Additional Relevant Details The Phase 3 trial compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3.The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005) which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm. Event-free survival was also statistically significant in favor of VYXEOS. The HR was 0.74 (p-value=0.021). The median event-free survival was 2.53 months in the VYXEOS arm compared to 1.31 months in the 7+3 arm.


VYXEOS also demonstrated a statistically significant improvement in induction response rate (CR+CRi of 47.7% versus 33.3%; p=0.016) and this significance was maintained for the analysis of CR alone (CR of 37.3% versus 25.6%, p=0.040). Thirty-four percent of VYXEOS treated patients received a stem cell transplant (SCT) compared to 25% of 7+3 treated patients. In a landmark survival analysis of patients receiving a SCT, VYXEOS patients had significantly improved survival post-transplant (HR was 0.46 (p-value=0.0046)). The median overall survival had not been reached in the VYXEOS treated patients compared to 10.25 months in the 7+3 treated patients.Thirty-day and sixty-day all-cause mortality favored VYXEOS. Thirty-day mortality was 5.9% compared to 10.6% and sixty-day mortality was 13.7% versus 21.2%.Grade 3-5 non-hematologic and hematologic adverse events were similar between the VYXEOS and 7+3 arms.