Researchers at Northwestern Medicine have discovered immune system biomarkers that may help predict whether patients with bladder cancer will respond to Bacillus Calmette-Guerin (BCG) therapy, according to a study published in the Journal of Clinical Investigation. The findings could enable clinicians to personalize treatment for bladder cancer patients, sparing non-responders from ineffective therapy and its side effects while allowing them to pursue alternative treatments sooner.
BCG therapy, a standard immunotherapy for non-muscle invasive bladder cancer, involves instilling a weakened strain of the tuberculosis bacteria into the bladder to stimulate an immune response against cancer cells. However, up to 40% of patients do not respond to the treatment, and current methods cannot reliably predict who will benefit. The Northwestern team analyzed tumor samples from bladder cancer patients and identified specific immune cell signatures that correlated with treatment outcomes.
“Our goal is to identify patients who are likely to respond to BCG therapy and those who are not, so we can tailor treatments accordingly,” said lead researcher Dr. Joshua J. Meeks, a urologist at Northwestern Medicine. “These biomarkers bring us closer to precision medicine for bladder cancer.”
The study highlights the role of immune cells, including CD8+ T cells and natural killer cells, in mounting an effective response to BCG. Patients with higher levels of these cells in their tumors tended to have better outcomes. Conversely, tumors with a suppressive immune microenvironment, characterized by regulatory T cells and myeloid-derived suppressor cells, were associated with poor response.
The implications of this research are significant. Bladder cancer is the sixth most common cancer in the United States, with an estimated 83,000 new cases annually. BCG therapy has been a mainstay for decades, but its efficacy varies widely. Identifying predictive biomarkers could improve patient selection, reduce unnecessary side effects, and lower healthcare costs by avoiding ineffective treatments.
Further research is needed to validate these biomarkers in larger clinical trials and develop standardized tests for clinical use. Meanwhile, other companies are also exploring immunotherapy advancements. For instance, Calidi Biotherapeutics Inc. (NYSE American: CLDI) is working on novel immunotherapies that harness the body’s immune system to fight cancer. However, the Northwestern study focuses specifically on identifying markers of response to existing therapies rather than developing new ones.
The study’s findings could also have broader implications for other immunotherapies, as similar immune biomarkers might predict responses to checkpoint inhibitors or other treatments. As precision oncology advances, the ability to forecast treatment outcomes becomes increasingly important, allowing for more personalized and effective cancer care.


