- Phase III ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results; Scemblix (asciminib) demonstrated superior MMR rates at week 48 vs. investigator-selected SoC TKIs (imatinib, nilotinib, dasatinib and bosutinib) (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%)1
- Scemblix also demonstrated a favorable safety and tolerability profile vs. imatinib and 2G TKIs, with fewer grade ≥3 AEs, dose adjustments, and half the rate of AEs leading to treatment discontinuation1
- TKIs have transformed CML treatment, but unmet need remains; many newly diagnosed patients do not meet molecular response goals, and many discontinue or change treatment due to intolerance2-17
- Scemblix was granted US FDA Breakthrough Therapy Designation, submission is now in review under the agency's Oncology Center of Excellence RTOR program; data will be presented as a plenary at EHA and today as a late-breaking abstract at ASCO
Novartis Scemblix Phase III Data Shows Superior Efficacy With A Favorable Safety And Tolerability Profile Vs. Standard-Of-Care TKIs In Adults With Newly Diagnosed CML
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