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ISAL 2025 | Primary analysis of the LD-VenEx trial: azacitidine and reduced duration venetoclax in AML
Anne Louise Tølbøll Sørensen, MD, PhD, Copenhagen University Hospital, Copenhagen, Denmark, presents the primary analysis from the Phase II LD-VenEx trial (Eudra-CT 2020-005461-14), which assesses the efficacy and safety of reduced duration venetoclax in combination with azacitidine for de novo, secondary, and relapsed/refractory (R/R) acute myeloid leukemia (AML). Dr Sørensen reports the primary endpoint outcomes of composite complete remission, as well as the overall survival. This interview took place at the 19th International Symposium on Acute Leukemias (ISAL XIX) in Munich, Germany.
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Transcript
The combination therapy with venetoclax and azacitidine has become the standard of treatment for unfit and elderly AML patients that are ineligible for intensive chemotherapy. But we have all learned that the combination therapy is myelosuppressive and we often need to adjust the treatment with extended treatment cycles and reduced dosing. So in the LD-VenEx trial we are assessing the efficacy and safety of reduced duration of venetoclax...
The combination therapy with venetoclax and azacitidine has become the standard of treatment for unfit and elderly AML patients that are ineligible for intensive chemotherapy. But we have all learned that the combination therapy is myelosuppressive and we often need to adjust the treatment with extended treatment cycles and reduced dosing. So in the LD-VenEx trial we are assessing the efficacy and safety of reduced duration of venetoclax. We are doing so in a prospective multicenter trial that is conducted by the Nordic AML group. So we are enrolling de novo AML, secondary AML and relapsed/refractory AML. The trial is still ongoing and we are still recruiting. Here we report on the primary efficacy endpoint and the key secondary endpoint. So the treatment is given in 28-day treatment cycles with standard dose of azacitidine and reduced duration of venetoclax. So we’re starting with 14 days in the induction therapy and then when blast clearance has been achieved we reduce to 7 days of venetoclax. And the analyzed study population that we present here at the meeting includes 89 patients, 43 with de novo AML, 20 with secondary AML and 26 with relapsed/refractory disease. And what we can show for the primary endpoint is that we have a response rate of 71% for composite complete remission for de novo AML and 50 and 62% for secondary AML and relapsed refractory AML. And when looking at overall survival, we have a median follow-up time of 13.8 months. And here we see that the median overall survival is not yet reached for de novo AML. For secondary and relapsed/refractory, the median overall survival is 7.8 months and 11.3 months respectively. So with this first data analysis of the study we conclude that reduced dose of venetoclax is comparable to full dose VEN-AZA as shown in the VIALE-A trial and also comparable to what we see in the prospective Finnish Venex trial for secondary relapsed/refractory AML and what also has been shown in other trials and previous real-world evidence.
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