Biomarker Testing Expands in Metastatic Bladder Cancer
Lisa Herms, PhD, discussed findings from a retrospective analysis from the US community oncology setting on biomarker testing for bladder cancer.
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A retrospective study presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) meeting demonstrated a decade-long surge in biomarker testing for metastatic bladder cancer across US community oncology practices. The findings show a move toward precision medicine but also underscore lingering gaps in testing access and adoption—especially for more recently actionable targets like FGFR2/FGFR3 and HER2.1
Researchers looked at electronic health records from nearly 5800 patients diagnosed between 2015 and 2024. Patients were predominately male (75%) and White (90%). The median age of those enrolled was 73 years, 61% of patients were de novo metastatic, 26% had disease progression from stage I to stage III, and 13% of patients had disease progression with an unknown initial stage.
What they saw was a dramatic rise in biomarker testing, from under 1% in 2015 to 72% by 2024, with a spike that began around 2019. This increase was largely driven by PD-L1 testing, which remains the most used. Notably, patients with disease progression from earlier-stage disease were tested at higher rates than those who presented de novo with metastatic disease.
In an interview with Targeted OncologyTM, Lisa Herms, PhD, associate director with the real-world research team at Ontada, discussed the findings from this comprehensive retrospective analysis from the US community oncology setting on biomarker testing for bladder cancer.
Lisa Herms, PhD
Targeted OncologyTM: Can you provide some background about the study?
Herms: We have been closely monitoring the evolution of cancer care in general, and as we have gained a better understanding of the molecular pathogenesis of bladder cancer, new treatments—specifically targeted therapies—have been developed. These therapies make certain biomarkers quite actionable.
Patients diagnosed with advanced or metastatic disease are now recommended to undergo testing for specific biomarkers. However, we also recognize that there are real-world barriers to biomarker testing. These may include issues related to access, cost, or variability in testing protocols across clinics. We were interested in understanding how biomarker testing patterns have changed. Has there been an increase in testing uptake, especially within the community oncology setting? This setting is diverse and presents a unique set of circumstances that can complicate the implementation of biomarker testing.
We did a real-world study looking at this and how this is changing over time in a large, nationally representative community oncology network. The study found a significant increase in biomarker testing for bladder cancer in the US community oncology setting over the past decade.
To what factors do you attribute this increase in your own clinical practice?
We unfortunately were not able to really establish the reason behind this uptick. We set out to describe the facts of what was happening—[specifically, to characterize] testing rates and assess whether they were increasing, and if so, whether certain patient groups were being tested more frequently than others. We did quickly find, like we said, a [clear] increase overall [in testing]. That trend held [true] for patients who presented with de novo metastatic disease and those who progressed from earlier stages to metastatic disease.
We did not necessarily look into the reasons behind this, but we did on a descriptive level. We did look into the annual trends compared with some drug approvals, as well targeted therapy approvals. We did find that generally, when there was a drug that was approved that was relevant or maybe biomarker actionable, we did see an increase in testing shortly thereafter, quite quickly thereafter. I would assume there's something going on there, although we did not formally test that.
The study indicates that testing rates for FGFR2/3 and HER2 remain lower compared with PD-L1. What are the main barriers you encounter in your practice when considering or ordering these tests?
I think some of this might have to do with the timing. PD-L1 was the first biomarker that became actionable with the approval of atezolizumab [Tecentriq] in 2016. It has been the one that [had the] longest period with an associated available treatment. Approvals for FGFR2 and FGFR3-targeted therapies—and the associated biomarkers—have been more recent. So, I think there may be a lag in uptake as testing protocols evolve. As practices become more comfortable, develop new protocols, and incorporate more comprehensive testing, we’re starting to see changes.
Encouragingly, we observed a consistent increase in testing over the years—not just overall, but for each individual biomarker as well. While the absolute testing rates aren’t yet aligned—with PD-L1 testing still being more common—the others are slowly but steadily catching up.
How important is molecular profiling in your treatment approach for metastatic bladder cancer, and how has it changed your management of the disease over the past few years?
I think it is extremely important because it allows targeted therapy selection based on the molecular profile of the disease. It is giving patients access to other types of treatment, and more targeted treatments. Certainly, the hope is that this will improve outcomes for the patients as well. So, it is a more targeted treatment selection that physicians are able to dig into and consider as you are treating the patients.
Can you provide an example of how a specific drug approval has changed your biomarker testing practices?
We only did a descriptive study, so we have to be a little bit careful about making statements about cause and effect here. But when we were plotting, essentially, the testing rates over time, the proportion of patients that received the test out of the proportion of patients that were newly diagnosed with metastatic disease each year, we plotted that over time, and then we overlay on top of that approvals for particularly 3 therapies: 1 for PD-L1, 1 for FGFR2 and FGFR3, and 1 for HER2. We saw that, with the exception of HER2, as soon as that approval hit, that is where the line started to increase or the percentage started to increase quite drastically, especially for PD-L1. Again, it is just a descriptive study, but overlapping those 2 data points suggests that there is something going on directionally, which is in line with what we were expecting. That is sort of a natural development.
How do you stay updated on the latest biomarker testing recommendations and guidelines, and what resources do you find most helpful in this process?
I read up on the literature and the new guidelines that get posted. I have a lot of colleagues that are in clinical practice, or formerly [were] in clinical practice, and they are very in tune with the guidelines that have come out, the testing protocols, [and] especially testing protocols within the US Oncology Network, which is where we are sourcing most of our data from. I rely a lot on the colleagues that are in practice, hearing what they have to say, in addition to just the literature, monitoring new approvals that come out, and new guidelines as well.
What are the next steps for this research?
We are seeing encouraging results. Again, it is a basic study, it is a descriptive study, it is just a preliminary look into what has been happening but seeing that increasing trend was encouraging. I am excited to be able to dig deeper into the data as a next step [to see] what is driving some of these. Who is getting tested? Who is not getting tested? What is driving those decisions? Is there anything that can be done to even further improve the testing rates or continue to make sure that they are [staying] at the positive levels that they are at? [It is important to make] sure the practices are set up because more targeted therapies are coming; they are always being developed, and [we need to make] sure that we have got the infrastructure and the processes in place so that when they are new agents, we are able to execute the biomarker testing for all patients.
