LBA105 - Results from SunRISe-1 in patients (Pts) with bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) receiving TAR-200 monotherapy

Background

Pts with BCG-unresponsive HR NMIBC are at high risk of disease progression with limited treatment (tx) options. TAR-200, an intravesical drug delivery system, provides sustained release of gemcitabine in the bladder over many days. SunRISe-1 (NCT04640623) is an ongoing, randomized, ph 2b study assessing efficacy and safety of TAR-200 + cetrelimab (anti-PD1) (Cohort 1 [C1]), TAR-200 alone (C2), or cetrelimab alone (C3) in pts with BCG-unresponsive HR NMIBC ineligible for or refusing radical cystectomy. We report results from C2.

Methods

Eligible pts aged ≥18 y had histologically confirmed carcinoma in situ (CIS) ± papillary disease (high-grade Ta, any T1), ECOG performance status 0-2, and persistent or recurrent HR NMIBC with last dose of BCG ≤12 mo prior to CIS diagnosis. TAR-200 was dosed Q3W through Wk 24, then Q12W until Wk 96. Response assessments: cystoscopy and centrally assessed urine cytology, CT/MRI, and bladder biopsy (at Wk 24, 48, and as clinically indicated). Primary end point: overall complete response (CR) rate. Secondary end points: duration of response (DOR), overall survival, safety, and tolerability.

Results

At 24 Aug 2023 data cutoff, 54 pts (median age, 71 y; range, 40-85; 33% with concurrent papillary disease) received TAR-200 monotherapy. 30 pts were efficacy evaluable. Centrally confirmed CR by urine cytology and/or biopsy was achieved in 23/30 pts (77%; 95% CI, 58-90). Median DOR was not reached (median follow-up in responders, 48 wks; range, 12-121); 21/23 responders remain in CR with 11/11 and 6/6 having response ≥6 mo and ≥12 mo from CR, respectively. CR rate by investigator assessment was comparable with central results. 29 pts (54%) had tx-related adverse events (TRAEs); most common (≥10%) were pollakiuria, dysuria, and micturition urgency. 4 pts (7%) had Gr ≥3 TRAEs; 1 (2%) had serious TRAE; 2 (4%) had TRAEs leading to discontinuation. No deaths were reported.

Conclusions

In SunRISe-1, TAR-200 monotherapy is associated with an unprecedented CR rate, durable responses, and a favorable tolerability profile in pts with BCG-unresponsive CIS, supporting its continued investigation in HR NMIBC.

Clinical trial identification

NCT04640623.

Editorial acknowledgement

Medical writing assistance was provided by Benjamin Ricca, PhD, of Parexel, and was funded by Janssen Global Services, LLC.

Legal entity responsible for the study

Janssen Research & Development.

Funding

Janssen Research & Development.

Disclosure

A. Necchi: Financial Interests, Institutional, Research Grant: Merck Gilead BMS; Financial Interests, Personal, Speaker, Consultant, Advisor, Consultancy Fees: Merck, Roche, Bayer, AstraZeneca, Astellas, BMS, Janssen, Pfizer, Incyte. J.M. Jacob: Financial Interests, Personal, Speaker, Consultant, Advisor: Verity Pharmaceuticals, Photocure Gennady Bratslavsky; Financial Interests, Personal, Other, Employment: AptametrixLeadership: Taurus Diagnostics. S. Daneshmand: Financial Interests, Personal, Speaker, Consultant, Advisor: Photocure, Taris, Ferring, QED Therapeutics; Financial Interests, Personal, Other, Travel: Photocure; Financial Interests, Personal, Stocks or ownership: Taris; Financial Interests, Personal, Other, Honoraria: Photocure, QED Therapetics, Olympus, Ferring, pacific Edge, Johnson & Johnson, Aduro Biotech, Janssen, Bristol-Myers Squibb, Allergan; Financial Interests, Personal, Research Funding: Photocure. G. Simone: Financial Interests, Personal, Speaker, Consultant, Advisor: Ipsen, S.p.A, Janssen, AIOM, J.T., Congredis, MI&T, Eurotrining, Summet, OVER, Start Promotion, Creggi Firenze, ASL Rieti, Delphi International, Associazione Progetto Ipporcrate, Universita la apienza di Roma; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Bayer, AB Medica. E. Xylinas: Financial Interests, Personal, Other, Support for attending meetings and/or travel: Janssen Oncology, Ipsen ; Financial Interests, Personal, Other, Participation on a Data Safety Monitoring Board or Advisory Board: Pfizer, Janssen Oncology, Astellas, AstraZeneca, MSD; Financial Interests, Personal, Other, Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid French and European Guidelines member in bladder Cancer. D. Morris: Financial Interests, Personal, Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Janssen, Astellas, Bayer, Merck, AstraZeneca, Myovant, Pfizer, Lantheus/progenics. P. Spiegelhalder: Financial Interests, Personal, Research Funding: Janssen, AstraZeneca, Lilly; Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen; Financial Interests, Personal, Other, Congress Funds: Janssen, Amgen. D. Zainfeld: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Immunity Bio, Bristol Myers Squibb. J.T. Matulay: Financial Interests, Personal, Advisory Board: Sanofi Advisory board Bristol Meyer Squibb, Advisory board. L. Belkoff: Financial Interests, Personal, Speaker, Consultant, Advisor: Marius; Financial Interests, Personal, Advisory Board: Immunity Bio, Janssen. H. Arentsen: Financial Interests, Personal, Other, Support for attending meetings and/or travel: EAU Congress Milan 2023; Financial Interests, Personal, Other, Support for conducting clinical trial: Janssen. S. Hampras: Financial Interests, Personal, Other, Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson & Johnson. C. Cutie: Financial Interests, Personal, Other, Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson & Johnson. H. Sweiti: Financial Interests, Personal, Other, Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson & Johnson. K. Stromberg: Financial Interests, Personal, Other, Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson & Johnson. J. Martin: Financial Interests, Personal, Other, Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson & Johnson. A. Shukla: Financial Interests, Personal, Other, Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson & Johnson. M.S. van der Heijden: Financial Interests, Institutional, Advisory Board: AstraZeneca, BMS, Janssen, MSD, Seagen, Pfizer; Financial Interests, Institutional, Funding, Investigator-initiated trial: BMS, Roche, AstraZeneca, 4SC; Financial Interests, Institutional, Steering Committee Member, Local PI + SSC member: BMS, AstraZeneca, MSD, Seagen; Financial Interests, Institutional, Steering Committee Member, Local PI + study co-PI: Janssen. All other authors have declared no conflicts of interest.