Bladder Cancer Update & Renal Cell Cancer Update, 2017 (Video Program)Results of the Phase III CheckMate 025 study: Activity and tolerability of nivolumab versus everolimus for advanced RCC
3:50 minutes.
TRANSCRIPTION:
DR LOVE: What do we know about response rate and duration and survival, specifically with single-agent anti-PD-1, nivolumab? DR MOTZER: So all the data is with nivolumab. And about 25% of patients will have an objective response. The median duration of response at the time we reported it was 12 months. There were many of the responders that were continuing in response at the time of that analysis. And there was an improvement in overall survival compared to everolimus, with the median overall survival for the different studies with nivolumab falling in the 24- to 25-month range. DR LOVE: What about tolerability issues in this situation, compared to everolimus? I think we’re kind of getting familiar now with what is typically seen with the anti-PD-1 agents alone. But I’m just kind of curious, thinking back — we’ve been talking so much about TKIs and everolimus — globally, clinically, how you would compare quality of life on a checkpoint inhibitor to either TKI or everolimus? DR MOTZER: So I think that’s a really important point. For the most part, of our different approved drugs before nivolumab, everolimus was our best-tolerated drug. I mean, everolimus is rapamycin, basically. And so it was the best-tolerated drug, and it was one of the reasons it was so widely used. And nivolumab did better with regard to a safety profile compared to everolimus. And it did, in the trial, it has, in my own experience. And even in the trial, there was improvement in quality of life for nivolumab compared to everolimus. So I think that that is really the deciding factor for me in terms of what drug to use in second-line therapy with these different drugs available. Cabozantinib or lenvatinib plus everolimus have both resulted in improvement in overall survival, but my choice for second-line treatment is nivolumab for most patients, because of the safety profile. So that being said, I think for many patients treated with nivolumab, they have no side effects. I mean, they feel really well. When I was conducting the trial, some of the patients coming off drugs like sunitinib and pazopanib, they were concerned they were getting placebo, because they felt so well. And that was something I heard over and over again. And I would reassure them that no, this is nivolumab. So I think that the safety profile has really been striking. Now, that being said, though, there is a concern for these kind of unusual, rare immune-related side effects, which have been well recognized for melanoma and other cancers. And so I think that as this goes into the community, we need to educate physicians to be really vigilant as far as, kind of, these unusual immune-related side effects. And they’re a challenge because of the fact that they’re also kind of, like, different and variable. It’s the whole spectrum of rheumatologic disorders, basically. And so I think that — but I do think, as these checkpoint inhibitors are incorporated into care not only for kidney cancer but across the board — I think for most malignancies, they’re going to become part of standard of care, that oncologists will need to be able to recognize these immune-related events and manage them. |