ASH 2020: Achieving Molecular Response With Nilotinib or Dasatinib in Chronic-Phase CML
Posted: Monday, December 7, 2020
According to Itaru Matsumura, MD, PhD, of the Kindai University Faculty of Medicine, Osakasayama, Japan, and colleagues, the tyrosine kinase inhibitors nilotinib and dasatinib seem to be equally effective in achieving molecular response 4.5 in patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML). The results of the multicenter phase III JALSG CML212 trial were presented during the virtual edition of the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 45).
Patients were randomly assigned to receive nilotinib or dasatinib, with 227 patients per arm. The most frequently reported grade 3 to 4 adverse events were lipase elevation (11.5%) in the nilotinib arm and neutropenia (12.8%) and thrombocytopenia (16.8%) in the dasatinib arm.
In the intention-to-treat population, the cumulative achievement rate of molecular response 4.5 seemed to be higher with nilotinib than with dasatinib at 18 months (33% vs. 30.8%, respectively; P = .62); this also seemed to be true in the per-protocol population (33.5% vs. 31.8%, respectively; P = .72). At 36 months, the progression-free survival, event-free survival, and overall survival rates were 98.8%, 67.2%, and 98.8% with nilotinib and 99%, 65.4%, and 99% with dasatinib, respectively; they did not seem to significantly differ between the arms.
The cumulative complete cytogenetic response rates at 12, 18, 24, and 36 months were 77.1%, 78%, 78.4%, and 78.4% with nilotinib and 78.4%, 78.9%, 78.9%, and 78.9% with dasatinib, respectively. At 12, 18, 24, and 36 months, the major molecular response rates were 62.6%, 67%, 72.3%, and 73.1% with nilotinib and 68.7%, 73.1%, 75.3%, and 77.1% with dasatinib, respectively. The achievement rates of molecular response 4.5 at 12, 24, and 36 months were 25.6%, 37.4%, and 40.5% with nilotinib and 23.4%, 36.6%, and 44.5% with dasatinib, respectively. Of note, the rates of cumulative complete cytogenetic response, major molecular response, and molecular response 4.5 did not seem to significantly differ between the arms.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.