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Novartis Tasigna(R) (nilotinib) Trial Shows Superior Results to Glivec(R) (imatinib) in Newly Diagnosed, Chronic Phase Chronic Myeloid Leukaemia
Date:12/8/2009

FRIMLEY, England, December 8 /PRNewswire/ --

- Nilotinib Surpassed imatinib in Key Measures of Treatment Effectiveness in the Trial, in Patients With Newly-Diagnosed Disease(1)

- At 12-Months, Significantly Fewer Patients Progressed to Later Stages of the Disease on nilotinib (300mg Twice-Daily and 400mg Twice-Daily) Than on imatinib 400mg Once-Daily(1)

- Nilotinib was Generally Well Tolerated; Only a Small Number of Patients Discontinued Due to Adverse Events(1)

- Novartis Plans to File for Use in Newly Diagnosed Patients With Ph+ CML in the EU in 2010

In a large clinical trial, nilotinib demonstrated greater efficacy over the current gold standard treatment, imatinib, in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase.(1)

In the first head-to-head study of these two oral treatments as initial therapy for this life-threatening leukaemia, nilotinib demonstrated statistically significant improvement over imatinib in key measures of effectiveness used in the trial.(1) These new data were presented as a late breaker abstract at the 51st annual meeting of the American Society of Haematology (ASH), held 5-8 December 2009, in New Orleans, USA.(1)

CML accounts for more than one in six leukaemias in adults, with around 600 new cases being registered in England and Wales each year.(2) The estimated prevalence of CML in 2003 in England and Wales was 2,660 patients.(2)

The trial showed that at 12 months, significantly fewer patients on nilotinib 300mg twice-daily progressed from the initial chronic phase of the disease to the later accelerated or blast crisis phases than those on imatinib 400mg once-daily.(1) This demonstrates that nilotinib provided significantly better control of the disease compared to imatinib.

Nilotinib was generally well tolerated in the study.(1) A small number of patients discontinued due to adverse events.(1)

"The impressive rates of response observed in this study, combined with the very low rate of disease progression seen in nilotinib-treated patients are very encouraging," said Professor Richard Clark, Consultant Haematologist at Royal Liverpool University Hospital and a trialist involved in this study. "Continued improvement in the treatment of Ph+ CML is very important and these results indicate that nilotinib may provide long-term improvement in progression-free survival."

95% of patients with CML have an abnormality known as the Philadelphia chromosome. This chromosome produces a type of protein called Bcr-Abl, which is responsible for the overproduction of the cancerous white blood cells that are the main feature in Ph+ CML.(3) Nilotinib is a potent and selective inhibitor of the Bcr-Abl protein, thereby inhibiting the production of these cancerous cells.(4,5)

"Novartis has been at the forefront of research on the molecular origin of Ph+ CML and this has led to the development of treatments with unprecedented effectiveness and safety," said Panos Alexakos, Oncology Business Unit Head for Novartis UK. "These data are exciting and the deeper molecular response demonstrated provides hope for further improvement in outcomes for patients with Ph+ CML in the future."

Novartis plans to file worldwide applications for approval of nilotinib as a treatment for adult patients with newly diagnosed Ph+ CML. Nilotinib is currently approved in more than 80 countries including the European Union (EU), United States and other countries for the treatment of adult patients with Ph+ CML in chronic phase or accelerated phase who are resistant or intolerant to prior treatment including imatinib.

Notes to editors

Study details

The clinical trial, Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), is a Phase III randomised, open-label, multicentre trial comparing the efficacy and safety of nilotinib versus imatinib in adult patients with newly diagnosed Ph+ CML in the chronic phase.(1) It is the largest global randomised comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients.

ENESTnd is being conducted at 220 global sites, including five sites in the UK, in total 846 patients are enrolled. Patients were randomised to receive nilotinib 400mg twice-daily (n = 281), nilotinib 300mg twice-daily (n = 282) or imatinib 400mg once-daily (n = 283).(1) The primary endpoint was MMR at 12 months; a secondary endpoint was CCyR by 12 months. It is planned that patients are followed up for five years. Patients on the imatinib treatment arm who had suboptimal response or treatment failure will be able to escalate dose and/or switch to nilotinib via a protocol extension.

