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TAR-200 monotherapy in patients with bacillus Calmette-Guérin-unresponsive papillary disease-only high-risk non-muscle-invasive bladder cancer: first results from Cohort 4 of SunRISe-1
Félix Guerrero-Ramos, MD, PhD
1, Joseph M. Jacob, MD
2, Michiel S. Van der Heijden, MD, PhD
3, Martin Bögemann, MD
4, Siamak Daneshmand, MD
5, Andrea Necchi, MD
6, Daniel Zainfeld, MD
7, Philipp Spiegelhalder, MD
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, Christopher J. Cutie, MD
16, Shalaka Hampras, PhD
14, Hussein Sweiti, MD
17, Giuseppe Simone, MD, PhD
18.
1Hospital Universitario 12 de Octubre, Madrid, Spain,
2Upstate Medical University, Syracuse, NY, USA,
3Netherlands Cancer Institute, Amsterdam, Netherlands,
4Münster University Hospital, Münster, Germany,
5University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA,
6IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy,
7Urology San Antonio, San Antonio, TX, USA,
8Urologie Neandertal, Gemeinschaftspraxis für Urologie, Mettmann, Germany,
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, Spring House, PA, USA,
18'Regina Elena' National Cancer Institute, Rome, Italy.
BACKGROUND: Standard-of-care for Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR NMIBC) is radical cystectomy (RC), which is associated with significant mortality rates and impacts on quality of life. TAR-200 is a targeted releasing system designed to provide sustained intravesical delivery of gemcitabine. The ongoing phase 2b SunRISe-1 study is assessing efficacy and safety of TAR-200 ± cetrelimab in patients with BCG-unresponsive carcinoma in situ (CIS) who are ineligible for/refused RC in Cohorts 1-3. Cohort 4 is assessing TAR-200 monotherapy in patients with papillary disease-only. We will report interim analysis data from Cohort 4.
METHODS: Eligible patients (≥18 years; ECOG performance status 0-2) with histologically confirmed papillary-only HR NMIBC (high-grade Ta, any T1, and absence of CIS) diagnosed ≤12 months of last dose of adequate BCG were enrolled in Cohort 4. All visible papillary disease was fully resected. TAR-200 was dosed every 3 weeks through Week 24, then every 12 weeks until Week 96. Response assessments included cystoscopy and centrally assessed urine cytology every 12 weeks, local imaging every 24 weeks, and centrally assessed biopsy, as clinically indicated. The primary end point was disease-free survival (DFS) rate at 12 months. Key secondary end points included safety and tolerability.
RESULTS: At the Sep 4, 2024, data cutoff, 52 patients have been enrolled. The 6-month DFS rate was 94.4% (95% CI, 67-99); 12-month DFS rate was not estimable. 39 patients (75%) had treatment-related adverse events (TRAEs); most were low-grade lower urinary tract events. 7 patients (14%) had grade ≥3 TRAEs and 3 (6%) had serious TRAEs; 4 (8%) had TRAEs leading to TAR-200 discontinuation. No treatment-related deaths occurred.
CONCLUSIONS: These will be the first data for TAR-200 in patients with BCG-unresponsive papillary disease-only HR NMIBC from SunRISe-1. Abstract will be revised to include updated data available in April.
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