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ESMO 2021

ESMO 2021: SunRISe-1: TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High Risk NMIBC Unresponsive to Intravesical BCG Who Are Ineligible for or Elected Not To Undergo Radical Cystectomy

(UroToday.com) In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Michiel Van der Heijden presented on the design of the SunRISe-1 trial (NCT04640623).  This study seems to address the paucity of treatment options for patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) unresponsive to intravesical bacillus Calmette–Guérin (BCG). The trial will examine the role of TAR-200, an intravesical drug-delivery system that provides local continuous release of gemcitabine within the bladder. In addition to TAR-200 monotherapy, the study will include treatment with TAR-200 and systemic cetrelimab (anti–PD-1 antibody) or systemic cetrelimab alone in patients with BCG-unresponsive HR-NMIBC who are ineligible for or who decline radical cystectomy.

The SunRISe-1 trial (NCT04640623) is an open-label, parallel-group, multicenter phase IIb study designed to assess efficacy and safety of TAR-200 + CET, TAR-200 alone, and CET alone. The study enrolls patients with BCG-unresponsive HR-NMIBC, defined as histologically confirmed carcinoma-in-situ, with or w/o papillary disease (T1, high-grade Ta). Further, to be eligible, patients must be aged >/=18 y with ECOG PS 0-2 and within 12 mo of completing BCG.

A total of 200 participants will be randomized in a 2:1:1 fashion to TAR-200 + CET (cohort 1, n = 100), TAR-200 (cohort 2, n = 50), or CET (cohort 3, n = 50). In cohorts 1 and 2, TAR-200 is dosed cystoscopically every 3 weeks (Q3W) through week 24, and every 12 weeks thereafter until week 96. Cystoscopy, urine cytology, and MRI/CT are performed at baseline. Subsequent cystoscopy and centrally read urine cytology occur every 12 weeks through year 2, then every 24 weeks until the end of year 3, with additional disease assessments in year 4 and year 5 in accordance with institutional standards of care. 


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The primary endpoint for the 3 cohorts is the overall complete response rate at any time point. Secondary endpoints include the duration of response (calculated as the time from the first CR achieved to the first evidence of recurrence, progression, or death for participants who achieve a CR), overall survival, pharmacokinetics, safety/tolerability, and patient-reported outcomes.

With enrollment initiated as of January 2021, currently, participants are being enrolled at approximately 165 study sites in 16 countries. The trial is expected to reach primary completion in October 2024.


Presented by: Michiel S. Van der Heijden, MD, Ph.D., Research Group Leader in The Division of Medical Oncology, Netherlands Cancer Institute in Amsterdam