Magazin
2004-11-30
Basel, Switzerland, November 30 (ots/PRNewswire) - Roche andGenentech, Inc., announced today that Avastin(TM) (bevacizumab,rhuMAb-VEGF), a new innovative anti-angiogenesis drug, has shown forthe first time that it significantly increases survival in patientswith metastatic colorectal cancer when used in combination with astandard oxaliplatin-containing chemotherapy regimen. These patientshad previously failed one chemotherapy regimen for their advanceddisease.
Preliminary results have shown the study has achieved its primaryendpoint showing that patients who received Avastin plus chemotherapylived nearly two months longer, on average, compared to those whoreceived chemotherapy alone (12.5 months vs 10.7 months). Patientsreceiving Avastin plus chemotherapy had a 26 percent reduction in therisk of death (hazard ratio of 0.74). Oxaliplatin-containingchemotherapy regimens are widely used in first- and second-linemetastatic colorectal cancer therapy.
Colorectal cancer is the third most commonly reported cancer, with945,000 new cases annually worldwide. It is estimated that more than50% of people diagnosed with colorectal cancer will die of thedisease. [1]
"We are delighted with this news," said William M. Burns, Head ofRoche Pharmaceuticals Division. "This is the first time that datahave demonstrated the significant survival benefit that Avastin canalso bring to patients whose disease progresses after initialanti-tumour treatment. Today's data highlight the potential ofAvastin for many patients with metastatic colorectal cancer, as ithas now shown survival benefit when used in either first- orsecond-line."
The randomised, controlled, multi-centre Phase III study,sponsored by the National Cancer Institute, part of the NationalInstitutes of Health, and conducted by a network of researchers ledby the Eastern Cooperative Oncology Group (ECOG), is the firstlarge-scale study to evaluate Avastin in combination with anoxaliplatin-containing chemotherapy regimen (FOLFOX4)*. It is alsothe first large-scale study in patients with metastatic colorectalcancer who had failed a previous chemotherapy regimen (relapsed). Atotal of 829 patients were enrolled in this trial and were randomisedto receive treatment with FOLFOX4 with or without Avastin. Accordingto ECOG, preliminary study results will be presented during the ASCOGastrointestinal Cancers Symposium, January 27-29, 2005 in Hollywood,Florida. Trials investigating the use of Avastin with anoxaliplatin-containing regimen as adjuvant (post operation) treatmentand first-line treatment for patients with metastatic colorectalcancer are currently ongoing.
"These trial results are immensely important because they providestriking evidence that Avastin can be safely combined with the manydifferent chemotherapy regimens commonly used in the treatment ofadvanced colorectal cancer," commented Stefan M. Manth, Head of RocheOncology.
Avastin received fast-track approval by the US Food and DrugAdministration (FDA) and was launched in the US in February 2004. InOctober 2004, Roche received a positive recommendation from theEuropean Committee for Medicinal Products for Human Use (CHMP) forAvastin for first-line treatment of patients with metastaticcarcinoma of the colon or rectum in combination with intravenous5-fluorouracil (5-FU)/folinic acid or intravenous 5-FU/folinicacid/irinotecan. Avastin will now be proposed for final marketingapproval by the European Commission.
Roche and Genentech are pursuing a comprehensive clinicalprogramme investigating the use of Avastin in advanced colorectalcancer with other chemotherapies and also expanding into the adjuvantsetting. As Avastin's mechanism may be relevant in a number ofmalignant tumours, Roche and Genentech are also investigating thepotential clinical benefit of Avastin in other cancers, includingnon-small cell lung cancer, pancreatic cancer, renal cell carcinomaand others. Approximately 15,000 patients are expected to be enrolledinto clinical trials over the next years worldwide.
About Avastin
Avastin is the first treatment that inhibits angiogenesis - thegrowth of a network of blood vessels that supply nutrients and oxygento cancerous tissues. Avastin targets a naturally occurring proteincalled VEGF (Vascular Endothelial Growth Factor), a key mediator ofangiogenesis, thus choking off the blood supply that is essential forthe growth of the tumour and its spread throughout the body(metastasis).
Earlier this year, the New England Journal of Medicine publishedresults of a pivotal Phase III study which demonstrated that theaddition of Avastin to standard IFL chemotherapy(irinotecan/5-FU/leucovorin) significantly extends survival inpatients with previously untreated advanced colorectal cancer. Thestudy, in which more than 900 patients participated, showed thatAvastin plus chemotherapy increased overall survival by nearly fivemonths (20.3 months vs 15.6 months) compared to chemotherapyalone.[2]
Roche in Oncology
Within the last five years the Roche Group, including its membersGenentech in the United States and Chugai in Japan, has become theworld's leading provider of anti-cancer treatments, supportive careproducts and diagnostics. Its oncology business includes anunprecedented five products with survival benefit in different majortumour indications: Xeloda and Herceptin in advanced stage breastcancer, MabThera in non-Hodgkin's lymphoma, Avastin in colorectalcarcinoma and Tarceva in non-small cell lung cancer and pancreaticcarcinoma.
