Pembrolizumab as Adjuvant Therapy for RCC

Eric A. Singer, MD, chief, Division of Urologic Oncology, director, Urologic Oncology Fellowship Program, and co-director, Genitourinary Disease-Specific Research Group at the Ohio State University Comprehensive Cancer Center, and professor, Department of Urology, Division of Bioethics at the Ohio State University College of Medicine, discusses some of the recent and ongoing research being done to evaluate the use of adjuvant therapy for patients with high-risk renal cell carcinoma (RCC).

Specifically, Singer highlights the double-blind, randomized, phase 3 KEYNOTE-564 study (NCT03142334) which evaluated treatment with intravenous pembrolizumab (Keytruda) as monotherapy for the adjuvant treatment of RCC post nephrectomy.

According to updated efficacy and safety data with 30.1 months of follow-up, disease-free survival was maintained among patients treated with pembrolizumab (HR, 0.63; 95% CI, 0.50-0.80; nominal P < .0001). However, mature overall survival data are not yet available.

Transcription:

0:08 | We have moved the needle quite a bit and we went from using targeted therapies to now, we have had a bunch of studies looking at immunotherapies. The 1 that got the most attention was KEYNOTE-564 which looked at nearly 1000 patients using intravenous pembrolizumab vs placebo. Again, at the initial end point and then at 30 months, [we saw] a reduction of about 37% likelihood of recovering, so a hazard ratio of 0.63 which was statistically significant. It changed and ushered in a new era of an approval for systemic immunotherapy to be used, and we continue to build on that.

0:58 | Now we continue to have additional studies. There's another study also from the same sponsor using pembrolizumab plus belzutifan [Welireg], a HIF inhibitor. Like we talked about earlier with the VEGF targeted therapies like sunitinib, this is sort of hitting a different place in that pathway where it's targeting HIF, hypoxia-inducible factor, itself and looking at [whether] pembrolizumab alone or pembrolizumab plus belzutifan is going to be a more successful option. That is a study that's ongoing now. There are additional other ongoing studies, but I would say right now in my current practice when I'm talking about adjuvant therapy, I am encouraging patients to think about clinical trials as well.