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
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
與之相比，諾華Scemblix三期數據顯示出卓越的功效和良好的安全性和耐受性新診斷的慢性白血病成人中的標準護理TKI
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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
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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
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III 期 ASC4FIRST 試驗達到了兩個主要終點，取得了具有臨床意義和統計學意義的結果；與研究者選擇的 SoC TKI（伊馬替尼、尼洛替尼、達沙替尼和博舒替尼）（67.7% 對 49.0%）和單獨的伊馬替尼（69.3% 對 40.2%）相比，第 48 周的 MMR 率更高 1
- 與伊馬替尼和2G TKI相比，Scemblix還表現出良好的安全性和耐受性，等級≥3 AE較少，劑量調整，AE率只有一半導致治療中斷1
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TKI 改變了 CML 的治療方式，但仍未得到滿足的需求；許多新診斷的患者未達到分子反應目標，許多人因不耐受而停止或改變治療2-17
- Scemblix被授予美國食品藥品管理局突破性療法稱號，該機構的腫瘤學卓越中心RTOR計劃目前正在審查中；數據將在EHA的全體會議上公佈，今天作爲最新摘要在ASCO上發佈
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