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An investigational drug shows promise in fighting a type of infectious disease that is difficult to treat. bladder cancer It is known as BCG non-responsive high-risk non-muscle invasive bladder cancer (NMIBC).
BCG (Bacillus Calmette-Guerin) is an immunotherapy drug that is a first-line treatment for certain early-stage bladder cancers.
The new drug, TAR-200, being evaluated in a clinical trial sponsored and conducted by Janssen Research & Development LLC, a subsidiary of Johnson & Johnson, may offer a less invasive alternative. cystectomy surgery.
According to the study’s press release, TAR-200 is a small drug-release device that is placed directly into the bladder in a simple outpatient procedure without the need for general anesthesia.
Once inserted, it will slowly come out Chemotherapy drug gemcitabine For several weeks.
Researchers say this new bladder insertion device could save patients from losing their bladder entirely. (St. Petersburg)
“Traditionally, these patients have had very limited treatment options. This new treatment is the most effective treatment reported to date for the most common form of bladder cancer,” study principal investigator Thea Dhaneshmand, M.D., director of the Department of Urologic Oncology at Keck Medicine USC, said in a press release.
“The results of this clinical trial represent a breakthrough in the treatment of certain types of bladder cancer, leading to improved outcomes and lifesaving outcomes.”
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Bladder cancer is the fourth most common cancer in men and the 11th most common cancer. For women.
According to the Urology Care Foundation, non-muscle-invasive bladder cancer begins in the tissue lining the bladder.
“Bladder cancer is one of the top 10 most common cancers worldwide, yet treatment options have remained largely unchanged for more than 40 years.”
High-risk NMIBC is more likely to relapse after treatment. The study aimed to find options for patients whose cancer has returned even after standard treatment.
“The standard treatment plan for these patients has been surgery. remove the bladder And the surrounding tissues and organs have many health risks that can negatively impact the patient’s quality of life,” Dhaneshmand said.
This new treatment may eventually allow some patients to avoid the procedure.
Trial results showed that many patients remained cancer-free for more than two years. (St. Petersburg)
All participants in the study had high-risk NMIBC that did not respond to the standard immunotherapy drug BCG. The study was divided into groups and tested different combinations of drugs and treatments.
In one group, patients received TAR-200 once every three weeks for about six months, followed by maintenance therapy every 12 weeks for up to two years.
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Of the 85 patients in this group, 82.4% showed no detectable signs of cancer after treatment. In that group, 52.9% remained cancer-free at 1 year, and many remained cancer-free for more than 2 years and did not require treatment. Additional therapy.
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Another group of patients with less aggressive forms of early-stage bladder cancer were initially disease-free. survival rate It was 85.3% at 6 months and 81.1% at 9 months. Overall, 94% were able to maintain their bladder.
The clinical trial results were published earlier this year in the Journal of Clinical Oncology.
The TAR-200 device delivers gemcitabine directly to the bladder, keeping the drug where it is needed most. (St. Petersburg)
The researchers emphasized that this is still mid-term (phase 2b) data. Long-term, large-scale trials and regulatory review are still needed before this therapy becomes standard of care.
“Because this study did not include a traditional comparison (there was no randomized control group), we cannot say with certainty how TAR-200 compares fairly with other treatments,” the researchers wrote.
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The patients in this study are a specific subset (patients who are non-BCG responsive and candidates for bladder preservation) and are not representative of all bladder cancer cases.
“Also, the follow-up period is still relatively short and the number of patients is not large, meaning it remains to be seen how long the benefit lasts and how it applies to a larger and more diverse group of people,” the researchers added.
