Key clinical point: Frontline nilotinib vs. imatinib therapy showed a positive benefit-risk ratio in Japanese patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukemia (CML-CP) at 10 years of follow-up.
Major finding: At 10 years, a higher proportion of patients achieved major molecular response (MR) and MR4.5 in the 300 mg (86.2% and 65.5%) and 400 mg (78.3% and 69.6%) nilotinib arms compared to the imatinib (60.0% and 48.0%) arm. Cardiovascular adverse events (14.3% and 18.2% vs. 0.0%) were more frequent with 300 and 400 mg nilotinib vs. imatinib.
Study details: Findings are from a 10-year follow-up of a Japanese subgroup of patients with newly diagnosed Ph+ CML-CP from the phase 3 ENESTnd trial randomly assigned to receive either 300 mg nilotinib twice daily (n = 29), 400 mg nilotinib twice daily (n = 23), or 400 mg imatinib once daily (n = 25).
Disclosures: No funding source was identified other than medical writing assistance funded by Novartis Pharma KK. Some investigators, including the lead author, reported being employees of or receiving research support and personal fees from various sources, including Novartis.
Source: Nakamae H et al. Int J Hematol. 2021 Sep 11. doi: 10.1007/s12185-021-03216-5.