Phase 3 Data Published in Lancet Show bendamustine (Levact®) Plus Rituximab Doubles Progression-Free Survival in Patients With Indolent Non-Hodgkin Lymphoma and Mantle Cell Lymphoma Compared With CHOP-R PR Newswire MECHELEN, Belgium, February 20, 2013 MECHELEN, Belgium, February 20, 2013 /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 anticancer effect of bendamustine in wide range of lymphoid malignancies - Bendamustine is currently licensed for use after rituximab, an application has been made on the basis of this data for first line use. 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 treatments 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 randomized trial, with 40% of the B-R group achieving a CR compared with 30.0% 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 could become the new preferred first-line treatment, capable of extending the time patients battling these malignancies live free of disease." Professor Fritz Offner, Head of heamatology at the University of Gent in Belgium, states : "The treatment of indolent non Hodgkin lymphoma has come a long way, from an ineffective oral treatment with few side effects to an immuno-chemotherapy with maintenance antibody treatment that results in median PFS above 3 years in patients requiring therapy. This has been obtained so far with chemotherapy that carries significant toxicities, from hair loss to hospital admissions for neutropenic fever and infections. The current study from the StiL-group represents a major advance in this field : not only does bendamustine have significantly lower toxicities, including no hair loss (which is important for patients continuing to be socially and professionally active during their treatment) but it also comes with a doubling of PFS, unseen with any other chemotherapeutic modification of the standard treatment. This is not only true for the more prevalent follicular NHL but also for other indolent lymphomas usually absent from major phase 3 trials, such as Waldenstrom's macroglobulinemia. It is a big step forward for patients to make cancer care better and less disruptive for daily life." 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 approved for Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. Medicinal products should not be used outside their approved indication. 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, randomized 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/m ^2 on days 1 and 2 of a 4-week cycle or CHOP (3-weekly cycles of cyclophosphamide 750 mg/m ^2 , doxorubicin 50 mg/m ^2 and vincristine 1.4 mg/m ^2 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/m ^2 on day 1 of each cycle. ^[ ^1 ^] CHOP-R Treatment Regimen Rituximab plus chemotherapy, most commonlyCHOP-R, is the current first-line standard of care for patients with advanced iNHL, and for elderly patients with MCL. ^[ ^1 ^] 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. For further information please visit: http://www.mundipharma.be 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®, Ribomustin®, Ribovact®) where it is marketed by the Mundipharma network of independent associated companies. Bendamustine is licensed (Levact®, Ribomustin®, Ribovact®) from Astellas Deutschland GmbH. 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.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence/#world. Accessed February 2012 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. 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. Accessed February 2012. Contact: For further information please contact: Lara Dow, Lara.Dow@mundipharma.co.uk , +44 (0) 7753 579 842, Michael Magagnin, Michael.email@example.com , +32 15 45 11 80
Phase 3 Data Published in Lancet Show bendamustine (Levact®) Plus Rituximab Doubles Progression-Free Survival in Patients With
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