HCRN GU16-260: Nivolumab and salvage nivolumab ipilimumab in treatment-naïve patients with advanced renal cell carcinoma

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Published: 12 Jun 2020
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Dr Elizabeth Plimack - Fox Chase Cancer Center, Philadelphia, USA

Dr Elizabeth Plimack talks to ecancer in an online interview for the ASCO virtual meeting 2020 about the HCRN: GU16-260 study.

This was a phase II study of nivolumab and salvage nivolumab ipilimumab in treatment-naïve patients with advanced renal cell carcinoma.

Dr Plimack outlines the reasoning behind the study, and the results which showed a lack of response from the addition of ipilimumab.

I was one of the co-authors on an important abstract describing the initial results of the HCRN GU16-260 study. This was a study designed and led by Mike Atkins where patients with clear cell renal cell carcinoma in the cohort we’re presenting at this meeting received first line nivolumab and then at progression received ipilimumab. We were really looking to see if we could get away with less in some of these patients.

The data with ipilimumab plus nivolumab in this population is set from phase III data. We know there are excellent response rates, also excellent long-term survival with this combination and it’s one that we use in clinical practice. But there is no question that adding ipilimumab adds toxicity up-front.

So this study asked the question can we start off slow? Can we start with nivolumab, understanding there’s a group of patients who will do beautifully with that and not require additional therapy, and then only bring in the ipilimumab when those patients need additional therapy. So far I would say the results suggest that we probably should stick with ipilimumab and nivolumab together up front, especially for poor and intermediate risk patients which are the patients who showed the most benefit in the phase III study. That’s because not all patients really respond when we add the ipilimumab and we saw a very low response rate to that salvage group. Not all patients make it to that salvage group through the front line and it seems like the biggest impact of the combination happens when we give the combination up front.

One of the surprising results we saw was that in the favourable risk population there was a response rate much higher than was seen in the phase III setting. I think it’s really too early and the number is too small to interpret this too much but certainly food for thought in this population.