2101, a Trial of TASIGNA in Imatinib-Resistant or -Intolerant Patients With Chronic or Accelerated Phase Ph+ CML1

Study 2101 demonstrates second-line Tasigna efficacy following imatinib1

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. Resistance to imatinib included failure to achieve complete hematologic response by 3 months, cytogenetic response by 6 months, or 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 chronic phase patients was MCyR.1,2

Tasigna Chronic and Accelerated Phase in CML

BID, twice a day; CHR, complete hematologic response; CyR, cytogenetic response; HR, hematologic response; Ph+, Philadelphia chromosome-positive.

  1. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
  2. Cortes JE, et al. Blood. 2011;117(21):5600-5606.
  3. Kantarjian HM et al. Blood. 2011;117(4):1141-1145.