ASH 2024 | The results of a Phase Ib/II study of CPX-351 plus venetoclax in patients with R/R AML
Vanthana Bharathi, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, comments on the results of a Phase Ib/II study (NCT03629171) evaluating the combination of CPX-351 and venetoclax in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). Dr Bharathi highlights the promising efficacy of this combination, with an overall response rate (ORR) of 55%, encouraging survival outcomes, and 61% of patients proceeding to stem cell transplantation (SCT). This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
CPX-351 is a liposomal formulation of cytarabine and daunorubicin, which is used in a fixed 5 to 1 molar ratio. It’s already FDA approved for secondary AML. So in our study, we wanted to evaluate the safety and efficacy of this CPX-351 in combination with venetoclax, which is a BCL2 inhibitor, in patients with relapsed/refractory AML. So this population historically has poor outcomes, and there’s limited treatment options...
CPX-351 is a liposomal formulation of cytarabine and daunorubicin, which is used in a fixed 5 to 1 molar ratio. It’s already FDA approved for secondary AML. So in our study, we wanted to evaluate the safety and efficacy of this CPX-351 in combination with venetoclax, which is a BCL2 inhibitor, in patients with relapsed/refractory AML. So this population historically has poor outcomes, and there’s limited treatment options.
So in our study, we enrolled 33 patients in total, with a median follow-up of 55 months. So in our study, we used the standard CPX-351 dose, and venetoclax was used at a dose of 300 milligrams from day two to 21. And venetoclax interruption was allowed if the day 14 bone marrow showed no evidence of leukemia. And then a second dose escalation was done where venetoclax was used from day two to day eight and with the reduced daunorubicin dose of 22 milligrams per meter squared. And this was the recommended Phase II dose.
So we had a total of 33 patients, like I said before, and the median age was 58 years. So with this combination, we observed an overall response rate of 55%. And most importantly, 61% of patients proceeded to stem cell transplant. And the most encouraging part of this study is the survival outcomes. The overall median survival was 5.3 months and extended to 19.6 months in patients that proceeded to transplant.
The most common adverse effects with this combination were febrile neutropenia, infections, and hemorrhage, but the neutropenia was managed with dose modifications, like I mentioned before.
Overall, I think this study shows safety and tolerability, as well as promising efficacy in relapsed/refractory AML, which is a very high-risk population, allowing the majority of patients to proceed to stem cell transplant.
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