Keytruda’s latest kidney cancer win: adjuvant use

If February’s positive readout of the Clear study gave Merck & Co’s Keytruda an important lead over its rivals in front-line kidney cancer, today’s apparent win in Keynote-564 could stretch the advantage further still. Keynote-564 was the first of several pivotal immunotherapy studies to read out in this cancer’s even earlier, adjuvant setting, a market currently untapped by anti-PD-(L)1 drugs. Adjuvant and neoadjuvant settings are becoming key battlegrounds for checkpoint-blocking drugs, but kidney cancer is somewhat under the radar. Nevertheless, all the big players are running phase 3 trials. Merck has said nothing about the magnitude of Keytruda’s disease-free survival win in Keynote-564, except that this is statistically and clinically significant; whether this endpoint is sufficient for approval rather than the gold standard of overall survival is up to regulators. However, bulls will note that DFS is a more robust measure than pathological complete response, the endpoint on which Merck tripped up when trying to extend Keytruda’s label to perioperative triple-negative breast cancer; that setting will require the company to wait until the Keynote-522 trial reads out for event-free survival.

Pivotal trials of anti-PD-(L)1 drugs in adjuvant renal cell carcinoma
Study Drug(s) Primary endpoint(s) Result
Keynote-564 Keytruda vs placebo DFS Said to be statistically significant & clinically meaningful for DFS
Immotion-010 Tecentriq vs placebo DFS Primary completion Jan 2022
Checkmate-914 Opdivo +/- Yervoy vs placebo DFS Primary completion Apr 2023
Rampart Imfinzi +/- tremelimumab vs placebo DFS & OS Primary completion Jul 2024
Source: Mizuho &

Share This Article