30May

Five year results of a phase III study of CPX-351 versus 7+3 in older adults with newly diagnosed high-risk/secondary AML

Five-year final results of a phase III study of CPX-351 versus 7+3 in older adults with newly diagnosed high-risk/secondary AML.


Abstract No : 7510

Abstract Type : Poster Discussion Session

Indication : Acute Myeloid Leukemia

Intervention : CPX-351

Company : Jazz Pharmaceuticals

Technology : Small molecule


Results:

In total, 309 pts were randomized to CPX-351 (n = 153) or 7+3 (n = 156). The survival rate at 5 y was higher for CPX-351 vs 7+3 (18% vs 8%; Table). Among pts who died, the most common primary cause of death was progressive leukemia in both arms (CPX-351: 56%; 7+3: 53%). After a median follow-up of 60.65 mo, improved median OS with CPX-351 vs 7+3 was maintained: 9.33 vs 5.95 mo; Kaplan-Meier (KM) OS curves plateaued at ~30 mo. HCT was received by 53 (35%) vs 39 (25%) pts after CPX-351 vs 7+3; among these pts, the survival rate at 5 y was higher for CPX-351 vs 7+3 (52% vs 23%), and median OS landmarked from the HCT date was not reached for CPX-351 vs 10.25 mo for 7+3 (Table).


Conclusion:

After 5 y of follow-up, improved OS was maintained in this phase 3 study, supporting that CPX-351 has the ability to produce or contribute to long-term remission and survival in older pts with newly diagnosed high-risk/secondary AML


Commentary:

Final results @5yr follow up demonstrate survival benefit of CPX-351 over 7+3 regimen (mOS 9.33 v 5.95 mos) in older patients.


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