BASEL & NEW ORLEANS, La., June 7 -- PRNewswire/ AsiaNet
New MabThera(R)/Rituxan(R) (1) data announced at the American Society ofClinical Oncology (ASCO) Annual Meeting reveal extremely positive survivalbenefits for younger patients with aggressive non-Hodgkin's lymphoma (NHL). The study showed an overall survival of 95% for those patients who receivedMabThera (rituximab) in combination with chemotherapy. These results come ontop of the impressive survival benefits previously seen in a study ofpatients over 60 years old. Based on these data, MabThera plus chemotherapyshould become the standard first-line treatment of patients of all agessuffering from this aggressive and life-threatening form of cancer.
The MabThera International Trial (MInT)(2) is the first phaseIII randomised study exploring clinical outcomes in people of this age groupwith aggressive non-Hodgkin's lymphoma. The combination of MabThera andchemotherapy was significantly more effective in all clinically relevantendpoints than chemotherapy alone. After a median observation time of twoyears, the study showed an overall survival of 95% for those patients whoreceived MabThera (rituximab) in combination with chemotherapy, compared to85% for those who received chemotherapy alone. Additionally, of thosepatients treated with the combination, 81% were free from treatment failure(compared to 58% of those patients treated with chemotherapy alone), and morepatients achieved a complete remission (85% versus 65%).
Professor M. Pfreundschuh, lead investigator of the MInT study,commented: "I did not dare to expect a survival of 95% in these patientsafter two years of follow up. These impressive results of the MInT studyprove that MabThera plus chemotherapy is the optimal treatment for patientswith aggressive NHL less than 60 years old."
In December 2003, the study was halted two years earlier thanexpected following an interim analysis of the study data that revealed thatthe pre-specified criteria for closing the study were reached early,demonstrated by a statistically significant improvement in time to treatmentfailure (TTF) in patients receiving MabThera plus chemotherapy.
Non-Hodgkin's lymphoma affects 1.5 million people worldwide. About 55% ofNHL patients have the aggressive form of the disease, which, if leftuntreated, can be fatal within six months. NHL is one of the fastest growingcancers and has grown in incidence by 80% since the early 1970s.(3)
About the study
The phase III study was conducted in 18 countries(4) andinvolved previously untreated patients between 18 and 60 years of age withlow-risk, diffuse large B-cell (DLBCL) NHL. Patients were randomised toreceive either MabThera in combination with chemotherapy, or chemotherapyalone. At the time the study was stopped, an interim analysis was conductedon 326 patients. The primary endpoint in this study was time to treatmentfailure, defined as failure to achieve complete remission, progressivedisease, relapse or death.
Further ASCO news: MabThera plus chemotherapy for mantle celllymphoma
Other phase III data reveal that previously untreated patientswith mantle cell lymphoma (MCL), an intermediate grade form of non-Hodgkin'slymphoma, treated with MabThera plus chemotherapy first-line experiencedsignificantly higher remission rates and prolonged time to treatment failurecompared to chemotherapy alone. Mantle cell lymphoma is a disease thattypically affects elderly patients and carries a poor prognosis, with amedian survival of only three to four years. The study(5), led by ProfessorW. Hiddemann of the German Low Grade Lymphoma Study Group (GLSG), indicatesthat MabThera plus chemotherapy is a highly effective first-line therapy intreating MCL.
About MabThera
MabThera is a therapeutic antibody that binds to a particularprotein - the CD20 antigen - on the surface of normal and malignant B-cells.It then recruits the body's natural defences to attack and kill the markedB-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20antigen, allowing healthy B-cells to regenerate after treatment and return tonormal levels within several months.
MabThera is indicated as a single-agent treatment for relapsedor refractory indolent NHL and received European approval in March 2002 forthe treatment of aggressive NHL in combination with CHOP chemotherapy. Thedrug is known as Rituxan in the United States, Japan and Canada and asMabThera in the rest of the world. More than 300,000 patients have beentreated with MabThera worldwide to date.
