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Induction with lower-intensity CPX-351 + venetoclax in patients with AML: Results from a phase 1b trial
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Results from a phase Ib, multicenter, open-label study (NCT04038437), evaluating the combination of lower-intensity CPX-351 and venetoclax in adults with AML who are unfit/ineligible for IC, were published in Blood Advances by Uy et al.1 A total of 35 patients were enrolled and received CPX-351 at 20 units/m2 (DL1; n = 4), 40 units/m2 (DL2; n = 7), or 30 units/m2 (DL1b; n = 24) during the dose-exploration phase. |
| Key learnings |
| No DLTs occurred in patients receiving DL1, while one of six patients at DL2 experienced two DLTs. Three patients receiving DL1b showed no DLTs and had a safety profile comparable with that of DL1. The RP2D was CPX-351 at 30 units/m2 [daunorubicin 13.2 mg/m2 and cytarabine 30 mg/m2] plus venetoclax 400 mg. |
| Most frequently reported TEAEs were nausea (42.9%), thrombocytopenia (40.0%), febrile neutropenia (37.1%), and neutropenia (34.3%). A total of 20% of patients had TEAEs leading to treatment discontinuation. By Day 60, the early mortality rate was 11.4%, with one death at DL1 (non-treatment-related myocardial infarction) and three at DL1b (treated-related worsening of lung function, n = 1; disease progression, n = 2). |
| ORR was 51.4%. CR/CRi was achieved by 54.8% of the evaluable patients (n = 31), of which 14 were MRD negative. CR/CRi rate was 57.7% in patients with wild-type TP53 (n = 26) and 12.5% in patients with TP53m AML (n = 8). |
| The findings indicate that lower-intensity CPX-351 + venetoclax is a well-tolerated alternative to HMA + venetoclax as induction therapy for adult and older patients with AML who do not have TP53 mutations and are unfit/ineligible for IC. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CR, complete remission; CRi, complete remission with incomplete hematologic recovery; DL, dose-level; DLT, dose-limiting toxicity; HMA, hypomethylating agent; IC, intensive chemotherapy; MRD, measurable residual disease; ORR, overall response rate; RP2D, recommended phase II dose; TEAE, treatment-emergent AE.
- Uy GL, Pullarkat VA, Baratam P, et al. Lower-intensity CPX-351 plus venetoclax induction for adults with newly diagnosed AML unfit for intensive chemotherapy. Blood Adv. 2024. Online ahead of print. DOI: 1182/bloodadvances.2024013687
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