I-131 apamistamab induces response among adults with advanced acute myeloid leukemia
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I-131 apamistamab induced durable complete remissions for adults with active relapsed or refractory acute myeloid leukemia, according to topline data released by the agent’s manufacturer.
I-131 apamistamab (Iomab-B, Actinium Pharmaceuticals) is a targeted radiotherapy intended to improve patient access to potentially curative bone marrow transplant by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45, according to an Actinium-issued press release.
The randomized phase 3 SIERRA trial included 153 patients aged 55 years or older with relapsed or refractory AML.
Researchers assigned patients to I-131 apamistamab or physician’s choice of salvage therapy. Physician’s choice included chemotherapies such as cytarabine and daunorubicin, or targeted agents such as Bcl-2, FLT3 or IDH1/2 inhibitors.
The study met its primary endpoint of durable complete remission — or complete remission of 6 months after initial remission after bone marrow transplant — in the experimental arm (P < .0001).
“This is a significant milestone in Actinium's lifecycle and a testimony to the quality of our team who undertook a pioneering study in a patient population that is considered largely futile to treat,” Sandesh Seth, chairman and CEO of Actinium Pharmaceuticals, said in a press release.
The SIERRA control arm reflected real-world treatment of patients with relapsed or refractory AML, a setting in which more than 20 single agents or combinations are used but no standard of care exists.
Actinium intends to submit a biologics license application seeking approval of I-131 apamistamab for adults aged 55 or older with relapsed or refractory AML who cannot proceed to bone marrow transplant with available therapies, according to the release.
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