Investor Update
Basel, 16 May 2005
Herceptin plus chemotherapy improved disease-free survival and overall survival in adjuvant setting for early-stage Her2-positive breast cancer patients
Results from two phase III adjuvant trials showed that adding Herceptin to chemotherapy reduced the risk of breast cancer recurrence by 52 percent
Roche and Genentech announced on Friday that data from a joint interim analysis of two phase III studies of Herceptin (trastuzumab) in early-stage breast cancer showed that human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients receiving Herceptin plus chemotherapy had a 52 percent reduction in the risk of disease recurrence compared to those patients who received chemotherapy alone (or a hazard ratio of 0.48). After four years in the study, 15 percent of women treated with Herceptin plus chemotherapy experienced disease recurrence, compared to 33 percent of women treated with chemotherapy alone. Preliminary survival data showed a 49 percent improvement in overall survival (or a hazard ratio of 0.67, which is equivalent to a 33 percent reduction in the risk of death). Survival data continue to mature.
“The reduction in disease recurrence observed in these trials was the largest improvement I’ve seen in breast cancer clinical research. Herceptin plus chemotherapy can potentially stop or delay early-stage HER2-positive breast cancer from relapsing,” said Edith Perez, M.D., professor of medicine at the Mayo Clinic in Jacksonville, Fla., and the lead investigator in one of the two Herceptin trials. “These trials also underscore the importance for every woman diagnosed with breast cancer to receive a HER2 test.”
A preliminary safety analysis showed that adverse events in these studies were consistent with those seen in previous Herceptin clinical trials. Each study had an independent external Data Monitoring Committee (DMC) that reviewed data from the studies, including cardiac safety data on a regular basis. According to the investigators, serious or life-threatening (and in rare cases, fatal) cardiac events, most commonly congestive heart failure (weakening of the heart muscle) occurred approximately 3 to 4 percent more often in the Herceptin plus chemotherapy arms than in the chemotherapy alone arms. Patients in these studies will continue to be followed for any additional side effects.
In these studies, women with early-stage (or cancer that has not spread beyond the breast and the associated lymph nodes) HER2-positive breast cancer received Herceptin plus chemotherapy or chemotherapy alone following initial treatment with surgery and anthracycline and cyclophosphamide (AC). HER2-positive breast cancer is an especially aggressive form of the disease that affects approximately 25 percent of women with breast cancer.
These data were featured in a press briefing at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). More detailed data from the study will be presented to meeting attendees by Edward Romond, M.D., of the University of Kentucky during a scientific symposium (“Advances in Monoclonal Antibodies for Breast Cancer” – Monday, May 16, 1.15 pm EDT).
"These results in early-stage HER2-positive breast cancer suggest that Herceptin may increase the chance of long-term survival by preventing the development of metastatic disease,” said Kapil Dhingra, M.D., Roche’s Vice President, Oncology. “We are also excited about the improvements seen in the adjuvant setting, since patient outcomes are measured in years rather than months. We will work closely with the health authorities to make this medicine accessible to patients with early-stage HER2-positive breast cancer as quickly as possible.”
About the study designs
The National Surgical Adjuvant Breast and Bowel Project (NSABP) study began enrollment in March 2000 and has enrolled 2,085 patients to date; the North Central Cancer Treatment Group (NCCTG) study enrolled its first patient in June 2000 and has enrolled 3,406 patients to date. The joint, interim analysis was based on data from 3,351 patients. Each of the studies was a randomized, controlled trial that evaluated the combination of anthracycline and cyclophosphamide (AC) followed by paclitaxel, with or without Herceptin using different treatment schedules of paclitaxel in women with HER2-positive breast cancer.
About the Herceptin adjuvant clinical trial program
In addition to the NSABP and NCCTG adjuvant studies, Roche and Breast International Group (BIG) announced in April 2005 that the interim analysis of HERA (HERceptin Adjuvant), a large scale, 39-country, phase III study with a wide range of chemotherapy regimens, showed that the addition of Herceptin increased disease-free survival for women with early-stage HER2-positive breast cancer.
Enrollment in the HERA trial began in December 2001, and nearly 5,100 patients have been enrolled at 480 sites in 39 countries worldwide. The interim analysis compared 12 months of Herceptin versus observation and did not include a comparison of 24 months of Herceptin versus observation. These data will become available as the study matures.
