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Home > Efficacy

EMR | MR4.5 | Disease Control | Second-line Switch | TFR

Frontline Efficacy

Start TASIGNA for the confidence of early molecular response (EMR)

More than 9 out of 10 patients achieved EMR with  
TASIGNA® (nilotinib) capsules, a predictor of long-term benefit1

An image illustrating EMR at 3 months for TASIGNA and imatinib in ENESTnd.
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TASIGNA delivers the deep responses that matter

 

More than half of patients receiving TASIGNA achieved MR4.5 by 5 years2,3

  • MR4.5 was achieved faster with TASIGNA: median of 3.8 years with TASIGNA vs 5.1 years with imatinib4

  • Higher rates of MR4.5 with TASIGNA irrespective of Sokal risk score3

An image illustrating the cumulative incidence rate of MR4.5 for TASIGNA and imatinib in ENESTnd.
Trust TASIGNA for deep responses.
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TASIGNA delivers improved long-term outcomes for your patients

Fewer patients progressed with TASIGNA vs imatinib, regardless of molecular response3

An image illustrating progressions to AP/BC by 5 years with TASIGNA and imatinib in ENESTnd.
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Second-line switch

Switch to TASIGNA for deeper responses when imatinib can’t deliver

More patients rapidly achieved MR4.5 with switch to TASIGNA2

  • By 1 year, TASIGNA delivered a 13% rate of confirmed undetectable BCR-ABL1 vs 6% with imatinib2

  • By 2 years, TASIGNA delivered significantly higher rates of confirmed undetectable BCR-ABL1 vs imatinib (22% vs 9%; P=0.0087)7

This difference was not significant (P=0.1083), and as a result, the study did not meet its primary end point.

Undetectable BCR-ABL1 was defined as undetectable based on RQ-PCR with a sample sensitivity of ≥4.5 logs below standardized baseline, and confirmed in next RQ-PCR sample with a sensitivity of ≥4 logs below baseline.7

An image illustrating cumulative incidence of MR4.5 in TASIGNA and imatinib in ENESTcmr.

Analysis includes patients without MR4.5 at study start, excluding responses achieved after crossover.

Switching to TASIGNA delivered deeper responses after imatinib warning response2

ENESTcmr response rates in patients who did not achieve MMR with imatinib
ENESTcmr response rates in patients who did not achieve MMR with imatinib
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TFR benefits

Start with TASIGNA for the opportunity to achieve TFR

Treatment-free remission offers a variety of potential benefits for patients8

Treatment-free Remission

Many international and local clinical guidelines, including ESMO (2017), recognized treatment-free remission as a treatment goal9

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TASIGNA is the only TKI with TFR data in label

TFR with TASIGNA is being evaluated in the largest set of global studies, with rigorous protocols and >1000 patients10-14

An image illustrating the studies where TFR was evaluated with TASIGNA.

*Data not available yet.

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ENESTfreedom results

Phase 1

ENESTfreedom results: TFR with TASIGNA in newly diagnosed patients

An image illustrating ENESTfreedom results with TASIGNA.
Trust TFR when you start with TASIGNA: No progressions to AP/BC at 144 weeks.

Overall AE rates decrease over time during TFR following TASIGNA treatment6

Close monitoring is an important requirement of TFR. Prompt reinitiation  
of therapy is necessary if a patient loses MMR or with confirmed loss of MR4.02

Definition of TFR eligibility: Patients entered the TFR phase after sustaining DMR during the consolidation phase of the trial. Patients with MR4.5 in their last assessment, no assessment worse than MR4.0, and 2 assessments between MR4.0 and MR4.5 were eligible to enter the TFR phase and stop treatment with TASIGNA.2,10

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Routine monitoring is critical throughout treatment with TASIGNA

Monitor patients regularly during therapy with a quality, accurate RQ-PCR test to ensure they are responding to TKI therapy and achieving disease control

An image illustrating that the RQ-PCR test is a quality, accurate way to ensure patient’s response to TKI therapy.

Frequency of monitoring depends on depth of response to therapy16,17

Frequency of Monitoring

Monitor patients in TFR according to on-label criteria

on label
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Reinitiating treatment

An image illustrating prompt reinitiation of treatment with TASIGNA if loss of response occurs in TFR.

*Or loss of confirmed MR4, for patients who were previously treated with imatinib.
†If patient does not regain MMR after 3 months of TKI reinitiation, perform BCR-ABL1 kinase domain mutation testing and continue monthly molecular monitoring for another 6 months.17

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TASIGNA Clinical Studies

ENESTnd

Evaluating Nilotinib Efficacy and Safety in Clinical Trials (ENEST)-Newly Diagnosed patients (ENESTnd) is a randomized, controlled, open-label, multicenter Phase 3 trial of 846 adult patients with newly diagnosed Ph+ CML-CP. Patients were randomized to receive either TASIGNA 400 mg bid (n=281), TASIGNA 300 mg bid (n=282), or imatinib 400 mg qd (n=283). The daily dose of imatinib could be escalated to 800 mg (400 mg bid), but no dose escalation was permitted with TASIGNA. A centralized laboratory was used for RQ-PCR testing. The primary end point was MMR at 12 months. MMR was defined as ≥3 logs below baseline (≤0.1% IS) as measured by RQ-PCR assay. Patients who did not undergo RQ-PCR assessment at 12 months were considered to have had no response.3