In the United States Herceptin, MabThera, Avastin and Tarceva aremarketed either by Genentech alone or together with its partnersBiogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the UnitedStates, Roche and its Japanese partner Chugai are responsible for themarketing of these medicines.
The Roche oncology portfolio also includes NeoRecormon (anaemia invarious cancer settings), Bondronat (prevention of skeletal events inbreast cancer and bone metastases patients, hypercalcaemia ofmalignancy), Kytril (chemotherapy and radiotherapy-induced nausea andvomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia,Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA isthe most recent demonstration of Roche's commitment to anaemiamanagement. The Roche Group's cancer medicines generated sales ofmore than 5.6 billion Swiss francs in the first nine months of 2004.
In addition to the medicines, Roche is developing new diagnostictests that will have a significant impact on disease management forcancer patients in the future. With a broad portfolio of tumourmarkers for prostate, colorectal, liver, ovarian, breast, stomach,pancreas and lung cancer, as well as a range of molecular oncologytests, Roche will continue to be the leader in providingcancer-focused treatments and diagnostics.
Roche has four research sites (two in the United States and oneeach in Germany and Japan) and five development sites (two in theUnited States and one each in UK, Australia and Switzerland).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-intensive healthcare groups. Its core businesses arepharmaceuticals and diagnostics. As a supplier of innovative productsand services for the prevention, diagnosis and treatment of disease,the Group contributes on a broad range of fronts to improvingpeople's health and quality of life. Roche is one of the world'sleading companies in the global diagnostics market, the leadingsupplier of medicines for cancer and transplantation and a marketleader in virology. In 2003, the Pharmaceuticals Division generated19.8 billion Swiss francs in prescription drug sales, while theDiagnostics Division posted sales of 7.4 billion Swiss francs. Rocheemploys roughly 65,000 people in 150 countries and has R&D agreementsand strategic alliances with numerous partners, including majorityownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legallyprotected.
Notes to Editor:
* FOLFOX4 is a standard chemotherapy combination withoxaliplatin, 5-fluorouracil and leucovorin.
Further information:
- www.roche.com
- www.gene.com
- www.health-kiosk.ch
References:
[1] J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000:Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0.IARC CancerBase No. 5. Lyon, IARCPress, 2001
[2] Hurwitz, H, Fehrenbacher, L, Novotny, W, et al. Bevacizumabplus Irinotecan, Fluorouracil, and Leucovorin for MetastaticColorectal Cancer. New England Journal of Medicine 2004; 350(23):2335-2342
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:Media Relations Contacts: Phone: +41-61-688-88-88 / e-mail: basel.mediaoffice@roche.com - Baschi Dürr - Alexander Klauser - Daniel Piller(Head Roche Group Media Office) - Katja Prowald (Head Science Communications) - Martina Rupp
Unique Cancer Drug Avastin Now Shown to Improve Survival Across Different Metastatic Colorectal Cancer Regimens
Preliminary results have shown the study has achieved its primaryendpoint showing that patients who received Avastin plus chemotherapylived nearly two months longer, on average, compared to those whoreceived chemotherapy alone (12.5 months vs 10.7 months). Patientsreceiving Avastin plus chemotherapy had a 26 percent reduction in therisk of death (hazard ratio of 0.74). Oxaliplatin-containingchemotherapy regimens are widely used in first- and second-linemetastatic colorectal cancer therapy.
Colorectal cancer is the third most commonly reported cancer, with945,000 new cases annually worldwide. It is estimated that more than50% of people diagnosed with colorectal cancer will die of thedisease. [1]
"We are delighted with this news," said William M. Burns, Head ofRoche Pharmaceuticals Division. "This is the first time that datahave demonstrated the significant survival benefit that Avastin canalso bring to patients whose disease progresses after initialanti-tumour treatment. Today's data highlight the potential ofAvastin for many patients with metastatic colorectal cancer, as ithas now shown survival benefit when used in either first- orsecond-line."
The randomised, controlled, multi-centre Phase III study,sponsored by the National Cancer Institute, part of the NationalInstitutes of Health, and conducted by a network of researchers ledby the Eastern Cooperative Oncology Group (ECOG), is the firstlarge-scale study to evaluate Avastin in combination with anoxaliplatin-containing chemotherapy regimen (FOLFOX4)*. It is alsothe first large-scale study in patients with metastatic colorectalcancer who had failed a previous chemotherapy regimen (relapsed). Atotal of 829 patients were enrolled in this trial and were randomisedto receive treatment with FOLFOX4 with or without Avastin. Accordingto ECOG, preliminary study results will be presented during the ASCOGastrointestinal Cancers Symposium, January 27-29, 2005 in Hollywood,Florida. Trials investigating the use of Avastin with anoxaliplatin-containing regimen as adjuvant (post operation) treatmentand first-line treatment for patients with metastatic colorectalcancer are currently ongoing.
"These trial results are immensely important because they providestriking evidence that Avastin can be safely combined with the manydifferent chemotherapy regimens commonly used in the treatment ofadvanced colorectal cancer," commented Stefan M. Manth, Head of RocheOncology.
