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.