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Bemcentinib in older patients with AML ineligible for intensive chemotherapy: A phase Ib/IIa trial
The prognosis of older patients with R/R AML remains poor due to high relapse rates. Bemcentinib, a potent, selective oral AXL inhibitor, has shown promising efficacy in preclinical studies. Results from a phase Ib/IIa trial (NCT02488408) evaluating the safety and efficacy of bemcentinib as monotherapy and in combination with LDAC in patients with ND and R/R AML or high-risk MDS ineligible for intensive chemotherapy were published by Loges et al. in Nature Communications.1 The DE cohort comprised 36 patients with R/R AML or high-risk MDS who received bemcentinib monotherapy. The primary endpoint was establishing the MTD of bemcentinib, with secondary endpoints of identifying DLTs, and safety and efficacy. The LDAC cohort included 36 patients with R/R AML or ND AML who received bemcentinib plus LDAC. The primary endpoint of the LDAC cohort was safety and tolerability of the bemcentinib plus LDAC combination, with efficacy as a secondary endpoint.
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Key learnings |
The RP2D was the 400/200 mg enhanced formulation of bemcentinib monotherapy. Three DLTs were observed, with one occurring outside the DLT assessment window. |
The most common Grade 3 TEAEs were febrile neutropenia (29%) and pneumonia (14%) in the monotherapy cohort, and anemia (39%), febrile neutropenia (28%), and prolonged QTcF (11%) in the LDAC cohort. The most common Grade 4 TEAEs were thrombocytopenia (14%) in the monotherapy cohort, and decreased platelet count (31%) in the combination cohort. Grade 5 pneumonia occurred in 3% of patients in each cohort. |
In the combination cohort, ORR was 50% with an mOS of 16.1 months in patients with ND AML and 20% with an mOS of 7.8 months in patients with R/R AML. |
Bemcentinib in combination with LDAC was safe and tolerable in elderly patients with AML or MDS, with promising efficacy. Bemcentinib in combination with venetoclax may have the potential to improve outcomes in this population and requires further investigation. |
Abbreviations: AML, acute myeloid leukemia; DE, dose escalation; DLT, dose-limiting toxicity; LDAC, low-dose cytarabine; MDS, myelodysplastic syndrome; mOS, median overall survival; ND, newly diagnosed; ORR, objective response rate; QTcF, corrected QT interval using Fridericia’s formula; RP2D, recommended phase II dose; R/R, relapsed/refractory; TEAE, treatment-emergent adverse event.
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