Ac­cel­er­at­ed ap­proval in­com­ing? Mod­er­na 'hope­ful' for per­son­al­ized can­cer vac­cine

Mod­er­na will look to use the FDA’s ac­cel­er­at­ed ap­proval path­way for its per­son­al­ized can­cer vac­cine, pres­i­dent Stephen Hoge said at Cowen’s an­nu­al con­fer­ence on health­care.

The com­pa­ny read out Phase IIb re­sults in De­cem­ber sug­gest­ing the mR­NA-based ther­a­py re­duced melanoma pa­tients’ risk of can­cer re­cur­rence or death by 44% in com­bi­na­tion with Keytru­da, with a p-val­ue of 0.0266 and a haz­ard ra­tio of 0.56. The tri­al was de­signed with a one-side p-val­ue, mean­ing these re­sults may not be enough to meet the FDA’s bar for ef­fi­ca­cy. How­ev­er, Hoge said on Mon­day that in­ves­ti­ga­tors are cu­ri­ous whether that haz­ard ra­tio may im­prove over time.

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