Johnson & Johnson (J&J) has shared promising results for its investigational bladder cancer treatment approach, TAR-200, at this year’s American Urological Association Annual Meeting.
More than 83,000 people are diagnosed with bladder cancer in the US every year, with non-muscle-invasive bladder cancer (NMIBC) accounting for up to 85% of all newly diagnosed cases.
Radical cystectomy, the removal of the bladder and nearby structures and organs, is currently recommended for NMIBC patients who fail standard-of-care Bacillus Calmette-Guérin (BCG) immunotherapy. However, as NMIBC usually affects older patients, many may be unwilling or unfit to undergo this procedure.
TAR-200 is an investigational targeted releasing system which enables the controlled release of the chemotherapy drug gemcitabine into the bladder. This increases the amount of time the drug delivery system spends in the bladder and sustains local drug exposure, according to J&J.
Cohort two of the phase 2b SunRISe-1 trial has been evaluating TAR-200 as a monotherapy in patients with BCG-unresponsive high-risk NMIBC with carcinoma in situ who are ineligible for, or decline, radical cystectomy.
Results demonstrated a centrally confirmed complete response (CR) rate of 82.8%, with 98% of CRs achieved at the first disease assessment at week 12, and four of five patients who have completed two years of treatment remaining in CR.
The estimated one-year duration of response rate is 74.6%, with median follow-up in responders of 29.9 weeks. Additionally, 85% remained in CR at the data cutoff in January and none of the responders progressed to muscle-invasive bladder cancer or metastasis.
“The high CR rate and durability of these responses observed in patients treated with TAR-200 underscores the potential of this treatment approach for patients with BCG-unresponsive high-risk NMIBC,” said presenting author Joseph Jacob, department of urology at Upstate Medical University.
SunRISe-1 is also evaluating TAR-200, which has already been granted Breakthrough Therapy Designation by the US Food and Drug Administration, in combination with the investigational anti-PD-1 monoclonal antibody cetrelimab, or cetrelimab alone, in the same patient population.
Christopher Cutie, vice president, disease area leader, bladder cancer, J&J Innovative Medicine, said: “These results reinforce the potential of TAR-200 to transform the treatment landscape and our ongoing dedication to address unmet needs for patients facing this challenging disease.”