Data from pivotal phase III AVADO study presented at ASCO for the first time
Basel, Switzerland | 31 May 2008 | Avastin (bevacizumab), significantly improves the time patients with metastatic breast cancer live without their disease getting worse (“progression-free survival”) when combined with a commonly used chemotherapy called docetaxel (Taxotere), compared with docetaxel alone. These findings were presented for the first time today at the American Society of Clinical Oncology (ASCO) meeting in Chicago. This is the second large phase III trial that met its primary endpoint by showing that Avastin provides a significant improvement in progression-free survival in HER 2 negative metastatic breast cancer patients. This follows the recently published landmark E2100 study (Avastin plus paclitaxel versus paclitaxel alone).
The results of the phase III “Avastin and Docetaxel” (“AVADO”, BO17708) study showed that the combination of Avastin and docetaxel resulted in:
* Up to a 64% increase in a patient’s chance of being alive without disease progression compared to docetaxel alone.
* Up to two thirds of patients (63%) experiencing major shrinkage of their tumor, which is unprecedented.
* No new safety signals related to Avastin. Furthermore, Avastin did not have a major impact on the known toxicity profile of docetaxel.
Principal investigator for AVADO, Dr David Miles, medical oncologist, Mount Vernon Hospital, UK said: “This is the second large phase III study to confirm that Avastin extends the time in which patients live without disease progression in combination with a widely used chemotherapy agent. Importantly this study has confirmed that Avastin can be used with taxane- based chemotherapy to provide a meaningful benefit for patients with metastatic breast cancer.”
Two doses of Avastin were investigated in the study (7.5 and 15 mg/kg given every three weeks). The AVADO study was not powered to detect a difference in efficacy between the two doses, however, there was a numerical advantage for efficacy parameters in favor of the 15 mg/kg dose arm. These results, and those of the other landmark study (E2100), support use of this dose (5mg/kg/week). Overall survival data are still immature at present and are expected in 2009.
“The positive results of the AVADO study are encouraging news for patients suffering from metastatic breast cancer and confirm Avastin’s benefits as a treatment against this devastating disease” said William M. Burns, CEO Pharmaceuticals Division of Roche. “With our Avastin development program – the biggest trial program in oncology ever – we will continue to develop the best possible treatment approaches to increase survival and improve quality of life of cancer patients.”
This second large phase III trial follows the recently published E2100 study. Results from E2100 formed the basis of European Commission approval and FDA accelerated approval of Avastin in combination with the widely used chemotherapy paclitaxel for the first-line treatment of metastatic (HER-2 negative) breast cancer in March 2007 and February 2008 respectively. Study E2100 showed that the addition of Avastin to paclitaxel doubled patients’ chance of being alive without disease progression compared to paclitaxel alone.
Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally.
About the AVADO study
AVADO is an international phase III trial which randomized 736 patients who did not receive previous chemotherapy for their metastatic breast cancer to one of three groups;
* Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel
* Avastin 15 mg/kg every 3 weeks in combination with docetaxel
* docetaxel + placebo as control arm
The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms compared to the control arm. Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, quality of life, safety and tolerability.
About Avastin
Avastin directly inhibits vascular endothelial growth factor (VEGF), a key mediator of angiogenesis (the growth of new blood vessels). Blocking tumor angiogenesis with Avastin starves the tumor of the blood supply that is critical for its growth and spread throughout the body (metastasis). Because Avastin directly blocks tumor angiogenesis, a process common to all types of tumor development, it has the potential to deliver patient survival benefits in a variety of different cancer types. Roche is therefore pursuing a comprehensive clinical trial program investigating the use of Avastin in over 20 tumor types and different settings (advanced, post surgical). The total development program is expected to include over 40,000 patients world-wide and has already resulted in approvals in advanced colorectal, breast, lung, and kidney cancer.
* February 2004 (US) and January 2005 (EU) – first-line treatment in patients with metastatic colorectal cancer (CRC)
* June 2006 (US) – second-line treatment in patients with metastatic CRC
* October 2006 (US) and August 2007 (EU) – first-line treatment in patients with advanced non-small cell lung cancer
* March 2007 (EU) – first-line treatment in patients with metastatic breast cancer (BC)
* April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
* December 2007 (EU) – first-line treatment in patients with advanced renal cell cancer
* January 2008 (EU) – first and later-line treatment in patients with metastatic CRC in combination with any chemotherapy
* February 2008 (US) – first line treatment in patients with HER-2 negative metastatic BC
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 the world’s biggest biotech company and an innovator of 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 the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.com.
