Recent Updates
UGN-102 Shows Durable Response for Recurrent Low-Grade Bladder Cancer
In the phase 3 ENVISION trial, UGN-102 delivered durable responses and bladder-sparing treatment for recurrent low-grade IR-NMIBC.
The phase 3 ENVISION trial highlights UGN-102 as a potentially groundbreaking nonsurgical option for patients with recurrent low-grade, intermediate-risk non–muscle-invasive bladder cancer (IR-NMIBC). This intravesical therapy provides a durable response while minimizing the need for invasive procedures like transurethral resection of bladder tumors (TURBT).
In the study, 240 patients received 6 weekly instillations of UGN-102, with response assessments performed via cystoscopy, cytology, and biopsies. At 3 months, 80% of patients achieved a complete response (CR). Among these responders, the probability of remaining event-free at 24 months was 72%, indicating strong durability of the treatment.
While 36 patients experienced low-grade disease recurrence after achieving CR, UGN-102 demonstrated excellent long-term efficacy in preventing progression or recurrence for the majority. Additionally, the safety profile was favorable, with dysuria emerging as the most common treatment-related adverse event.
For oncology teams managing low-grade, IR-NMIBC, UGN-102 represents an exciting advance. It offers an effective, bladder-sparing alternative for patients with recurrent disease, particularly those seeking options beyond surgery. By reducing the need for TURBT, UGN-102 may alleviate procedural risks and healthcare burdens while maintaining high rates of durable response.
However, practitioners should be aware of study limitations, including the single-arm design and limited racial diversity of the patient population, which may affect the generalizability of results. Future trials could address these gaps by including more diverse cohorts and comparative arms.
With UGN-102, oncology teams have a promising tool to improve outcomes for patients with recurrent low-grade, IR-NMIBC, ensuring effective treatment while preserving quality of life.
Reference
Prasad SM, Shishkov D, Vladimirov N, 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 t+rial. J Urol. 2026 Mar 25. Online ahead of print.
The phase 3 ENVISION trial highlights UGN-102 as a potentially groundbreaking nonsurgical option for patients with recurrent low-grade, intermediate-risk non–muscle-invasive bladder cancer (IR-NMIBC). This intravesical therapy provides a durable response while minimizing the need for invasive procedures like transurethral resection of bladder tumors (TURBT).
In the study, 240 patients received 6 weekly instillations of UGN-102, with response assessments performed via cystoscopy, cytology, and biopsies. At 3 months, 80% of patients achieved a complete response (CR). Among these responders, the probability of remaining event-free at 24 months was 72%, indicating strong durability of the treatment.
While 36 patients experienced low-grade disease recurrence after achieving CR, UGN-102 demonstrated excellent long-term efficacy in preventing progression or recurrence for the majority. Additionally, the safety profile was favorable, with dysuria emerging as the most common treatment-related adverse event.
For oncology teams managing low-grade, IR-NMIBC, UGN-102 represents an exciting advance. It offers an effective, bladder-sparing alternative for patients with recurrent disease, particularly those seeking options beyond surgery. By reducing the need for TURBT, UGN-102 may alleviate procedural risks and healthcare burdens while maintaining high rates of durable response.
However, practitioners should be aware of study limitations, including the single-arm design and limited racial diversity of the patient population, which may affect the generalizability of results. Future trials could address these gaps by including more diverse cohorts and comparative arms.
With UGN-102, oncology teams have a promising tool to improve outcomes for patients with recurrent low-grade, IR-NMIBC, ensuring effective treatment while preserving quality of life.
Reference
Prasad SM, Shishkov D, Vladimirov N, 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 t+rial. J Urol. 2026 Mar 25. Online ahead of print.
