Nilotinib Appears Superior to Imatinib in Newly Diagnosed Chronic Myeloid Leukaemia Patients: Presented at ASH
By Ed Susman
NEW ORLEANS -- December 8, 2009 -- Nilotinib appears to outperform imatinib -- the first targeted agent to control and achieve widespread cytogenetic responses in patients with chronic myeloid leukaemia -- according to data presented here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition.
“The superior efficacy and favourable tolerability profile of nilotinib compared with imatinib suggests that nilotinib may become the standard of care in newly diagnosed chronic myeloid leukaemia,” said Giuseppe Saglio, MD, University of Turin, Turin, Italy, during a late-breaker session here today.
Dr. Saglio and colleagues in the Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd) study recruited 846 patients with chronic myeloid leukaemia and randomised them to 1 of 3 treatment arms: (1) nilotinib 300 mg twice a day (n = 282); (2) nilotinib 400 mg twice a day (n = 281); or (3) imatinib 400 mg once daily (n = 283).
After 1 year of treatment, the rates of major molecular response -- the primary endpoint of the study -- were superior for treatment with both arms of nilotinib compared with imatinib.
Dr. Saglio said that about 44% of patients taking nilotinib 300 mg twice a day achieve the major molecular response criteria after 1 year compared with 22% of imatinib patients (P < .001) About 43% of patients taking nilotinib 400 mg twice a day achieved a major molecular response, also statistically superior to imatinib (P < .001).
“The median time to a major molecular response among patients who achieved that response was faster for nilotinib 300 mg twice a day [5.7 months] and nilotinib 400 mg twice a day [5.8 months] compared with imatinib 400 mg once a day,” he said. Those patients did not achieve the major molecular response until a mean of 8.3 months had passed, he said.
Major molecular response was defined as a value of <=0.1% of BCR-ABL/ABL ratio on the International Scale.
The major secondary endpoint was rate of complete cytogenetic response by 12 months based on bone marrow cytogenetics, Dr. Saglio said, and the results followed the same pattern. At 12 months, 80% of patients on nilotinib 300 mg twice a day and 78% of patients taking 400 mg of nilotinib twice a day had achieved that landmark compared with 65% of those patients taking imatinib (P = .0005).
Both drugs are inhibitors of BCR-ABL, the only proven molecular target for chronic myeloid leukaemia.
Overall, 84% of the patients on nilotinib 300 mg twice a day and 82% of the patients on nilotinib 400 mg twice a day and 79% of the patients on imatinib once daily remained on treatment through the study period.
Rates of discontinuation due to adverse events or laboratory abnormalities were 7% for nilotinib 300 mg twice a day, 11% for nilotinib 400 mg twice a day, and 9% for imatinib 400 mg once a day.
Funding for this study was provided by Novartis Pharma AG.
[Presentation title: Nilotinib Demonstrates Superior Efficacy Compared With Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase: Results From the International Randomized Phase III ENESTnd Trial. Abstract LBA-1]
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