Avastin received fast-track approval by the US Food and DrugAdministration (FDA) and was launched in the US in February 2004. InOctober 2004, Roche received a positive recommendation from theEuropean Committee for Medicinal Products for Human Use (CHMP) forAvastin for first-line treatment of patients with metastaticcarcinoma of the colon or rectum in combination with intravenous5-fluorouracil (5-FU)/folinic acid or intravenous 5-FU/folinicacid/irinotecan. Avastin will now be proposed for final marketingapproval by the European Commission.
Roche and Genentech are pursuing a comprehensive clinicalprogramme investigating the use of Avastin in advanced colorectalcancer with other chemotherapies and also expanding into the adjuvantsetting. As Avastin's mechanism may be relevant in a number ofmalignant tumours, Roche and Genentech are also investigating thepotential clinical benefit of Avastin in other cancers, includingnon-small cell lung cancer, pancreatic cancer, renal cell carcinomaand others. Approximately 15,000 patients are expected to be enrolledinto clinical trials over the next years worldwide.
About Avastin
Avastin is the first treatment that inhibits angiogenesis - thegrowth of a network of blood vessels that supply nutrients and oxygento cancerous tissues. Avastin targets a naturally occurring proteincalled VEGF (Vascular Endothelial Growth Factor), a key mediator ofangiogenesis, thus choking off the blood supply that is essential forthe growth of the tumour and its spread throughout the body(metastasis).
Earlier this year, the New England Journal of Medicine publishedresults of a pivotal Phase III study which demonstrated that theaddition of Avastin to standard IFL chemotherapy(irinotecan/5-FU/leucovorin) significantly extends survival inpatients with previously untreated advanced colorectal cancer. Thestudy, in which more than 900 patients participated, showed thatAvastin plus chemotherapy increased overall survival by nearly fivemonths (20.3 months vs 15.6 months) compared to chemotherapyalone.[2]
Roche in Oncology
Within the last five years the Roche Group, including its membersGenentech in the United States and Chugai in Japan, has become theworld's leading provider of anti-cancer treatments, supportive careproducts and diagnostics. Its oncology business includes anunprecedented five products with survival benefit in different majortumour indications: Xeloda and Herceptin in advanced stage breastcancer, MabThera in non-Hodgkin's lymphoma, Avastin in colorectalcarcinoma and Tarceva in non-small cell lung cancer and pancreaticcarcinoma.
In the United States Herceptin, MabThera, Avastin and Tarceva aremarketed either by Genentech alone or together with its partnersBiogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the UnitedStates, Roche and its Japanese partner Chugai are responsible for themarketing of these medicines.
The Roche oncology portfolio also includes NeoRecormon (anaemia invarious cancer settings), Bondronat (prevention of skeletal events inbreast cancer and bone metastases patients, hypercalcaemia ofmalignancy), Kytril (chemotherapy and radiotherapy-induced nausea andvomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia,Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA isthe most recent demonstration of Roche's commitment to anaemiamanagement. The Roche Group's cancer medicines generated sales ofmore than 5.6 billion Swiss francs in the first nine months of 2004.
In addition to the medicines, Roche is developing new diagnostictests that will have a significant impact on disease management forcancer patients in the future. With a broad portfolio of tumourmarkers for prostate, colorectal, liver, ovarian, breast, stomach,pancreas and lung cancer, as well as a range of molecular oncologytests, Roche will continue to be the leader in providingcancer-focused treatments and diagnostics.
Roche has four research sites (two in the United States and oneeach in Germany and Japan) and five development sites (two in theUnited States and one each in UK, Australia and Switzerland).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-intensive healthcare groups. Its core businesses arepharmaceuticals and diagnostics. As a supplier of innovative productsand services for the prevention, diagnosis and treatment of disease,the Group contributes on a broad range of fronts to improvingpeople's health and quality of life. Roche is one of the world'sleading companies in the global diagnostics market, the leadingsupplier of medicines for cancer and transplantation and a marketleader in virology. In 2003, the Pharmaceuticals Division generated19.8 billion Swiss francs in prescription drug sales, while theDiagnostics Division posted sales of 7.4 billion Swiss francs. Rocheemploys roughly 65,000 people in 150 countries and has R&D agreementsand strategic alliances with numerous partners, including majorityownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legallyprotected.
Notes to Editor:
* FOLFOX4 is a standard chemotherapy combination withoxaliplatin, 5-fluorouracil and leucovorin.
Further information:
- www.roche.com
- www.gene.com
- www.health-kiosk.ch
References:
[1] J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000:Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0.IARC CancerBase No. 5. Lyon, IARCPress, 2001
[2] Hurwitz, H, Fehrenbacher, L, Novotny, W, et al. Bevacizumabplus Irinotecan, Fluorouracil, and Leucovorin for MetastaticColorectal Cancer. New England Journal of Medicine 2004; 350(23):2335-2342
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:Media Relations Contacts: Phone: +41-61-688-88-88 / e-mail: basel.mediaoffice@roche.com - Baschi Dürr - Alexander Klauser - Daniel Piller(Head Roche Group Media Office) - Katja Prowald (Head Science Communications) - Martina Rupp
Roche Pharmaceuticals
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