KEYNOTE-564: Favorable Long-Term Safety With Adjuvant Pembrolizumab in RCC

In an interview with Targeted Oncology^TM, Naomi Haas, MD, Abramson Cancer Center at the University of Pennsylvania, discussed the 5-year follow-up of the KEYNOTE-564 study with a focus on the long-term safety of adjuvant pembrolizumab for the treatment of renal cell carcinoma (RCC).

Over the past 3 years, safety signals have remained consistent, showing no new concerns. As health care providers become more familiar with managing immune-mediated toxicities, there is a positive trend emerging. While there is a natural concern for physicians and paients about permanent severe adverse effects like diabetes, myocarditis, myasthenia gravis, or hypophysitis, these are occurring at a very low rate, according to Haas. Increased physician education in immunotherapy is leading to earlier recognition and more prompt treatment of these toxicities, an improvement over what was observed in earlier trials.

Haas emphasizes that with this favorable safety profile comes the confirmation that this regimen is beneficial for patients with RCC.

"I think what's really confirmatory is that the Kaplan-Meier curves continue to remain well separated at the at the previous end point. And the reason that that's important is sometimes, when you follow clinical trials for a while out, things get a little bit diluted as the number of patients are followed," Haas says. "But the separation of the curves for overall survival continues to be looking very robust. In addition, this is really the first time that we've reached the median follow-up."

REFERENCES:

Haas NB, Powles T, Tomcak P, et al. Five-year follow-up results from the phase 3 KEYNOTE-564 study of adjuvant pembrolizumab (pembro) for the treatment of clear cell renal cell carcinoma (ccRCC). J Clin Oncol. 43, 4514-4514(2025).DOI:10.1200/JCO.2025.43.16_suppl.4514