TAR-200 eradicated tumors in 82% of sufferers in a section 2 trial for sufferers with high-risk non-muscle-invasive bladder most cancers.
The drug-releasing system TAR-200 has been discovered to eradicate tumors in 82% of sufferers taking part in a section 2 medical trial for folks with high-risk non-muscle-invasive bladder most cancers whose illness was beforehand proof against remedy.
The event was introduced in a information launch issued by Keck Drugs of USC. Trial outcomes had been additionally revealed within the Journal of Scientific Oncology.
Amongst most sufferers the most cancers disappeared after three months of remedy, with almost half of sufferers cancer-free a 12 months later, in response to the information launch.
“Historically, these sufferers have had very restricted remedy choices. This new remedy is the simplest one reported up to now for the most typical type of bladder most cancers,” Dr. Sia Daneshmand, director of urologic oncology with Keck Drugs of USC and lead writer of the research, stated within the information launch. “The findings of the medical trial are a breakthrough in how sure forms of bladder most cancers is likely to be handled, resulting in improved outcomes and saved lives.”
TAR-200, as detailed within the information launch, is a pretzel-shaped system containing the chemotherapy gemcitabine and is inserted into the bladder through a catheter, and it slowly releases the drug into the bladder for 3 weeks every remedy cycle.
“The speculation behind this research was that the longer the drugs sits contained in the bladder, the extra deeply it could penetrate the bladder and the extra most cancers it could destroy,” stated Daneshmand within the information launch.
The SunRISe-1 trial enrolled 85 sufferers and was performed at 144 places, in response to the information launch. All sufferers had beforehand acquired remedy, however their most cancers had returned.
“The usual remedy plan for these sufferers was surgical procedure to take away the bladder and surrounding tissue and organs, which has many well being dangers and should negatively affect sufferers’ high quality of life,” stated Daneshmand within the information launch.
As a substitute, sufferers acquired remedy with TAR-200 each three weeks for six months after which 4 instances a 12 months for 2 years, ensuing within the disappearance of most cancers in 70 sufferers. Contributors within the trial can be adopted for an additional 12 months.
In July, the U.S. Meals and Drug Administration (FDA) granted precedence evaluate to the brand new drug utility for TAR-200 for sufferers with high-risk non-muscle invasive bladder most cancers that’s unresponsive to Bacillus Calmette-Guérin (BCG) and consists of carcinoma in situ, with or with out papillary tumors. This was introduced in a information launch from Johnson & Johnson.
“TAR-200 represents an innovation in drug supply that has not been seen in many years,” Dr. Yusri Elsayed, international therapeutic space head, Oncology, Johnson & Johnson Modern Drugs, stated within the information launch issued on the time. “The FDA precedence evaluate for TAR-200 underscores our mission to essentially change the way in which urologists deal with sure forms of bladder most cancers.”
Amongst sufferers with BCG-unresponsive, high-risk non–muscle-invasive bladder most cancers with carcinoma in situ with or with out papillary illness, remedy with TAR-200 elicited excessive full response charges, in response to knowledge from the section 2b SunRISe-1 research that had been shared in the course of the 2025 American Urological Affiliation Annual Assembly, the place investigators highlighted knowledge from Cohort 2 of the trial which evaluated 85 sufferers inside this inhabitants. Sufferers who acquired TAR-200 had been reported to have achieved an total full response charge of 82.4% and the 12-month full response charge was 45.9%.
References
- “New remedy eliminates bladder most cancers in 82% of sufferers,” information launch, Aug. 13, 2025; https://information.keckmedicine.org/new-treatment-eliminates-bladder-cancer-in-82-of-patients/
- “FDA Grants Precedence Evaluation to TAR-200 for Bladder Most cancers Subset,” CURE, July 18, 2025; https://www.curetoday.com/view/fda-grants-priority-review-to-tar-200-for-bladder-cancer-subset
- “TAR-200 Reveals Excessive Response Charges in Bladder Most cancers Subset,” CURE, April 29, 2025; https://www.curetoday.com/view/tar-200-shows-high-response-rates-in-bladder-cancer-subset
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