Novartis' Tasigna better than Gleevec in Ph+ CML
Last Updated: 2011-12-13 19:25:15 -0400 (Reuters Health)
ZURICH (Reuters) - Novartis's blood cancer drug Tasigna (nilotinib) is more effective at treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase than the Swiss drugmaker's older drug Gleevec (imatinib), new data show.
The data, presented at the American Society of Hematology's annual meeting, are from the Phase III ENESTcmr trial, which looked at the impact of switching adult patients with residual disease after a minimum of two years of treatment with Gleevec to Tasigna to see if a deeper level of response could be reached.
The results showed that twice as many patients switched to Tasigna 400 mg twice a day achieved undetectable Bcr-Abl levels by 12 months compared to Gleevec (23% taking Tasigna 400 mg twice daily and 11% taking Gleevec 400 mg or 600 mg once daily; p= 0.0202).
The primary endpoint, which the company said in a statement "is more stringent than conventional measures," was undetectable Bcr-Abl level in two consecutive samples. This endpoint showed a two-fold difference in confirmed undetectable complete metabolic response for 13% of patients on Tasigna versus 6% of patients on Gleevec, although statistical significance was not achieved (p=0.108). The study has a planned follow-up of four years.
Meanwhile follow-up data from the ENESTnd trial after 36 months showed that Tasigna was better at slowing progression of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia than Gleevec.
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