Janssen-Cilag International NV, a Johnson & Johnson company, has released updated results from Cohort 2 of the Phase IIb SunRISe-1 study evaluating the efficacy and safety of investigational TAR-200 monotherapy in patients with BCG - HR-NMIBC with carcinoma in situ (CIS), who are ineligible for — or decline — radical cystectomy.
These data were featured in a plenary session (Abstract #P2-01) at the 2024 American Urological Association Annual Meeting (AUA) taking place 3-6 May 2024, in San Antonio, Texas.1
“The high complete response rate and durability of these responses observed in patients treated with TAR-200 underscores the potential of this treatment approach for patients with BCG-unresponsive HR-NMIBC,” said the presenting author Joseph Jacob*, Department of Urology, Upstate Medical University. “These results address an area of high unmet need for bladder sparing therapies in this patient population.”
The results
Results included an evaluation of 85 patients (median age of 71 years old: range 40-88; 32.9% with concurrent papillary disease) who received TAR-200 monotherapy.1 The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval (CI), 70.6-91.4).1
98% of CRs were achieved at first disease assessment at week 12
The study protocol did not allow retreatment for nonresponders, consistent with US Food and Drug Administration (FDA) guidance.1 The estimated one-year duration of response (DOR) rate is 74.6% (95% CI, 49.8-88.4), with median follow-up in responders of 29.9 weeks (range, 14-140); 41 of 48 responders (85%) remain in CR at data cutoff as of 2 January, 2024, and none of the responders progressed to muscle-invasive bladder cancer or metastasis.1
98% (47 of 48) of CRs were achieved at first disease assessment at week 12, and four of five patients who have completed two years of treatment remain in CR.1 The investigator-assessed confirmed CR rate correlated strongly with central results.1
“By focusing on bladder preservation through targeted, sustained release, these data underscore the potential of TAR-200 to offer a differentiated approach that not only improves clinical outcomes, but also the quality of life for patients with this otherwise difficult-to-treat form of bladder cancer.” Said Henar Hevia, Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine.
Interim results from the SunRISe-1 study were featured at the European Society for Medical Oncology 2023 Congress and shared at AUA 2023. These results were also presented at the European Association of Urology 2024 Congress.
Observed TRAEs
Treatment-related adverse events (TRAEs) occurred in 61 patients (71.8%).1 The most common (≥10%) were pollakiuria (35.3%), dysuria (29.4%), micturition urgency (15.3%), and urinary tract infections (15.3%).1 Seven patients (8.2%) had Grade 3 or higher TRAEs and four patients (4.7%) had one or more serious TRAEs.1 Four patients (4.7%) had TRAEs leading to discontinuation and no deaths were reported.1