SOURCE: Roche
Post Views: 64
Data from pivotal phase III AVADO study presented at ASCO for the first time
Basel, Switzerland | 31 May 2008 | Avastin (bevacizumab), significantly improves the time patients with metastatic breast cancer live without their disease getting worse (“progression-free survival”) when combined with a commonly used chemotherapy called docetaxel (Taxotere), compared with docetaxel alone. These findings were presented for the first time today at the American Society of Clinical Oncology (ASCO) meeting in Chicago. This is the second large phase III trial that met its primary endpoint by showing that Avastin provides a significant improvement in progression-free survival in HER 2 negative metastatic breast cancer patients. This follows the recently published landmark E2100 study (Avastin plus paclitaxel versus paclitaxel alone).
The results of the phase III “Avastin and Docetaxel” (“AVADO”, BO17708) study showed that the combination of Avastin and docetaxel resulted in:
* Up to a 64% increase in a patient’s chance of being alive without disease progression compared to docetaxel alone.
* Up to two thirds of patients (63%) experiencing major shrinkage of their tumor, which is unprecedented.
* No new safety signals related to Avastin. Furthermore, Avastin did not have a major impact on the known toxicity profile of docetaxel.
Principal investigator for AVADO, Dr David Miles, medical oncologist, Mount Vernon Hospital, UK said: “This is the second large phase III study to confirm that Avastin extends the time in which patients live without disease progression in combination with a widely used chemotherapy agent. Importantly this study has confirmed that Avastin can be used with taxane- based chemotherapy to provide a meaningful benefit for patients with metastatic breast cancer.”
Two doses of Avastin were investigated in the study (7.5 and 15 mg/kg given every three weeks). The AVADO study was not powered to detect a difference in efficacy between the two doses, however, there was a numerical advantage for efficacy parameters in favor of the 15 mg/kg dose arm. These results, and those of the other landmark study (E2100), support use of this dose (5mg/kg/week). Overall survival data are still immature at present and are expected in 2009.
“The positive results of the AVADO study are encouraging news for patients suffering from metastatic breast cancer and confirm Avastin’s benefits as a treatment against this devastating disease” said William M. Burns, CEO Pharmaceuticals Division of Roche. “With our Avastin development program – the biggest trial program in oncology ever – we will continue to develop the best possible treatment approaches to increase survival and improve quality of life of cancer patients.”
This second large phase III trial follows the recently published E2100 study. Results from E2100 formed the basis of European Commission approval and FDA accelerated approval of Avastin in combination with the widely used chemotherapy paclitaxel for the first-line treatment of metastatic (HER-2 negative) breast cancer in March 2007 and February 2008 respectively. Study E2100 showed that the addition of Avastin to paclitaxel doubled patients’ chance of being alive without disease progression compared to paclitaxel alone.
Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally.
About the AVADO study
AVADO is an international phase III trial which randomized 736 patients who did not receive previous chemotherapy for their metastatic breast cancer to one of three groups;
* Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel
* Avastin 15 mg/kg every 3 weeks in combination with docetaxel
* docetaxel + placebo as control arm
The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms compared to the control arm. Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, quality of life, safety and tolerability.
About Avastin
Avastin directly inhibits vascular endothelial growth factor (VEGF), a key mediator of angiogenesis (the growth of new blood vessels). Blocking tumor angiogenesis with Avastin starves the tumor of the blood supply that is critical for its growth and spread throughout the body (metastasis). Because Avastin directly blocks tumor angiogenesis, a process common to all types of tumor development, it has the potential to deliver patient survival benefits in a variety of different cancer types. Roche is therefore pursuing a comprehensive clinical trial program investigating the use of Avastin in over 20 tumor types and different settings (advanced, post surgical). The total development program is expected to include over 40,000 patients world-wide and has already resulted in approvals in advanced colorectal, breast, lung, and kidney cancer.
* February 2004 (US) and January 2005 (EU) – first-line treatment in patients with metastatic colorectal cancer (CRC)
* June 2006 (US) – second-line treatment in patients with metastatic CRC
* October 2006 (US) and August 2007 (EU) – first-line treatment in patients with advanced non-small cell lung cancer
* March 2007 (EU) – first-line treatment in patients with metastatic breast cancer (BC)
* April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
* December 2007 (EU) – first-line treatment in patients with advanced renal cell cancer
* January 2008 (EU) – first and later-line treatment in patients with metastatic CRC in combination with any chemotherapy
* February 2008 (US) – first line treatment in patients with HER-2 negative metastatic BC
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 the world’s biggest biotech company and an innovator of 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 the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.com.
SOURCE: Roche
Post Views: 64
