Switch to TASIGNA resulted in responses in patients with imatinib-resistant or imatinib-intolerant Ph+ CML-CP1,2

The primary study endpoint was the proportion of patients achieving major cytogenetic response (CyR). All patients were followed for > 24 months or discontinued early.2

Response rates after switch to TASIGNA 400 mg bid2

Response rates after switch to TASIGNA 400 mg bid

TASIGNA Deep Responses in the Second-line

24 Months

48 Months

  • Of patients achieving CCyR, 56% achieved MMR2
  • 87% overall survival at 24 months2
  • 48% of evaluable patients achieved BCR-ABLIS ≤10% at 3 months after switching to TASIGNA3
  • Patients with deeper responses at 3 and 6 months had the longest median PFS and OS at 48 months4
  • 4-year overall survival was nearly 80% after switch to TASIGNA4

BID, twice a day; CCyR, complete cytogenetic response; MCyR, major cytogenetic response; MMR, major molecular response; Ph+ CML-CP, Philadelphia-positive chronic myeloid leukemia chronic phase; QD, once a day; MR4.5, molecular response 4.5-logs below baseline.

The 2101 study was a large, open-label, registration trial in imatinib-resistant or -intolerant patients with separate treatment arms for chronic phase (n=321) and accelerated phase (n=137) disease. Imatinib-intolerant patients had discontinued imatinib because of toxicity and were not in MCyR at the time of study entry. The primary endpoint in chronic phase patients was MCyR.

  1. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
  2. Kantarjian HM et al. Blood. 2011;117(4):1141-1145.
  3. Branford S, et al. J Clin Oncol. 2012;30(35):4323-4329.
  4. Giles FJ et al. Leukemia. 2013;27(1):107-112.