Clinical Trial Data Updates in Advanced Renal Cell Carcinoma


Continuing discussion on advanced renal cell carcinoma, Robert J. Motzer, MD, reviews recent clinical trial data presented at ASCO 2023 and KCRS 2023.


Robert J. Motzer, MD: The KEYNOTE-426 update was presented at ASCO [American Society of Clinical Oncology Annual Meeting], as well. This was the first of the TKI-IO [tyrosine kinase inhibitor/immuno-oncology] combinations to be compared with sunitinib and demonstrate a higher level of efficacy. It serves as proof of principle for the approach of a TKI-IO in first-line therapy for [renal cell carcinoma]. And [because] it was the first study that was reported, it’s subject to the longest follow-up. It likewise demonstrated a durable effect for axitinib plus pembrolizumab, and generally manageable safety program over the course of the patient’s [treatment]. This was confirmatory to me in terms of the initial results for the KEYNOTE-426 that were reported a few years back and establishes this as an acceptable standard option in first-line therapy.

At ASCO and KCRS [Kidney Cancer Research Summit], the updated data from the CLEAR trial [NCT02811861] and the KEYNOTE trial were really the lead contenders in terms of first-line therapy. [At KCRS], there was also longer follow-up of the Study 111 trial [NCT02501096], which was a phase 1/2 study of lenvatinib plus pembrolizumab that was conducted in different groups based on prior treatment and a treatment-naïve group in patients who had progressed on a [TKI] and progressed on an IO. That was presented by Chung-Han Lee, MD, PhD, from Memorial Sloan Kettering Cancer Center, and likewise favored the durability of the regimen over time and, in general, the tolerability in patients who were treated on that trial regardless of their prior line of therapy.

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