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Novel Chemotherapy Agent Bendamustine Significantly More Effective First-Line Therapy Than Chlorambucil in CLL

Cambridge, England (ots/PRNewswire)

- Blood Marrow Normalised in 31% (Versus 2%) of Patients, With
Manageable Side-Effects
Nearly a third (31%) of all bendamustine-treated patients saw all
clinical evidence of their advanced chronic lymphocytic leukaemia
(CLL) disappear when used as a first-line treatment option, according
to the results of a large new multicentre phase III study published
online by the Journal of Clinical Oncology today. Only 2% of patients
treated with chlorambucil (the standard treatment) in the study
achieved the same results.(1)
Professor Wolfgang U. Knauf of the Onkologische
Gemeinschaftspraxis, Frankfurter Diakonie Kliniken, Frankfurt,
Germany, who led the study, said: "CLL is the most common form of
adult leukaemia in the Western world. It is also incurable, and so
the goal of treatment is to stabilise the cancer over the long-term
by extending periods of remission, during which patients can lead
practically normal lives, symptom-free. Existing treatment options
are limited for those with advanced CLL, but our new study shows that
bendamustine couples significantly better efficacy with a manageable
toxicity profile, so offering patients the hope of a better quality
of life, for longer than traditional treatments."
CLL is a slowly progressing blood and bone marrow form of the
disease presenting mostly in the elderly (average age of diagnosis is
68)(2). Blood cells that are normally produced in a controlled way
lose this control and an increasing number of abnormal leukaemic
lymphocytes circulate in the blood, eventually replacing the normal
white cells, red cells and platelets in the bone marrow. Bendamustine
has a unique mode of action compared with other cytotoxic agents.
This means that it is able to kill cancer cells that have become
resistant to previous chemotherapies(3) and may return the blood
marrow to normal, resulting in a complete response and thus a
disappearance of all signs and symptoms of the disease.
In the study, patients treated with the chemotherapy agent
bendamustine (162 of the total 319 patients) achieved a median
progression-free survival of 21.6 months, compared to only 8.3 months
for chlorambucil (p<0.0001), enabling them to live without worsening
CLL for over a year longer.(1)
An improvement in the duration of remission was also shown
(median 21.8 months in the bendamustine group, versus 8.0 months in
the chlorambucil group), and complete or partial responses were
achieved in 68% of bendamustine-treated, and 31% of
chlorambucil-treated patients (p<0.0001).(1)
Haematological adverse events (grades III-IV Common Toxicity
Criteria (CTC)) were more common with bendamustine than with
chlorambucil (occurring in 40% versus 19% of patients). Severe
infections (grades III-IV) occurred in 7% of bendamustine-treated
patients and 3% of chlorambucil-treated patients. The side effects
experienced by patients treated with bendamustine, were manageable
and of short duration.
About the study
The study was a randomised, open-label, parallel-group, phase III
trial conducted at 45 centres in Austria, Bulgaria, France, Germany,
Italy, Spain, Sweden and the UK. 319 previously untreated patients
(is than or equal to 75 years of age) with Binet stage B* or Binet
stage C** were randomised to receive either bendamustine 100mg/m2/day
intravenously on days 1-2 (n=162), or chlorambucil 0.8mg/kg (Broca's
normal weight)*** orally on days 1 and 15 (n=157). Treatment cycles
were repeated every four weeks for a maximum of six cycles, and
response was assessed according to National Cancer Institute Working
Group criteria. Safety endpoints included infection rates and adverse
events.
About Bendamustine
Bendamustine has marketing authorisations in Germany (RIBOMUSTIN)
and Switzerland and will be marketed by the Mundipharma independent
associated companies in Europe with indications as a single-agent or
in combination with other anti-cancer agents for diseases such as
indolent non-Hodgkin's lymphomas (NHL), multiple myeloma (MM) and
chronic lymphocytic leukaemia (CLL). RIBOMUSTIN is licensed from
Astellas Deutschland GmbH. In the United States, bendamustine
(TREANDA(R)) is marketed by Cephalon Inc and indicated for the
treatment of patients with CLL, and indolent B-cell NHL that
progressed during or within six months of treatment with rituximab or
a rituximab-containing regimen. SymBio Pharmaceuticals Ltd holds
exclusive rights to develop and market bendamustine HCL in Japan
(sublicensed to Eisai Co Ltd) and selected Asian countries.
Bendamustine is currently undergoing regulatory review in 12
countries across Europe. Significantly, the American Society of
Clinical Oncology (ASCO) included bendamustine for the treatment of
CLL in its 2008 shortlist of major clinical advancements in the
treatment of cancer, with the greatest potential impact on patient
care.(4)
About CLL
CLL can lead to bone marrow failure, infection and eventually, a
spreading of the cancer to other areas of the body. These patients
often have more than two co-morbidities, making them less suitable
for fludarabine based regimens, thereby limiting treatment options.
Such patients also have a lower overall survival rate.(5)
About Mundipharma
The Mundipharma independent associated companies, including
Mundipharma International, Purdue Pharma and Napp Pharmaceuticals are
privately owned companies and joint ventures covering the world's
pharmaceutical markets. The companies worldwide are dedicated to
bringing to patients with severe and debilitating diseases the
benefit of novel treatment options in fields such as severe pain,
haemato-oncology, rheumatoid arthritis and respiratory disease. For
more information: http://www.mundipharma.co.uk
* is greater than or equal to 3 lymph node regions involved
including hepatomegaly and splenomegaly
** Anaemia and/or thrombocytopenia regardless of the number of
lymph node regions
*** Broca's normal weight in kg: the body weight for the dose
being the height of the patient in cm minus 100)
References
(1) Knauf W.U, et al. Phase III Randomized Study of Bendamustine
Versus Chlorambucil in Previously Untreated Patients with Chronic
Lymphocytic Leukemia. J Clin Oncol 2009;
http://jco.ascopubs.org/papbyrecent.dtl
(2) Leukaemia Research Fund. Accessed at
http://www.lrf.org.uk/en/1/discllhome.html. June 16th 2009
(3) Leoni LM et al Bendamustine (Treanda) displays a distinct
pattern of cytotoxicity and unique mechanistic features compared with
other alkylating agents. Clin Cancer Res. 2008 Jan 1;14(1):309-17
(4) Winer E., et al. Clinical Cancer Advances 2008: Major
Research Advances in Cancer Treatment, Prevention, and Screening - A
Report from the American Society of Clinical Oncology. J Clin Oncol
2009; 27 (5): 812-826
(5) Eichhorst B, Goede V and Hallek M. Treatment of elderly
patients with chronic lymphocytic leukemia. Leuk and Lymph 2009;
50(2):171-178

Contact:

For further information, please contact: Nicole Moores, Cohn & Wolfe,
+44(0)20-7331-5337, nicole.moores@cohnwolfe.com; Alison Wright, Cohn
& Wolfe, +44(0)20-7331-5386, alison.wright@cohnwolfe.com

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