Researchers have developed an innovative drug-delivery implant that may help patients with hard-to-treat bladder cancer avoid surgery and maintain long-term cancer-free status.
In a significant advancement for bladder cancer treatment, researchers have introduced a new drug-delivery implant that could allow patients to avoid bladder removal surgery. This innovative approach targets a challenging form of bladder cancer known as BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC).
The experimental drug, TAR-200, has shown promise in clinical trials conducted by Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson. Traditionally, Bacillus Calmette-Guérin (BCG) is the first-line immunotherapy for early-stage bladder cancers. However, for patients whose cancer does not respond to BCG, options have been limited.
TAR-200 is a small device that releases the chemotherapy drug gemcitabine directly into the bladder. The implant is inserted through a simple outpatient procedure that does not require general anesthesia. This method allows for a targeted delivery of the drug, potentially reducing the need for more invasive treatments.
Dr. Sia Daneshmand, director of urologic oncology at Keck Medicine of USC and lead author of the study, emphasized the significance of this new therapy. “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,” he stated 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.”
Bladder cancer ranks as the fourth most common cancer among men and the eleventh most common among women. According to the Urology Care Foundation, non-muscle-invasive bladder cancer affects the tissue lining the bladder’s inner surface. High-risk NMIBC is particularly concerning due to its higher likelihood of recurrence following treatment.
The study aimed to provide an alternative for patients whose cancer recurred despite standard therapies. Previously, the standard treatment for these patients involved surgical removal of the bladder and surrounding tissues, a procedure that carries significant health risks and can adversely affect quality of life.
In the clinical trial, participants with high-risk NMIBC who did not respond to BCG were divided into groups to test various drug combinations and treatment methods. One group received TAR-200 every three weeks for approximately six months, followed by maintenance treatments every 12 weeks for up to two years.
Among the 85 patients in this group, an impressive 82.4% showed no detectable signs of cancer following treatment. Furthermore, 52.9% remained cancer-free at the one-year mark, with many maintaining their cancer-free status for over two years without the need for additional therapy.
In another group of patients with a less aggressive form of early-stage bladder cancer, early disease-free survival rates were recorded at 85.3% at six months and 81.1% at nine months. Notably, 94% of participants in this group were able to retain their bladders.
The results of the clinical trial were published earlier this year in the Journal of Clinical Oncology. However, researchers caution that this data is still in the mid-stage (Phase 2b) of testing. Larger-scale trials and regulatory reviews will be necessary before TAR-200 can be considered standard care.
As the researchers noted, “Because the study didn’t include a traditional comparison (no randomized control arm), we can’t definitively say how TAR-200 stacks up against other treatments in a fair head-to-head way.” They also pointed out that the patient group studied is a specific subset of those who are BCG-unresponsive and eligible for bladder preservation, which may not represent all bladder cancer cases.
Additionally, the follow-up period remains relatively short, and the number of participants modest. Consequently, the long-term benefits of TAR-200 and its applicability to larger, more diverse populations are still uncertain.
As research continues, the hope is that TAR-200 and similar therapies will provide new avenues for treatment, improving outcomes for patients battling bladder cancer.
Source: Original article