Israeli trial reports strong results for high-risk bladder cancer treatment

An international study led by Prof. Boris Chetirkin at Shaare Zedek Medical Center in Jerusalem has reported promising results for a new treatment for high-risk non-muscle-invasive bladder cancer (NMIBC). Researchers say the findings could change standard care for the disease worldwide.

According to the study, about 95% of patients achieved a complete response, with the tumor disappearing after three months of treatment. After one year of follow-up, 76% of the participants still had no evidence of disease. The strongest results were seen among patients whose cancer had become resistant to BCG, the current standard therapy, and who were facing the possibility of bladder removal. In that group, 80% had complete disappearance of the disease after one year.

The researchers also reported that no patients in the study progressed to an invasive stage during follow-up, and none needed a cystectomy. The treatment tested, called NDV-01, uses a biodegradable polymer gel inserted into the bladder. It acts as a drug reservoir that steadily releases the chemotherapy drugs gemcitabine and docetaxel over 14 days, which the team says may reduce the need for repeated treatments and more complex procedures.

The treatment appeared safe as well. No serious side effects were reported, and the local side effects were mild, mainly temporary burning during urination. All participants completed the treatment and remained in the study. The results were presented recently at the annual conference of the American Urological Association. Following the phase 2 success, Relmada Therapeutics said it is preparing large phase 3 trials to advance the therapy toward a new standard of care.