Phase 3 Data Published in The Lancet Show Bendamustine (Levact®) Plus Rituximab Doubles Progression-Free Survival in Patients With Indolent Non-Hodgkin Lymphoma and Mantle Cell Lymphoma Compared With

Cambridge, England (ots/PRNewswire) -

NOT INTENDED FOR MEDIA IN THE NETHERLANDS

-Treatment with bendamustine plus rituximab (B-R) doubles
progression free survival (PFS) compared with current standard of
care CHOP-R (69.5 versus 31.2 months;

p<0.0001)

- B-R better tolerated than CHOP-R in study designed to explore
simplified

regimen as new first-line treatment

- Data adds to growing body of clinical evidence that demonstrates

anti-cancer effect of bendamustine in wide range of lymphoid
malignancies

Results from the StiL NHL-1 study published in the Lancet today
show that a first-line treatment regimen of bendamustine plus
rituximab (B-R) doubles progression-free survival (PFS) compared with
the most often used treatment CHOP plus rituximab (CHOP-R), in newly
diagnosed patients with indolent non-Hodgkin lymphoma (iNHL) and
mantle cell lymphoma (MCL).[1]

Median PFS for patients treated with B-R was 69.5 months, compared
with 31.2 months for patients treated with CHOP-R, the most common
chemoimmunotherapy regimen used for the treatment of these diseases
(p<0.0001).[1]

The statistically significant PFS benefit was maintained in the
B-R group, regardless of age and across all subtypes; follicular
lymphoma, MCL and Waldenström's macroglobulinaemia, with the
exception of marginal zone lymphoma, which was non-inferior.[1]

The results also represent the first time that a simplified
treatment regimen has led to a superior complete response (CR) rate
compared to CHOP-R in a randomised trial, with 40% of the B-R group
achieving a CR compared with 30% for CHOP-R (p=0.021).[1] The B-R
group also experienced fewer side effects to those receiving CHOP-R,
with serious adverse events occurring in 19% of the B-R group
compared with 29% for patients receiving CHOP-R.[1]

Patients receiving B-R experienced less myelosuppression, with
severe neutropenia occurring in only 29% of patients compared to 69%
with CHOP-R (p<0.0001).[1] Infections, a challenging side effect of
chemoimmunotherapy, were also significantly reduced with the B-R
regimen (p=0.0025).[1] A commonly acknowledged side effect of CHOP-R
is hair loss; however, hair loss was not reported in a single patient
receiving B-R (p<0.0001).[1]

"These results represent a significant breakthrough in cancer
treatment for patients with indolent non-Hodgkin lymphoma and mantle
cell lymphoma, who in the past have had to endure particularly
aggressive and toxic chemotherapy combinations," said Professor
Mathias J. Rummel, Head of the Department for Haematology at the
University Hospital in Giessen, Germany, who led the study. "Our
study showed bendamustine and rituximab offered a significant
improvement in PFS, and that the combination was better tolerated
than CHOP-R. This means that the regimen, if approved by the
regulatory authorities, could become the new preferred first-line
treatment, capable of extending the time patients battling these
malignancies live free of disease."

"The results of this study are very encouraging for indolent
non-Hodgkin lymphoma patients," said Professor John Gribben, Chair of
the International Workshop on non-Hodgkin Lymphoma. "The fact that
bendamustine and rituximab results in fewer adverse effects with
significantly better efficacy than the traditional CHOP-R treatment
regimen indicates that this could be a new cornerstone in the
treatment of NHL."

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.[2] Indolent lymphomas represent 40% and MCL
3-10% of all NHL subtypes.[1] The estimated average incidence of NHL
in 2008 in the European Union is 10.8 per 100,000, with the highest
estimated incidence being for men living in Luxembourg (around 19
cases per 100,000).[2],[3]

Bendamustine is currently licensed as a monotherapy for the
treatment of iNHL in patients who have progressed during, or within 6
months following, treatment with rituximab or a rituximab containing
regimen. Data from the StiL NHL-1 study have been submitted to
regulatory authorities for their consideration of a bendamustine and
rituximab combination as a first-line treatment for iNHL and MCL.

-Notes to Editors-

StiL NHL-1 Study Methodology

The StiL NHL-1 study was a prospective, open-label, multi-centre,
randomised phase 3 non-inferiority trial, which involved 549 patients
aged 18 years or older, with newly diagnosed stage III or IV indolent
NHL and MCL.[1] Patients were stratified according to histological
lymphoma subtype and then randomised to receive bendamustine 90mg/m2
on days 1 and 2 of a 4-week cycle or CHOP (3-weekly cycles of
cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2 and vincristine 1.4
mg/m2 on day 1, and prednisone 100 mg/day for 5 days) for a maximum
of 6 cycles. Patients in both treatment arms received rituximab 375
mg/m2 on day 1 of each cycle.[1]

CHOP-R Treatment Regimen

Rituximab plus chemotherapy, most commonly CHOP-R, is the current
first-line standard of care for patients with advanced iNHL, and for
elderly patients with MCL.[1]

About Mundipharma

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consists of privately owned companies and joint ventures covering the
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bringing to patients the benefits of pioneering treatment options in
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http://www.mundipharma.com

About Bendamustine

In 2008 the US Food and Drug Administration (FDA) approved
bendamustine for the treatment of iNHL and chronic lymphocytic
leukemia (CLL), and it subsequently received European approval in
2010 for certain types of iNHL, CLL and multiple myeloma.

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(R), Ribomustin(R), Ribovact(R)) where it is marketed by the
Mundipharma network of independent associated companies.

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

In the United States, bendamustine (TREANDA(R)) is marketed by
Teva Pharmaceutical Industries Ltd. 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.

References

1. Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus
rituximab versus CHOP plus rituximab as first-line treatment for
patients with indolent and mantle-cell lymphomas: an open-label,
multicentre, randomised, phase 3 non-inferiority trial. The Lancet,
20 February 2013 (online publication, ahead of print).

2. Non-Hodgkin lymphoma incidence statistics: In the EU and
worldwide. Cancer Research UK. Available at http://www.cancerresearch
uk.org/cancer-info/cancerstats/types/nhl/incidence/#world [http://www
.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence ].
Accessed February 2013

3. 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.cancerresearc
huk.org/cancer-info/cancerstats/types/nhl/incidence ]. Accessed
February 2013.

ots Originaltext: Mundipharma International
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For further information please contact: Lara Dow,
Lara.Dow@mundipharma.co.uk, +44(0)7753-579842. Emma-Fleur Hartley,
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