Key clinical point: Asciminib, a first-in-class STAMP inhibitor, may be a new treatment option for patients with chronic myeloid leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosine kinase inhibitors.
Major finding: Major molecular response rate at 24 weeks was 25.5% with asciminib and 13.2% with bosutinib (BOS). The between-arm common treatment difference after adjustment for major cytogenetic response status at baseline was 12.2% (2-sided P = .029). Patients treated with asciminib were also twice as likely to achieve a deep molecular response. Grade 3 or greater adverse events were reported in 50.6% and 60.5% of patients receiving asciminib and BOS, respectively.
Study details: In this phase 3 ASCEMBL trial, 233 patients with CML-CP previously treated with 2 or more TKIs were randomly assigned (2:1) to receive asciminib 40 mg twice daily or BOS 500 mg once daily (median follow-up duration, 14.9 months).
Disclosures: The study is sponsored by Novartis. Some of the investigators reported ties with pharmaceutical companies, including Novartis.
Source: Hochhaus A et al. ASH Annual Meeting and Exposition 2020. Abstract LBA-4 .