During GU ’26, ASCO GU, that occurred in February 2026 in San Francisco, we presented during an oral session the result of LITESPARK-022. In LITESPARK-022 we wanted to build on the success of adjuvant pembrolizumab, the first therapy to show an overall survival benefit in patients with kidney cancer at risk for recurrence. So in order to do that we have combined in the experimental arm, in this large study of more than 1,800 patients, we combined pembrolizumab with belzutifan. Belzutifan is an oral HIF-2 inhibitor, a new class of agent approved in metastatic kidney cancer patients who experience disease progression after PD-1 and VEGF inhibitor. So in a refractory population.
The combination resulted in a disease free survival advantage, that’s the primary endpoint, over pembrolizumab only: a 28% decrease in the risk of recurrence or death. The side effects overall were higher in patients with the combination, two drugs versus one drug, but overall what I can say, we did not have things we were not aware about. So hypoxia higher because that’s a side effect of belzutifan, as well as anaemia, which is a hallmark of HIF-2 inhibitors, if you want. We looked at specific subgroups that were prespecified and also the combination resulted in higher efficacy. There wasn’t a subgroup where we can say for sure these patients would not benefit.
In addition, we took an early look at overall survival, a key secondary endpoint. The hazard ratio was 0.78, too immature for the time being to look at and we will continue looking at.
The study follow-up is 28 months only so we can say that this is very possibly, maybe when approved and if approved, a new standard of care. It’s amazing to see pembrolizumab being built upon so fast by another positive study. So we’re very happy to provide this to patients when it’s available. It’s another shot at kidney cancer.