Peter O’Donnell, MD
An FDA safety warning suggests that the role of immunotherapy in the treatment of patients with metastatic bladder cancer may need altering, explained Peter O’Donnell, MD, an associate professor of medicine at the University of Chicago Medicine.
on Renal Cell Carcinoma and Bladder Cancer, O’Donnell discussed the integration of immunotherapy in the treatment paradigm of advanced bladder cancer and its potential role as combination therapy.
OncLive®: How has the landscape of advanced bladder cancer changed?
O'Donnell: It's an exciting time in metastatic bladder cancer, in the sense that over the past several years we've had the introduction of 5 new FDA-approved immunotherapies. When the immunotherapies first came to market, they were approved in the platinum-refractory setting. Essentially, every patient was getting those therapies.
Then, of course there's that small segment of patients who are not chemotherapy-eligible at all. They're not fit for any type of chemotherapy, even carboplatin-based treatment. According to the new FDA guidance, those patients would be eligible to receive immunotherapy as opposed to no treatment at all.
Can these agents be compared?
Only by extrapolation; they haven't been compared head-to-head. In the platinum-refractory setting, we have Level 1 data for pembrolizumab. The randomized phase III trial showed an OS benefit against taxane-based chemotherapy. Unfortunately, the randomized phase III trial of atezolizumab was negative in that same comparison. In the platinum-refractory setting, I find myself using pembrolizumab as the first choice because of its Level 1 designation.
I don't think we know as much about the other 3 immunotherapies. They certainly are valid options in that setting, we just don't know the survival benefit of those therapies yet.
Is PD-L1 testing now required?
It's now required if you have a cisplatin-ineligible patient in the frontline setting in whom you're thinking about using immunotherapy. If a patient can't receive chemotherapy, you're going to want to think about PD-L1 testing. It's also required if you're going to use an immunotherapy in a patient who is chemotherapy-eligible, but if a patient could receive gemcitabine/carboplatin, I'm generally going to choose that.
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