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Record Number of Bendamustine Abstracts Accepted for Presentation at the Annual Meeting of the American Society of Hematology (ASH)

CAMBRIDGE, England, December 3, 2012 /PRNewswire/ --

  • Total of 43 bendamustine abstracts to be presented at ASH, including five oral presentations
  • New data supports use of bendamustine-rituximab (B-R) regimen in indolent non-Hodgkin lymphoma (NHL) and mantle cell lymphoma (MCL)

43 abstracts, announcing the results of studies involving bendamustine in a number of lymphoid malignancies, including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), indolent NHL and MCL, will be presented at the 54th Annual Meeting of the American Society of Hematology (ASH), taking place from 8-11 December 2012 in Atlanta, Georgia. Five will be oral presentations.

Two oral and three poster presentations focus on indolent NHL (iNHL) and MCL, comparing treatment with bendamustine-rituximab (B-R) to the standard first-line treatment, CHOP-R/CVP-R. One study demonstrated improved complete response rates and progression free survival (PFS) vs. CHOP-R, whilst another study demonstrated improved quality of life with B-R compared to the current standards of care (CHOP-R/CVP-R) for patients with iNHL or MCL.[1],[2],[3]

"We are delighted that such a wealth of bendamustine data has been included in the ASH scientific program," said Antony Mattessich, Regional Director, Europe, at Mundipharma. "Mundipharma is commited to bringing innovative treatments to the cancer community, and we expect the impact of bendamustine-rituximab on the quality of life and outcomes of indolent non-Hodgkin lymphoma patients to remain of central interest in the future."

A summary of the new B-R data being presented at ASH in iNHL and MCL, is as follows:

Oral presentations

  • Differences in Quality of Life Between Bendamustine Plus Rituximab Compared with Standard First-Line Treatments in Patients with Previously Untreated Advanced Indolent Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

B-R significantly improved global health status/quality of life (GHS/QOL) compared to CHOP-R/CVP-R in previously untreated iNHL and MCL patients.[3]

Session: 623. Lymphoma - Chemotherapy, excluding Pre-Clinical Models: Mantle Cell Lymphoma and Follicular Lymphoma. Sunday, December 9, 2012: 5:30pm, Sidney Marcus Auditorium, Level 4, Building A

  • An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study

B-R produced a non-inferior complete response (CR) rate compared to CHOP-R/CVP-R in patients with advanced iNHL and MCL (31% B-R vs. 25% CHOP-R/CVP-R, p=0.0225). [1]

Session: 624. Lymphoma - Therapy with Biologic Agents, excluding Pre-Clinical Models: Optimizing Current Treatment Strategies. Tuesday, December 11, 2012: 7:45am, B405-B407, Level 4, Building B

Poster Presentations

  • Subanalysis of the StiL NHL 1-2003 Study: Achievement of Complete Response with Bendamustine-Rituximab (B-R) and CHOP-R in the First-Line Treatment of Indolent and Mantle Cell Lymphomas Results in Superior Survival Compared to Partial Response

This subanalysis demonstrated significantly prolonged PFS (p=0.0037) and overall survival (OS) (p=0.0008) for iNHL and MCL patients who achieved a CR compared with a partial response (PR), irrespective of the treatment arm.[2] When comparing the two treatment arms, first-line treatment with B-R resulted in superior PFS compared to CHOP-R, regardless of the quality of response.[2]

Session: 623. Lymphoma - Chemotherapy, excluding Pre-Clinical Models: Poster II. Sunday, December 9, 2012, 6:00pm-8:00pm. Hall B1-B2, Level 1, Building B

  • Bendamustine-Rituximab Induction Followed by Observation or Rituximab Maintenance for Newly Diagnosed Patients with Waldenström's Macroglobulinemia: Results From a Prospective, Randomized, Multicenter Study (StiL NHL 7-2008 -MAINTAIN-; ClinicalTrials.gov Identifier: NCT00877214)

B-R was shown to be an efficacious treatment in patients with Waldenström's Macroglobulinemia, achieving an overall response rate of 86%, with no uncommon toxicities observed.[4]

Session: 624. Lymphoma - Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster II. Sunday, December 9, 2012, 6:00pm-8:00pm. Hall B1-B2, Level 1, Building B

  • Bendamustine-Rituximab (B-R) Replaces R-CHOP As "Standard of Care" in the Treatment of Indolent Non-Hodgkin Lymphoma in German Hematology Outpatient Centres

An analysis of 645 patients receiving systemic first-line treatment for iNHL in the clinical registry on lymphoid neoplasms (TLN Registry) found that B-R was the most frequently used systemic treatment for patients with iNHL in German hematology outpatient centres, with 66% (n=428) of cases receiving B-R, compared to just 16% receiving CHOP-R as first-line treatment.[5]

Session: 623. Lymphoma - Chemotherapy, excluding Pre-Clinical Models: Poster III. Monday, December 10, 2012, 6:00pm-8:00pm. Hall B1-B2, Level 1, Building B

-Notes to Editors-

About Non-Hodgkin Lymphoma

NHL is the tenth most common cancer worldwide and figures from 2008 indicate that there are an estimated 356,000 new cases diagnosed every year, comprising two out of five haematological cancers.[6] iNHL represent 40% of all NHL subtypes.[7] The estimated average incidence of NHL in 2008 in the European Union is 10.8 per 100,000.[6],[8]

About Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis. They are also committed to independent thinking and ground breaking solutions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers cutting-edge treatments to meet the most pressing needs of healthcare professionals and patients. For further information please visit: http://www.mundipharma.com

About Bendamustine

Bendamustine was first discovered in Germany 50 years ago in what was then the German Democratic Republic (East Germany). In 2008 the US Food and Drug Administration (FDA) approved bendamustine for the treatment of iNHL and CLL, and it subsequently received European approval in 2010 for certain types of iNHL, CLL and MM.

