has released positive data from the Phase III ASC4FIRST trial showing that its tyrosine kinase inhibitor (TKI) therapy Scemblix (asciminib) is more effective than the current standard of care (SoC) therapies as a first-line treatment for Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML). The results from the open-label (NCT04971226) were released in a late-breaking abstract and will be presented at the (ASCO) Annual Meeting today. The conference, which started today is taking place in Chicago, US, until 4 June.
The trial met its primary endpoint with the Scemblix arm demonstrating a superior major molecular response (MMR) rate of 67.7% at week 48, compared to a 49% MMR rate with an investigator-selected SoC tyrosine kinase inhibitors (TKIs) such as ’s ), ’s and Novartis’ Gleevec/Glivec (imatinib) and . The therapy also showed an MMR rate of 69.
3% at 48 weeks, compared to an MMR of 40.2% with Gleevec. “Scemblix is the first CML treatment to show significantly better efficacy compared to investigator-selected standard-of-care TKIs,” said Dr Tim Hughes, South Australian Health & Medical Research Institute (SAHMRI), in the company announcement accompanying the results.
“When you combine superior response with the excellent safety and tolerability profile of Scemblix, we have a very promising potential frontline option for newly diagnosed patients to support them in achieving their treatment goals.” The Scemblix patient group also observed lower .
