Esmo 2022 – Keytruda secures a renal cancer monopoly

Merck & Co should be able to make its recently won claim to have the first anti-PD-(L)1 drug approved for adjuvant treatment of kidney cancer for some time to come. Judging by two late-breaking abstracts just revealed for the upcoming Esmo conference, its two rivals Bristol Myers Squibb and Roche slipped up here by similarly wide margins. The Checkmate-914 study of Opdivo plus Yervoy, and the Immotion-010 trial of Tecentriq, both showed sub-10% numerical improvements in risk of disease progression versus placebo, but with highly non-significant p values the datasets offer no meaningful value. The authors of each concede that primary endpoints were not met, and the Checkmate-914 investigators note higher discontinuations due to adverse events with Opdivo plus Yervoy than with placebo. Merck won US approval in adjuvant renal cancer based on a 32% reduction in disease progression favouring Keytruda in the Keynote-564 trial, and no doubt reasons for the differing readouts will be discussed at Esmo. Interestingly, Checkmate-914 also had an Opdivo monotherapy cohort, though nothing has been disclosed about this. Perhaps more will be forthcoming when Checkmate-914 is discussed at Esmo’s presidential symposium on Sunday.

Cross-trial comparison in adjuvant renal cell carcinoma
  Disease-free survival  
Drug (company) Trial Medians Stats Status
Keytruda (Merck & Co) Keynote-564 NR vs NR HR=0.68 (0.53, 0.87), p=0.001 US approved Nov 2021
Opdivo + Yervoy (Bristol Myers Squibb) Checkmate-914 NR vs 50.7mth HR=0.92 (0.71, 1.19), p=0.535 Study fail
Tecentriq (Roche) Immotion-010 57.2 vs 49.5mth HR=0.93 (0.75, 1.15), p=0.495 Study fail
NR=not reached. HR=hazard ratio (95% confidence intervals in brackets). Source: product label & Esmo.

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