Bendamustine has marketing authorisations in Germany, France, UK, Italy, Spain, Austria, Switzerland, Sweden, Norway, Finland, Denmark, Poland, Slovakia, Ireland, Cyprus, Iceland, Belgium, The Netherlands, Greece, Slovenia, Portugal, Czech Republic, Romania and Bulgaria (Levact®, Ribomustin®, Ribovact®) where it is marketed by the Mundipharma network of independent associated companies.

Bendamustine is licensed (Levact®, Ribomustin®, Ribovact®) from Astellas Deutschland GmbH.

In the United States, bendamustine (TREANDA®) is marketed by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) 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 including Hong Kong and Singapore. In South America and Australasia the commercial rights are held by Janssen-Cilag Ltd.

CHOP-R/CVP-R Treatment Regimens

Rituximab plus chemotherapy, most commonly CHOP or CVP, is the current first-line standard of care for patients with advanced iNHL, and patients with mantle cell lymphoma who are not fit for high-dose chemotherapy.[9] 

CHOP, a multi-drug chemotherapy regimen, is a combination of three chemotherapy injections/infusions (cyclophosphamide, doxorubicin and vincristine) on a single day, with a fourth agent (prednisone) taken orally for five days. Each cycle is repeated every three weeks for 6-8 cycles.

CVP treatment follows a similar regimen but comprises two chemotherapy injections/infusions (cyclophosphamide and vincristine), followed by a five-day course of prednisone tablets.

References

1. Flinn IW, Van der Jagt RH, Kahl BS, et al. An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study. Abstract presented at ASH 2012. Available at https://ash.confex.com/ash/2012/webprogram/Paper51442.html.

2. Rummel MJ, Niederle N, Maschmeyer G, et al. Subanalysis of the StiL NHL 1-2003 Study: Achievement of Complete Response with Bendamustine-Rituximab (B-R) and CHOP-R in the First-Line Treatment of Indolent and Mantle Cell Lymphomas Results in Superior Survival Compared to Partial Response. Abstract presented at ASH 2012. Available at https://ash.confex.com/ash/2012/webprogram/Paper48063.html.

3. Burke JM, Van der Jagt RH, Kahl BS, et al. Differences in Quality of Life Between Bendamustine Plus Rituximab Compared with Standard First-Line Treatments in Patients with Previously Untreated Advanced Indolent Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma. Abstract presented at ASH 2012. Available at https://ash.confex.com/ash/2012/webprogram/Paper49604.html.

4. Rummel MJ, Lerchenmüller C, Greil R, et al. Bendamustin-Rituximab Induction Followed by Observation or Rituximab Maintenance for Newly Diagnosed Patients with Waldenström's Macroglobulinemia: Results From a Prospective, Randomized, Multicenter Study (StiL NHL 7-2008 -MAINTAIN-; ClinicalTrials.gov Identifier: NCT00877214). Abstract presented at ASH 2012. Available at https://ash.confex.com/ash/2012/webprogram/Paper48052.html.

5. Ulrich Knauf W, Abenhardt W, Nusch A, Grugel R, Marschner N. Bendamustine-Rituximab (BR) Replaces R-CHOP As "Standard of Care" in the Treatment of Indolent Non-Hodgkin Lymphoma in German Hematology Outpatient Centres. Abstract presented at ASH 2012. Available at https://ash.confex.com/ash/2012/webprogram/Paper53051.html.

6. Non-Hodgkin lymphoma incidence statistics: In the EU and worldwide. Cancer Research UK. Available at http://www.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence/#world [http://www.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence]. Accessed November 2012. European Age-Standardised rates calculated by the Cancer Research UK Statistical Information Team, 2011, using data from GLOBOCAN 2008 v1.2, IARC, version 1.2 [http://globocan.iarc.fr].

7. Gascoyne, Randy D. Hematopathology approaches to diagnosis and prognosis of indolent B-cell lymphomas. ASH Education Program Book 2005.1 (2005): 299-306.

8. European Age-Standardised rates calculated by the Cancer Research UK Statistical Information Team, 2011, using data from GLOBOCAN 2008 v1.2, IARC, version 1.2 [http://globocan.iarc.fr]. Available at Non-Hodgkin lymphoma incidence statistics: In the EU and worldwide. Cancer Research UK http://www.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence/#world [http://www.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence]. Accessed November 2012.

9. Gribben JG; How I treat indolent lymphoma. Blood 2007;109:4617-4626.


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