KEYNOTE 564 is a pivotal phase III trial in the adjuvant setting where pembrolizumab for a year was tested against placebo in patients with intermediate-high, high and M1 NED after nephrectomy.
Overall we presented these results actually at the 2021 ASCO meeting in the plenary session. Now we have an update of the results that includes six more months of follow-up.
We saw consistent results upon follow-up. The disease free survival advantage remained from 9% difference, 68% versus 77%. The result changed to 67% versus 78%, so from 9% to 11% disease free survival advantage. That was the absolute difference.
In addition there was no new safety signal which is quite encouraging after more follow-up. The overall survival while not statistically significant is evolving and the hazard ratio is in the same range, around 0.52 here. So overall these updated results cement the fact that adjuvant pembrolizumab is efficacious in patients with risk features at recurrence. It’s no surprise that a couple of months earlier the FDA has approved pembrolizumab for the indication in the adjuvant setting in renal cell cancer.