ENESTcmr

ENEST-Complete Molecular Response (ENESTcmr) is a 48-month, open-label, randomized, Phase 3 study investigating whether 207 patients with CML-CP who achieved a complete cytogenetic response (CCyR) but were still BCR-ABL positive by RQ-PCR after ≥24 months on imatinib could achieve deeper molecular responses by switching to nilotinib 400 mg twice daily (n=104) vs imatinib 400 mg or 600 mg QD (n=103). The primary end point was the rate of confirmed best cumulative CMR by 12 months of study with nilotinib or imatinib. The study also explored the impact of the achieved CMR on patient outcomes such as progression free survival, event free survival, and overall survival.18

ENESTfreedom

ENESTfreedom is a single-arm, Phase 2 trial assessing the potential for treatment-free remission in 215 patients with Ph+ CML-CP following frontline nilotinib treatment. The primary efficacy end point was the proportion of patients who were in MMR without reinitiation of treatment at week 48 of the TFR phase. ENESTfreedom is the largest frontline TFR study for TASIGNA (n=190 entered TFR phase) and the second-largest frontline CML study overall.10

ENESTop

ENESTop is a single-arm, Phase 2 trial assessing treatment-free remission in 163 patients with Ph+ CML-CP who had switched from imatinib to nilotinib. The primary efficacy end point 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. ENESTop is the largest prospective TFR study in patients who switched to TASIGNA from imatinib (n=126 entered the TFR phase).11

MR, molecular response; AP, accelerated phase; BC, blast crisis; RQ-PCR, real-time quantitative polymerase chain reaction; MMR, major molecular response; AE, adverse event; TKI, tyrosine kinase inhibitors; QoL, quality of life; ESMO, European Society for Medical Oncology; TFR, treatment-free remission; DMR, deep molecular response; IS, International Scale.

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References: 1.  Hughes TP, Saglio G, Kantarjian HM, et al. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014;123(9):1353-1360. 2. Habucky K, Duverger B, Kreft R, Kozlovsky V. TASIGNA® (nilotinib) 50 mg, 150 mg and 200 mg hard capsules core data sheet, version 1.8. West Sussex, United Kingdom: Novartis Europharm Limited; 2016:1-54. 3. Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016;30(5):1044-1054. 4. Larson RA, Kim D-W, Issaragrilsil S, et al. Efficacy and safety of nilotinib (NIL) vs imatinib (IM) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): long-term follow-up (f/u) of ENESTnd. Blood. 2014;124(21):4541. 5. Hughes TP, Larson RA, Kim D-W, et al. Efficacy and safety of nilotinib vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase: 6-year follow-up of ENESTnd. Presented at: European Hematology Association annual meeting; June 12, 2015; Vienna, Austria. Abstract P228. 6. Data on file. Study CAMN107A2303. Novartis Pharmaceuticals Corp; 2014. 7. Hughes T, Lipton J, Spector N, et al. Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib. Blood. 2014;214(5):729-736. 8. Saglio G, Sharf G, Almeida A, et al. Considerations for treatment-free remission in patients with chronic myeloid leukemia: a joint patient-physician perspective. Clin Lymphoma Myeloma Leuk. 2018;18(6):375-379. 9. Hochhaus A, Saussele S, Rosti G, et al; ESMO Guidelines Committee. Chronic myeloid leukaemia: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl 4):iv41-iv51. 10. Hochhaus A, Masszi T, Giles FJ, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study. Leukemia. 2017;31(7):1525-1531. 11. Mahon F-X, Boquimpani C, Kim D-W, et al. Treatment-free remission after second-line nilotinib treatment in patients with chronic myeloid leukemia in chronic phase: results from a single-group, phase 2, open-label study. Ann Intern Med. 2018;168(7):461-470. 12. Rea D, Rosti G, Cross NCP, et al. ENESTpath: a phase III study to assess the effect of nilotinib treatment duration on treatment-free remission (TFR) in chronic phase-chronic myeloid leukemia (CP-CML) patients (pts) previously treated with imatinib: interim analysis from the first year of induction phase. Blood. 2015;126(23):4040. 13. Ritchie EK, Catchatourian R, Klisovic RB, et al. Rapid achievement of MR4.5 after switching from imatinib (IM) to nilotinib (NIL) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): preliminary results from ENESTgoal. Blood. 2015;126:4050. 14. Hughes TP, Ross DM. Moving treatment-free remission into mainstream clinical practice in CML. Blood. 2016;128(1):17-23. 15. Radich JP, Masszi T, G’omez Casares MT, et al. ENESTfreedom 144-week update: long-term treatment-free remission (TFR) following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase (CML-CP). Clin Lymphoma Myeloma Leuk. 2018;18(suppl1):S226. 16. Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013;122(6):872-884. 17. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia V.3.2020. ©National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 11, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 18. Hughes TP, Leber B, Cervantes F. Sustained deep molecular responses in patients switched to nilotinib due to persistent BCR-ABL1 on imatinib: final ENESTcmr randomized trial results. Leukemia. 2017;31:2529-2531.

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