Non-muscle–invasive bladder cancer (NMIBC) treatment is undergoing a transformative shift fueled by cutting-edge therapies, novel strategies, and refined approaches to patient care. Let’s explore the pivotal breakthroughs driving progress in NMIBC care.
BCG Plus Mitomycin: A Practical Option During BCG Shortages
The ANZUP 1301 trial explored combining bacillus Calmette-Guérin (BCG) with mitomycin in BCG-naive patients.1 Results showed similar effectiveness to BCG alone, with no significant difference in disease-free survival.
A key advantage was efficiency. The combination used nearly 40% fewer BCG doses and had higher treatment completion rates. In the context of ongoing global shortages, this approach offers a practical way to maintain treatment continuity without compromising outcomes.
UGN-102 a Nonsurgical Option for NMIBC With Durable Response
The ENVISION trial assessed UGN-102 in patients with recurrent low-grade, intermediate-risk NMIBC.2 At 3 months, 80% achieved complete response, and most remained event-free at 2 years.
The therapy was generally well tolerated, with urinary symptoms being the most common side effect. UGN-102 introduces a meaningful bladder-sparing option that can reduce the need for repeat surgical procedures while maintaining durable disease control.
SWOG S1602 Trial Findings Expand BCG Options
This trial compared different BCG strains and found that Tokyo-172 performs similarly to the commonly used TICE strain for high-grade NMIBC.3
While Tokyo-172 showed slightly higher rates of serious side effects, overall effectiveness was comparable. Intradermal priming did not improve outcomes. These findings support the use of alternative BCG strains, an important consideration when supply constraints limit access to standard formulations.
Immunotherapy Yields Bladder-Sparing Breakthrough
The BOND-003 trial evaluated cretostimogene in patients with high-risk, BCG-unresponsive NMIBC. Results were highly encouraging.4
Complete response rates reached 75%, with many patients maintaining responses beyond 2 years. More than 80% avoided cystectomy at 24 months, and no severe treatment-related side effects were reported. This therapy represents a significant step forward for patients seeking to preserve their bladder while still achieving strong disease control.
References
- 1. Hayne D, Zhang AY, Thomas H, et al. Bacillus Calmette-Guérin plus mitomycin versus bacillus Calmette-Guérin alone for bacillus Calmette-Guérin-naïve non-muscle-invasive bladder cancer: a randomised phase 3 trial (ANZUP 1301). Eur Urol. doi: 10.1016/j.eururo.2026.01.009
2. Prasad SM, Shishkov D, Mihaylov NV, et al. UGN-102 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer: 24-month duration of response results from the phase 3 ENVISION trial. J Urol. doi: 10.1097/JU.0000000000005041
3. Svatek RS, Tangen C, Meeks JJ, et al. SWOG S1602: a phase III randomized trial to evaluate BCG strain differences and priming with intradermal BCG before intravesical therapy for BCG-naïve high-grade non-muscle invasive bladder cancer (NCT #03091660). J Clin Oncol. doi: 10.1200/JCO.2026.44.7_suppl.LBA629\
4. 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. doi: 0.1200/JCO.2026.44.7_suppl.741