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February 20, 2020
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CPX-351 prolongs OS compared with 7 + 3 chemotherapy in AML with myelodysplasia-related changes

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ORLANDO — CPX-351 extended OS compared with 7 + 3 chemotherapy among patients with acute myeloid leukemia and myelodysplasia-related changes who achieved complete remission or complete remission with incomplete neutrophil or platelet recovery, according to an exploratory subgroup analysis of a phase 3 study presented at TCT | Transplantation & Cellular Therapy Meetings.

Perspective from Bart Scott, MD

“The longer OS with CPX-351 in this subgroup suggests potentially deeper responses may be achieved with [this treatment],” Stefan Faderl, MD, executive medical director of clinical development in hematology and oncology at Jazz Pharmaceuticals, said during a presentation.

CPX-351 (Vyxeos, Jazz Pharmaceuticals), a liposomal preparation of cytarabine and daunorubicin at synergistic ratio, received FDA approval for treatment of adults with untreated, therapy-related AML or AML with myelodysplasia-related changes.

Results of the phase 3 trial showed CPX-351 significantly prolonged median OS compared with standard 7 + 3 chemotherapy among 309 patients aged 60 to 75 years with newly diagnosed high-risk/secondary AML.

Faderl and colleagues analyzed 246 patients enrolled in the trial who were diagnosed with AML with myelodysplasia-related changes. Half of these patients (n = 123) had been randomly assigned to one to two induction cycles of CPX-351 at 100 units/m2 (100 mg/m2 cytarabine plus 44 mg/m2 daunorubicin) on days 1, 3 and 5 as a 90-minute infusion, with second induction on days 1 and 3. The other half (n = 123) received 7 + 3 chemotherapy, consisting of 100 mg/m2 cytarabine daily through continuous infusion for 7 days, with second induction for 5 days, and 60 mg/m2 daunorubicin on days 1 to 3, with second induction on days 1 and 2.

Patients who achieved complete remission or complete remission with incomplete neutrophil or platelet recovery could receive as many as two consolidation cycles with CPX-351 or 5 + 2 chemotherapy. Patients also could receive HSCT at the discretion of their physician.

Results of the subgroup analysis showed 48% of patients who received CPX-351 achieved complete remission or complete remission with incomplete neutrophil or platelet recovery, compared with 33% who received 7 + 3 chemotherapy (OR = 1.83; 95% CI, 1.09-3.09).

Median OS was superior in the CPX-351 group compared with the 7 + 3 group among patients who achieved complete remission with or without neutrophil or platelet recovery (19.15 months vs. 11.58 months).

Patients who received CPX-351 vs. 7 + 3 chemotherapy and achieved complete remission with or without neutrophil or platelet recovery also had a higher HSCT rate (54% vs. 43%; RR = 1.18; 95% CI, 0.79-1.76).

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OS landmarked from the transplant date also was longer in the CPX-351 group.

Safety profiles appeared similar in both groups.

“The safety profile of CPX-351 in this subgroup was consistent with that of the overall study population and the known safety profile of 7 + 3,” Faderl said. “These results may suggest better remissions following CPX-351, with the caveat that data on minimal residual disease from these patients [are] not available.”– by John DeRosier

Reference:

Ryan D, et al. Abstract 9. Presented at: TCT | Transplantation & Cellular Therapy Meetings; Feb. 19-23, 2020; Orlando.

Disclosures: Faderl reports employment with and stock ownership in Jazz Pharmaceuticals. Please see the abstract for all other authors’ relevant financial disclosures.