demonstrated that cretostimogene grenadenorepvec, an innovative oncolytic immunotherapy, provides a bladder-sparing solution for patients with high-risk (HR), BCG-unresponsive non–muscle-invasive bladder cancer (NMBIC) with carcinoma in situ (CIS). This patient population, which has few effective, well-tolerated treatment options, may benefit from the dual mechanisms of action of cretostimogene: direct cancer cell lysis and amplification of antitumor immune responses via the GM-CSF transgene.
In the study, 112 patients received 6 weekly induction doses of cretostimogene, followed by maintenance cycles over 3 years. At a median follow-up of 25.8 months, the therapy achieved a complete response rate of 75.5%, with durable responses extending to 27.9 months. By 24 months, cystectomy-free survival was an impressive 81.3%, and 96.6% of patients remained free from progression to muscle-invasive disease (≥T2). Among those who underwent cystectomy due to recurrence or progression, 83.3% had non–muscle-invasive disease or no cancer at all (pT0), preserving the potential for less aggressive management.
Safety was another highlight of the trial, with no grade ≥3 treatment-related adverse events reported. This favorable profile makes cretostimogene an attractive option for patients who may otherwise face the significant physical and emotional challenges of radical cystectomy.
For oncology teams, these findings underscore the potential of cretostimogene as a transformative therapy for HR BCG-unresponsive NMIBC, particularly for patients with CIS. By reducing the need for radical surgery and offering durable responses, this treatment expands options for bladder preservation while maintaining a manageable safety profile.
As investigations into cretostimogene continue, this innovative therapy may play a key role in addressing the unmet needs of NMIBC patients, offering hope for effective, bladder-sparing outcomes.
Reference
Steinberg GD, Li R, Joshi S, et al. Cystectomy-free survival following cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ: results from the phase 3 BOND-003 trial (Cohort C). J Clin Oncol. 2026 Mar 2. Epub ahead of print.
