Next Steps for Treatment With Pembrolizumab in RCC

Toni K. Choueiri, MD, medical director, International Strategic Initiatives, director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg chair and professor of Medicine, Harvard Medical School, discusses a key next step for using pembrolizumab (Keytruda) in the treatment of renal cell carcinoma (RCC).

In the KEYNOTE-564 clinical trial (NCT03142334), sustained clinical benefit was demonstrated with the use of adjuvant pembrolizumab in patients with post nephrectomy RCC.

Whereas pembrolizumab was used as an experimental agent in KEYNOTE-564, the phase 3 trial LITESPARK-022 (NCT05239728) trial will now use pembrolizumab in the control arm of LITESPARK-022. Patients will then be administered an experimental agent, belzutifan (Welireg).

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0:08 | For future work, we are using pembrolizumab as control. It is called LITESPARK-022. Pembrolizumab, which was used in the experimental of KEYNOTE-564 will be used in the control arm of LITESPARK-022. Then, we are adding an experimental agent called belzutifan, which is a HIF-2α inhibitor that showed efficacy in metastatic disease.

0:26 | We're adding it to pembrolizumab in the adjuvant setting to see if we can improve on pembrolizumab efficacy because despite the benefit over placebo, there will be patients who will not respond to pembrolizumab. Also, despite adjuvant pembrolizumab, patients will experience cancer that will come back.