Dr. Nanus on Trials Investigating Immunotherapy in RCC

David M. Nanus, MD
Published: Tuesday, Apr 10, 2018



David M. Nanus, MD, medical oncologist, Weill Cornell Medicine/NewYork-Presbyterian Hospital, discusses trials investigating immunotherapy regimens for patients with renal cell carcinoma (RCC).

There are several phase III upfront randomized trials of immunotherapy that are interesting, says Nanus. One of the issues with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy), which has shown great efficacy as a treatment in the upfront setting, is the risk of immunologic side effects. It was seen that some of the trials with PD-1/PD-L1 inhibitors plus tyrosine kinase inhibitors may have less toxicity with similar efficacy. In the adjuvant setting, there are 3 or 4 adjuvant trials investigating this strategy.

In December 2017, the FDA granted a priority review to a supplemental biologics license application for the use of the combination of nivolumab and ipilimumab as a frontline treatment for intermediate- and poor-risk patients with RCC. This is based on the phase III CheckMate-214 trial, in which the combination reduced the risk of death by 32% compared with sunitinib (Sutent) for patients with metastatic RCC. The median overall survival was not reached with the combination versus 32.9 months with sunitinib (HR, 0.68; 99.8% CI, 0.49-0.95; P = .0003).
 


David M. Nanus, MD, medical oncologist, Weill Cornell Medicine/NewYork-Presbyterian Hospital, discusses trials investigating immunotherapy regimens for patients with renal cell carcinoma (RCC).

There are several phase III upfront randomized trials of immunotherapy that are interesting, says Nanus. One of the issues with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy), which has shown great efficacy as a treatment in the upfront setting, is the risk of immunologic side effects. It was seen that some of the trials with PD-1/PD-L1 inhibitors plus tyrosine kinase inhibitors may have less toxicity with similar efficacy. In the adjuvant setting, there are 3 or 4 adjuvant trials investigating this strategy.

In December 2017, the FDA granted a priority review to a supplemental biologics license application for the use of the combination of nivolumab and ipilimumab as a frontline treatment for intermediate- and poor-risk patients with RCC. This is based on the phase III CheckMate-214 trial, in which the combination reduced the risk of death by 32% compared with sunitinib (Sutent) for patients with metastatic RCC. The median overall survival was not reached with the combination versus 32.9 months with sunitinib (HR, 0.68; 99.8% CI, 0.49-0.95; P = .0003).
 

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