Treating bladder cancer patients and identifying bladder cancer patients responsive to treatment
Patent Number: US9523689
Executive Summary:
General Description:
BCG is commonly used to treat bladder cancer, but 20-40% of patients do not respond to the treatment. This invention is a predictive biomarker of BCG therapy response: patients having an initial tumor immune microenvironment with more tumor-infiltrating Th2 lymphoid cells are more likely to respond to BCG therapy.
Scientific Progress:
Retrospective study including 38 bladder cancer patients
Future Directions:
Strengths:
Weaknesses:
Patent Status:
Legal Status: Active, expires 2032.12.19
Publication PMID: 24055426
Publications:
Nunez-Nateras R, Castle EP, Protheroe CA, Stanton ML, Ocal TI, Ferrigni EN, Ochkur SI, Jacobsen EA, Hou YX, Andrews PE, Colby TV, Lee NA, Lee JJ. Predicting response to bacillus Calmette-Guérin (BCG) in patients with carcinoma in situ of the bladder. Urol Oncol. 2014 Jan;32(1):45.e23-30. doi: 10.1016/j.urolonc.2013.06.008. Epub 2013 Sep 18.
Inventor Bio: Nancy A. Lee
http://www.mayo.edu/research/faculty/lee-nancy-a-ph-d/bio-00085960
Executive Summary:
- Invention Type: Diagnostic
- Patent Status: US Grant
- Patent Link: https://patents.google.com/patent/US9523689/
- Research Institute: Mayo Clinic
- Disease Focus: Bladder cancer
- Basis of Invention: Infiltrating tumor T-cell signature
- How it works: From a tumor biopsy, evaluation of the ratio of tumor-infiltrating Th2 lymphoid cells to tumor-infiltrating Th1 lymphoid cells to identify bladder cancer patients who are likely to respond to BCG therapy
- Lead Challenge Inventor: Nancy A. Lee
- Inventors: James J. Lee, Erik P. Castle, Rafael Nunez Nateras, Nancy A. Lee
- Development Stage: Tumor biopsies from a retrospective study
- Novelty: First signature biomarker of the kind to predict BCG response in bladder cancer patients
- Clinical Applications: companion diagnostic for BCG immunotherapy
General Description:
BCG is commonly used to treat bladder cancer, but 20-40% of patients do not respond to the treatment. This invention is a predictive biomarker of BCG therapy response: patients having an initial tumor immune microenvironment with more tumor-infiltrating Th2 lymphoid cells are more likely to respond to BCG therapy.
Scientific Progress:
Retrospective study including 38 bladder cancer patients
Future Directions:
- Validation with another larger retrospective cohort
- Prospective clinical trial
Strengths:
- No other biomarker to predict BCG response
- Assay sensitivity: 100% of BCG nonresponders and 80% of BCG responders are correctly identified
Weaknesses:
- Competition with non-invasive biomarkers (urinary IL-2 levels…)
- The influence of Th1/Th2 polarization in the tumor microenvironment on BCG response has not been validated in large studies
Patent Status:
Legal Status: Active, expires 2032.12.19
- Priority date: 2011.11.23
- Filing date: 2012.11.21
- Publication date: 2016.12.20
- Grant date: 2016.12.20
Publication PMID: 24055426
Publications:
Nunez-Nateras R, Castle EP, Protheroe CA, Stanton ML, Ocal TI, Ferrigni EN, Ochkur SI, Jacobsen EA, Hou YX, Andrews PE, Colby TV, Lee NA, Lee JJ. Predicting response to bacillus Calmette-Guérin (BCG) in patients with carcinoma in situ of the bladder. Urol Oncol. 2014 Jan;32(1):45.e23-30. doi: 10.1016/j.urolonc.2013.06.008. Epub 2013 Sep 18.
Inventor Bio: Nancy A. Lee
http://www.mayo.edu/research/faculty/lee-nancy-a-ph-d/bio-00085960
