Af­ter years of ef­fort, Ac­tini­um meets pri­ma­ry end­point in piv­otal AML tri­al

Ac­tini­um has made head­way on a piv­otal read­out, and the next step is get­ting all the da­ta in­to reg­u­la­tors’ hands.

The NY-based ra­dio­ther­a­pies biotech re­vealed top line da­ta Hal­loween morn­ing that lead can­di­date Iomab-B met the pri­ma­ry end­point in the piv­otal Phase III SIER­RA tri­al, test­ing the can­di­date in re­lapsed or re­frac­to­ry acute myeloid leukemia. The end­point of the study was durable, com­plete re­mis­sion of at least six months af­ter ini­tial re­mis­sion, de­ter­mined af­ter a bone mar­row trans­plant. Com­pared to place­bo, the re­sult was sta­tis­ti­cal­ly sig­nif­i­cant, with a p-val­ue of p<0.0001.

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