Karyopharm Absorbs Selinexor AML Blow, Focuses On Other Cancers
Upcoming Phase II in diffuse large B-cell lymphoma offers opportunity for a rebound after single agent selinexor disappoints in SOPRA study of acute myeloid leukemia.
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Oncologic Drugs Advisory Committee will consider whether approval for Karyopharm’s proposed refractory myeloma therapy selinexor should await results from an ongoing Phase III randomized trial.
Karyopharm has reported positive top-line Phase IIb data from the STORM study showing the potential benefits of its orally active lead compound, selinexor, in "penta-refractory" multiple myeloma, and is aiming for rapid approval of the first-in-class agent in the US and Europe.
Response rates for candidates from Stemline, Seattle Genetics and Karyopharm look highly encouraging, but the real test in AML will be survival, as the field is still in the shadow of Pfizer's failed Mylotarg.