Taris Biomedical today announced positive results from the second arm of a study of its TAR-200 system for the treatment of patients with muscle-invasive bladder cancer (MIBC).

The most recent study arm involved 10 patients treated with TAR-200 and yielded positive safety, tolerability and preliminary efficacy data, according to Lexington, Mass.-based Taris. Combined data from both study arms shows a robust antitumor response on final histopathologic analysis after radical cystectomy (removal of the bladder and surrounding pelvic organs), good tolerability, and no detectable systemic drug exposure or associated adverse events, Taris said.

The results provide early evidence of the potential benefit of TAR-200 in the treatment of MIBC for both patients who can receive radical cystectomy and those who are unfit for surgical intervention.

“The TAR-200-101 study has revealed exciting results in patients with muscle-invasive bladder cancer,” said principal investigator Dr. Siamak Daneshmand, director of urologic oncology at the University of Southern California Institute of Urology, in a news release. “Such evidence of response, while early, may enable definitive treatment in patients currently unfit for curative intent therapy, including treatment with checkpoint inhibitors. Moreover, TAR-200 may also ultimately enable organ preservation strategies in lieu of radical cystectomy in patients who are unfit or unwilling to undergo bladder removal.”

During the window between diagnosis and RC, the TAR-200 system, which continuously delivers gemcitabine in the bladder, was administered twice for seven days per dose separated by a two-week rest. There was no delay to RC for any patient in either arm, with surgery proceeding as planned on Day 28 in Arm 1 and Day 42 in Arm 2, the company said.

“These data provide strong, histopathologically confirmed evidence of TAR-200’s anti-tumor activity and highlight our product candidate’s potential to fundamentally change the management of the full spectrum of disease for patients with MIBC,” said Taris president & CEO Tony Kingsley. “The study results support our next stage of development that focuses first on the large portion of patients who do not receive potentially curative therapies. These patients typically have significant comorbidities and a poor overall performance status, rendering them unfit for current standards of care. With few options, these patients face rapid mortality from this unmanaged disease. We believe that TAR-200 is uniquely positioned to address this substantial and serious unmet need.”