Phase 3 study of Tasigna for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)

Novartis announced new 24-month data from its Phase 3 trial comparing Tasigna (nilotinib) 150mg capsules to Gleevec (imatinib mesylate, from Novartis) tablets in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), a randomized, open-label, multicenter study, showed that first-line treatment with Tasigna 300mg twice daily was found to result in a lower incidence of progression to accelerated phase and blast crisis, compared to the standard approved dose of Gleevec 400mg once daily.

Tasigna induced deeper and more durable complete cytogenetic response (CCyR) and major molecular response (MMR) compared to Gleevec. Rates of MMR and CCyR remain statistically higher for Tasigna versus Gleevec at the 24-month minimum follow-up. MMR was achieved by 71% of patients taking Tasigna 300mg twice daily and 67% of patients taking Tasigna 400mg twice daily, compared to 44% of patients taking Gleevec by 24 months. Durable MMR rates were statistically significantly higher in the Tasigna 300mg twice daily and Tasigna 400mg twice daily arms compared to Gleevec 400mg once daily (42%, 39% and 21% respectively). Significantly more patients achieved CCyR in the Tasigna 300mg and 400mg arms compared to the Gleevec arm at 87% and 85% vs. 77% respectively by 24 months. The data also showed that Tasigna demonstrated a significantly higher rate of an even deeper response (compared to Gleevec) – a trace amount of 0.0032% or less of the Bcr-Abl protein that causes Ph+ CML, which is considered a complete molecular response (CMR). Fewer patients taking Tasigna in the study discontinued treatment due to adverse events compared to Gleevec. Patients receiving Tasigna also had a lower incidence of suboptimal response and treatment failure as defined by study criteria.

Tasigna is a potent and selective (kinase) inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML. Tasigna is already approved for newly diagnosed adults with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna is also approved for chronic and accelerated phase Ph+ CML in adults resistant or intolerant to imatinib.

For more information call (800) 693-9993 or visit www.tasigna.com.