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To assess the impact of concurrently inducing the extrinsic and intrinsic apoptosis-signaling pathways in acute myeloid leukemia (AML), we evaluated activity of the TRAIL receptor agonistic fusion protein eftozanermin alfa (eftoza; ABBV-621) in combination with the B-cell lymphoma protein-2 selective inhibitor venetoclax in preclinical models and human patients. Simultaneously stimulating intrinsic and extrinsic apoptosis-signaling pathways with venetoclax and eftoza, respectively, enhanced their activities in AML cell lines and patient-derived ex\u00a0vivo\/in\u00a0vivo models. Eftoza activity alone or plus venetoclax required death receptor 4\/5 (DR4\/DR5) expression on the plasma membrane but was independent of TP53 or FLT3-ITD status. The safety\/tolerability of eftoza as monotherapy and in combination with venetoclax was demonstrated in patients with relapsed\/refractory AML in a phase 1 clinical trial. Treatment-related adverse events were reported in 2 of 4 (50%) patients treated with eftoza monotherapy and 18 of 23 (78%) treated with eftoza plus venetoclax. An overall response rate of 30% (7\/23; 4 complete responses [CRs], 2 CRs with incomplete hematologic recovery, and 1 morphologic leukemia-free state) was reported in patients who received treatment with eftoza plus venetoclax and 67% (4\/6) in patients with myoblasts positive for DR4\/DR5 expression; no tumor responses were observed with eftoza monotherapy. These data indicate that combination therapy with eftoza plus venetoclax to simultaneously activate the extrinsic and intrinsic apoptosis-signaling pathways may improve clinical benefit compared with venetoclax monotherapy in relapsed\/refractory AML with an acceptable toxicity profile. This trial was registered at www.clinicaltrials.gov as #NCT03082209.<\/jats:p>","DOI":"10.1182\/blood.2022017333","type":"journal-article","created":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T21:04:50Z","timestamp":1675199090000},"page":"2114-2126","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":18,"title":["Activity of eftozanermin alfa plus venetoclax in preclinical models and patients with acute myeloid leukemia"],"prefix":"10.1182","volume":"141","author":[{"given":"Stephen K.","family":"Tahir","sequence":"first","affiliation":[{"name":"1Oncology Discovery, AbbVie Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4921-829X","authenticated-orcid":false,"given":"Emiliano","family":"Calvo","sequence":"additional","affiliation":[{"name":"2START Madrid-CIOCC, Centro Integral Oncol\u00f3gico Clara Campal, Madrid, 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