Johnson & Johnson’s drug-device combo has disappointed in a late-stage test in people with an advanced form of bladder cancer, but it says it is still confident in the technology’s overall blockbuster potential.
The company decided to stop the Phase 3 SunRISe-2 study because TAR-200 plus its PD-1 drug candidate cetrelimab did not show superiority to chemoradiotherapy at a pre-planned interim analysis, according to a release late Monday. The trial aimed to recruit around 550 patients with muscle-invasive bladder cancer who are not getting bladder removal surgery.
TAR-200 consists of an old chemo product, gemcitabine, delivered in very low doses to the bladder through a silicone tube, or “pretzel,” over an extended period of time.
The candidate has already passed a separate Phase 3 test called SunRISe-1 in non-muscle invasive bladder cancer, with 83% of treated patients achieving a complete response at three months’ follow-up. The company is set to file those monotherapy data with the FDA early next year.
J&J obtained the technology behind TAR-200 during its buyout of Taris Biomedical in 2019. “We remain confident in the TARIS platform having $5B+ potential,” J&J said in a statement.
The tech from Taris is also being deployed in a separate bladder cancer asset called TAR-210, which is designed for sustained local release of fibroblast growth factor receptor inhibitor erdafitinib. In May, results from a Phase 1 trial showed that 90% of high-risk non-muscle invasive bladder cancer patients given TAR-210 did not see their cancer recur at the one-year mark.
As for TAR-200, the candidate is being evaluated alone and in combination with three other Phase 3 studies in various settings of bladder cancer: SunRISe-3, SunRISe-4 and SunRISe-5.