The use of CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin, was tied to long-term remission and survival in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML), according to final results of a.
As part of the American Society of Clinical Oncology virtual scientific program,, of the Moffitt Cancer Center in Tampa, Fla., presented the 5-year final data from a trial comparing CPX-351 vs. the conventional 7+3 regimen of cytarabine and daunorubicin in more than 300 older adult patients (age 60-75 years) with newly diagnosed high-risk or secondary AML. Early mortality rates for CPX-351 vs. 7+3 were 6% vs. 11% at Day 30 and 14% vs. 21% at day 60, respectively.
The final 5-year follow-up results had a median follow-up of just greater than 60 months, and maintained the improved median overall survival previously observed in the trial with CPX-351 (153 patients), compared with 7+3 (155 patients), Dr. Lancet.
Allogeneic hematopoietic stem cell transplant was received by 35% of the patients in the CPX-351 arm and 25% of patients in the 7+3 arm. The median overall survival after transplant was not reached for the CPX-351 arm, compared with 10.3 months with the 7+3 treated patients.
Remission, either complete remission or complete remission with incomplete neutrophil or platelet recovery, was achieved by 48% of patients in the CPX-351 arm and 33% of patients in the 7+3 arm, according to the results of the 5-year follow-up. In addition, among all patients who achieved remission, median overall survival was longer with CPX-351 than with 7+3, and the Kaplan-Meier estimated survival rate was higher for CPX-351 at both 3 years and 5 years.
At 5 years of follow-up, 81% of patients in the CPX-351 arm and 93% of patients in the 7+3 arm had died, with similar causes cited in each arm. Progressive leukemia was the most common primary cause of death in both treatment arms, according to Dr. Lancet.
“The final 5-year follow-up results from this phase 3 study support the prior evidence that CPX-351 has the ability to produce or contribute to long-term remission and survival in older patients with newly diagnosed high-risk or secondary AML,” Dr. Lancet concluded.
CPX-351 (Vyxeos) has beenand the European Medicines Agency for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplastic syndrome–related changes.
The study was funded by Jazz Pharmaceuticals. Dr. Lancet disclosed that he has a consulting or advisory role for Agios, Daiichi Sankyo, Jazz Pharmaceuticals, and Pfizer.
SOURCE: Lancet JE et al. ASCO 2020, Abstract 7510.