Novartis Announces Positive Phase 3 Results for Scemblix in Newly Diagnosed CML

Novartis today announced positive results from the Phase 3 ASC4FIRST trial evaluating Scemblix (asciminib) in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (CML-CP). The trial met its primary endpoint, demonstrating a statistically significant improvement in the major molecular response (MMR) rate at 48 weeks compared to standard-of-care TKIs. The MMR rate was 67.7% for Scemblix versus 49.0% for standard-of-care TKIs. Asciminib is a STAMP inhibitor that specifically targets the ABL myristoyl pocket, offering a differentiated mechanism of action. These results support the use of Scemblix as a first-line treatment for newly diagnosed CML.