Novartis 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 Phase III ASC4FIRST study (NCT04971226) were released in a late-breaking abstract and will be presented at the American Society of Clinical Oncology (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 Pfizer’s Bosulif (bosutinib), Bristol Myers Squibb’s Sprycel (dasatinib) and Novartis’ Gleevec/Glivec (imatinib) and Tasigna (nilotinib). 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 adverse event (AE) rates of 38% for Grade 3 or worse adverse events, compared to the 55% and 44% AE rates in the Gleevec monotherapy and investigator-selected SoC groups, respectively.

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Scemblix is a tyrosine kinase inhibitor that blocks a BCR-ABL tyrosine kinase protein found in CML cells and stops cell growth and multiplication. In 2021, it received accelerated approval from the US Food and Drug Administration (FDA) as a third-line therapy for patients with Ph+ CML in the chronic phase.

Novartis plans to submit the data from the trial to the FDA via the agency’s Oncology Center of Excellence Real-Time Oncology Review (RTOR) programme. The company reported $136m in sales for Scemblix in Q1 this year, with GlobalData expecting the therapy to pull in approximately $2.4bn by 2030.

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