Toni Choueiri, MD, Dana-Farber Cancer Institute, gives a summary of the findings from the phase 3 KEYNOTE-564 study, which analyzed the overall survival of pembrolizumab for the treatment of clear renal cell carcinoma. The study results were presented at the 2024 ASCO Genitourinary Cancers Symposium. 

Transcript: 

Toni Choueiri, MD: Hi everyone. Toni Choueiri from Dana-Farber. I was really very honored to present the result of KEYNOTE 564 at the GU Cancer Symposium of ASCO in San Francisco in January.

KEYNOTE 564 is an adjuvant study of close to 1,000 patients where a patient with kidney cancer at high risk of recurrence were randomized to receive a year of the PD1 inhibitor, pembrolizumab or placebo. This is the first time ever in the history of kidney cancer studies of adjuvant treatment to show that a drug can lead to cures and extent overall survival. For the first time ever since the first adjuvant randomized study with radiation in 1973, we showed that pembrolizumab extends survival. It doesn't only delay recurrence. This is not only disease-free survival, but over overall survival. Pembrolizumab treatment for a year led to an increased in overall survival and 38% reduction in the risk of deaths overall. We updated safety profile. We updated disease-free survival. There is no change.

Overall, since 1973, over 13,000 patients, 13,390 to be exact, were subjected to adjuvant studies versus a control arm. Most of the time placebo, active monitoring, observation, and none of them showed that the experimental arm extend people life till we have the first study. So it was really great to have that as an option finally for our patient after 50 years, half a century, and the work happened here with all our team and all our international collaborators. Thank you.