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NEWLY DIAGNOSED PATIENTS
Significantly fewer TASIGNA-treated patients progressed to accelerated phase/blast crisis (AP/BC) vs imatinib1-3
>99% of TASIGNA-treated patients remained free from progression to AP/BC1
Fewer TASIGNA-treated patients died of Ph+ CML, and the estimated overall survival (OS) rate at 24 months for the TASIGNA 300-mg-bid group was 97.4% vs 96.3% with imatinib 400 mg qd.1
TASIGNA remains significantly superior over 2 years vs imatinib on CCyR, MMR, and CMR1-3
In the 24-month follow-up of ENESTnd, TASIGNA maintained significantly superior complete cytogenetic response (CCyR) rates, with 87% of TASIGNA patients achieving CCyR by 24 months vs 77% with imatinib (P=0.0018).1 TASIGNA also maintained significantly superior MMR rates vs imatinib, which showed no signs of catching up between 12 and 24 months.2
TASIGNA sustained significant superiority in MMR rates vs imatinib through 24 months1
*MMR was defined as ≤0.1% BCR-ABL/ABL by international scale (IS) measured by RQ-PCR, which
corresponds to a ≥3-log reduction of BCR-ABL transcripts from standardized baseline.3
TASIGNA achieved significantly higher CMR rates by 24 months vs imatinib1
†Complete molecular response (CMR) corresponds with a ≥4-log (CMR4.0 0.01% IS) or ≥4.5-log
(CMR4.5 0.0032% IS) reduction of BCR-ABL transcripts from standardized baseline.1
Similar to the CCyR and MMR rates, TASIGNA maintained a significantly superior difference in CMR rates vs imatinib, which showed no signs of catching up after 2 years.1,3
TASIGNA has a favorable tolerability profile for chronic long-term therapy3
ENESTnd has now confirmed the safety and tolerability of TASIGNA through 24 months.1 TASIGNA-related adverse events (AEs) were typically early, transient, and manageable.3 Discontinuations due to adverse events were lower with TASIGNA, and patients treated with TASIGNA 300 mg bid received 99% of the intended dose at 24 months.1,2
Less neutropenia was seen with TASIGNA2
TASIGNA was associated with lower rates of GI side effects (nausea, vomiting, diarrhea) and edema than imatinib, and pleural and pericardial effusions occurred in 1% of patients receiving TASIGNA.2,3 In ENESTnd, no TASIGNA patient had a QTc prolongation >500 msec, and no cases of sudden death were reported.2,3
Most commonly reported AEs in ENESTnd (all grades)2
TASIGNA 300 mg bid had low rates of Grade 3/4 biochemical abnormalities in ENESTnd2
Experience with TASIGNA has demonstrated that biochemical abnormalities are generally mild, transient, and manageable, and TASIGNA was safe and effective in patients with Type 2 diabetes.5,6
ENESTnd: A large, international, head-to-head Phase III trial powered to prove superiority to imatinib1
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- ENESTnd was the first positive registration trial to use MMR as a primary end point
- Stringent primary end point of MMR was measured at 12 months1
- No crossover between treatment groups was allowed3
- TASIGNA demonstrated superiority over the best possible dose of imatinib3
- No dose escalation of TASIGNA was allowed
- 16% of imatinib patients were dose escalated to 800 mg per day (400 mg bid) due to suboptimal response or intolerance
- ENESTnd used a centralized laboratory with a standardized PCR test3
References:
1. Hochhaus A, Saglio G, le Coutre PD, et al. Superior efficacy of nilotinib compared with imatinib in newly-diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP): ENESTnd minimum 24-month follow-up. Paper presented at: 16th Annual Congress of the European Hematology Association; June 9-12, 2011; London, UK.
2. Hughes TP, Hochhaus A, Saglio G, et al; for the ENESTnd investigators. ENESTnd 24-month update: continued superiority of nilotinib versus imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Slides presented at: 52nd Annual Meeting of the American Society of Hematology; December 4-7, 2010; Orlando, FL. Abstract 207.
3. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; June 2011.
4. Saglio G, Kim D-W, Issaragrisil S, et al; for the ENESTnd investigators. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010;362(24):2251-2259.
5. Pinilla-Ibarz J, Cortes J, Mauro MJ. Intolerance to tyrosine kinase inhibitors in chronic myeloid leukemia: definitions and clinical implications. Cancer. 2011;117(4):688-697.
6. Saglio G, Larson RA, Hughes TP, et al. Efficacy and safety of nilotinib in chronic phase (CP) chronic myeloid leukemia (CML) patients (pts) with Type 2 diabetes in the ENESTnd trial. Blood. 2010;116(21):Abstract 3430.
7. Weisberg E, Manley PW, Cowan-Jacob SW, Hochhaus A, Griffin JD. Second generation inhibitors of BCR-ABL for the treatment of imatinib-resistant chronic myeloid leukaemia. Nat Rev Cancer. 2007;7(5):345-356.
