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Aptevo Therapeutics Announces APVO436 Monotherapy is Active in Patients Who Have Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Phase 1 study showed some patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) achieved a remission with APVO436 after
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"Phase 1 study showed some patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) achieved a remission with APVO436 after failing 1-8 lines of prior therapiesData was published in the prestigious oncology journal CancersSEATTLE, WA / ACCESSWIRE / August 17, 2021 / Aptevo Therapeutics Inc. (\"Aptevo\" or \"the Company\") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced the publication of a peer-reviewed research article in the prestigious oncology journal Cancers. The research article reports the results of a multi-institutional Phase 1 clinical study of Aptevo's lead leukemia drug candidate APVO436 in 46 adult patients with relapsed or refractory AML or MDS.\"AML and MDS are common forms of blood cancer in adults. Patients with AML or MDS who relapse following available standard of care treatments have a dismal prognosis and they are in urgent need for new treatment options,\" explained Dr. Fatih Uckun, a leukemia expert and Chief Clinical Advisor at Aptevo, who is the lead author of the new article. He added: \"This study was undertaken to evaluate if AML or MDS patients who have failed the available standard treatment options could tolerate and potentially benefit from a new form of therapy which activates patient's own immune system against AML cells. Specifically, APVO436 is a recombinant protein engineered to redirect host immune system to leukemic cells from patients with hematologic malignancies that express on their surface a protein known as the interleukin 3 receptor or CD123.\"A total of 46 relapsed AML/MDS patients received APVO436 as weekly intravenous (IV) infusions at 10 different dose levels. APVO436 exhibited a favorable safety profile with acceptable tolerability and generally manageable drug-related adverse events (AEs), and its maximum tolerated dose (MTD) was not reached at a weekly dose of 60 mcg. The most common APVO436-related AEs were infusion-related reactions (IRR) occurring in 13 (28.3%) patients and cytokine release syndrome (CRS) occurring in 10 (21.7%) patients. The incidence of severe CRS was 8.7%.Promising clinical activity was observed in 11 of 40 patients (27.5%) evaluable for efficacy: Eight of 34 (23.5%) evaluabl...