Enliven Therapeutics (ELVN) 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA summary

Company strategy and upcoming milestones

• Focused on executing first phase III trial in second-line-plus CML and preparing for commercial launch in the coming years.

• Near-term priorities include aligning with health authorities on pivotal trial design and initiating the trial.

• Plans to engage regulators for requirements to start a frontline CML pivotal trial and initiate a phase II IST for frontline data.

• Building organizational capabilities to support multiple pivotal trials and future commercial activities.

Clinical data highlights and interpretation

• Phase I-B trial of ELVN-001 in CML shows strong safety and tolerability, with a 6% discontinuation rate due to AEs and less than 10% dose reductions.

• Achieved MMR rates: 38% in mature 80 mg group, 53% in less mature 60/120 mg cohorts; cumulative MMR rates of 47% and 69% respectively, with data maturity impacting results.

• Efficacy in patients previously treated with asciminib: 38% achieved MMR, 47% cumulative MMR, despite heavy pretreatment.

• No dose response observed between 60, 80, and 120 mg; 80 mg selected for future development based on PK/PD modeling and target coverage.

• Updated data with more patients and longer follow-up to be presented at EHA.

Competitive landscape and positioning

• ELVN-001 is the only selective ATP-competitive TKI, offering a different mechanism from allosterics like asciminib and TERN-701.

• Positioned to address resistance after asciminib, with potential to capture second- and third-line market share.

• Lower propensity for drug-drug interactions and no food effect compared to competitors.

• SCEMBLIX's strong launch demonstrates market appetite for new CML therapies and supports the potential for multiple blockbusters.