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(RTTNews) - Novartis AG (NVS) reported Friday positive results from the pivotal Phase III ASC4FIRST trial, which 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

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 discontinuation

This is compared to imatinib alone in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

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.

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