Hot on Roche’s heels, Mer­ck spells out mixed Keytru­da da­ta in ad­ju­vant NSCLC

Is Mer­ck ready to crack open a ma­jor new mar­ket for its PD-1 star?

The phar­ma gi­ant said so as it re­leased full da­ta from the Phase III KEYNOTE-091 study, which test­ed Keytru­da against place­bo as an ad­ju­vant treat­ment for a group of pa­tients with stage IB-II­IA non-small cell lung can­cer.

Keytru­da, when giv­en af­ter sur­gi­cal re­sec­tion of tu­mor, met the co-pri­ma­ry end­point of dis­ease-free sur­vival re­gard­less of PD-L1 ex­pres­sion, cut­ting the risk of dis­ease re­cur­rence or death by 24% (HR=0.76, p=0.0014). But in­ex­plic­a­bly, the oth­er co-pri­ma­ry end­point — which fo­cus­es on a sub­group of pa­tients whose tu­mors ex­press PD-L1, as mea­sured by tu­mor pro­por­tion score ≥50% — was not sta­tis­ti­cal­ly sig­nif­i­cant (HR=0.82, p=0.14).

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