Novartis Reports Superior Efficacy of Scemblix in Phase 3 Trial

Novartis has reported promising longer-term results from the pivotal Phase 3 ASC4FIRST trial, indicating that Scemblix demonstrates superior major molecular response (MMR) rates at week 96. This study evaluated Scemblix against investigator-selected standard-of-care (SoC) tyrosine kinase inhibitors (TKIs) and imatinib in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase. The results were presented at the 66th American Society of Hematology Annual Meeting & Exposition.

The trial's findings highlighted that over 22% more patients treated with once-daily Scemblix achieved MMR at week 96 compared to those receiving SoC TKIs. Additionally, nearly 30% more patients achieved MMR with Scemblix compared to imatinib alone. The MMR rate for Scemblix was 15.1% higher than that for second-generation (2G) TKIs. Furthermore, patients on Scemblix experienced deeper molecular responses than those on SoC TKIs.

The median follow-up period was 2.2 years for both Scemblix and investigator-selected SoC TKIs. These results are seen as encouraging for clinicians who aim to balance efficacy and tolerability to help newly diagnosed adult CML patients achieve and maintain treatment goals. Dr. Jorge Cortes, Director of the Georgia Cancer Center, remarked on the sustained superior efficacy, deeper responses, and favorable safety profile of Scemblix, suggesting it as a potentially practice-changing treatment option.