Researchers at Northwestern Medicine have identified immune system biomarkers that may help predict which patients respond to BCG (Bacillus Calmette-Guérin) therapy for bladder cancer and which do not. The findings, published in the Journal of Clinical Investigation, could lead to more personalized treatment approaches for patients with non-muscle invasive bladder cancer.
BCG therapy, an immunotherapy that uses a weakened form of the tuberculosis bacterium to stimulate the immune system to attack cancer cells, is a standard treatment for high-risk non-muscle invasive bladder cancer. However, up to 40% of patients do not respond to the therapy, and currently, there are no reliable predictors of response. The new research, led by Dr. Joshua Meeks and colleagues at Northwestern University Feinberg School of Medicine, analyzed tumor samples from patients before and during BCG treatment to identify immune markers associated with response.
The study found that patients who responded to BCG therapy had higher levels of certain immune cells, including CD8+ T cells and natural killer cells, in their tumors before treatment. Additionally, a specific gene expression signature related to interferon signaling was associated with positive outcomes. Conversely, non-responders had higher levels of immunosuppressive cells, such as regulatory T cells and myeloid-derived suppressor cells.
These biomarkers could help clinicians identify patients who are likely to benefit from BCG therapy, sparing non-responders from unnecessary side effects and allowing them to pursue alternative treatments sooner. The findings also open the door to developing combination therapies that could modulate the immune microenvironment to improve response rates.
Bladder cancer is the sixth most common cancer in the United States, with an estimated 82,000 new cases diagnosed annually. The identification of predictive biomarkers is a critical step toward precision medicine in bladder cancer treatment. Companies like Calidi Biotherapeutics Inc. (NYSE American: CLDI) are also advancing immunotherapy approaches, further refining options for patients.
The Northwestern team plans to validate these biomarkers in larger clinical trials and explore whether they can be used to guide treatment decisions in real time. The research was supported by the National Institutes of Health and the U.S. Department of Veterans Affairs.
For more information on the study, visit the Journal of Clinical Investigation at https://www.jci.org. Insights from companies like Calidi Biotherapeutics Inc. (NYSE American: CLDI) are part of the evolving landscape of immunotherapy research.
