So in ASCO GU 2025 I was presenting data on LITESPARK-005, a sub-analysis to assess the outcomes of patients with metastatic renal cell carcinoma treated with either belzutifan or everolimus. And we were looking specifically at the baseline location of metastases and also we were looking at tumour burden.

What was the study design?

Briefly, you need to understand the LITESPARK-005, that was a randomised phase III clinical trial, that study, comparing in patients progressing to both PD-1 and tyrosine kinase inhibitor to either everolimus or belzutifan, a HIF-2α inhibitor. So the study showed that belzutifan improves PFS as compared with everolimus. And here we were presenting the data based on different locations of metastases, baseline metastases. So what we found is that belzutifan did better for patients with or without bone metastasis; belzutifan did better for patients with liver or without liver metastasis and also belzutifan did better regardless of the tumour burden.

But what I think was really interesting is for patients specifically with liver mets we saw that there was a real increase in the PFS, a real increase in the response rate and also increase in the overall survival for patients treated with belzutifan as compared with everolimus. So we’re seeing that the study did meet the primary endpoint of PFS but not OS, however, looking at, for example, those patients with liver mets you would expect not seeing a big difference and the delta was quite, quite impressive with belzutifan as compared with everolimus.

What were the results of this study?

Yes, so what I mean, as I was saying, is that the most important result of the study is that it doesn’t really matter which type of subgroup you see in that LITESPARK-005, that all patients benefit with belzutifan as compared with everolimus. But, as I was saying, specifically for those patients that you would expect less difference, like high tumour burden or liver mets, you see that belzutifan is quite active and you see a big delta in response rate, PFS and also in overall survival.

What is next for this study and what is the clinical significance?

I guess the next step is we are waiting to see approval in Europe, in different countries, so we have access to this drug. I think it’s only the beginning of using HIF-2α inhibitors in the context of metastatic renal cell carcinoma. We know that there are many other trials ongoing or that have already finished accrual and we are waiting to see the results, whether we can elaborate on when exactly we should be using belzutifan because this study was planned for patients after PD-1 and after tyrosine kinase inhibitor but there are now plenty of studies moving to the first line or even in the adjuvant setting. So now it’s about where is the best place to set this new treatment.