More news for ASH meeting

In continuing news from the 53rd annual meeting of the American Society of Hematology (ASH) in San Diego, data from two Phase III clinical trial were presented by Swiss drug major Novartis (NOVN: VX) which contribute to the growing evidence that adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who are treated with the company’s Tasigna (nilotinib) have deeper levels of response compared to those treated with Gleevec (imatinib mesylate) tablets.

ENEST (Evaluating Nilotinib Efficacy and Safety in clinical Trials) cmr is the first exploratory randomized trial to investigate the impact of switching adult patients with residual disease after a minimum of two years of treatment with Gleevec to Tasigna to determine if a deeper level of response could be achieved(1).

The study showed that twice as many patients switched to Tasigna 400mg twice a day achieved undetectable Bcr-Abl levels by 12 months compared to Gleevec (23% taking Tasigna 400mg twice daily and 11% taking Gleevec 400mg or 600mg once daily; p=0.0202). The primary endpoint, which is more stringent than conventional measures, is undetectable Bcr-Abl level in two consecutive samples. Samples with any detectable level were not considered to be in complete molecular response (CMR). The lowest detected Bcr-Abl value was 0.00073%. This endpoint showed a two-fold difference in confirmed undetectable CMR 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.