Abstract 719TiP
Background
Treatment options are limited for patients (pts) with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) unresponsive to intravesical bacillus Calmette–Guérin (BCG). TAR-200 is an intravesical drug-delivery system which provides local continuous release of gemcitabine within the bladder. This study will assess rate of complete response (CR) upon treatment with TAR-200 + systemic CET (anti–PD-1 antibody), TAR-200, and CET in BCG-unresponsive pts with HR-NMIBC ineligible for or who decline radical cystectomy.
Trial design
SunRISe-1 (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 in participants with BCG-unresponsive HR-NMIBC. Eligible participants are aged >/=18 y with ECOG PS 0-2 and histologically confirmed carcinoma-in-situ, with or w/o papillary disease (T1, high-grade Ta), and within 12 mo of completing BCG. Participants (N = 200) are randomized 2:1:1 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 every 3 wks (Q3W) through wk 24, and Q12W thereafter until wk 96. Cystoscopy, urine cytology, and MRI/CT are performed at baseline. Subsequent cystoscopy and centrally read urine cytology occur Q12W through y 2, then Q24W until end of y 3, with additional disease assessments in y 4 and y 5 in accordance with institutional standards of care. Primary endpoint for the 3 cohorts is overall CR rate at any time point. Secondary endpoints include duration of response (time of first CR achieved to first evidence of recurrence, progression, or death for participants who achieve a CR), overall survival, PK, safety/tolerability, and patient-reported outcomes. Participants are being enrolled at ∼165 study sites in 16 countries. Enrollment initiated January 2021.
Clinical trial identification
NCT04640623.
Editorial acknowledgement
Editorial assistance was provided by Jennifer Klem, of Parexel, and was funded by Janssen Global Services, LLC.
Legal entity responsible for the study
Janssen Research & Development, LLC.
Funding
Janssen Research & Development, LLC.
Disclosure
M.S. van der Heijden: Financial Interests, Institutional, Advisory Role: Roche/Genentech; Financial Interests, Institutional, Advisory Role: Astellas Pharma; Financial Interests, Institutional, Advisory Role: AstraZeneca/MedImmune; Financial Interests, Institutional, Advisory Role: Bristol-Myers Squibb; Financial Interests, Institutional, Advisory Role: MSD Oncology; Financial Interests, Institutional, Advisory Role: Seattle Genetics; Financial Interests, Institutional, Advisory Role: Janssen; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Novartis; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Astellas Pharma; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: MSD Oncology; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Roche; Financial Interests, Institutional, Funding: Astellas Pharma; Financial Interests, Institutional, Funding: Bristol-Myers Squibb; Financial Interests, Institutional, Funding: Roche; Financial Interests, Institutional, Funding: AstraZeneca. C. Cutie: Financial Interests, Personal, Full or part-time Employment: Janssen Oncology; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson; Financial Interests, Personal, Royalties: TARIS Biomedical; Financial Interests, Personal, Advisory Role: Blue Earth Diagnostics; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Johnson & Johnson. M. Acharya: Financial Interests, Personal, Full or part-time Employment: Janssen Oncology; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Janssen Oncology. K. Stromberg: Financial Interests, Personal, Full or part-time Employment: Janssen Oncology. X. Li: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. N. Beeharry: Financial Interests, Personal, Full or part-time Employment: Janssen Oncology; Financial Interests, Personal, Stocks/Shares: AI Therapeutics; Financial Interests, Personal, Royalties: AI Therapeutics. R. Stewart: Financial Interests, Personal, Full or part-time Employment: Janssen Oncology; Financial Interests, Personal, Funding: Janssen Oncology; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson; Financial Interests, Personal, Royalties: Universty of Utah; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Janssen Onoclogy. J. Maffeo: Financial Interests, Personal, Full or part-time Employment: Janssen Oncology. C. Indoria: Financial Interests, Personal, Full or part-time Employment: Janssen Oncology. W. Levin: Financial Interests, Personal, Advisory Role: Johnson & Johnson; Financial Interests, Personal, Advisory Role: AstraZeneca. J. Jacob: Financial Interests, Personal, Advisory Role: Verity Pharmaceuticals; Financial Interests, Personal, Advisory Role: Photocure.