Roche halts en­roll­ment in a PhII com­bo study of Tecen­triq and Cotel­lic in wake of sev­er­al pa­tient deaths

A string of deaths in a co­hort of colon can­cer pa­tients tak­ing a com­bi­na­tion of Roche’s PD-L1 check­point Tecen­triq with Ex­elix­is’ MEK in­hibitor Cotel­lic forced the in­de­pen­dent mon­i­tor­ing board to halt en­roll­ment of new pa­tients in their Phase II MOD­UL study. And Roche says one of those deaths was a treat­ment-re­lat­ed case of car­diotox­i­c­i­ty.

The study was de­signed to bring in about 1,400 pa­tients with an eye to divvy­ing them up in­to var­i­ous com­bi­na­tions with Tecen­triq for metasta­t­ic colon can­cer. Ac­cord­ing to a state­ment from Genen­tech, in­ves­ti­ga­tors opt­ed to take a proac­tive safe­ty step af­ter see­ing an im­bal­ance in pa­tient deaths in this co­hort get­ting the com­bo as a main­te­nance ther­a­py for front­line cas­es of colon can­cer, paus­ing en­roll­ment as treat­ment con­tin­ues for the pa­tients al­ready in the study.

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