KEYNOTE-564 Paves the Way for New Renal Cell Carcinoma Trials


Rana R. McKay, MD, discusses KEYNOTE-564 and the future of adjuvant immunotherapy in renal cell carcinoma.

Rana R. McKay, MD, a medical oncologist and associate professor of Medicine at the University of California San Diego Health, discusses KEYNOTE-564 (NCT03142334) and how it can lead us in the right direction for the future of adjuvant immunotherapy in renal cell carcinoma (RCC).

While adjuvant immunotherapy in patients with RCC has demonstrated efficacy and improved overall survival, there are only a scarcity of agents which can be used in this setting.

The introduction of checkpoint inhibitors for patients with advanced RCC made it so testing could occur in the adjuvant setting. This led to the creation of KEYNOTE-564, the first adjuvant immunotherapy trial to report on RCC.

Based on the study’s results, pembrolizumab (Keytruda) was approved by the FDA for the use of RCC with an intermediate-high or high-risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions for adjuvant use in November 2021. The phase 3 trial was overall positive as it met its primary end point of improved disease-free survival, according to McKay.


0:08 | I think this trial is a landmark study that catapults us into a new era in renal cell carcinoma of testing the utility of adjuvant checkpoint inhibitors for patients with advanced disease, or localized disease that's high risk of recurring. There's going to be a series of other trials that are going to report out over the next several years that I think are going to further inform the field. As we get additional follow-up data from KEYNOTE-564, we will begin to understand the implications of the therapy with regards to overall survival.

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