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 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
| Project | Trial | Setting | Regimen | Note |
|---|---|---|---|---|
| TAR-200 (gemcitabine eluting) | Ph2 Sunrise-1 | 2nd-line high-risk NMIBC, BCG unresponsive | +/- cetrelimab vs cetrelimab | Data at ESMO 2024: CR 84% vs 46% with TAR-200 mono vs cetrelimab; final data & regulatory filings due Q1 2025 |
| Ph3 Sunrise-2 | 1st-line MIBC not receiving cystectomy | + cetrelimab vs chemoradiotherapy | Discontinued for futility Oct 2024 | |
| Ph3 Sunrise-3 | 1st-line high-risk NMIBC | +/- cetrelimab vs BCG | Confirmatory trial, “almost fully enrolled”, data possible in next 12-18mo | |
| Ph2 Sunrise-4 | Neoadjuvant MBIC pts undergoing cystectomy | + cetrelimab vs cetrelimab | Data at ESMO 2024: pCR 42% vs 23% with TAR-200 + cetrelimab vs cetrelimab | |
| Ph3 Sunrise-5 | 2nd-line high-risk NMIBC, BCG experienced | Monontherapy vs intravesical chemotherapy | Primary completion Nov 2030 | |
| TAR-210 (erdafitinib eluting) | Ph3 Moonrise-1 | 1st-line intermediate-risk NMIBC with FGFR alterations | Monontherapy vs intravesical chemotherapy | Primary completion Jun 2028 |
Note: MIBC=muscle-invasive bladder cancer; NMIBC=non-muscle invasive bladder cancer. Source: OncologyPipeline.
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