Slow–release gemcitabine device targets bladder cancer more effectively
A slow–release device termed TAR-200, which releases a common chemotherapy agent over 3 weeks eliminated tumors in 80% of patients studied.
A Phase II trial of a novel intravesical drug-releasing system that provides sustained delivery of gemcitabine, a common chemotherapy agent, has reported complete response rates of 82% of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) whose cancer had previously resisted treatment. In many cases, patients were cancer-free after just 3 months of treatment.
The standard treatment for high-risk NMIBC is an immunotherapy drug, Bacillus Calmette–Guérin (BCG); however, around 40% of patients will not respond [1]. Gemcitabine is a common chemotherapy drug that is delivered in a liquid form, which only persists in the bladder for a few hours, so has limited effectiveness.
A new approach
In the SunRISe-1 trial, a device containing gemcitabine, TAR-200, was inserted into the bladders of 85 patients with BCG–resistant disease. TAR-200 is a miniature, pretzel–shaped drug–device duo that slowly and consistently released the gemcitabine for 3 weeks per treatment cycle.
“The theory behind this study was that the longer the medicine sits inside the bladder, the more deeply it would penetrate the bladder and the more cancer it would destroy,” explained lead author of a study Sia Daneshmand, Keck Medicine of University of Southern California (CA, USA). “And it appears that having the chemotherapy released slowly over weeks rather than in just a few hours is a much more effective approach.”
Sustained delivery, sustained results
NMIBC patients were treated with TAR-200 every 3 weeks for 6 months, and then four times a year for the next 2 years. The study reported that TAR-200 eliminated tumors in 82% of patients and almost half the patients were cancer–free a year later. TAR-200 was demonstrated to be well-tolerated, with minimal side effects. When co-administered with cetrelimab, another immunotherapy drug, TAR-200 was less effective.
TAR-200 has been granted a New Drug Application Priority Review by the FDA (MD, USA), which means it plans to take quicker action on the application than other applications.
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“Traditionally, these patients have had very limited treatment options. This new therapy is the most effective one reported to date for the most common form of bladder cancer,” commented Daneshmand. “Our mission is to deliver cancer–fighting medications into the bladder that will offer lasting remission from cancer, and it looks like we are well on our way toward that goal.”