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ESMO 2025 | Insights from the CALYPSO trial and biomarker advances in ccRCC

Sara Coca Membribes, MD, Barts Health NHS Trust, London, UK, comments on the impact of the CALYPSO trial (NCT02819596) in clear cell renal cell carcinoma (ccRCC). Whilst the trial was a negative trial that will not impact standard of care therapies due to its timing and design, it still provides valuable insights from its control arm and experimental arms. However, biomarker findings support further research on KIM-1, which will be prospectively validated in the ongoing CARE1 trial (NCT06364631). This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

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Transcript

The calypso trial was a negative trial so it’s not going to change or not going to impact the standard of care therapies because also it was done in a period of time where the standard of care for first line was different than what we have right now but it was a necessary trial done back in the day because we can also learn from the standard, not from the experimental arm, but also from the control arm...

The calypso trial was a negative trial so it’s not going to change or not going to impact the standard of care therapies because also it was done in a period of time where the standard of care for first line was different than what we have right now but it was a necessary trial done back in the day because we can also learn from the standard, not from the experimental arm, but also from the control arm. It was a good control arm, it was a good trial, it has four different arms, and we have Durvalumab alone. Our PFS correlated with the Checkmate 257. In Checkmate 257, it was 4.5 months. In ours, it’s 6.5 in the Durvalumab alone and 7.5 in the Durvalumab plus Tremelimumab. So our results correlated with this trial, even though we didn’t find any significance in the PFS or in the OS. So I think the biggest point is not the impact in the standard of care, but also what we have learned from it. And what we have in the future ahead, which is really promising, is that we know that PD-L1 hasn’t consistently confirmed any enrichment in response. So we need to prospectively validate PD-L1 and we’re going to prove its role prospectively for the first time in the ongoing CARE-1 trial which is actively enrolling. So we really think PD-L1 will be proven in this trial and our trial just proved again that when we look at PD-L1 retrospectively and as part of an exploratory analysis we didn’t find anything. And KIM-1, because it’s very promising, we have shown again that Q1 is consistent and it’s promising and we definitely need to pursue the role of KIM-1 and we need to prove its efficacy prospectively.

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