Merck KGaA’s evobrutinib disappoints in PhIII multiple sclerosis test, casting dark cloud over BTK class

Mer­ck KGaA’s BTK in­hibitor has failed to meet the pri­ma­ry end­point in a pair of reg­is­tra­tional tri­als in re­laps­ing mul­ti­ple scle­ro­sis (RMS), a dis­ap­point­ment that could read through to oth­er Big Phar­ma can­di­dates vy­ing for suc­cess in the same space, ac­cord­ing to an­a­lysts.

The Phase III EVO­LU­TION tri­als stud­ied Mer­ck KGaA’s evo­bru­ti­nib ver­sus stan­dard of care Auba­gio in RMS pa­tients with the pri­ma­ry end­point of re­duc­tion in an­nu­al­ized re­lapse rates (ARR) for up to 156 weeks. Evo­bru­ti­nib did not reach sta­tis­ti­cal sig­nif­i­cance ver­sus Sanofi’s Auba­gio in ei­ther of the stud­ies.

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