Novartis recently presented positive results from the pivotal Phase III ASC4FIRST study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting: the treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) with Scemblix® at Week 48 demonstrated greater efficacy and safety than the investigator's choice of tyrosine kinase inhibitors (TKIs) (imatibe Scemblix demonstrated a superior major molecular response (MMR) rate at week 48 than both investigator-selected tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib) and imatinib alone.Scemblix demonstrated a higher MMR rate at week 48 than the second-generation TKIs (nilotinib, dasatinib, and bosutinib) with higher rate values.The MMR rate was higher than that of the second-generation TKIs. In addition, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events (AEs) and treatment interruptions relative to imatinib and second-generation TKIs.

Tim Hughes, M.D., professor at the South Australian Health and Medical Research Institute (SAHMRI), said Scemblix is the first CML treatment with head-to-head studies supporting superiority in efficacy over the investigator's choice of standard-of-care TKIs, and when you combine Scemblix's efficacy with its safety and tolerability, we have a potentially promising first-line treatment option to help newly diagnosed patients achieve their treatment goals.

The median follow-up times for Scemblix and the investigator's choice of standard-of-care TKI were 16.3 and 15.7 months, respectively.The MMR response rate at week 48 for patients in the Scemblix treatment group was nearly 20% higher than the investigator's choice of standard-of-care TKI group, and nearly 30% higher than that of the imatinib group. Patients treated with Scemblix also achieved higher rates of deeper molecular responses (MR4 and MR4.5) than the investigator's choice of standard-of-care TKI and imatinib alone.

In newly diagnosed patients, the safety profile of Scemblix was consistent with previous registry studies, with no new safety concerns observed. Relative to imatinib and the second-generation TKI, the Scemblix arm reported a lower incidence of grade ≥3 AEs, dose adjustments due to AEs, or treatment discontinuations due to AEs.

The study is ongoing, with the next data readout scheduled for Week 96 to assess the key secondary endpoint (MMR at Week 96) as well as other secondary endpoints.

Scemblix received its third FDA Breakthrough Therapy designation based on the results of the 48-week data. These data will also be presented to the public in a plenary session at the June 2024 European Hematology Association (EHA) Annual Meeting.

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