ELVN-001 Positioning and Market Opportunity - The BCR::ABL1 TKIs market has historically generated approximately $6 billion in combined annual sales, even with generic options available[10] - There is a potential $9 billion opportunity in the U S alone for differentiated TKIs, which is validated by the successful launch of Scemblix[10] - The U S branded CML market has the potential to reach approximately $9 billion based on historical sales, adjusted for current prevalence and pricing[28] CML Landscape and Treatment - Prior to imatinib, the annual CML survival rate was less than 20%[14] - The 10-year survival rate for CML improved from less than 20% to over 80%[14] - Approximately 30% of second-line patients switch therapy within the first year of treatment[22] - Approximately 25% of first-line patients switch therapy within the first year[22] - In Q1 2025, Novartis reported Scemblix NBRx of 40% in 2L and 10% in 1L in the U S, highlighting the need for improved treatment options across all lines of therapy[32] ELVN-001 Clinical Data and Development - In the Phase 1 trial, the overall MMR (BCR::ABL1 ≤ 0 1%) by 24 weeks was 47% (25/53)[68] - 80% of patients in the ELVN-001 Phase 1 trial remained on the study, with a median duration of exposure of 29 weeks[58, 59] - The company expects to initiate the first ELVN-001 head-to-head pivotal trial in 2026[10]
Enliven Therapeutics (ELVN) Earnings Call Presentation