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Novartis Scemblix shows long-term efficacy and tolerability in 96-week follow-up of chronic myeloid leukemia trial

Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket3. It is also known in scientific literature as STAMP inhibitor.

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Additionally, more patients treated with Scemblix than Bosulif had BCR::ABL1≤1% (45.1% vs 19.4%) at 96 weeks. (File)

Novartis announced on Wednesday its 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) Annual Meeting.

According to the pharma major’s press statement, during the 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, the company claims.

“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,” the company stated in its press statement on Thursday.

“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. This 96-week data shows the potential of Scemblix and its unique mechanism of action to help change the treatment paradigm in CML,” said Jorge E. Cortes, MD, Director, Georgia Cancer Center, Augusta University.

Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket3. It is also known in scientific literature as STAMP inhibitor. According to Novartis, 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.

Additionally, 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,” the company claims.

“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. 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,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis.

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