The Seattle Cancer Care Alliance Expert offered background on the first-line use of pembrolizumab monotherapy in advanced clear cell renal cell carcinoma.
Well, the Keynote study, you know, it started a few years ago, the primary clinical outcomes have been presented previously. But at the time it was conceived and enrolled, there was no data set for frontline, PD-1 or PD-L1 as monotherapy for renal cell carcinoma. So judging how much that's bringing to the table versus what's being added by the various doublets that are now standard of therapy was very helpful insight.
It's certainly the case in clinic you encounter patients that are elderly, they're frail, you're concerned about the toxicity of whatever therapy you're offering. And I certainly have some patients where I've started them on PD-1 a lot of therapy and held back either it'd be lymphoma or held back the exit nip doublet component to see how they fared and make sure they held up okay. So having some reference data set to know what you're getting into and what you can counsel a patient on the likely success. Starting off with just a single drug is extremely helpful.
And then pembrolizumab is moved into the Agilent space. And so having a reference data set as the monotherapy experience in the metastatic setting to know that the drug is active and feeling confident it's rational to pursue the adjuvant treatment protocol. So I think it has a lot of merits granted that pembrolizumab monotherapy doesn't have a formal FDA approval, but it is approved of course in combination with axitinib and then leaves it to the treating physician judgment about how to manage the axitinib component. So it is certainly available to us clinically to use now in our routine clinical population.