J&J Halts Late-Stage Trial For Bladder Cancer Prospect

Johnson & Johnson’s SunRISe-2 study has officially been discontinued. Johnson & Johnson terminated the phase 3 bladder cancer study after an interim analysis indicating that the TAR-200 prospect was not superior to chemoradiation.

TAR-200 is a drug-device combo designed to provide a continuous administration of gemcitabine to the bladder over a three-week period. Johnson & Johnson announced an 83% complete rate of response in a phase 2b study involving individuals who have non-muscle-invasive bladder cancer (NMIBC) earlier this year, supporting its projection that TAR-200 may achieve peak sales exceeding $5 billion.

In the patient population of SunRISe-2, which consisted of individuals with muscle-invasive bladder cancer (MIBC), Johnson & Johnson has been unable to replicate the prior accomplishment. The purpose of the clinical study was to evaluate the efficacy of TAR-200 in comparison to chemoradiation in a group of 550 patients diagnosed with MIBC who were not undergoing bladder removal.

Due to the fact that TAR-200 was not demonstrating superiority in comparison to chemoradiation, the independent data monitoring panel suggested termination of SunRISe-2 at an interim analysis. Despite the fact that the move removes one chance for the candidate, Johnson & Johnson is continuing to maintain its peak sales prediction of more than $5 billion for the TARIS platform, which is the foundation of both the TAR-200 and TAR-210.

J&J will depend on indications outside the SunRISe-2 group to produce such numbers, commencing with the administration of TAR-200 as a single treatment for NMIBC. A submission for green light of TAR-200 in that scenario, the subject of J&J’s successful SunRISe-1 study, is anticipated for early next year. J&J is undertaking two further phase 3 studies in NMIBC; SunRISe-3 and SunRISe-5 are anticipated to be done and dusted in 2029 and 2030, respectively.

SunRISe-2 was initially designed as a long-term clinical trial, with completion planned for six years after it began. However, due to underwhelming interim results, the study was terminated ahead of schedule. The trial’s duration matched the treatment plan, where patients were administered TAR-200 every three weeks for the first 18 weeks. After this initial phase, the dosing intervals were extended to every 12 weeks, continuing throughout the third year. The objective was to evaluate the long-term effects of the treatment, but the early data did not justify continuing the trial to its full length.

Those in the TAR-200 group received the treatment alongside cetrelimab, Johnson & Johnson’s anti-PD-1 antibody. The study compared this group with a cohort receiving a chemotherapy med, either cisplatin or gemcitabine, combined with radiotherapy. The plan was to track both groups for up to eight years to compare key outcomes like progression to MIBC and overall survival.

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