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TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non-muscle-invasive bladder cancer

May 3, 2024 – Clinical Trials, Drug Discovery – Johnson & Johnson, bladder cancer, monotherapy

New data from phase 2b SunRISe-1 study show rapid achievement of complete response (CR) with 98% achieving a CR within 12 weeks
TAR-200 provides durable CRs in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ – a disease area with limited treatment options for patients.

3 May 2024 — Beerse, Belgium — Janssen-Cilag International, a Johnson & Johnson company, announced today updated results from Cohort 2 of the phase 2b 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 today 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, US.

“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 Joseph Jacob MD MS, Department of Urology, Upstate Medical University, presenting author. “These results address an area of high unmet need for bladder sparing therapies in this patient population.”

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. The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval (CI), 70.6-91.4). The study protocol did not allow retreatment for non-responders, consistent with US Food and Drug Administration (FDA) guidance. 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 cut-off as of 2 January 2024, and none of the responders progressed to muscle-invasive bladder cancer or metastasis. 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. The investigator-assessed confirmed CR rate correlated strongly with central results.

“The SunRISe-1 study results reinforce our dedication to improving the lives of patients with bladder cancer,” said Henar Hevia, senior director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “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.”

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.

Treatment-related adverse events (TRAEs) occurred in 61 patients (71.8%). The most common (≥10%) were pollakiuria (35.3%), dysuria (29.4%), micturition urgency (15.3%) and urinary tract infections (15.3%). Seven patients (8.2%) had Grade 3 or higher TRAEs and four patients (4.7%) had one or more serious TRAEs. Four patients (4.7%) had TRAEs leading to discontinuation and no deaths were reported.

“These study results mark a significant step in our mission to bring new treatment options to patients that focus on bladder preservation and long-term survival,” said Christopher Cutie MD, vice president, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. “These results reinforce the potential of TAR-200 to transform the treatment landscape and our ongoing dedication to address unmet needs for patients facing this challenging disease.”

Europe has one of the highest rates of bladder cancer in the world with nearly 225,000 patients diagnosed in 2022, a 10% increase from 2020. NMIBC accounts for approximately 75% of all newly diagnosed bladder cancers. Although BCG immunotherapy has been accepted as the standard of care for nearly five decades, 30-40% of patients do not respond to BCG, and experience disease recurrence or progression. In such scenarios for patients with HR-NMIBC, radical cystectomy (removal of the bladder and neighbouring structures and organs) emerges as the primary treatment option. This major abdominal procedure requires a urinary diversion to be created to collect and store urine.

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