Novartis announces its Phase III study of Scemblix showed ‘superior efficacy’

Novartis presents results from the pivotal Phase III ASC4FIRST trial as a late-breaking abstract at the 2024 American Society of Clinical Oncology, ASCO, meeting. Novartis Scemblix Phase III data is the first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML. Scemblix demonstrated superior major molecular response, MMR, rates at week 48 compared to investigator-selected standard-of-care, SoC, tyrosine kinase inhibitors imatinib, nilotinib, dasatinib and bosutinib, and compared to imatinib alone in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Scemblix also showed a numerical improvement in MMR at week 48 vs. second generation TKIs. Additionally, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events and treatment discontinuations vs. both imatinib and 2G TKIs. The trial met both primary endpoints with clinically meaningful and statistically significant results. Nearly 20% more patients treated with Scemblix achieved MMR at week 48 vs. investigator-selected SoC TKIs and nearly 30% more patients achieved MMR at week 48 vs. imatinib alone1. Patients treated with Scemblix also achieved deeper rates of molecular responses compared with investigator-selected SoC TKIs and imatinib alone. In newly diagnosed patients, the safety profile was consistent with previous registration studies with no new safety concerns observed. The trial remains ongoing, with the next scheduled analysis at week 96 to evaluate the key secondary endpoint and additional secondary endpoints.