ASH 2024 | CLIA (cladribine, idarubicin, and cytarabine) plus venetoclax in newly diagnosed AML

So, hey, I’m happy to be here at ASH. We are presenting quite a few abstracts and one of the important ones is CLIA and venetoclax. The CLIA regimen is composed of cladribine, idarubicin, and high-dose cytarabine, at 1.5 grams per meter squared as induction. And based on the excellent data from venetoclax with low-intensity therapy, we decided to add venetoclax to this regimen for the frontline treatment of younger patients who are fit for intensive chemotherapy and newly diagnosed AML. So we have now 89 patients with newly diagnosed AML treated with CLIA plus venetoclax. We showed that with this larger number and with longer follow-up, we’re still maintaining very high rates of remission and long-term survival. So the CR rate, the CRc or composite CR rate is 94%. And of those 94% of patients, 89% of them had MRD negative complete remission after one cycle of chemotherapy. This translated into an outstanding long-term survival with a one and five year survival of 75 and 73 percent respectively. So outstanding survival, very deep remissions. The deep remissions allowed patients to go to stem cell transplantation, leading to almost 70 percent of patients who received therapy to go to allogeneic stem cell transplantation. So we also saw really nice activity in subgroups of patients. So for example, those patients with NPM1 mutated AML or DDX41 mutated AML, their long-term survival at one in four years was around 85 to 90 percent long-term survival. Among those with p53 mutation that was not the case so we had a few patients with p53 mutated AML or complex karyotype where the survival was inferior in the range of about a year with this intensive chemotherapy approach. Now although it was very effective it is intensive chemotherapy and that’s why we restrict it to patients under the age of 65. The median age is only 49 years and We did see toxicity. Myelosuppression was universal. Infections were present. We had a high rate of infections. But all the infections were manageable. To that we had an early mortality rate of only 1% at four weeks and 1% at eight weeks. Infections included things like bacteremia, pneumonias, sepsis, cellulitis. And these were managed well with antibiotics, prophylactic antibiotics, and as you’ll see In a separate abstract, the use of GCSF, including neupogen and tevagrastim for long-acting. So again, a very active regimen, getting a lot of people to stem cell transplant, leading to really good long-term outcomes.

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