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An experimental treatment method has shown promise in fighting a hard-to-treat form of bladder cancer known as BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC).
BCG (Bacillus Calmette-Guérin) is an immunotherapy drug that is often the first-line treatment for certain early-stage bladder cancers.
The new treatment mechanism, INLEXZO — 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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INLEXZO is a small, drug-releasing system placed directly into the bladder through a simple outpatient procedure, without general anesthesia, according to the study press release.
Once inserted, it slowly releases the chemotherapy drug gemcitabine over several weeks.
Researchers say the new bladder-inserted system could spare patients from losing their bladder entirely. (iStock)
“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,” said study lead Sia Daneshmand, M.D., director of urologic oncology with Keck Medicine of USC, in a press release.
“The findings of the clinical trial are a breakthrough in how certain types of bladder cancer might be treated, leading to improved outcomes and saved lives.”
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Bladder cancer is the fourth most common cancer in men and the 11th 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, yet treatment options have remained largely unchanged for over 40 years.”
High-risk NMIBC carries a greater 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 tissue and organs, which has many health risks and may negatively impact patients’ quality of life,” said Daneshmand.
This new therapy could eventually allow some patients to avoid that procedure.
Trial results showed that many patients stayed cancer-free for more than two years. (iStock)
All participants in the study had high-risk NMIBC that did not respond to the standard immunotherapy drug BCG. The study was split into multiple groups who tested different combinations of drugs and treatment methods.
In one group, patients received INLEXZO 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 stayed 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. Overall, 94% were able to keep their bladders.
The clinical trial results were published earlier this year in the Journal of Clinical Oncology.
The INLEXZO system delivers gemcitabine directly to the bladder, keeping the drug where it’s needed most. (iStock)
The researchers emphasized that this is still mid-stage (Phase 2b) data. Longer-term, larger trials and regulatory reviews are still needed before the treatment could become standard care.
“Because the study didn’t include a traditional comparison (no randomized control arm), we can’t definitively say how INLEXZO stacks up against other treatments in a fair head-to-head way,” the researchers wrote.
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Patients in this study are a specific subset (BCG-unresponsive and eligible for bladder preservation) and may not represent all bladder-cancer cases.
“Also, follow-up time remains relatively short and the number of patients modest, meaning we don’t yet know how long the benefits will last or how they apply to larger, more diverse groups of people,” the researchers added.