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SWITCHING TO TASIGNA

Switching to TASIGNA can help patients reach MMR faster¹

The ENESTcmr study compared switching to TASIGNA 400 mg bid with remaining on imatinib in patients who had achieved a complete cytogenetic response (CCyR) but still had persistent BCR-ABL positivity by real-time quantitative polymerase chain reaction (RT-Q-PCR) after ≥2 years on imatinib. In this study, switching to TASIGNA doubled the percentage of patients who achieved MMR vs remaining on imatinib.

ENESTcmr study design: A randomized trial evaluating the potential benefit of switching Ph+ CML-CP patients with detectable BCR-ABL transcripts after ≥2 years on imatinib (N=207) to TASIGNA. Patients were randomized to receive TASIGNA 400 mg bid (n=104) or continue their imatinib 400-mg or 600-mg qd dose (n=103). The primary endpoint was confirmed undetectable BCR-ABL by RT-Q-PCR with a sample sensitivity of ≥4.5 logs in 2 consecutive samples (complete molecular response [CMR]) by 12 months.

After switching to TASIGNA, twice as many patients achieved the deepest molecular response¹

Ph+ CML patients who switched to TASIGNA 400 mg bid experienced faster rates of MR^4.5 compared with those who remained on imatinib. By 12 months, the rate of MR^4.5 was 33% for TASIGNA and 16% for imatinib.

In the 2101 study, TASIGNA proved tolerable in pretreated imatinib patients²

2101 study design: A large, open-label, multicenter registration trial in imatinib-resistant or -intolerant patients with separate treatment arms for CP (n=321) and AP (n=137) disease. Resistance to imatinib included failure to achieve complete hematologic response (CHR) by 3 months, cytogenetic response (CyR) by 6 months, or major cytogenetic response (MCyR) by 12 months, or progression of disease after a previous cytogenetic or hematologic response. Imatinib-intolerant patients had discontinued imatinib because of toxicity and were not in MCyR at the time of study entry. The primary endpoint in CP patients was MCyR.³

In the 2101 study, patients who discontinued imatinib due to intolerance were unlikely to experience the same AEs on TASIGNA 400 mg bid.²

The ENACT study confirms the favorable safety and tolerability profile of TASIGNA⁴

With 1422 CP patients, ENACT is the world’s largest study of any available tyrosine kinase inhibitor (TKI) in patients with imatinib-resistant or -intolerant Ph+ CML. In this study, TASIGNA 400 mg bid demonstrated a favorable safety and tolerability profile, with infrequent discontinuation due to AEs (4%). Furthermore, most Grade 3/4 AEs could be managed either by temporarily interrupting treatment or by adjusting the dose.

ENACT study design: A Phase lllb, open-label, multicenter study that evaluated the efficacy and safety of TASIGNA in 1603 adult patients with imatinib-resistant or -intolerant CML-CP (n=1422) or AP (n=181) in a clinical practice setting outside of a registration program. Data from ENACT are used to characterize the patterns and management of AEs in patients receiving TASIGNA 400 mg bid.

Important safety information

• TASIGNA can increase the QT interval, which may expose patients to the risk of a fatal outcome
• TASIGNA should be used with caution in patients who have or are at risk of developing QT prolongation
• Concomitant use of strong CYP3A4 inhibitors or other drugs that can prolong the QT interval should be avoided with TASIGNA
• TASIGNA should not be taken with food, and ECGs are recommended prior to initiating therapy and as clinically indicated

*Missing information on imatinib-resistant/intolerant status for one patient.

References:
1. Cervantes C, Hughes T, Etienne G, et al. Nilotinib induces deeper molecular responses vs continued imatinib in patients with Ph+ chronic myeloid leukemia (CML) with detectable disease after ≥2 years on imatinib: ENESTcmr 12-month results [EHA abstract 0586]. Haematologica. 2012;97(suppl 1):239.
2. Cortes JE, Hochhaus A, le Coutre PD, et al. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011;117(21):5600-5606.
3. TASIGNA^® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; September 2012.
4. le Coutre PD, Ceglarek B, Turkina A, et al. Patterns and management of selected adverse events of adult patients with imatinib-resistant or -intolerant chronic myeloid leukemia (CML) from the ENACT (expanding nilotinib access in clinical trials) study. Blood. 2009;114(22):Abstract 1115.