Some cancer patients could avoid surgery with innovative new therapy
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An experimental drug has shown promise in fighting a difficult-to-treat form of bladder cancer known as high-risk non-muscle-invasive bladder cancer unresponsive to BCG (NMIBC).
BCG (Bacillus Calmette-Guérin) is an immunotherapy drug that is often the first-line treatment for certain early-stage bladder cancers.
The new drug, TAR-200, which was evaluated in a trial sponsored and conducted by Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, may offer a less invasive alternative to bladder removal surgery.
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TAR-200 is a small drug-delivery device that is placed directly into the bladder through a simple outpatient procedure, without general anesthesia, according to the study’s news release.
Once inserted, it slowly releases the chemotherapy drug gemcitabine over several weeks.
Researchers say the new device inserted into the bladder could prevent patients from losing their bladder completely. (iStock)
“Traditionally, these patients have had very limited treatment options. This new therapy is the most effective reported to date for the most common form of bladder cancer,” study leader Sia Daneshmand, MD, director of urologic oncology at Keck Medicine of USC, said in a news release.
“The findings from the clinical trial are a major advance in how certain types of bladder cancer could be treated, leading to better outcomes and saving lives.”
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Bladder cancer is the fourth most common cancer in men and the eleventh most common cancer in women.
According to the Urology Care Foundation, non-muscle invasive bladder cancer is found in the tissue that lines the inner surface of the bladder.
“Bladder cancer is one of the 10 most common cancers worldwide, but treatment options have remained largely unchanged for more than 40 years.”
High-risk NMIBC carries a higher chance of coming back after treatment. This study aimed to find an option for patients whose cancer recurred even after standard therapy.
“The standard treatment plan for these patients was surgery to remove the bladder and surrounding tissues and organs, which carries many health risks and can negatively impact patients’ quality of life,” Daneshmand said.
This new therapy could eventually allow some patients to avoid that procedure.
Trial results showed that many patients remained cancer-free for more than two years. (iStock)
All study participants had high-risk NMIBC that did not respond to the standard immunotherapy drug BCG. The study was divided into several groups that tested different combinations of medications and treatment methods.
In one group, patients received TAR-200 once every three weeks for about six months, followed by maintenance treatments every 12 weeks for up to two years.
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Among 85 patients in this group, 82.4% showed no detectable signs of cancer after treatment. In that group, 52.9% remained cancer-free at one year, and many remained cancer-free for more than two years without needing additional therapy.
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In another group of patients with a less aggressive type of early-stage bladder cancer, early disease-free survival rates were 85.3% at six months and 81.1% at nine months. In total, 94% were able to preserve their bladder.
The results of the clinical trial were published earlier this year in the Journal of Clinical Oncology.
The TAR-200 device delivers gemcitabine directly to the bladder, keeping the medication where it is needed most. (iStock)
The researchers emphasized that this is still data from the intermediate stage (Phase 2b). Larger, longer-term trials and regulatory reviews are still needed before the treatment can become standard care.
“Because the study did not include a traditional comparison (no randomized control arm), we cannot definitively say how TAR-200 compares to other treatments comparatively,” the researchers wrote.
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Patients in this study are a specific subset (non-BCG responders and eligible for bladder preservation) and may not represent all bladder cancer cases.
“In addition, the follow-up time remains relatively short and the number of patients is modest, meaning we do not yet know how long the benefits will last or how they will apply to larger, more diverse groups of people,” the researchers added.
Khloe Quill is a lifestyle production assistant at News Digital. She and the lifestyle team cover a range of topics including food and drink, travel and health.