The sun has set on Johnson & Johnson’s SunRISe-2 study. J&J called a halt to the phase 3 bladder cancer trial after an interim look at the data showed the TAR-200 candidate was no better than chemoradiation.
TAR-200 is a drug-device combination that is designed to deliver a continuous supply of gemcitabine to the bladder for three weeks. J&J reported an 83% complete response rate in a phase 2b trial in patients with non-muscle-invasive bladder cancer (NMIBC) earlier this year, lending credence to its forecast that TAR-200 can generate peak sales of more than $5 billion.
J&J has failed to repeat the success in patients with muscle-invasive bladder cancer (MIBC), the patient population in SunRISe-2. The drugmaker designed the trial to compare TAR-200 to chemoradiation in 550 people with MIBC who weren’t having their bladders removed.
At a prespecified interim analysis, the independent data monitoring committee recommended stopping SunRISe-2 because TAR-200 wasn’t showing superiority versus chemoradiation. While the action shuts off one opportunity for the candidate, J&J is sticking with its $5 billion-plus peak sales forecast for the TARIS platform that underpins TAR-200 and its sibling TAR-210.
J&J will rely on indications beyond the SunRISe-2 population to generate those sales, starting with the use of TAR-200 as a monotherapy treatment for NMIBC. A filing for approval of TAR-200 in that setting, the focus of J&J’s successful SunRISe-1 trial, is planned for early next year. J&J is running two more phase 3 trials in NMIBC, SunRISe-3 and SunRISe-5, that have primary completion dates in 2029 and 2030, respectively.
SunRISe-2 was another long-term project, with the primary completion scheduled for six years after the start of the trial, but has been cut short by the lackluster interim data. The duration of the trial reflected the treatment regimen. Patients received TAR-200 every three weeks for the first 18 weeks. After that, the gap between deliveries extended to every 12 weeks through to the third year of the trial.
Participants in the TAR-200 arm received the treatment in combination with cetrelimab, J&J’s anti-PD-1 antibody. J&J was comparing the TAR-200 arm to an active comparator cohort that took a chemotherapy drug, either cisplatin or gemcitabine, in combination with radiotherapy. The plan was to track patients for up to eight years to compare the time to events such as MIBC and death in the two cohorts.