An experimental treatment method for a severe form of bladder cancer, known as BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC), has demonstrated significant success in a recent clinical trial, according to a report published by Fox News.
This innovative therapy, called INLEXZO, may offer certain patients a less invasive alternative to radical bladder removal surgery.
The study, which was sponsored and conducted by Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, tested INLEXZO in patients whose cancer had not responded to the standard immunotherapy drug, BCG (Bacillus Calmette-Guérin).
Key Trial Findings (Reported by Fox News):
- In a core group of 85 patients, 82.4% showed no detectable signs of cancer following treatment.
- Over half of the patients in this group (52.9%) remained cancer-free at the one-year mark.
- Many patients in the trial stayed cancer-free for more than two years without requiring additional therapy.
- Overall, 94% of participants were able to keep their bladders.
INLEXZO is described as a small, drug-releasing system that is placed directly into the bladder via a simple outpatient procedure, which does not require general anesthesia. Once inserted, the system slowly releases the chemotherapy drug gemcitabine over several weeks. The study’s results were published earlier this year in the Journal of Clinical Oncology.
Sia Daneshmand, M.D., director of urologic oncology with Keck Medicine of USC and the study lead, stated that the findings represent a breakthrough in treating certain bladder cancers, potentially leading to improved outcomes and saved lives.
“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
Bladder cancer is a globally common disease, ranking as the fourth most common cancer in men and the 11th most common in women. Treatment options for the disease have remained “largely unchanged for over 40 years”.
Researchers emphasized that the reported results stem from mid-stage (Phase 2b) data. Longer-term, larger trials and necessary regulatory reviews are still required before INLEXZO can be considered standard care.
The researchers also noted limitations, including that the study did not feature a traditional randomized control arm, meaning they “can’t definitively say how INLEXZO stacks up against other treatments in a fair head-to-head way”. Furthermore, patients involved in the study represent a specific subset (BCG-unresponsive), and the follow-up time remains relatively short with a modest number of patients.