Real-world evidence may complement the findings of randomized controlled
trials.¹⁶ Results should be interpreted with caution as these are real-world evidence studies that are not powered to determine statistical significance; direct comparisons between real-world results and randomized controlled trials should be avoided.

REAL-WORLD EVIDENCE

Real-world studies of VYXEOS examined rates of MRD negativity^17-19

MRD is a marker of deep remission.²⁰ MRD was not assessed in the Phase 3 study for VYXEOS, and its relevance as a predictor of OS remains under investigation.¹⁰

Real-world evidence studies were conducted to evaluate the effectiveness and safety of VYXEOS.

Limitations:

Results cannot be compared across studies as MRD assessment in AML lacks standardization with several technologies available for MRD assessment²⁰
Results should be interpreted with caution as these are real-world evidence studies that are not powered to determine statistical significance
Direct comparisons between real-world evidence studies and randomized controlled trials are difficult²¹

Back to clinical data

In real-world studies, up to 64% of patients treated with VYXEOS achieved MRD negativity following CR/CRi.^17-19

MRD negativity rate in evaluable patients

MRD assessment may occur after the completion of initial induction and before HSCT.⁸

Back to clinical data

Real-world studies of VYXEOS examined rates of MRD negativity17-19

In real-world studies, up to 64% of patients treated with VYXEOS achieved MRD negativity following CR/CRi.17-19

Germany17

France18

Italy19

GERMANY17

France18

Italy19

References

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Real-world studies of VYXEOS examined rates of MRD negativity^17-19

In real-world studies, up to 64% of patients treated with VYXEOS achieved MRD negativity following CR/CRi.^17-19

Germany¹⁷

France¹⁸

Italy¹⁹

GERMANY¹⁷

France¹⁸

Italy¹⁹