Two doses of a simple tuberculosis (TB) vaccination after surgery helps the immune system fight cancer cells and may improve patient outcomes among those with non–muscle-invasive bladder cancer, according to a pilot study of 40 patients. Initial results from the RUTIVAC-1 Trial were presented by Martinez Rodriguez et al at the European Association of Urology (EAU) Congress 2025 in Madrid (Abstract A0595).
In the randomized controlled trial, administering the vaccine alongside standard treatment led to an elevated immune response, which is known to improve the body’s ability to suppress future tumors. Patients who received the vaccine had no discernible side effects and every patient enrolled was cancer-free after 5 years.
Background
Following surgery to remove the tumor, patients with bladder cancer are typically given a live bacillus Calmette-Guérin (BCG) inoculation directly into the bladder to help their immune system destroy any remaining cancer cells. While this reduces the chances of their cancer coming back, up to 50% of patients go on to experience disease recurrence or progression.
Principal investigator Cecilia Cabrera, PhD, of IrsiCaixa and IGTP, Barcelona, and colleagues tested whether an additional injection of a nonlive TB vaccine, called RUTI, would further boost patients’ immune response in a small pilot study.
Findings
The investigators found that the RUTI vaccine significantly enhanced the BCG-induced immune response in patients who received it compared with the control group. RUTI vaccination was also associated with significantly higher progression-free survival, with every patient in the RUTI group tumor-free 5 years later compared with 13 of 18 patients in the control group.
Dr. Cabrera said: “We expected that the RUTI vaccine would improve the immune response for patients, but we didn’t know what effect this might have on cancer progression over 5 years. It was very surprising for us to see such a vast improvement in cancer progression, even with such a small group of patients.”
RUTI vaccination was also well tolerated by patients, with only mild reaction at the injection site reported and no systemic adverse effects.
Dr. Cabrera continued, “This was a small pilot study, but we’ve been really encouraged by the reduction in disease recurrence and progression in patients treated with the RUTI vaccine. We were particularly pleased to see that these results are further supported by an exploratory subanalysis including only [patients with] high-grade T1 bladder cancer. With such high rates of recurrence in bladder cancer, finding new ways to prevent this is very important.”
The researchers cautioned that a larger trial will be needed to confirm the results before the treatment can be considered for wider use.
Disclosure: RUTI is being developed as a therapeutic vaccine against tuberculosis by Archivel Farma SL. In parallel, RUTI is being developed as an immunotherapeutic agent for bladder cancer as a collaboration between IrsiCaixa, IGTP, and Archivel Farma. For full disclosures of the study authors, visit urosource.uroweb.org.
