J&J’s Sunrise dims

The gemcitabine-eluting bladder cancer project TAR-200, one of Johnson & Johnson’s big pipeline hopes, took a blow this week with discontinuation of the phase 3 Sunrise-2 study in muscle-invasive bladder cancer. True, the trial was looking at a niche within the already small indication of MIBC: patients ineligible for or refusing to undergo radical cystectomy, the gold standard therapy. J&J has another study in MIBC, Sunrise-4, testing TAR-200 as neoadjuvant therapy in cystectomy patients, as well as trials in non-muscle invasive bladder cancer (NMIBC), a bigger market. But the news highlights how much J&J has riding on projects acquired via Taris Biomedical, including TAR-200 and the erdafitinib-eluting TAR-210; the company has said that, together, annual peak sales of these could hit $5bn. If TAR-200 is approved next year in NMIBC, as J&J hopes, it will go into an increasingly crowded space, where Keytruda is approved along with Ferring’s Adstiladrin and ImmunityBio’s Anktiva, and where CG Oncology’s oncolytic virus candidate cretostimogene grenadenorepvec could soon be heading to regulators. J&J said it was still “highly confident” in TAR-200; final data from the Sunrise-1 trial, which could support accelerated approval in NMIBC, are due in early 2025, and durability will be a key question.

Mid to late-stage trials with TAR-200 & TAR-210

Note: MIBC=muscle-invasive bladder cancer; NMIBC=non-muscle invasive bladder cancer. Source: OncologyPipeline.