Long-term results from the ENESTnd trial indicate a favourable risk-benefit profile for frontline use of nilotinib in patients within 6 months of chronic phase-chronic myeloid leukaemia (CP-CML) diagnosis.
"Throughout the study, nilotinib has demonstrated several benefits over imatinib in surrogate endpoints of therapeutic efficacy, such as higher rates of response and lower rates of disease progression, death due to advanced CML and treatment-emergent BCR-ABL mutations", the researchers report in Leukemia.
"The risk of AEs [adverse events] (regardless of AE type) appears to be similar with nilotinib and imatinib; however, each TKI [tyrosine kinase inhibitor] is associated with different types of AEs, including a higher risk of CVEs [cardiovascular events] with nilotinib vs imatinib."
By 5 years, 77.0% of the 282 patients randomly assigned to receive nilotinib 300 mg twice daily and 77.2% of the 281 using nilotinib 400 mg twice daily achieved a major molecular response (BCR-ABL ≤0.1% on the International Scale [BCR-ABLIS]) compared with 60.4% of the 283 patients given imatinib 400 mg once daily.
Deep molecular responses by 5 years were also more common with nilotinib 300 mg and 400 mg than with imatinib, with rates of MR4 (BCR-ABLIS ≤0.01%) of 65.6%, 63.0% and 41.7%, respectively. The corresponding rates for MR4.5 (BCR-ABLIS ≤0.0032%) were 53.5%, 52.3% and 31.4%.
And estimated 5-year progression-free survival was 92.2%, 95.8% and 91.0% for the nilotinib 300 mg and 400 mg groups and the imatinib group, respectively. Overall survival at 5 years was estimated to be 93.7%, 96.2% and 91.7%, respectively.
