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GU Cancers 2024 | CLEAR: lenvatinib and pembrolizumab efficacy in aRCC across baseline tumor sizes

Viktor Grünwald, MD, University Hospital Essen, Essen, Germany, discusses findings from the Phase III CLEAR trial (NCT02811861) of lenvatinib and pembrolizumab in patients with advanced renal cell carcinoma (aRCC) across varying baseline tumor sizes. Regardless of tumor size, lenvatinib and pembrolizumab exhibited clinically meaningful improvements in overall survival, progression-free survival, and objective response rate. These findings suggest the efficacy of lenvatinib and pembrolizumab as a first-line treatment across varying baseline tumor sizes. This interview took place at the ASCO GU Cancers Symposium 2024 in San Francisco, CA.

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Transcript (edited for clarity)

The CLEAR study is one of the trials that set a new standard of care in kidney cancer, and the first line treatment of kidney cancer. So the CLEAR study investigated the use of lenvatinib plus pembrolizumab and compared it to sunitinib, which at the time being it has been a standard of care. So what it really showed is that len-pem has been superior in terms of response, progression free survival and overall survival when compared to sunitinib single agent therapy...

The CLEAR study is one of the trials that set a new standard of care in kidney cancer, and the first line treatment of kidney cancer. So the CLEAR study investigated the use of lenvatinib plus pembrolizumab and compared it to sunitinib, which at the time being it has been a standard of care. So what it really showed is that len-pem has been superior in terms of response, progression free survival and overall survival when compared to sunitinib single agent therapy. So the question that we had is really more clinically driven. So when you have a specific patient sitting in front of you, you know, those patients could have a high or low tumor burden at the beginning of their start of therapy. And we kind of questioned, questioned ourself, you know, how does it impact the outcome. You know, is there, what to expect in these kind of scenarios. So for that purpose we came up with four quartiles. So we used the tumor burden at the start or at the baseline assessment as the starting point. And we built up those four quartiles and group patients. And then we looked into the outcome parameters, which is response its progression free survival and overall survival. And what we have seen for lenvatinib plus pembrolizumab that basically are the efficacy has been maintained. So we see similar responses. We’ve seen a similar progression free survival across those four different groups. And we haven’t seen major deviations in terms of overall survival. But there were numerically different. So higher tumor burden had a had a lower survival expectancy than those that had a lower tumor burde and I think that needs to be further explored. So overall I think len-pem performed irrespective of the tumor load basically. But there are some items that I think need to be followed and better understood.

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