EHA 2026 | ENABLE study highlights the promise of ELVN-001 in chronic-phase CML
Dennis Kim, MD, PhD, Princess Margaret Cancer Centre, Toronto, Canada, discusses findings from the ENABLE study (NCT05304377) evaluating ELVN-001 in patients with previously treated chronic-phase chronic myeloid leukemia (CP-CML). He highlights the agent’s favorable safety profile, encouraging molecular response rates, and unique mechanism of action, which may help overcome resistance mutations while offering convenient once-daily dosing. This interview took place at the 31st Congress of the European Hematology Association (EHA) in Stockholm, Sweden.
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Transcript
ENABLE study is focusing on evaluating the efficacy and safety of ELVN-001 compound, which is an ATP pocket-specific inhibiting compound in CML patients previously treated. So in that study, I will give you some summary. Number one is that it seems to show a really excellent safety and toxicity profile. And we found that the optimal biological dose was found to be 80 milligrams daily. And its efficacy was also unexpectedly pretty high...
ENABLE study is focusing on evaluating the efficacy and safety of ELVN-001 compound, which is an ATP pocket-specific inhibiting compound in CML patients previously treated. So in that study, I will give you some summary. Number one is that it seems to show a really excellent safety and toxicity profile. And we found that the optimal biological dose was found to be 80 milligrams daily. And its efficacy was also unexpectedly pretty high. It showed about 60% of MMR rate by week 24. And even in the patients who failed multiple TKI treatment in the past, or those patients who failed prior treatment as well. That is the main finding for this study, and they are now looking for the phase three study to be opened soon. So ELVN-001 does have a unique feature and it will solve our unmet needs. Number one is that it does improve its tolerability by inhibiting by its unique mechanism of action and it doesn’t have that much of an off-target side effect. That’s number one. And number two is that it can tackle the resistance issues, particularly it can overcome the T315I as well. And also other allosteric inhibition-related mutations, it can also overcome that kind of issue. Number three is that it will solve our administration issues, such as it just requires one steady dose without any food restriction. And you can take the pill with even PPI. That is another benefit of this compound.
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