Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components
Enliven Therapeutics reported positive Phase 1 data for ELVN-001 in chronic myeloid leukemia, showing a 61% major molecular response rate in the 80 mg once-daily cohort. The company also announced alignment with the FDA on using the 80 mg dose and a 2L+ patient population for the upcoming pivotal ENABLE-2 Phase 3 trial.
Key figures
- Drug Name
- ELVN-001
- Phase Of Trial
- Phase 1
- Dmr 80mg qd
- 30%
- Mmr 80mg qd
- 61%
- Patients enrolled
- 161
- Dmr overall phase1b
- 22%
- Mmr overall phase1b
- 54%
- Mmr achieved 80mg qd
- 48%
- Grade 3 plus teae 80mg
- 24%
- Discontinuation rate ae
- 6%
- Grade 3 plus teae overall
- 34%
- Median treatment duration weeks
- 35
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