Some cancer patients could avoid surgery with innovative new therapy

BCG (Bacillus Calmette-Guérin) is an immunotherapy drug that is often the first-line treatment for certain early-stage bladder cancers.

TAR-200 is a small, drug-releasing device placed directly into the bladder through a simple outpatient procedure, without general anesthesia, according to the study press release. 

"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."

According to the Urology Care Foundation, non-muscle-invasive bladder cancer is found in the tissue that lines the inner surface of the bladder. 

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.

This new therapy could eventually allow some patients to avoid that procedure.

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 TAR-200 once every three weeks for about six months, followed by maintenance treatments every 12 weeks for up to two years.

The clinical trial results were published earlier this year in the Journal of Clinical Oncology.

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 TAR-200 stacks up against other treatments in a fair head-to-head way," the researchers wrote. 

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.