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Transcript

((Dr. Abbas))

Hello, I’m Dr Jonathan Abbas. I’m the director of the acute leukemia and blood cancer program with Tennessee Oncology in Nashville, Tennessee. I specialize in hematologic malignancies, specifically acute leukemia, and my center treats over a hundred patients a year with aggressive chemotherapy for AML many of whom have sAML, including t-AML and AML-MRC.

CPX-351 (or VYXEOS) is a liposomal combination of a synergistic ratio of daunorubicin and cytarabine and is the only treatment recommended in the NCCN Guidelines® for induction in patients ≥60 years of age with t-AML or antecedent MDS/CMML or AML-MRC being a category 1 recommendation.

The 1:5 molar ratio of daunorubicin to cytarabine has been shown to have synergistic effects at killing leukemia cells in vitro and in murine models.

VYXEOS was approved by the FDA based on the results of a large Phase 3 trial in newly-diagnosed patients with t-AML or AML-MRC.

Patients could receive up to 2 cycles of induction and 2 cycles of consolidation in each arm. A second induction was highly recommended for patients who did not achieve a response and was mandatory for patients achieving >50% reduction in percent blasts.

VYXEOS is the first chemotherapy to demonstrate superior overall survival versus 7+3 in adults with newly-diagnosed t-AML or AML-MRC.

The Phase 3 multicenter, open-label, randomized study of VYXEOS versus 7+3 included 309 patients with newly-diagnosed t-AML or AML-MRC, aged 60 to 75 years.

Primary endpoint was OS.

Patient and disease characteristics were similar across both the VYXEOS and 7+3 treatment study arms.

Overall survival is more than double at 5 years with VYXEOS at 18% versus 8% with 7+3, based on KM estimate.

The reported adverse reactions for VYXEOS in the Phase 3 trial were generally consistent with the known safety profile of cytarabine and daunorubicin therapy.

VYXEOS was associated with lower 30- and 60-day mortality rates compared to treatment with 7+3.

  • 6% of patients in both the VYXEOS arm and the control arm had a fatal adverse reaction on treatment or within 30 days of therapy that was not in the setting of progressive disease. Overall, all-cause 30-day mortality was 6% in the VYXEOS arm and 11% in the control arm
  • During the first 60 days of the study, 14% of patients in the VYXEOS arm and 21% of patients in the 7+3 arm died
  • Fatal adverse reactions in the VYXEOS arm included infection, CNS hemorrhage, and respiratory failure

For years we have known that sAML is one of the most challenging types of AML to treat because so few of the diseases actually go into a remission.

Historically we’ve always used 7+3 as our induction due to the lack of superiority of any regimen in a randomized clinical trial, and this is why the study with VYXEOS is so significant because now we see not only improved overall survival but we also see a higher percentage of patients achieving that first remission, which opens the door for the potential curative stem cell transplant.

INDICATION

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t‑AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

IMPORTANT SAFETY INFORMATION

INDICATION

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t‑AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Important Safety Information

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.