Novartis’ Scemblix® shows promise in pivotal phase III trial for newly diagnosed CML patients

Novartis has reported successful outcomes for Scemblix® (asciminib) in its pivotal Phase III ASCFIRST trial, a head-to-head comparison for newly diagnosed patients with Philadelphia chromosome-positive CML (Ph+ CML-CP).

Given that over 60% of newly diagnosed CML patients fail to achieve treatment goals within a year, the study’s results offer significant promise for the CML community.

Scemblix demonstrated superior major molecular response rates (MMR) at week 48 compared to standard-of-care tyrosine kinase inhibitors (TKIs) in newly diagnosed Ph+ CML-CP patients. Additionally, Scemblix exhibited a favorable safety and tolerability profile, with fewer adverse events (AEs) and treatment discontinuations than standard-of-care TKIs.

Prof. Tim Hughes, MD, South Australian Health & Medical Research Institute (SAHMRI), said: “We are very encouraged by these results given that a significant proportion of patients with newly diagnosed chronic myeloid leukemia, or CML, do not achieve their treatment goals. There remains a significant need in first-line therapy of CML for tolerable treatment options, allowing people with CML to balance their treatment alongside their quality of life.”

The trial remains ongoing, with the next scheduled data readout planned for week 96, which will evaluate the key secondary endpoint (MMR at week 96) as well as additional secondary endpoints.