Dr Necchi on the Efficacy of TAR-200 Monotherapy in BCG-Unresponsive NMIBC

Andrea Necchi, MD, director, Genitourinary Medical Oncology, IRCCS San Raffaele Hospital and Scientific Institute, associate professor, Vita-Salute San Raffaele University, Milan, Italy, discusses results from the phase 2b SunRISe-1 trial (NCT04640623) of TAR-200 in patients with Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk, non–muscle-invasive bladder cancer (NMIBC).

The ongoing SUNRISE-1 trial assessed the efficacy of this intravesical delivery system as a monotherapy or in combination with cetrelimab in patients with BCG-unresponsive high-risk NMIBC, Necchi begins. This includes those with carcinoma in situ (CIS) with or without papillary disease, who either decline radical cystectomy or are ineligible for the procedure. The TAR-200 system was designed to deliver localized, sustained low-dose gemcitabine directly to the bladder, Necchi explains.

Findings from cohort 2 were presented at the 2023 ESMO Congress, and showed that efficacy evaluable patients treated with TAR-200 monotherapy achieved a complete response (CR) rate of 76.7% (95% CI,57.7-90.1) and a comparable investigator-assessed CR rate of 80.0% (95% CI, 61.4-92.3), Necchi reports. Of these CRs, 91% were ongoing at a median follow-up of 48 weeks. At the time of analysis, the median duration of response (DOR) was not reached (range, 12-121), although 11 complete responders had a DOR of at least 6 months and 6 had a DOR of at 12 least months, Necchi states. All responses in this latter group were ongoing. Kaplan-Meier estimates for DOR rates were 93% (95% CI, 61-99) at 6 months 84% (95% CI, 49-96) at 12 months, he adds.

These data support the ongoing investigation of TAR-200 in the SUNRISE-2 trial (NCT04658862) for patients with MIBC who are radical cystectomy–ineligible or refuse to receive the surgery; SUNRISE-3 trial (NCT05714202) of patients with BCG-naive high-risk NMIBC; and SUNRISE-4 trial (NCT04919512) in the neoadjuvant MIBC setting, Necchi concludes.