Bladder Cancer Update & Renal Cell Cancer Update, 2017 (Video Program)Activity of nivolumab alone and in combination with ipilimumab for metastatic RCC
2:34 minutes.
TRANSCRIPTION:
DR LOVE: Can you talk about some of the key clinical research data sets we have right now with checkpoint inhibitors, anti-PD-1 as well as combinations? DR RINI: The largest, of course, is with nivolumab, right, as single-agent PD-1 inhibitor, showing a survival advantage against everolimus, as we alluded to. Response rate in the 20% range, similar to other TKIs in the refractory setting. No PFS advantage, interestingly. So perhaps a little bit more of a delayed effect. But again, very well tolerated. The trial that this patient was on was the combination with ipilimumab, a lot of the melanoma data. And there’s a large Phase III with that combination compared to sunitinib that’s completed accrual. And I know will be the first of these large checkpoint-based Phase IIIs to be reported hopefully in the next year or so whenever the timing is. So that’s a really important trial. That may change our initial standard approach to much of kidney cancer. DR LOVE: What’s your experience and what’s the clinical research data in terms of both anti-PD-1, say nivolumab alone, as well as with anti-CTLA-4, for example, ipilimumab? What we’ve heard from melanoma and other areas is a lot more toxicity but qualitatively the same kinds of autoimmune problems. Is that the situation here? DR RINI: Yes. Yes, I think so. What I tell patients is that we’re trying to inflame the tumor, but obviously you can inflame any organ, most commonly skin and gut and liver and what not. I think on paper, the toxicities by organ system are very similar. But certainly the percentages and the severity are much higher with the combo. And that’ll be something that I think will need to be sorted out in each disease. I know it’s being done in melanoma. The kidney cancer patients are going to be a little older, a little less healthy. So whether or not it’ll be able to be tolerated in kidney cancer to a large extent I think remains to be seen. DR LOVE: What do we know about efficacy with the combination at this point? And indirectly comparing it to single agent? DR RINI: We know from the cohort studies, the Phase II studies of combination the response rate was about 40%. And that’s been report in a couple of abstracts. And there’s a manuscript on its way to being submitted. And that, on the surface, is about double what the nivolumab monotherapy is. Progression-free survival is harder to interpret because that trial was a mix of front-line and refractory patients.. So PFS can be a little hard to interpret in that setting. And I don’t even know if survival was reported, honestly. It’s only a Phase II. So there’s clearly activity. And I would say there’s clearly more activity and more toxicity. So again, that balance will be important. |