Novartis presented new 96-week results from the Phase III ASC4FIRST trial of Scemblix (asciminib) at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition. The data showcased Scemblix's favorable safety and tolerability profile compared to investigator-selected tyrosine kinase inhibitors (TKIs) in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP).
The ASC4FIRST study is a pivotal Phase 3 trial evaluating asciminib as a first-line treatment for CML-CP. The study's primary endpoint was major molecular response (MMR) at 24 weeks, with secondary endpoints including safety, tolerability, and deeper molecular responses over time. The 96-week data provides longer-term insights into the efficacy and safety of asciminib in this patient population.
Key Findings from ASC4FIRST
The data presented at ASH highlighted the sustained efficacy and favorable tolerability of Scemblix over a longer follow-up period. Patients treated with Scemblix demonstrated a consistent rate of major molecular response (MMR) and a lower incidence of adverse events compared to those treated with traditional TKIs.
Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis, stated, "By prioritizing research in areas of greatest medical need and focusing on earlier stages of disease, we aim to change the treatment paradigm for people who require additional treatment options." He further emphasized that the data presented at ASH and SABCS underscores Novartis' commitment to patients with cancer or blood disorders.
Additional Novartis Presentations at ASH and SABCS
In addition to the Scemblix data, Novartis is presenting over 65 abstracts at the ASH and SABCS meetings. These presentations cover a range of hematologic diseases and cancers, demonstrating the company's broad commitment to oncology research and development. Key abstracts include data on Fabhalta (iptacopan) in paroxysmal nocturnal hemoglobinuria (PNH), Ianalumab (VAY736) in primary immune thrombocytopenia, and Kisqali (ribociclib) in early breast cancer.
Implications for CML Treatment
The 96-week data from the ASC4FIRST trial further supports the potential of Scemblix as a valuable first-line treatment option for patients with CML-CP. Its novel mechanism of action, targeting the ABL myristoyl pocket, offers an alternative approach to traditional TKIs, potentially overcoming resistance and improving long-term outcomes for patients. The favorable safety profile observed in the trial also suggests that Scemblix may be a well-tolerated option for newly diagnosed patients.
