On June 7, 2022 Novartis reported longer-term follow-up data from the Phase III ASCEMBL trial for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs), presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Novartis, JUN 7, 2022, View Source [SID1234615712]). In this analysis, the proportion of patients in the Scemblix (asciminib) arm (n=157) who achieved a major molecular response (MMR) at 96 weeks was more than double that in the Bosulif (bosutinib) arm (n=76) (37.6% vs. 15.8% [P=.001]), substantially increasing from previous analyses1,2. Additionally, the probability of maintaining MMR for at least 72 weeks for patients treated with Scemblix was 96.7% (95% CI, 87.4%–99.2%), reflecting long-term durability of efficacy1.
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Despite longer duration of exposure for patients in the Scemblix arm – with a median of 23.7 months vs. 7.0 months for patients in the Bosulif arm – the updated 96-week analysis showed the proportion of patients treated with Scemblix who discontinued treatment due to adverse events (AEs) continued to be more than three times lower than those treated with Bosulif (7.7% vs. 26.3%). No new on-treatment deaths were reported since the primary analysis at 24 weeks1,2.
"In a chronic cancer where resistance can develop to many of the existing therapies, or where patients can have their quality of life negatively impacted by treatment side effects over time, it’s encouraging to see sustained and increasing efficacy with consistent adequate tolerability for patients treated with Scemblix in the longer term," said Jorge E. Cortes, MD, Director, Georgia Cancer Center, Augusta University. "This 96-week data shows the potential of Scemblix and its unique mechanism of action to help change the treatment paradigm in CML."
Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket3. With this novel mechanism of action, it is also known in scientific literature as STAMP inhibitor, Scemblix can help address resistance to TKI therapy in patients with Ph+ CML-CP and overcome mutations at the defective BCR-ABL1 gene, which is associated with the over-production of leukemic cells2,4-10. Scemblix continues to be studied across multiple lines of treatment for CML-CP11-18.
In addition to durable responses consistent with the primary analysis, more patients treated with Scemblix than Bosulif had BCR::ABL1≤1% (45.1% vs 19.4%) at 96 weeks. The most frequent (>10% in any treatment arm) grade ≥3 AEs on Scemblix vs. Bosulif, respectively, were thrombocytopenia (22.4%, 9.2%), neutropenia (18.6%, 14.5%), diarrhea (0%, 10.5%), and increased alanine aminotransferase (0.6%, 14.5%)1. The values for these AEs were similar to the values reported at the 24 and 48 week analyses1,2,19.
"These longer-term results offer a more robust view of the promising potential of Scemblix, and will help support ongoing regulatory filings as we seek to bring this therapy to more patients across the globe," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "As leaders in CML treatment innovation, we believe that with Scemblix, we have the potential to once again transform the standard of care for people affected by this disease."
Visit View Source for the latest information from Novartis at ASCO (Free ASCO Whitepaper), including our bold approach to reimagining cancer care, and access to our ASCO (Free ASCO Whitepaper) data presentations. Additional updates on trials evaluating Scemblix in earlier lines of therapy – as well as for patients with the T315I mutation – will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, with more information available at View Source
About Scemblix (asciminib)
Scemblix (asciminib) is FDA-approved for the treatment of adult patients with Ph+ CML-CP pre-treated with two or more TKIs, as well as adult patients with Ph+ CML-CP with the T315I mutation. The first indication is approved under the US FDA Accelerated Approval Program based on MMR rate at 24 weeks; continued approval for the first indication may be contingent upon verification and description of clinical benefit from confirmatory evidence3.
Scemblix represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies, and it is being studied across multiple treatment lines for CML-CP, both as monotherapy and in combination2,11-18. Specifically, the ASC4FIRST Phase III study (NCT04971226) evaluates Scemblix in newly-diagnosed adult patients with Ph+ CML-CP vs. an investigator-selected TKI, with recruitment proceeding ahead of plan12.
Regulatory reviews for Scemblix in multiple countries and regions across the globe are ongoing. These updated 96-week ASCEMBL results are being shared with regulatory authorities, as we seek to bring Scemblix to more patients in more countries across the globe.