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Ph+ CML TREATMENT GOALS

Evolving goals in Ph+ CML therapy¹

Today, the goals of treatment for patients with Ph+ CML-CP have evolved — clinical evidence confirms that faster and deeper reductions of Ph+ CML disease burden, such as MMR, can significantly improve long-term outcomes for patients.

Complete hematologic response (CHR) is just the first step¹

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ELN recommends stable or improving MMR at any time or by 18 months for optimal response

Today’s European LeukemiaNet (ELN) recommendations identify MMR as an important component of achieving an optimal response in Ph+ CML. In addition, ELN recommendations support molecular monitoring as a routine standard of care for patients with Ph+ CML, as a way to measure minimal levels of residual disease.

CCyR is not enough^2,3

As IRIS demonstrated and ENESTnd confirmed, a small but significant percentage of Ph+ CML-CP patients treated with imatinib progress to AP/BC early in the course of therapy. And ENESTnd confirmed what we saw in IRIS, that patients who achieve CCyR alone are not necessarily safe from progression. In IRIS, 3% of patients who achieved CCyR progressed. And in ENESTnd, of the 11 imatinib patients who progressed to AP/BC at 12 months, 3 had achieved CCyR. Patients who achieved MMR had lower rates of progression — and TASIGNA helps more patients achieve MMR more rapidly.

ENESTnd showed that TASIGNA significantly reduces progression to AP/BC vs. imatinib in patients newly diagnosed with Ph+ CML.³

Many patients fail to meet current treatment goals with imatinib⁴

The ENESTnd study demonstrated that tyrosine kinase inhibitor therapy can get better in newly diagnosed patients with Ph+ CML. The study compared treatment outcomes using 2009 ELN criteria and confirmed that many patients do not achieve optimal outcomes with imatinib. Even with imatinib dose escalation, a clinically meaningful percentage of imatinib-treated patients fail Ph+ CML therapy or do not achieve optimal results.⁴

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*Primarily due to lack of MMR at 18 months.⁴
†Treatment failure: no CyR (cytogenetic response,  Ph+ >95%) at 6 months; <PCyR (partial cytogenetic response, Ph+ >35%) at 12 months; <CCyR (Ph+ >0%) at 18 months; at any time within 18 months: loss of CHR, loss of CCyR, progression to AP/BC, or clonal evolution.¹

Fewer patients fail treatment with TASIGNA at 12 and 18 months vs imatinib⁴

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^‡An escalation in dose to imatinib 400 mg bid was permitted in patients on the
imatinib arm who had suboptimal response or treatment failure, using the ELN criteria.⁴

References:
1. Baccarani M, Cortes J, Pane F, et al; European LeukemiaNet. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol. 2009;27(35):6041-6051.
2. Deininger M, O’Brien SG, Guilhot F, et al. International Randomized Study of Interferon vs STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib. Blood. 2009;114(22):Abstract 1126.
3. TASIGNA^® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; June 2011.
4. Saglio G, Hochhaus A, Guilhot F, et al. Nilotinib is associated with fewer treatment failures and suboptimal responses vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): results from ENESTnd. Paper presented at: 16th Annual Congress of the European Hematology Association; June 9-12, 2011; London, UK.
5. 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.