P074 | CPX-351 IN SECONDARY ACUTE MYELOID LEUKEMIA: A REAL LIFE REGIONAL MULTICENTER EXPERIENCE.

Background: CPX351 is considered standard of care for fit patients (pts) with secondary Acute Leukemias (sAML). The advantage for Overall Response Rate (ORR) and for Overall Survival (OS) is widely demonstrated in pts eligible for allogenic hematopoietic stem cell transplantation (HSCT). Methods:To confirm these findings in a real world setting, we collected data from sAML pts receiving CPX351 in 11 Lazio Centers. The Composite ORR [cORR] complete remission (CR)+CR with incomplete hematologic recovery (CRi)+partial remission (PR)] and OS were assessed. Results: A total of 111 pts with sAML treated between January 2019 and December 2023 were included. Median age was 65 y (range, 34÷79), with a slight female prevalence (50.5%). The median response time to induction therapy was 30 days(d)(range, 21-60). The ORR was 66.5% after one (n=111) or two (n=23) induction cycles, with 49.5% and 55% of pts in CR/CRi after the first (Ind1) and the second (Ind2) induction cycle, respectively. Median time to neutrophil (ANC) and platelet (PLTs) recovery after Ind1 was evaluable in 86/111 (77.5%) and in 80/111 (72%) pts respectively and was of 35d (range 15-78) and 35d (range 18-80) for ANC and PLTs recovery, respectively. Median time to ANC and PLTs recovery after Ind2 was evaluable in 11/23 (47.8%) and 10/23 (43.4%) pts, respectively and it was of 35d (range 22-78) and 37d (range 21-80) for ANC and PLTs recovery respectively. Ninety-one/111(81.9%) pts experienced adverse events (grade >1) after Ind1 and 12/23 (52.1%) after Ind2. Mucositis occurred in 23/111 (20.7%) pts. Mortality at 30d and 60d from Ind1 was 4.3% and 6.5%, respectively. Thirty-four pts (30.6%) proceeded to HSCT. After a median follow up of 11.3 months, median OS was 13.3 months (Fig 1A) and was not affected by ANC (Fig 1B) or PLTs (Fig. 1C) recovery time (<28d vs. 28-35d vs >35d) after induction. Finally, for pts submitted to HSCT once in CR, a clear OS advantage was observed over pts not receiving transplant (median OS not reached vs. 22.7 months for CR pts receiving HSCT we not transplanted ones. [Fig 1D]; p=0.017). Conclusions: At a median follow-up of 11.3 months, the efficacy and safety of CPX351 were confirmed in this real-life setting. Pts receiving two cycles of induction appeared to have a better response in terms of cCR but not of OS. Time to ANC and PLTS recovery in CR pts had no influence on OS, whereas HSCT confirmed its role in significantly influencing long-term outcome.