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On October 29, 2024, the Food and Drug Administration approved asciminib (Scemblix, Novartis AG) for adults who have just been diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP).
The effectiveness of asciminib for newly diagnosed Ph+ CML in chronic phase was assessed in ASC4FIRST (NCT04971226), a multicenter, randomized, active-controlled, open-label study. A total of 405 patients were randomized in a 1:1 ratio to receive either asciminib or investigator-selected tyrosine kinase inhibitors (IS-TKIs), including imatinib, nilotinib, dasatinib, or bosutinib.
The primary effectiveness endpoint was the major molecular response (MMR) rate at 48 weeks. At 48 weeks, the MMR rate was 68% (95% CI: 61, 74) in the asciminib group and 49% (95% CI: 42, 56) in the IS-TKIs group, resulting in a difference of 19% (95% CI: 10, 28), with a p-value of <0.001. In the imatinib cohort, the MMR rate was 69% (95% CI: 59, 78) for the asciminib group and 40% (95% CI: 31, 50) for the IS-TKIs group, resulting in a difference of 30% (95% CI: 17, 42, p-value <0.001).
Patients with newly diagnosed and previously treated Ph+ CML in chronic phase experienced the most prevalent adverse events (≥20%), including musculoskeletal pain, rash, exhaustion, upper respiratory tract infection, headache, abdominal discomfort, and diarrhea.
The predominant laboratory abnormalities (≥40%) in patients with newly diagnosed Ph+ CML in chronic phase included reduced lymphocyte count, reduced leukocyte count, reduced platelet count, reduced neutrophil count, and decreased corrected calcium levels.
The advised dosage of asciminib is 80 mg administered orally once daily at a consistent time or 40 mg taken orally twice daily at approximately 12-hour intervals.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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