Dr. Erba on Unique Characteristics of CPX-351 in AML

Harry Erba, MD, PhD
Published: Tuesday, Aug 22, 2017



Harry Erba, MD, PhD, professor of medicine, director, University of Alabama (UAB) Hematologic Malignancy Program, UAB School of Medicine, discusses unique characteristics of CPX-351 (Vyxeos) in acute myeloid leukemia (AML).

Another characteristic of this formulation is that it targets the bone marrow and the leukemic blast, decreasing the off-target types of toxicity that occur, such as mucositis and alopecia, Erba explains. In the randomized phase II study—which led to the phase III study that was the basis for the FDA approval of CPX-351, patients were randomized to receive CPX-351 or 7+3. If they achieved remission they would then receive 2 cycles of CPX-351 at a lower dose or 2 cycles of daunorubicin plus cytarabine in a 2+5 schedule at a lower dose. Patients could then go on to receive stem cell transplant if they experienced a remission or at the physician's discretion.

Results showed that the primary endpoint was met; there was an improvement in overall survival (OS). The median OS with CPX-351 was 10 months, and was 6 months with 7+3.


Harry Erba, MD, PhD, professor of medicine, director, University of Alabama (UAB) Hematologic Malignancy Program, UAB School of Medicine, discusses unique characteristics of CPX-351 (Vyxeos) in acute myeloid leukemia (AML).

Another characteristic of this formulation is that it targets the bone marrow and the leukemic blast, decreasing the off-target types of toxicity that occur, such as mucositis and alopecia, Erba explains. In the randomized phase II study—which led to the phase III study that was the basis for the FDA approval of CPX-351, patients were randomized to receive CPX-351 or 7+3. If they achieved remission they would then receive 2 cycles of CPX-351 at a lower dose or 2 cycles of daunorubicin plus cytarabine in a 2+5 schedule at a lower dose. Patients could then go on to receive stem cell transplant if they experienced a remission or at the physician's discretion.

Results showed that the primary endpoint was met; there was an improvement in overall survival (OS). The median OS with CPX-351 was 10 months, and was 6 months with 7+3.



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