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Frontline Pembrolizumab Approval Leaves Questions for Later Lines in Bladder Cancer

Gina Columbus @ginacolumbusonc
Published: Friday, Jun 23, 2017

Jorge Garcia, MD

Jorge Garcia, MD

With 5 checkpoint inhibitors approved for the second-line setting of urothelial carcinoma treatment, and 1 available for a frontline indication, how will researchers choose which drug to administer to patients?

on Genitourinary Cancers, Garcia, a medical oncologist at Cleveland Clinic, discussed how the field of bladder cancer has transformed with the FDA approval of pembrolizumab, and how oncologists should choose between 5 checkpoint inhibitors now available for the second-line setting and beyond.

OncLive: Can you provide an overview of your lecture on bladder cancer?

Garcia: We discussed the standard of care that has existed in bladder cancer for the last 20 years or so. Then, I dove into immunotherapy and the emerging role of PD-1 inhibitors. Now, we have 5 agents that are FDA approved as of today. I briefly reviewed the data of each of those trials and put that data into context when you look for biomarkers and patient selection: What does the future hold for bladder cancer?

Pembrolizumab was recently granted approval by the FDA. What impact is this decision going to have?

That is a huge and important approval for us because, thus far, the approval and the registration of atezolizumab, avelumab, nivolumab, and durvalumab have all been in the context of phase I/II studies that are based upon response rates and durability of responses. However, none of the trials has had survival benefit. Pembrolizumab and the KEYNOTE-045 trial demonstrated, for the first time, that a checkpoint inhibitor in the second-line space against chemotherapy was able to lead to a survival benefit in patients in that context.

Now, how do you put that data into context with the IMvigor data from Genentech/Roche, that was in a press release, as a negative trial? It randomized patients to atezolizumab versus chemotherapy. That trial’s press release was negative for survival. We have to wait to see the data to put it into context.

It has been more than 1 year now since the first checkpoint inhibitor was approved. What has it been like for you to see this invasion of immunotherapy unfold?

It has been great, because bladder cancer has been traditionally considered an orphan disease. There fully have not been any data supporting any treatment for the last 10 to 15 years outside of chemotherapy. That is rewarding for us and for our patients; it allows them to have options. The tricky part of getting 4 to 5 agents approved within 24 months is, which one are you going to use? Do we need to use all 5 treatments when roughly, biologically, they may be the same?
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Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Advancing the Treatment of Bladder Cancers Using Evidence-Based Immuno-Oncology StrategiesJul 30, 20191.0
Medical Crossfire®: Where Are We Headed in the Treatment of Triple-Negative Breast Cancer?Jul 31, 20191.5
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