Among the intermediate- and poor-risk patients, nivolumab plus ipilimumab produced significantly higher rates of overall survival and objective response, according to investigators.
At a median follow-up of 25.2 months, the 18-month overall survival rate for intermediate- and poor-risk patients was 75% for the immunotherapy combination versus 60% for sunitinib, with a median overall survival not reached versus 26.0 months for standard therapy (p<.001). The objective response rate was 42%, compared to 27% for the control arm (p<.001), with a complete response rate of 9% versus 1%.
By contrast, outcomes in favorable risk patients did not seem to be any better in the immunotherapy arm, with a significantly higher objective response rate and significantly longer progression-free survival favoring the sunitinib arm, though longer-term follow-up data are awaited.
“For now, it's safe to say that VEGF TKIs will continue to be a standard option for those patients,” said Dr. McDermott, who also served as an investigator in CheckMate 214. “I think observation is also appropriate in those patients, too. If we're seeing a good risk patient in clinic, we often tell them, ‘We can just wait and watch and we'll treat you if your scans show growth.’ ”
Dr. McDermott cautioned that clinicians and patients need to be attuned to the toxicities associated with immune checkpoint inhibitor therapy, which can be serious. In CheckMate 214, there were four deaths in the sunitinib group and eight in the nivolumab-plus-ipilimumab group that investigators said were related to treatment.
“The toxicities need to be diagnosed early and treated early, at which point they can be reversed,” Dr. McDermott said.
Dr. McDermott has received honoraria and consulting fees from Bristol-Myers Squibb, Pfizer, Merck Novartis, Eisai, Exelixis, Array BioPharma, and Genetech BioOncology, as well as grant support from Prometheus Laboratories. Dr. Hammers has received grants and personal fees from Bristol-Myers Squibb and personal fees from Pfizer and Exelixis.
Checkmate 214 was supported by Bristol-Myers Squibb and Ono Pharmaceutical.
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