Novartis says longer-term data for Scemblix ‘reinforce superior efficacy’

Novartis (NVS) announced “positive,” longer-term results from the pivotal Phase 3 ASC4FIRST trial with Scemblix showing superior major molecular response rates at week 96. The study compared the MMR rate of Scemblix to investigator-selected standard-of-care tyrosine kinase inhibitors and to imatinib alone in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase at the week 96 evaluation, the study’s key secondary endpoints. The longer-term results showed an increasing difference in Scemblix MMR rate vs. SoC, vs. imatinib and vs. 2G TKIs. Results were presented at the 66th American Society of Hematology Annual Meeting & Exposition. The median follow-up was 2.2 years for Scemblix and investigator-selected SoC TKIs1. Over 22% more patients treated with once-daily Scemblix achieved MMR at week 96 vs. all investigator-selected SoC TKIs, and nearly 30% more patients achieved MMR at week 96 vs. imatinib alone. The Scemblix MMR rate was 15.1% higher vs. 2G TKIs. Patients treated with Scemblix also achieved deeper rates of molecular responses compared with investigator-selected SoC TKIs, the company reported. “These 96-week results are very encouraging for clinicians who aspire to obtain a balance of efficacy and tolerability profiles to help newly diagnosed adult CML patients achieve and maintain treatment goals,” said Jorge Cortes, M.D., Director, Georgia Cancer Center. “The sustained superior efficacy, deeper and more durable responses, and favorable safety and tolerability profile compared to standard of care TKIs continue to support the promise of Scemblix as a potentially practice-changing treatment option.”