Genentech and Biogen Idec co-market MabThera in the UnitedStates and Roche markets MabThera in the rest of the world, except Japan,where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
Roche in Oncology
Within the last five years the Roche Group has become the world's leadingprovider of anti-cancer treatments, supportive care products and diagnostics.Its oncology business includes an unprecedented four marketed products withsurvival benefit: Herceptin, MabThera, Xeloda and Avastin (launched byGenentech in the US recently), which treat a range of malignancies such asbreast cancer, non-Hodgkin's lymphoma and colorectal cancer. Other keyproducts include NeoRecormon (anaemia in various cancer settings), Bondronat(prevention of skeletal events in breast cancer and bone metastases patients,hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-inducednausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignantmelanoma, renal cell carcinoma). CERA is the most recent demonstration of thecommitment to anaemia management. Roche's cancer medicines generated sales ofmore than 6 billion Swiss francs in 2003.
In a recent phase III study Tarceva met its primary endpoint of improvingoverall survival in patients with non-small cell lung cancer.
Roche is developing new tests, which will have a significant impact ondisease management for cancer patients in the future. With a broad portfolioof tumor markers for prostate, colorectal, liver, ovarian, breast, stomach,pancreas and lung cancer, as well as a range of molecular oncology tests, wewill continue to be the leaders in providing cancer focused treatments anddiagnostics.
Roche Oncology has four research sites (two in the US, Germany and Japan)and four Headquarter Development sites (two in the US, UK and Switzerland).
About Roche
Headquartered in Basel, Switzerland, Roche is one of theworld's leading innovation-driven healthcare groups. Its core businesses arepharmaceuticals and diagnostics. Roche is number one in the globaldiagnostics market and is the leading supplier of pharmaceuticals for cancerand a leader in virology and transplantation. As a supplier of products andservices for the prevention, diagnosis and treatment of disease, the Groupcontributes on a broad range of fronts to improving people's health andquality of life. Roche employs roughly 65,000 people in 150 countries. TheGroup has alliances and research and development agreements with numerouspartners, including majority ownership interests in Genentech and Chugai.
About Genentech
Genentech is a leading biotechnology company that discovers,develops, manufactures and commercializes biotherapeutics for significantunmet medical needs. Eighteen of the currently approved biotechnologyproducts originated from or are based on Genentech science. Genentechmanufactures and commercializes 13 biotechnology products in the UnitedStates. The company has headquarters in South San Francisco, California andis traded on the New York Stock Exchange under the symbol DNA. For additionalinformation about the company, please visit http://www.gene.com
About Biogen Idec
Biogen Idec creates new standards of care in oncology andimmunology. As a global leader in the development, manufacturing, andcommercialization of novel therapies, Biogen Idec transforms scientificdiscoveries into advances in human healthcare. For product labelling, pressreleases and additional information about the company, please visitwww.biogenidec.com
For more information, please contact:
Roche - Holly Kania,
Tel: +41 (79) 593 4310,
Email: [email protected] or
Ketchum - Susan McCue,
Tel: +44 207 611 3578,
Email: [email protected]
For further information about lymphoma, please visit:www.lymphomacoalition.org For further information about MabThera, pleasevisit www.roche.com
Notes to Editors:
(1) The drug is known as Rituxan in the United States, Japan, and Canada,
and as MabThera in the rest of the world.
(2) Pfreundschuh M et al. Abstract #6500. Randomized intergroup trial of
first line treatment for patients <=60 years with diffuse large B-cell
non-Hodgkin's lymphoma (DLBCL) with a CHOP-like regiment with or
without the anti-CD20 antibody rituximab - early stopping after first
interim analysis. Annual Meeting of the American Society of Clinical
Oncology (ASCO), June 2004.
(3) World Health Report 2000, World Health Organization, www.who.int.
(4) Countries that participated in the study: Argentina, Australia,
Austria, Brazil, Canada, Czech Republic, Denmark, Finland, France,
Germany, Israel, Italy, Norway, Poland, Sweden, Switzerland, Spain, UK.
(5) Hiddemann, M et al. Abstract #6501. The addition of Rituximab to
front line therapy with Cyclophosphamide, Doxorubicin, Vincristine and
Prednisone (CHOP) increases the remission rate and prolongs the time to
treatment failure (TTF) significantly over CHOP alone in mantle cell
lymphoma (MCL) - Results of a prospective randomized trial of the
German Low Grade Lymphoma Study Group (GLSG). Annual Meeting of the
American Society of Clinical Oncology (ASCO), June 2004.
All trademarks used or mentioned in this release are legally protected.
SOURCE: Roche Pharmaceuticals
--Distributed by AsiaNet (www.asianetnews.net)--