Johnson & Johnson on Friday unveiled updated data from its Phase IIb SunRISe-1 study, which found that its investigational drug-device combination TAR-200 can induce rapid complete response in patients with high-risk non-muscle invasive bladder cancer.
Friday’s readout, which was presented at the American Urological Association’s annual meeting, came from 85 patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ and who are either ineligible for or decline radical cystectomy. Results demonstrated a centrally confirmed complete response rate of 82.8%, as quantified by biopsies or urine cytology.
Almost all incidences of complete response were achieved within 12 weeks of treatment, according to J&J.
SunRISe-1 also had an estimated 1-year duration of response of 74.6%, with 85% of all responders still showing complete treatment response as of the data cutoff on January 2, 2024. None of the responders progressed to muscle-invasive or metastatic disease.
Christopher Cutie, J&J’s vice president and disease area leader for bladder cancer, in a statement called these findings “a significant step” in the pharma’s quest to provide patients with new treatment options focused on “bladder preservation and long-term survival.”
“These results reinforce the potential of TAR-200 to transform the treatment landscape” in NMIBC, Cutie said.
Designed to be easily installed, TAR-200 is an investigational targeted drug releasing system that allows for the controlled dosing of gemcitabine into the bladder. The drug-device system prolongs the exposure of the bladder to the anti-cancer drug. TAR-200’s installation procedure only takes three to five minutes and can be completed in a physician’s office without anesthesia.
In SunRISe-1, J&J is testing TAR-200 as a monotherapy or in combination with the intravenous PD-1 blocker cetrelimab. The trial has so far enrolled 200 patients and is designed to evaluate complete response as its primary endpoint. Key secondary outcomes include duration of response, overall survival and quality of life.
J&J is also running the Phase III SunRISe-3 and SunRISe-5 studies of TAR-200 in NMIBC, as well as SunRISe-2 and SunRISe-4 in muscle-invasive bladder cancer.
Friday’s readout adds another bladder cancer victory for J&J. In January 2024, the pharma won the FDA’s approval for its FGF kinase inhibitor Balversa (erdafitinib) for locally advanced or metastatic urothelial carcinoma.
The regulator also recently approved ImmunityBio’s first-in-class IL-15 superagonist Anktiva (nogapendekin alfa inbakicept-pmln), in combination with Bacillus Calmette-Guérin, for NMIBC.
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