One of the key effectiveness measures used in the study was called major molecular response (MMR). This is defined as the reduction in levels of the Bcr-Abl protein to less than or equal to 0.1% of the level seen before treatment. MMR is an important measure in CML, as data show that patients who achieve MMR are unlikely to progress to the later stages of the disease.(6) With nilotinib 300mg twice-daily, the rate of MMR at 12 months was twice that of patients receiving imatinib 400mg once-daily (44% vs. 22%, p < 0.0001).(1)

Another effectiveness measure used in the study was called complete cytogenetic response (CCyR). CCyR indicates that no CML cells containing the Ph chromosome can be seen in a sample of bone marrow taken from the patient. 80% of patients achieved CCyR with nilotinib versus 65% with imatinib 400mg once-daily (p < 0.0001).(1) Responses were achieved faster in the nilotinib group than in the imatinib group.(1)

All patients had a minimum of 12 months of treatment or discontinued early; the median follow-up was 14 months. Overall, 84%, 82% and 79% of patients remained in the study on nilotinib 300mg twice-daily, nilotinib 400mg twice-daily and imatinib 400mg once-daily, respectively.(1)

About Ph+ CML

CML is a disease in which the body produces cancerous (leukaemic) white blood cells. 95% of patients with CML have an abnormality known as the Philadelphia chromosome. This chromosome produces a protein called Bcr-Abl, which is responsible for the proliferation of leukaemic white blood cells in Ph+ CML.(3)

CML accounts for more than one in six leukaemias in adults, with around 600 new cases being registered in England and Wales each year.(2) The estimated prevalence of CML in 2003 in England and Wales was 2,660 patients.(2)

About Tasigna (nilotinib)

Nilotinib, a second generation TKI, is a potent and selective inhibitor of the Bcr-Abl protein, which is responsible for the proliferation of leukaemic white blood cells in Ph+ CML.(4,5) Nilotinib is indicated for the treatment of adults with chronic phase and accelerated phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available.(5)

For nilotinib summary of product characteristics, please see: http://emc.medicines.org.uk/medicine/20827/SPC/ Tasigna%20200%20mg%20hard%20capsules

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

About Glivec (imatinib)(7)

Imatinib is approved in the EU for the treatment of all phases of Ph+ CML. Imatinib is also indicated for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) and the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.

Furthermore, imatinib is approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy, adult patients with relapsed or refractory Ph+ ALL as monotherapy, adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR alpha rearrangement and the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

    For imatinib summary of product characteristics, please see:
    http://emc.medicines.org.uk/document.aspx?documentId=15014

    References

    (1) Saglio G, Kim DW, Issaragrisil S, Philipp le Coutre, et al.
        Nilotinib Demonstrates Superior Efficacy Compared with Imatinib in
        Patients with Newly Diagnosed Chronic Myeloid Leukaemia in Chronic
        Phase: Results from the International Randomized Phase III ENESTnd
        Trial. American Society of Hematology 2009. Abstract number LBA-1

    (2) NICE Guidance on the use of imatinib for chronic myeloid leukaemia
        - Technology Appraisal 70. October 2003

    (3) Faderl S; Talpaz M; Estrov Z; O'Brien S; Kurzrock R; Kantarjian HM.
        The biology of chronic myeloid leukemia. N Engl J Med. 341:164-72,
        1999.

    (4) National Cancer Institute. General Information about Chronic
        Myelogenous Leukaemia (PDQ).
        http://www.cancer.gov/cancertopics/pdq/treatment/CML/patient/.
        Accessed March 2009.l 1: definition of PCR.

    (5) Tasigna (nilotinib) European Summary of Characteristics. Novartis AG.
        http://emc.medicines.org.uk/medicine/20827/SPC/Tasigna%20200%20mg%
        20hard%20capsules. 21/09/2009

        (Due to the length of this URL, it may be necessary to copy and paste
        this hyperlink into your Internet browser's URL address field. Remove
        the space if one exists.)

    (6) Hughes et al. Reduction of BCR-ABL Transcript Levels at 6, 12, and
        18 Months (mo) Correlates with Long-Term Outcomes on Imatinib (IM) at
        72 Mo: An Analysis from the International Randomized Study of
        Interferon versus STI571 (IRIS) in Patients (pts) with Chronic Phase
        Chronic Myeloid Leukemia (CML-CP). ASH. 2008. Abstract #334

    (7) Glivec (imatinib) European Summary of Characteristics. Novartis AG.
        http://emc.medicines.org.uk/document.aspx?documentId=15014.
        03/06/2009

SOURCE Novartis Oncology


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SOURCE Novartis Oncology
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