ENEST studies of Tasigna (nilotinib) show superiority to imatinib in PH+CML

ENESTcmr study 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 Glivec (imatinib) to Tasigna (nilotinib) to determine if a deeper level of response could be achieved. The study showed that twice as many patients switched to Tasigna 400 mg twice a day achieved undetectable Bcr-Abl levels by 12 months compared to Glivec (23% taking Tasigna 400 mg twice daily and 11% taking Glivec 400 mg or 600 mg once daily; p= 0.0202>. After 36 months of follow-up, data from the Phase III ENESTnd clinical trial in adult patients with newly diagnosed Ph+ CML in chronic phase continued to show significantly more patients achieved CMR, defined in this study as at least a 4.5 log reduction from baseline or a trace amount of 0.0032% or less of Bcr-Abl compared to Glivec (32% taking Tasigna 300 mg twice daily and 15% taking Glivec 400 mg once daily). The ENESTnd study also continued to show that first-line treatment with Tasigna resulted in significantly fewer patients progressing to advanced phase and blast crisis (AP/BC) stages of disease compared to Glivec, leading to a significantly lower number of CML-related deaths in patients taking Tasigna versus Glivec (p=0.0356).see Hughes TP, Lipton JH, Leber B et al. Complete Molecular Response (CMR) Rate With Nilotinib in Patients (pts) With Chronic Myeloid Leukemia in Chronic Chase (CML-CP) Without CMR After = 2 Years on Imatinib: Preliminary Results From the Randomized ENESTcmr Trial of Nilotinib 400 mg Twice Daily (BID) vs Imatinib. Abstract no. 606. December 12, 2011. see also Saglio G, le Coutre PD, Pasquini R et al. Nilotinib Versus Imatinib in Patients (pts) With Newly Diagnosed Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTnd 36-month (mo) Follow-up. Abstract no. 452. December 12, 2011.