New Data on Bendamustine Offers Hope to Non-Hodgkin's Lymphoma Patients Resistant to Standard Therapy

Cambridge (United Kingdom), 5 November 2009: New data published today in the journal, Cancer, reveals that three quarters (75%) of patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL), responded to treatment with Bendamustine following a single-arm, multicentre study. Significantly, all patients participating in the study had become resistant or were unresponsive to rituximab (the standard treatment for the disease) when used either as a single agent or in combination with other therapies.

Professor Brad S. Kahl of the University of Wisconsin School of Medicine and Public Health, Maddison, USA, who led the study, said: “Although many patients undergo effective initial treatment with rituximab – sometimes in combination with chemotherapy – most will, unfortunately, become refractory or resistant to their treatment over time. Traditionally, this significant proportion of patients whose cancer has relapsed would be faced with limited treatment options. However, bendamustine with its unique mode of action now offers an effective alternative treatment for these patients with proven progression-free survival that could give many patients the opportunity to spend additional quality time with their families.”

Notably, 14% percent of patients participating in the study demonstrated a complete disappearance of clinical evidence of their disease. In addition, the average duration of their response to treatment and progression-free survival (PFS) was more than nine months.1 This means that, following treatment with bendamustine, patients’ cancer did not progress or worsen, therefore providing renewed hope and enabling them to get on with their lives.

Furthermore, 64% of patients who had no response to their previous chemotherapy (refractory) and had few options left, responded to bendamustine treatment.

Non-Hodgkin’s Lymphoma (NHL) is a cancer of the lymphatic system, one of the body’s natural defences against infection. In NHL, lymphocytes (cells that circulate in the lymphatic system and help to kill viruses and bacteria) become malignant, reproduce uncontrollably and form tumours, which mean they are no longer able to carry out their normal function properly. NHL is the most common haematological (blood-related) cancer and the fifth most common cancer among adults in the UK.2,3 Worldwide incidence is also steadily increasing, with an estimated rise of 4.2% per year in Western Europe4.

Bendamustine was generally well-tolerated with manageable side effects.1 Grade III or IV reversible haematological toxicities included neutropenia (61%), thrombocytopenia (25%), and anaemia (10%). The most frequent non-haematological adverse events (any grade) included nausea (77%), infection (69%), fatigue (64%), diarrhoea (42%), vomiting (40%), pyrexia (36%), constipation (31%), and anorexia (24%).1 In this study, a higher incidence of patient mortality was reported when compared to a similar trial in a virtually identical patient population where none occurred.

“The exact cause of why this difference was encountered is still under investigation”, says Professor Kahl. “It is, however, important to consider the whole body of evidence when weighing-up the risk versus benefit of bendamustine treatment to patients who are elderly and have already received numerous chemotherapy treatments and are therefore more vulnerable.”

 

About the study

* The study was an open-label, single-arm trial conducted in 28 centres in the USA and Canada. * One-hundred patients aged 31-84 years with indolent (slow-growing) NHL were given intravenous infusions over 60-120 minutes, of bendamustine 120mg/m2 on days one and two every 21 days, for six to eight cycles. * Primary endpoints included overall response rate (ORR) and duration of response (DOR), whilst secondary endpoints were safety and PFS. * An overall response rate of 75% was observed; 14% showed a complete response, 3% an unconfirmed complete response and 58% a partial response.1 * Patients had undergone an average of two chemotherapies prior to enrolment and all were rituximab-refractory.

About Bendamustine Bendamustine has marketing authorisations in Germany (Ribomustin® IV) and Switzerland and will be marketed, upon approval, 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®) 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 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: www.mundipharma.co.uk<http://www.mundipharma.co.uk/>

-Ends-

References 1. Kahl B. S., et al. Bendamustine Is Effective Therapy in Patients With Rituximab-Refractory Indolent B-cell Non-Hodgkin's Lymphoma: Results From a Multicenter Study. Cancer 2009; published online, 4th November 2009. 2. Cancer Research UK website. Accessed at: http://www.cancerhelp.org.uk/help/default.asp?page=5629 3. The Leukemia and Lymphoma Society website. Accessed at http://www.leukemia-lymphoma.org/all_page?item_id=8965&viewmode=print 4. Cartwright R, Brincker H, Carli PM, et al.The rise in incidence of lymphomas in Europe 1985-1992. Eur J Cancer 1999;35(4):627-33. 5. 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

For further information, please contact:

Nicole Moores Cohn & Wolfe 020 7331 5337 nicole.moores@cohnwolfe.com

cohn&wolfe nicole moores | cohn&wolfe | account manager | lynton house | 7-12 tavistock square | london | WC1H 9LT | t: +44 (0) 20 7331 5337 | f: +44 (0) 207 331 9083 | nicole.moores@cohnwolfe.com | www.cohnwolfe.com

Posted: November 2009

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