Two adjuvant kidney cancer failures embolden Keytruda

Today’s failure of Bristol Myers Squib’s Checkmate-914 trial in adjuvant renal cell carcinoma comes just a week after Roche quietly slipped out news that Immotion-010, its own study in the same setting, was a dud. The developments strengthen the position of Merck & Co’s Keytruda, which secured US approval here last November based on a disease-free survival (DFS) benefit seen in the Keynote-564 trial. Perioperative settings are becoming increasingly important for anti-PD-(L)1 drugs, and Checkmate-914 compares Opdivo with or without Yervoy against placebo, but Bristol said this had failed to show a benefit on DFS. Roche’s earnings presentation last week revealed that Immotion-010, testing Tecentriq monotherapy against placebo, had failed the same endpoint in the second quarter. The remaining phase 3 player in adjuvant kidney cancer is Astrazeneca: the Rampart study of Imfinzi with or without tremelimumab has DFS and overall survival co-primary endpoints, and is due to end in mid-2024. However, Rampart is investigator sponsored, and was not listed in the clinical trials appendix Astra released with its second-quarter report today.

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 Hazard ratio for DFS 0.68, p=0.001; US approval 18 Nov 2021
Immotion-010 Tecentriq vs placebo DFS Failed
Checkmate-914 Opdivo +/- Yervoy vs placebo DFS Failed
Rampart Imfinzi +/- tremelimumab vs placebo DFS & OS Primary completion Jul 2024
Source: company information &

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