Researchers at Northwestern Medicine have identified immune system markers 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 strain of Mycobacterium bovis 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 biomarkers to predict response. The Northwestern team analyzed tumor samples from patients before and after BCG treatment, identifying specific immune cell populations and gene expression patterns that correlated with treatment outcomes.
“Our study provides a comprehensive immune landscape of bladder tumors and identifies potential biomarkers that could guide clinical decision-making,” said lead researcher Dr. Joshua J. Meeks, a professor of urology at Northwestern University Feinberg School of Medicine. “If validated, these markers could help identify patients who are likely to benefit from BCG and spare others from ineffective treatment and its side effects.”
The researchers found that patients who responded to BCG had higher levels of certain T cells and natural killer cells in their tumors before treatment, as well as distinct gene expression profiles associated with immune activation. Non-responders showed a more immunosuppressive tumor microenvironment. The study also identified a set of 10 genes that could predict response with high accuracy in their cohort.
While these findings are promising, the researchers emphasize that further validation in larger, prospective studies is needed before the biomarkers can be used in clinical practice. The study was supported by the National Institutes of Health and the U.S. Department of Veterans Affairs.
As immunotherapy continues to evolve in oncology, other companies are also working on novel approaches. Calidi Biotherapeutics Inc. (NYSE American: CLDI) is among the enterprises refining immunotherapy strategies, though their work is not directly related to this study. For more information on Calidi Biotherapeutics, visit their website at https://www.calidibio.com.
This research underscores the potential of immune biomarkers to transform bladder cancer care, moving toward precision medicine where treatment is tailored to each patient’s immune profile. The full study is available in the Journal of Clinical Investigation at https://www.jci.org.
