publication date: Jan. 2, 2015

Tasigna Shows High Response, PFS Benefit Compared to Gleevec in Phase III CML Study


Six-year results from the randomized phase III ENESTnd study continued to show higher rates of early, deep and sustained molecular responses when using Tasigna (nilotinib) compared to Gleevec (imatinib mesylate) in newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.

The data also demonstrated a reduced risk of progression compared to Gleevec. The update was presented at the annual meeting of the American Society of Hematology in San Francisco.

The difference in the rates of MR4.5 showed continued improvement for both Tasigna 300 mg and 400 mg twice-daily arms compared to Gleevec (MR4.5: 6-10 percent difference by one year, 22-23 percent difference by six years). MR4.5 represents an extremely low level of detectable BCR-ABL protein, the cause of Ph+ CML (measured in the blood at 0.0032 percent or less on a standardized international scale).

A higher proportion of patients in the Tasigna arms versus the Gleevec arm achieved BCR-ABL(IS) greater than or equal to 10 percent at three months.

Further, there were fewer progressions to accelerated phase/blast crisis with Tasigna versus Gleevec. Sixteen patients treated with Gleevec had CML-related deaths, compared to six and four patients on the Tasigna 300 mg and 400 mg twice-daily arms, respectively.

The estimated rates of patients whose disease did not progress to AP/BC on study at 72 months in the Gleevec, Tasigna 300 mg and Tasigna 400 mg twice-daily arms were 92.2, 95.8 and 97.8 percent, respectively.

The estimated overall survival rates at 72 months in the Gleevec, Tasigna 300 mg and Tasigna 400 mg twice-daily arms were 91.4, 91.6 and 95.8 percent, respectively.

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