Real-World Trends in Biomarker Testing for Bladder Cancer With Lisa Herms, PhD

The Importance of Biomarker Testing

Dr. Herms began with emphasizing the transformative impact of understanding the molecular pathogenesis of bladder cancer. She noted, “Understanding the molecular pathogenesis of bladder cancer has led to a lot of advancements in treatments, specifically developments of targeted therapies based on certain biomarkers that have become actionable.” Since 2016, several targeted therapies have been approved, and current guidelines recommend molecular profiling for patients with advanced or metastatic disease.

However, Dr. Herms highlighted that, as seen in other tumor types, barriers to biomarker testing persist. These can include access, cost, and variability in testing protocols across clinics. Her team sought to examine how these factors have played out over the past decade, particularly in the diverse and challenging environment of community oncology.

Study Design and Key Findings

The study analyzed electronic health records from nearly 6,000 patients diagnosed with metastatic bladder cancer. About 60% were de novo metastatic cases, while the remainder progressed from earlier-stage disease. The team specifically tracked testing for PD-L1, HER2, and FGFR2/3 biomarkers, calculating annual testing rates and comparing trends between de novo and progressive cases.

Dr. Herms reported a dramatic increase in biomarker testing over the study period: “Since 2015, where there was very little testing, testing rates have massively increased over time. Towards the end of the study period in 2024, we’re looking at about 70% of patients getting at least one of the biomarkers as compared to closer to 0% in 2015.” PD-L1 testing led the way, reflecting its status as the first actionable biomarker, but HER2 and FGFR2/3 testing also rose significantly. Notably, there was no significant difference in testing rates between de novo and progressive metastatic patients.

The study also overlaid the timing of therapy approvals with annual testing rates, revealing a correlation between new drug approvals and increased testing uptake.

Improving Outcomes Through Precision

Dr. Herms underscored the clinical value of biomarker testing, “Biomarker testing across the board is becoming quite common in cancer patients. It’s helpful for identifying risk, or in the case of bladder cancer, it helps providers identify targeted treatments.” She stressed that targeted therapies, guided by biomarker results, can spare patients from the toxicity of traditional treatments and improve both their experiences and long-term outcomes.

Study Limitations and Data Gaps

A key limitation of the study was its reliance on structured data from electronic health records. As Dr. Herms explained, “We did not have access in this particular study to unstructured data, which is provider narrative, progress notes, lab reports, and pathology reports. So, I think as a result of this, our testing rates are probably underestimated.” Additionally, the study only captured tests performed within 30 days of metastatic diagnosis, potentially missing tests conducted earlier or later in the disease course. Dr. Herms concluded, “We might even be underestimating the testing rates here, or we’ve got very conservative estimates of what’s going on.”

Addressing Disparities and Deepening Insights

Looking ahead, Dr. Herms outlined plans to further analyze patient characteristics to identify potential disparities in testing access. “The next logical step would be to dive into the patients that were tested and the ones that were not tested and figure out if there is anything systematic going on, anything that might reflect potential access issues or disparities issues.” She also aims to study the relationship between biomarker testing and treatment selection, as well as to monitor the uptake of newer biomarkers like HER2 and FGFR2/3 over time.

Future Directions and Hope for Bladder Cancer Care

Dr. Herms expressed optimism about the future: “The findings from this initial research are really promising, really encouraging. We want patients to get tested for biomarkers, as many biomarkers as possible, and then that will help make sure that they’re getting the right treatments.” She anticipates that increased testing will not only improve current patient outcomes but also drive the discovery of new therapeutic targets and the development of future drugs.

Key Takeaways for Oncology Professionals

• Biomarker testing in bladder cancer has increased dramatically in the past decade, with approximately 70% of metastatic patients now receiving at least one test.
• PD-L1 remains the most commonly tested biomarker, but HER2 and FGFR2/3 testing are on the rise.
• No significant differences were observed in testing rates between de novo and progressive metastatic cases.
• Structured EHR data likely underestimates true testing rates, highlighting the need for more comprehensive data capture.
• Ongoing research will focus on identifying disparities in testing and linking biomarker results to treatment decisions.

Conclusion

Dr. Herms’ research highlights the rapid adoption of biomarker testing in community oncology and its critical role in advancing precision medicine for bladder cancer. As testing becomes more widespread and new biomarkers emerge, oncology professionals are poised to deliver increasingly personalized and effective care to their patients.

About Dr. Herms

Lisa Herms, PhD, is an Associate Director of Real-World Research at Ontada, specializing in the analysis of biomarker testing trends and treatment patterns in oncology. Her research focuses on leveraging real-world data to understand and improve patient outcomes, particularly in the context of bladder cancer and other malignancies.