Asim Amin, MD
Since the FDA approved the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for patients with advanced intermediate- and poor-risk advanced renal cell carcinoma (RCC), other immunotherapy regimens are moving through the pipeline with encouraging activity.
State of the Science Summit™ on Genitourinary Cancers, Amin, director of immunotherapy at the Levine Cancer Institute, discussed the current role of checkpoint inhibitors in advanced RCC and where the future is heading in this space.
OncLive: What is the current landscape for frontline immunotherapy in advanced RCC?
: I took the liberty of adding the word "evolving" to the name of my presentation because this field is rapidly evolving. Every day there is a new development. I discussed how we got to the approval of the first immunotherapy combination in this space: nivolumab and ipilimumab. I also briefly discussed the next steps that are following this combination.
What was the impact of the CheckMate-214 trial?
The CheckMate-214 study took root when the initial phase I data in advanced RCC showed clinical benefit and tolerability with the combination of nivolumab and ipilimumab. The combination had previously shown significant clinical activity in advanced melanoma and was approved in that space. One of the standards of care for frontline treatment in advanced RCC has been sunitinib, which is a VEGF TKI.
The primary endpoints were to look at OS for those patients who were intermediate and poor risk; secondary endpoints included PFS. The trial accrued very rapidly and was first reported in the New England Journal of Medicine. There was a statistically significant difference in OS and response rate in favor of the immunotherapy combination. The toxicity was very manageable. With those data, it was FDA approved.
What are the next steps?
With the proof of concept for combination immunotherapy, there has been significant interest in exploring other combinations. As we mentioned, the response rate for CheckMate-214 with nivolumab and ipilimumab was 40%. That essentially means that 60% of patients did not respond. This is still an area of unmet need.
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