Positive Phase III results for Novartis’ Scemblix in Ph+ CML-CP

Swiss pharma giant Novartis (NOVN: VX) today announced positive results from the primary analysis of ASC4FIRST, a pivotal Phase III trial comparing Scemblix (asciminib) with investigators’ choice of tyrosine kinase inhibitor (TKI) treatment in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

Novartis noted that ASC4FIRST is the first and only randomized head-to-head Phase III trial comparing a CML treatment versus approved standard-of-care first- and second-generation TKIs.

The trial met both primary endpoints of major molecular response (MMR) rate for Scemblix compared to investigator-selected TKIs (imatinib, nilotinib, dasatinib, and bosutinib) and compared to imatinib, demonstrating clinically meaningful and statistically significant results for both endpoints.