ALX Oncology Holdings announced the presentation of clinical data from the Phase 1a dose escalation part of the ASPEN-05 trial evaluating evorpacept in combination with azacitidine and venetoclax for the treatment of patients with relapsed or refractory or newly diagnosed acute myeloid leukemia. The new results, shared in a poster at the 64th American Society of Hematology Annual Meeting, show that the combination of evorpacept with azacitidine and venetoclax is active and generally well tolerated. As of October 3, 2022, 14 patients with either r/r or ND AML have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks or 60 mg/kg once every 4 weeks together with standard dosing of azacitidine and venetoclax. Evorpacept in combination with azacitidine and venetoclax was generally well tolerated with no maximum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W. In 10 relapsed or refractory AML response-evaluable patients, including 8 that had progressed after prior venetoclax treatment, all experienced a reduction in bone marrow blasts, and 4 achieved a response.In 3 newly diagnosed AML response-evaluable patients, all 3 achieved a response, including 1 complete response 1 CR with incomplete hematologic recovery, and 1 morphologic leukemia free state .
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