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|
|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.|