“Biomarker Integration in Drug Development”
The integration of biomarkers has become a cornerstone in the development of urothelial cancer drugs. By leveraging specific biomarkers such as PD-L1 expression and tumor mutational burden (TMB), clinicians and pharmaceutical companies can stratify patients based on their likelihood to respond to immunotherapies. This targeted approach reduces unnecessary exposure to ineffective treatments and improves overall response rates.
For instance, clinical trials for checkpoint inhibitors like atezolizumab and pembrolizumab now routinely incorporate PD-L1 status to determine enrollment eligibility and assess treatment efficacy. Furthermore, tumor mutational burden has emerged as a predictive biomarker in identifying patients who may benefit from immune checkpoint blockade, especially in high-risk or treatment-refractory cases.
This trend is accelerating the development of companion diagnostics and fostering a more personalized oncology treatment paradigm.
