Key clinical point: In 10-year follow-up of ENESTnd trial , nilotinib demonstrated benefits over imatinib for various clinical outcomes in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) .
Major finding: Cumulative 10-year rates of treatment-free remission eligibility and molecular response rate with nilotinib 300 mg and 400 mg vs. imatinib was 48.6% and 47.3% vs. 29.7% and 77.7% and 79.7% vs. 62.5%, respectively. Progression to accelerated (6 and 4 vs. 11) or blast (6 and 6 vs. 14) phase was lower with nilotinib 300 mg and 400 mg vs. imatinib, respectively. Overall, the frequency of adverse events was similar, but r ates of cardiovascular events were higher with nilotinib.
Study details: ENESTnd, a phase 3 study, randomly allocated patients with newly diagnosed CML-CP to receive nilotinib 300 mg twice daily (n=282), nilotinib 400 mg twice daily (n=281), or imatinib 400 mg once daily (n=283).
Disclosures: The study was funded by Novartis Pharmaceuticals Corporation. The presenting author reported ties with Pharmaceuticals companies including Novartis. Some of the study investigators reported being an employee of, receiving grants, honoraria, support, and/or consulting for Novartis and other pharmaceutical companies.
Source: Kantarjian HM et al. Leukemia. 2021 Jan 7. doi: 10.1038/s41375-020-01111-2 .