FDA Grants BTD to TAR-200 in Bladder Cancer Subset

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TAR-200, a novel targeted therapy, has been granted breakthrough therapy designation by the FDA in high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin.

Bladder Cancer, Urinary Bladder Image: © reineg - stock.adobe.com

Bladder Cancer, Urinary Bladder Image: © reineg - stock.adobe.com

  • The FDA has granted TAR-200 (JNJ-63723283) a breakthrough therapy designation (BTD) for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who are ineligible for radical cystectomy.1
  • The breakthrough therapy designation is designed to help speed up the development and review of drugs that are intended to treat a serious condition and the use of which is supported by early clinical findings.
  • TAR-200 is a novel investigational targeted releasing system to deliver sustained local release of gemcitabine into the bladder.

TAR-200 has received a BTD from the FDA in BCG-unresponsive HR-NMIBC that is not amenable to radical cystectomy. The BTD is supported by findings from the phase 2 SunRISe-1 trial (NCT04640623).

“TAR-200 represents a novel interventional approach for the treatment of localized bladder cancer where today, unfortunately, options are limited and include antiquated BCG therapy or radical cystectomy,” said Kiran Patel, MD, vice president, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine, in a press release. “This breakthrough therapy designation recognizes TAR-200 as a promising advancement and marks an important step forward in our innovative focus to transform the treatment of bladder cancer.”

TAR-200 is an investigational agent that can deliver a targeted, sustained release of gemcitabine into the bladder for weeks at a time. The agent is being further investigated in NMIBC in the SunRISe-3 trial (NCT05714202), as well as in muscle-invasive bladder cancer in the SunRISe-2 (NCT04658862) and SunRISe-4 (NCT04919512) studies.

About SunRISe-1

SunRISe-1 is a phase 2 study evaluating TAR-200 plus cetrelimab (JNJ-63723283) compared with each agent individually in patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.2

The primary end points are overall complete response rate and disease-free survival. The secondary end points are duration of response, overall survival, gemcitabine concentrations in urine and plasma, serum concentrations of anti-cetrelimab antibodies, number of patients with anti-cetrelimab antibodies, change from baseline in quality-of-life, and number of patients with adverse events.

TAR-200 is administered transurethrally every 3 weeks for the first 24 weeks, then every 12 weeks through 99 weeks. Cetrelimab is dosed every 3 weeks through 78 weeks.

To be eligible to participate in the study, patients must be ineligible for or elected not to have radical cystectomy, received treatment with adequate BCG therapy, and have an ECOG performance status of 0-2. Patients are not eligible to participate if they have muscle-invasive or metastatic disease, have received a live virus vaccine within 30 days of study initiation, have active hepatitis B or C infection, or have received prior therapy with an anti-PD-1 or anti-PD-L2 agent.

REFERENCES:
1. Johnson & Johnson’s investigational TAR-200 granted U.S. FDA breakthrough therapy designation for the treatment of high-risk non-muscle-invasive bladder cancer. News release. Johnson & Johnson. December 4, 2023. Accessed December 5, 2023. https://tinyurl.com/ydebn542
2. A study of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical Bacillus Calmette-Guérin who are ineligible or elected not to undergo radical cystectomy (SunRISe-1). ClinicalTrials.gov. Updated November 8, 2023. Accessed December 5, 2023. https://clinicaltrials.gov/study/NCT04640623
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