ESMO 2025 | CALYPSO: final efficacy data and biomarker analysis in the ccRCC cohort

The CALYPSO trial was a Phase II trial. It was in VEGF treated patients. It was in a time where the VEGF was the standard of care therapy for first line. We enrolled 139 patients in the clear cell cohort and we randomized them across the four different arms. It was durvalumab, durvalumab plus tremelimumab, durvalumab plus savolitinib and savolitinib. The savolitinib arm was closed early due to a lack of efficacy. The primary endpoint was confirmed response rates above 50%. So what we presented yesterday was the final analysis and with a minimum follow-up of 40 months, we showed that the durvalumab plus tremelimumab arm had significantly higher response rates compared to durvalumab alone with a p-value of 0.026. And then the durvalumab plus savolitinib arm did not do much better than the durvalumab alone. And when we looked at the measurable tumors, we did not find any enrichment. We also presented the final PFS and the final OS with a minimum follow-up of 40 months. We didn’t show any clear benefit despite the higher response rates, probably because our population was too small. And then we presented exploratory analysis, exploratory biomarker analysis. We measured PD-L1 in about 100 of patients. We used tumor cell staining and CPS, and when we looked at the PD-L1 positive population in both approaches, we didn’t find any enriched benefit in the durvalumab-tremelimumab arm or in the other arms. We also measured KIM-1 using the standard procedure and we measured KIM-1 at baseline and after a median of 12 weeks of therapy was not mentioned but we measured some biomarker and we showed that KIM-1 at baseline was prognostic and we showed also that among responders the drop in some biomarker was highest, was statistically significant, and the biggest reduction was seen in the durvalumab plus tremelimumab arm.

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