After the precedent in myeloma achieved last year at the FDA ODAC hearing that led to the approval of MRD as a co-primary endpoint in multiple myeloma, there is now interest in escalating these findings and making it happen also in AML. Well, now we know the pathway to make it happen and the pathway must include clear demonstration that MRD is more sensitive and more prognostic than conventional response criteria...
After the precedent in myeloma achieved last year at the FDA ODAC hearing that led to the approval of MRD as a co-primary endpoint in multiple myeloma, there is now interest in escalating these findings and making it happen also in AML. Well, now we know the pathway to make it happen and the pathway must include clear demonstration that MRD is more sensitive and more prognostic than conventional response criteria. Number one, it should be applied in as many treatment scenarios as possible. In AML, particularly, patients eligible to intensive chemotherapy and patients that are ineligible, typically the elderly, prognostic in different genetic subgroups and to some extent the rates of MRD after each treatment strategy will correlate with event-free survival. The difference in the MRD-negative rates will correlate with different event-free survival after different treatment strategies. And this is what we try to demonstrate in this study. We do show that even decentralized multi-parameter flow cytometry with all its advantages and limitations is more sensitive and more prognostic than conventional complete response. It is a clear independent prognostic value, both in patients eligible and ineligible to intensive chemotherapy. It yields additional prognostic information in well-defined genetic risk groups. And we do see that MRD-negative rates are completely different after treatment schemas that are inducing longer versus shorter event-free survival.
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