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TAR-200 monotherapy in patients with bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1
Joseph M. Jacob, MD
1, Félix Guerrero-Ramos, MD, PhD
2, Andrea Necchi, MD
3, Martin Bögemann, MD
4, Michiel S. Van der Heijden, MD, PhD
5, Daniel Zainfeld, MD
6, Philipp Spiegelhalder, MD
7, Giuseppe Simone, MD, PhD
8, Evanguelos Xylinas, MD
9, David Cahn, MD
10, Yair Lotan, MD
11,
Katie S. Murray, DO12, Takashi Kawahara, MD, PhD
13, Katharine Stromberg, PhD
14, Jason Martin, PhD
15, Abhijit Shukla, PhD
16, Kristi Bertzos, PhD
17, Shalaka Hampras, PhD
14, Hussein Sweiti, MD
18, Siamak Daneshmand, MD
19.
1Upstate Medical University, Syracuse, NY, USA,
2Hospital Universitario 12 de Octubre, Madrid, Spain,
3IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy,
4Münster University Hospital, Münster, Germany,
5Netherlands Cancer Institute, Amsterdam, Netherlands,
6Urology San Antonio, San Antonio, TX, USA,
7Urologie Neandertal, Gemeinschaftspraxis für Urologie, Mettmann, Germany,
8'Regina Elena' National Cancer Institute, Rome, Italy,
9Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université de Paris Cité, Paris, France,
10Colorado Urology, Lakewood, CO, USA,
11UT Southwestern Medical Center, Dallas, TX, USA,
12NYU Langone Health, New York, NY, USA,
13Yokohama City University Medical Center, Yokohama, Japan,
14Johnson & Johnson, Raritan, NJ, USA,
15Johnson & Johnson, High Wycombe, United Kingdom,
16Johnson & Johnson, Lexington, MA, USA,
17Johnson & Johnson, Horsham, PA, USA,
18Johnson & Johnson, Spring House, PA, USA,
19University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
BACKGROUND: Patients (pts) with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR NMIBC) have high risk of disease progression and limited treatment options. TAR-200 is a targeted releasing system designed to provide sustained intravesical delivery of gemcitabine
in the bladder. SunRISe-1 (NCT04640623) is an ongoing phase 2b study assessing TAR-200 in pts with BCG-unresponsive HR NMIBC, ineligible for/refused radical cystectomy. Cohorts 1-3 enrolled pts with carcinoma in situ (CIS) ± papillary disease. We report 1-y duration of response (DOR) and patient-reported outcomes (PRO) in pts receiving TAR-200 monotherapy (Cohort 2).
METHODS: Pts (≥18 y; ECOG PS 0-2) had CIS ± papillary disease (high-grade Ta, any T1), after adequate BCG (last dose ≤12 months before CIS diagnosis). TAR-200 was dosed Q3W to W24 then Q12W to W96. No re-induction for nonresponders was allowed. Primary endpoint was overall complete response (CR) rate. Secondary endpoints included DOR, overall survival, PROs, safety, and tolerability. Response assessments included cystoscopy, centrally-assessed urine cytology, centrally‑assessed biopsy, and local imaging. Change from baseline in Global Health Status (GHS) and Physical Functioning (PF) scores was assessed.
RESULTS: At Sep 4, 2024 data cutoff, 85 pts received TAR-200 monotherapy. Centrally-confirmed and investigator-assessed CR rates were both 84% (95% CI, 74-91). Estimated median DOR and 1-y DOR rate were 26 mo (95% CI, 9-NE) and 55% (95% CI, 40-68), respectively. Mean GHS and PF scores were stable on treatment. Treatment-related adverse events (TRAEs) occurred in 84% of patients; most were low-grade lower urinary tract AEs. 6% of patients had serious TRAEs and 4% had TRAEs leading to treatment discontinuation. No treatment-related deaths occurred.
CONCLUSIONS: In SunRISe-1, TAR-200 monotherapy is associated with a high CR rate in patients with BCG-unresponsive HR NMIBC CIS, with a favorable risk-benefit profile. Data will be updated after final results in April.
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