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
BID, twice a day; CHR, complete hematologic response; CyR, cytogenetic response; HR, hematologic response; Ph+, Philadelphia chromosome-positive.
- TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
- Cortes JE, et al. Blood. 2011;117(21):5600-5606.
- Kantarjian HM et al. Blood. 2011;117(4):1141-1145.