Impact of Adjuvant Pembrolizumab Approval on RCC Treatment Landscape


Two key opinion leaders review data from a phase 3 clinical trial assessing the use of lenvatinib plus pembrolizumab for the treatment of advanced renal cell carcinoma.

Eric Jonasch, MD: Let me ask you a final question before we move on to your case. In November, there was the FDA [Food and Drug Administration] approval of adjuvant pembrolizumab [Keytruda] and that's obviously going to change the algorithms. How is this going to change your algorithm for subsequent treatment? You have a person that comes in, stage III disease, and let’s say you put them on adjuvant pembrolizumab and then they progress. What are you going to do next?

Sumeet Bhatia, MD: I’ve been unfortunate enough that I’ve had somebody who did that within 12 weeks, and when that happened, we defaulted to capacity in that situation as a single agent and he had a rapid response to it. There are patients that for some reason or another do not do well with immunotherapy whether it’s in the adjuvant or the metastatic setting. Since this patient had never received a TKI [tyrosine kinase inhibitor] that was a fairly easy choice from my standpoint. What would be more interesting is what happens to these people 2 to 3 years down the road when they relapse? I’d be curious about those patients who were in clinical trials and got immunotherapy and failed to respond. How did you deal with them in your clinical practice?

Eric Jonasch, MD: I think the big question here is in a person that’s progressing on adjuvant pembrolizumab, would you keep the PD-1 [programmed cell death protein 1] blockade and then add the TKI, or do you just give the TKI? And I don’t think we have an answer for that. Base extrapolating from the IO/IO [immuno-oncology] data you start with the lead-in of nivolumab [Opdivo] and then add ipilimumab [Yervoy] as a rescue strategy. That seems to be less of a profitable approach for patients. I think the question for the field, and we really do need clinical trials for this, is do these people get on a single agent TKI when they progress, or do we give them IO/TKI? And I don’t think we have an answer for that in 2022.

Sumeet Bhatia, MD: In my practice, the reason I did not choose ipilimumab had to do with the fact that there was a trial in the metastatic setting that when somebody progressed on the PD-L1 [programmed death-ligand 1] therapy adding ipilimumab really did not help. So that is what guided me in this situation. In melanoma, we do that routinely, but these are different diseases and probably the biology is different. Until there is more data, it will be probably reasonable to add Cabometyx [cabozantinib] or TKI in this situation. Whether we continue immunotherapy or not, I think it is the dealer’s choice at that point.

Transcript edited for clarity.

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