Announced today that a phase III study investigating Avastin (bevacizumab) in combination with chemotherapy met its primary endpoint of improving progression free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC), the most common form of the disease.
BASEL, Switzerland | Feb 22, 2007 | Roche announced today that a phase III study investigating Avastin (bevacizumab) in combination with chemotherapy met its primary endpoint of improving progression free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC), the most common form of the disease. This benefit was seen in patients who received either one of two different Avastin doses investigated in the trial.
The results of the phase III "Avastin in Lung" ("AVAiL", BO17704) study showed that Avastin administered in a schedule of either 7.5 or 15 mg/kg every 3 weeks in combination with gemcitabine/cisplatin chemotherapy significantly prolonged the time patients with advanced NSCLC lived without their disease progressing ("progression-free survival") when compared to chemotherapy alone. Although the study was not designed to compare the Avastin doses, a similar treatment effect in progression-free survival was observed between the two arms. The benefit and relative safety of each arm will be presented at an upcoming medical meeting. There were no new safety signals associated with the use of Avastin at either dose in this clinical setting.
"In addition to supporting Avastin’s efficacy in advanced lung cancer, these positive results demonstrate Avastin’s treatment benefits when used in combination with a different chemotherapy regimen than the one investigated in the pivotal E4599 trial," said William M. Burns, CEO Roche Pharmaceuticals. "We look forward to sharing the findings with health authorities in Europe and working with them to make Avastin available to patients with advanced lung cancer as soon as possible."
The results from BO17704 complement the dossier for the filing of Avastin in NSCLC which was submitted to EU health authorities in August 2006. In the US, Avastin was approved for the treatment of NSCLC in October 2006.
About BO17704
BO17704 is an international Phase III trial which includes more than 1000 patients with previously untreated advanced NSCLC, the most common form of lung cancer, with histology other than predominant squamous cell. The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms versus the control regimen.
About E4599
In another phase III trial E45991, Avastin was investigated with a different platinum-based chemotherapy regimen (carboplatin/paclitaxel). The study showed that the median duration of survival in the Avastin plus paclitaxel and carboplatin chemotherapy group was 12.3 months compared to 10.3 months in the group treated with chemotherapy alone. Overall patients treated with Avastin plus chemotherapy had a 27 percent improvement in survival compared to patients receiving chemotherapy alone.
About Lung Cancer
Lung cancer accounts for 1 in 3 and 1 in 4 cancer-related deaths in men and women, respectively. NSCLC is the most common form of the disease and accounts for more than 80 percent of all lung cancers, with histology other than predominant squamous cell as the most common subtype accounting for approximately 60 percent of NSCLC cases. Sadly, the majority of NSCLC cases are diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than five percent of people with advanced NSCLC survive for five years after diagnosis and most die within twelve months2.
About Avastin
Avastin is the first treatment that inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).
Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
1) Sandler A et al. Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer. New England Journal of Medicine 2006; 355:2542-50
2) Wilking N and Jonsson B. A Pan-European comparison regarding patient access to cancer drugs. Karolinska Institute in collaboration with Stockholm School of Economics, Stockholm, Sweden, 2005.
SOURCE: Roche
Post Views: 196
Announced today that a phase III study investigating Avastin (bevacizumab) in combination with chemotherapy met its primary endpoint of improving progression free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC), the most common form of the disease.
BASEL, Switzerland | Feb 22, 2007 | Roche announced today that a phase III study investigating Avastin (bevacizumab) in combination with chemotherapy met its primary endpoint of improving progression free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC), the most common form of the disease. This benefit was seen in patients who received either one of two different Avastin doses investigated in the trial.
The results of the phase III "Avastin in Lung" ("AVAiL", BO17704) study showed that Avastin administered in a schedule of either 7.5 or 15 mg/kg every 3 weeks in combination with gemcitabine/cisplatin chemotherapy significantly prolonged the time patients with advanced NSCLC lived without their disease progressing ("progression-free survival") when compared to chemotherapy alone. Although the study was not designed to compare the Avastin doses, a similar treatment effect in progression-free survival was observed between the two arms. The benefit and relative safety of each arm will be presented at an upcoming medical meeting. There were no new safety signals associated with the use of Avastin at either dose in this clinical setting.
"In addition to supporting Avastin’s efficacy in advanced lung cancer, these positive results demonstrate Avastin’s treatment benefits when used in combination with a different chemotherapy regimen than the one investigated in the pivotal E4599 trial," said William M. Burns, CEO Roche Pharmaceuticals. "We look forward to sharing the findings with health authorities in Europe and working with them to make Avastin available to patients with advanced lung cancer as soon as possible."
The results from BO17704 complement the dossier for the filing of Avastin in NSCLC which was submitted to EU health authorities in August 2006. In the US, Avastin was approved for the treatment of NSCLC in October 2006.
About BO17704
BO17704 is an international Phase III trial which includes more than 1000 patients with previously untreated advanced NSCLC, the most common form of lung cancer, with histology other than predominant squamous cell. The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms versus the control regimen.
About E4599
In another phase III trial E45991, Avastin was investigated with a different platinum-based chemotherapy regimen (carboplatin/paclitaxel). The study showed that the median duration of survival in the Avastin plus paclitaxel and carboplatin chemotherapy group was 12.3 months compared to 10.3 months in the group treated with chemotherapy alone. Overall patients treated with Avastin plus chemotherapy had a 27 percent improvement in survival compared to patients receiving chemotherapy alone.
About Lung Cancer
Lung cancer accounts for 1 in 3 and 1 in 4 cancer-related deaths in men and women, respectively. NSCLC is the most common form of the disease and accounts for more than 80 percent of all lung cancers, with histology other than predominant squamous cell as the most common subtype accounting for approximately 60 percent of NSCLC cases. Sadly, the majority of NSCLC cases are diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than five percent of people with advanced NSCLC survive for five years after diagnosis and most die within twelve months2.
About Avastin
Avastin is the first treatment that inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).
Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
1) Sandler A et al. Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer. New England Journal of Medicine 2006; 355:2542-50
2) Wilking N and Jonsson B. A Pan-European comparison regarding patient access to cancer drugs. Karolinska Institute in collaboration with Stockholm School of Economics, Stockholm, Sweden, 2005.
SOURCE: Roche
Post Views: 196
