A catheter-delivered implant that slowly releases gemcitabine eliminated visible tumors in 82% of patients with BCG‑unresponsive, high‑risk non‑muscle‑invasive bladder cancer in a phase 2 study. More than half of responders remained cancer‑free for at least a year, and the device has since been approved by the FDA as Inlexzo for patients with carcinoma in situ who are ineligible for, or decline, bladder removal.
SunRISe-1, a phase 2b study, reported an 82.4% complete response rate with TAR‑200 (a gemcitabine‑releasing intravesical system) in patients with BCG‑unresponsive, high‑risk non‑muscle‑invasive bladder cancer (CIS with or without papillary tumors). The results were published online in the Journal of Clinical Oncology. (pubmed.ncbi.nlm.nih.gov)
According to the sponsor’s submission and published data, 70 of 85 patients treated with TAR‑200 monotherapy achieved a complete response; 52.9% of responders remained cancer‑free for at least 12 months from the time of response. (jnj.com)
The global trial enrolled patients across 144 sites, including Keck Hospital of USC. In the monotherapy cohort, TAR‑200 was dosed every three weeks through week 24, then every 12 weeks up to week 96. (ascopost.com)
TAR‑200 monotherapy also showed a more favorable risk‑benefit profile than either cetrelimab alone or the combination. In BCG‑unresponsive CIS, complete response rates were 82.4% with TAR‑200 alone, 67.9% with TAR‑200 plus cetrelimab, and 46.4% with cetrelimab alone. Grade ≥3 treatment‑related adverse events occurred in 12.9%, 37.7%, and 7.1% of patients, respectively; no treatment‑related deaths were reported. (pubmed.ncbi.nlm.nih.gov)
How it works: TAR‑200 is inserted via catheter and remains in the bladder for about three weeks per cycle, delivering sustained local gemcitabine exposure. As lead author Sia Daneshmand, MD, noted, the rationale was that “the longer the medicine sits inside the bladder, the more deeply it would penetrate … and the more cancer it would destroy.” (sciencedaily.com)
Context: Most bladder cancers are initially non‑muscle‑invasive, and for patients whose disease is unresponsive to BCG, radical cystectomy has long been the standard option. TAR‑200 offers a bladder‑sparing alternative for some of these patients. (auanet.org)
Regulatory status: The FDA granted Priority Review to the TAR‑200 New Drug Application on July 17, 2025, and subsequently approved the product—now branded Inlexzo—on September 9, 2025, for adults with BCG‑unresponsive NMIBC with CIS, with or without papillary tumors, who are ineligible for or decline cystectomy. The approved regimen calls for insertion once every three weeks for up to six months (eight doses), then once every 12 weeks for up to 18 months (six doses), or until recurrence, progression, or unacceptable toxicity. (The phase 2 study dosed through 24 months.) (jnj.com)
Keck Medicine of USC said participants will continue to be followed; trial enrollment has closed. (sciencedaily.com)
