CPX-351 produces long-term remission in older patients with AML
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After 5-years follow-up, more patients with newly diagnosed high-risk/secondary acute myeloid leukemia achieved remission with CPX-351 than with 7 + 3 chemotherapy, according to data presented at ASCO20 Virtual Scientific Program.
Further, median overall survival was longer with CPX-351 than with 7 + 3 chemotherapy in those who achieved remission, the results showed.
“CPX-351 is a dual-drug liposomal encapsulation of both cytarabine and daunorubicin in a synergistic 5-to-1 molar ratio and it has been approved by the FDA and the European Medicines Agency for the treatment of adults with newly diagnosed therapy-related AML or AML with MDS-related changes,” Jeffrey E. Lancet, MD, of the Moffitt Cancer Center & Research Institute, said during his ASCO presentation.
Lancet presented final 5-year follow-up results from a pivotal phase 3 study that found CPX-351 significantly improved median overall survival vs. conventional 7 + 3 chemotherapy with a comparable safety profile.
Investigators randomly assigned patients 1:1 to receive either two or less induction cycles of CPX-351 (cytarabine 100 mg/m2 plus daunorubicin 44 mg/m2 as a 90-minute infusion on days 1, 3 and 5), or 7 + 3 (cytarabine 100 mg/m2/d continuously for 7 days plus daunorubicin 60 mg/m2 on days 1 to 3), according to the abstract. Follow-up was until death or up to 5 years after randomization.
Researchers reported 153 patients received CPX-351 and 156 received 7 + 3.
Lancet and colleagues found that survival rates were higher with CPX-351 than 7 + 3 at 5 years (18% vs. 8%). Forty-eight percent of patients in the CPX-351 arm and 33% of patients in the 7 + 3 arm achieved either CR or CRi. Among patients who achieved remission, median overall survival was longer with CPX-351 than with 7 + 3 at both 3 years and 5 years, according to the presentation.
Fifty-three patients and 39 patients received hematopoietic cell transplant after CPX-351 and 7 + 3. Kaplan-Meier estimates showed that the survival rate among these patients was higher for CPX-351 vs. 7 + 3 (52% vs 23%).
“These data indicated the potential for long-term survival following transplant amongst patients who were treated with CPX-351 as initial therapy,” Lancet said during the presentation.
During the follow-up, 81% of patients in the CPX-351 arm and 93% of patients in the 7 + 3 arm had died and the most common primary cause of death was progressive leukemia in both arms (CPX-351 = 56%; 7 + 3 = 53%). Also, early mortality rates were lower with CPX-351 than 7 + 3 at day 30 and day 60, according to the poster.
“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,” Lancet said.
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Lancet JE, et al. Abstract 7510. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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