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Two-dimensional dose escalation (DE, n\u00a0= 50) was performed for venetoclax daily with idasanutlin on days 1 to 5 in 28-day cycles, followed by dosing schedule optimization (n\u00a0=\u00a06) to evaluate reduced venetoclax schedules (21-\/14-day dosing). Common adverse events (occurring in \u226540% of patients) included diarrhea (87.3% of patients), nausea (74.5%), vomiting (52.7%), hypokalemia (50.9%), and febrile neutropenia (45.5%). During DE, across all doses, composite complete remission (CRc; CR\u00a0+ CR with incomplete blood count recovery\u00a0+ CR with incomplete platelet count recovery) rate was 26.0% and morphologic leukemia-free state (MLFS) rate was 12%. For\u00a0anticipated recommended phase 2 doses (venetoclax 600 mg\u00a0+ idasanutlin 150\u00a0mg; venetoclax 600 mg\u00a0+ idasanutlin 200 mg), the combined CRc rate was 34.3% and the MLFS rate was 14.3%. Pretreatment IDH1\/2 and RUNX1 mutations were associated with higher CRc rates (50.0% and 45.0%, respectively). CRc rate in patients with TP53 mutations was 20.0%, with responses noted among those with co-occurring IDH and RUNX1 mutations. In 12\u00a0out of 36 evaluable patients, 25\u00a0emergent TP53 mutations were observed; 22\u00a0were present at baseline with low TP53 variant allele frequency (median 0.0095% [range, 0.0006-0.4]). Venetoclax-idasanutlin showed manageable safety and encouraging efficacy in unfit patients with R\/R AML. IDH1\/2 and RUNX1 mutations were associated with venetoclax-idasanutlin sensitivity, even in some patients with co-occurring TP53 mutations; most emergent TP53 clones were\u00a0preexisting. Our findings will aid ongoing\/future trials of BCL-2\/MDM2 inhibitor combinations. This trial was registered at www.clinicaltrials.gov as #NCT02670044.<\/jats:p>","DOI":"10.1182\/blood.2022016362","type":"journal-article","created":{"date-parts":[[2022,10,20]],"date-time":"2022-10-20T19:57:02Z","timestamp":1666295822000},"page":"1265-1276","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":91,"title":["Venetoclax and idasanutlin in relapsed\/refractory AML: a nonrandomized, open-label phase 1b trial"],"prefix":"10.1182","volume":"141","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7103-373X","authenticated-orcid":false,"given":"Naval G.","family":"Daver","sequence":"first","affiliation":[{"name":"1Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monique","family":"Dail","sequence":"additional","affiliation":[{"name":"2Genentech, Inc, South San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2118-6302","authenticated-orcid":false,"given":"Jacqueline S.","family":"Garcia","sequence":"additional","affiliation":[{"name":"3Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4921-5809","authenticated-orcid":false,"given":"Brian A.","family":"Jonas","sequence":"additional","affiliation":[{"name":"4University of California Davis Comprehensive Cancer Center, Sacramento, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2572-9952","authenticated-orcid":false,"given":"Karen W. 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