This is an international site for TASIGNA® (Nilotinib) and is intended for Health Care Professionals outside the U.S. The information on the site is not country-specific, and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country.

 
explore
 
  • FIRST-LINE DATA

    Aim for a deep molecular response—MR4.51

    With TASIGNA, significantly more patients reached MR4.5 by 3 years and by 5 years, vs imatinib1

    In ENESTnd
     
  • FIRST-LINE DATA

    Patients reached MR4.5 more than 1 year faster with TASIGNA, vs imatinib2

    Median time to achieve MR4.52
    TASIGNA n=282
    3.8 years
    Imantinib n=283
    5.1 years
  • FIRST-LINE DATA

    Patients achieved deeper responses faster with TASIGNA than with imatinib2

    Cumulative Incidence of MR4.52


    Patients treated with imatinib DID NOT CATCH UP to the TASIGNA arm by 6 years2

    Adverse events occurring at ≥10% in patients on TASIGNA: rash, pruritus, dry skin, headache, nausea, fatigue, alopecia, myalgia, constipation, and upper abdominal pain. Most were mild to moderate in severity (grade 1/2).1,2
    ENESTnd is a randomized, controlled, open-label, international, multicenter trial of 846 patients with newly diagnosed Ph+ CML-CP. Patients were randomized to 1 of 2 TASIGNA arms or to imatinib. The primary endpoint was MMR at 12 months.1

  1. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
  2. Larson RA, et al. Blood. 2014;124. Abstract 4541.
 
  • With the TFR clinical trial program for TASIGNA, Novartis continues its commitment to transform the treatment of CML




    Evaluating >1000 adult patients with Ph+ CML and comprising the largest set of global studies assessing TKI discontinuation2-5




    Evaluating >1000 adult patients with Ph+ CML and comprising the largest set of global studies assessing TKI discontinuation2-5

    ENESTfreedom is a single-arm, phase II trial assessing the potential for treatment-free remission in 215 patients with Ph+ CML-CP following frontline nilotinib treatment. The primary efficacy endpoint was the proportion of patients who were in MMR without reinitiation of treatment at week 48 of the TFR phase.

    ENESTop is a single-arm, phase II trial assessing treatment-free remission in 163 patients with Ph+ CML-CP who had switched from imatinib to nilotinib. The primary efficacy endpoint was the proportion of patients with successful TFR at 48 weeks, defined as no loss of MMR or confirmed loss of MR4 (2 consecutive RQ-PCR tests) within the first 48 weeks of TFR.

    ENESTpath is a two-arm, phase II randomized trial of 619 patients with Ph+ CML-CP. The study evaluates the treatment-free remission rate in patients after two different durations of consolidation treatment with nilotinib 300mg BID. The primary efficacy endpoint is the proportion of patients who remain in TFR (≥MR4.0) for ≥ 1 year after nilotinib discontinuation, without molecular relapse, in the nilotinib 12 months consolidation treatment arm versus the nilotinib 24 months consolidation treatment arm.

    ENESTgoal is a phase II randomized multicenter study of treatment-free remission in 59 patients with Ph+ CML-CP who achieve and sustain MR4.5 after switching to nilotinib from imatinib. The primary efficacy endpoint is the percentage of patients remaining in treatment-free remission (no loss of MMR) at 6 months from start of the treatment-free phase.

  • TFR eligibility requirements: TASIGNA first- and second-line patients2




  • FIRST-LINE DATA

    Focus on sustained DMR, a key criterion of TFR eligibility2

    of enrolled first-line TASIGNA patients successfully completed the consolidation phase sustaining DMR for ≥1 year and were eligible to enter the TFR phase.1,2

    ENESTfreedom is a single-arm, phase II trial assessing the potential for treatment-free remission in 215 patients with Ph+ CML-CP following frontline nilotinib treatment. The primary efficacy endpoint was the proportion of patients who were in MMR without reinitiation of treatment at week 48 of the TFR phase.

  • SECOND-LINE DATA

    For those patients who have been switched from imatinib:

    Focus on sustained DMR, a key criterion of TFR eligibility3

    of enrolled second-line TASIGNA patients successfully completed the consolidation phase sustaining DMR for ≥1 year and were eligible to enter the TFR phase.1,3

    ENESTop is a single-arm, phase II trial assessing treatment-free remission in 163 patients with Ph+ CML-CP who had switched from imatinib to nilotinib. The primary efficacy endpoint was the proportion of patients with successful TFR at 48 weeks, defined as no loss of MMR or confirmed loss of MR4 (2 consecutive RQ-PCR tests) within the first 48 weeks of TFR.

  1. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
  2. Hochhaus A, et al. ENESTfreedom Study. Leukemia [published online March 17, 2017]. 2017:1-7. doi:10.1038/leu.2017.63.
  3. Hughes TP, et al. ENESTop Study. ASCO; June 3-7, 2016; Chicago, Illinois. Poster 7054.
  4. Rea D, et al. ASH; December 4, 2016; San Diego, CA. Abstract 3094.
  5. Ritchie EK, et al. Blood. 2015;126:4050.
 
  • FIRST-LINE DATA

    More than half of TASIGNA patients with sustained DMR were able to remain in TFR after stopping therapy1,2

    of patients who met the stringent eligibility criteria to attempt TFR remained in TFR (no loss of MMR) 48 weeks after stopping TASIGNA1,2

    As the prespecified statistical null hypothesis (TFR rate ≤50%) could not be rejected due to the lower limit of the 95% CI being ≤50%, the primary endpoint failed statistically2

    ENESTfreedom is a single-arm, phase II trial assessing the potential for treatment-free remission in 215 patients with Ph+ CML-CP following frontline nilotinib treatment. The primary efficacy endpoint was the proportion of patients who were in MMR without reinitiation of treatment at week 48 of the TFR phase.

  • FIRST-LINE DATA

    Nearly 100% of patients who lost MMR after stopping treatment regained response after promptly re-initiating TASIGNA1,2

    of patients who restarted TASIGNA due to loss of DMR, were able to regain MMR rapidly. 88% of patients (76/86) who lost DMR regained MR4.5 after re-initiation of TASIGNA.1,2

    Eligible patients who discontinue TASIGNA therapy must have their BCR-ABL transcript levels and complete blood count with differential monitored monthly for one year, then every 6 weeks for the second year, and every 12 weeks thereafter. Prompt re-initiation of therapy within 4 weeks is necessary if a patient loses MMR.1

    ENESTfreedom is a single-arm, phase II trial assessing the potential for treatment-free remission in 215 patients with Ph+ CML-CP following frontline nilotinib treatment. The primary efficacy endpoint was the proportion of patients who were in MMR without reinitiation of treatment at week 48 of the TFR phase.

  • SECOND-LINE DATA

    More than half of TASIGNA patients with sustained DMR were able to remain in TFR after stopping therapy1,3

    of patients who the met stringent eligibility criteria to attempt TFR remained in TFR (no loss of MMR or confirmed loss of MR4.0) 48 weeks after stopping second-line TASIGNA1,3

    The study met the primary efficacy endpoint, the proportion of patients with successful TFR at 48 weeks3

    ENESTop is a single-arm, phase II trial assessing treatment-free remission in 163 patients with Ph+ CML-CP who had switched from imatinib to nilotinib. The primary efficacy endpoint was the proportion of patients with successful TFR at 48 weeks, defined as no loss of MMR or confirmed loss of MR4 (2 consecutive RQ-PCR tests) within the first 48 weeks of TFR.

  • SECOND-LINE DATA

    Nearly 100% of patients who lost MR4.0 or MMR after stopping treatment regained molecular responses after promptly re-initiating TASIGNA1,3

    of patients who needed to restart TASIGNA due to loss of MR4.0 (confirmed) or MMR, were able to regain MMR or better.1,3 92.2% (47/51) were able to regain MR4.5.3

    Eligible patients who discontinue Tasigna therapy must have their BCR-ABL transcript levels and complete blood count with differential monitored monthly for one year, then every 6 weeks for the second year, and every 12 weeks thereafter. Prompt re-initiation of therapy is necessary if a patient loses MMR or with confirmed loss of MR4.1

  1. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
  2. Hochhaus A, et al. ENESTfreedom Study. Leukemia [published online March 17, 2017]. 2017:1-7. doi:10.1038/leu.2017.63.
  3. Hughes TP, et al. ENESTop Study. ASCO; June 3-7, 2016; Chicago, Illinois. Poster 7054.