The HERA study has an external Independent Data Monitoring Committee (IDMC) that regularly reviews safety data. No safety concerns have been raised by the IDMC to date. Patients in this study will continue to be followed for any side effects.
About breast cancer and Herceptin
Eight to nine percent of women will develop breast cancer during their lifetime, making it one of the most common types of cancer in women. Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year. According to the American Cancer Society, an estimated 211,000 women will be diagnosed with breast cancer and approximately 40,000 women will die of the disease in the United States in 2005. In the United States, breast cancer is the most prevalent form of cancer among women and a woman is diagnosed with breast cancer every three minutes.
In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2 positivity.’ High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20-30% of women with breast cancer.
Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. Herceptin has demonstrated improved survival in the advanced (metastatic) setting, where its addition to chemotherapy allows patients to live up to one-third longer than chemotherapy alone. Herceptin received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein, as first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in second- and third-line therapy. In 2004, it also received approval for use in combination with docetaxel as a first-line therapy in HER2-positive patients who have not received chemotherapy for their metastatic disease. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat over 230,000 HER2-positive breast cancer patients worldwide.
Roche in Oncology
The Roche Group, including its members Genentech in the United States and Chugai in Japan, is the world’s leading provider of cancer care products, including anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products proven to provide survival benefit in different major tumour indications: Avastin, Herceptin, and Xeloda in advanced-stage breast cancer, Herceptin in early-stage HER2-positive breast cancer, MabThera in non-Hodgkin’s lymphoma, Avastin and Xeloda in colorectal cancer, Avastin and Tarceva in non-small cell lung cancer and Tarceva in pancreatic cancer.
In addition to these anti-cancer agents, the Roche oncology portfolio includes a comprehensive collection of medicines that can help improve the quality of life of cancer patients: Bondronat (for prevention of skeletal events in patients with breast cancer and bone metastases, hypercalcaemia of malignancy), Kytril (for chemotherapy and radiotherapy-induced nausea and vomiting), Neupogen (for cancer-related neutropenia), and NeoRecormon (for anaemia in various cancer settings). CERA is the most recent demonstration of Roche’s commitment to anaemia management. Other oncology products include Furtulon (for colorectal cancer) and Roferon-A (for hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). The Roche Group’s cancer medicines generated sales of more than 7.7 billion Swiss francs in 2004.
In addition to the medicines, Roche is developing new diagnostic tests that will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.
The unmatched Roche oncology portfolio as well as an extensive external innovation base through collaborations with companies and academia is what makes it possible for Roche to provide more effective cancer therapies.
In the United States Herceptin, MabThera (Rituxan), Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.
About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is leading clinical development programs for Rituxan® (Rituximab), Herceptin (Trastuzumab), Avastin (bevacizumab) and Tarceva (erlotinib), and markets all four products in the United States alone (Avastin and Herceptin), with Biogen Idec Inc. (Rituxan) or with OSI Pharmaceuticals (Tarceva). Genentech has licensed Rituxan, Herceptin, and Avastin, and OSI Pharmaceuticals has licensed Tarceva to Roche for sale by the Roche Group outside of the United States.
The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e. programmed cell death), the HER pathway and B-cell biology. Potential oncology therapies directed at the HER pathway include a therapeutic antibody currently in Phase II trials. Also in early development are a small molecule directed at the hedgehog pathway, a soluble human protein targeting apoptosis and a humanized anti-CD20 antibody for hematology/oncology indications.
Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from, or are based on, Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit www.gene.com.
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 disease, 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 medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 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 (www.roche.com).
Further information:
- Cancer: www.health-kiosk.ch
Herceptin plus chemotherapy improved disease-free survival and overall survival in adjuvant setting for early-stage Her2-positive breast cancer patients
Results from two phase III adjuvant trials showed that adding Herceptin to chemotherapy reduced the risk of breast cancer recurrence by 52 percent
Roche and Genentech announced on Friday that data from a joint interim analysis of two phase III studies of Herceptin (trastuzumab) in early-stage breast cancer showed that human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients receiving Herceptin plus chemotherapy had a 52 percent reduction in the risk of disease recurrence compared to those patients who received chemotherapy alone (or a hazard ratio of 0.48). After four years in the study, 15 percent of women treated with Herceptin plus chemotherapy experienced disease recurrence, compared to 33 percent of women treated with chemotherapy alone. Preliminary survival data showed a 49 percent improvement in overall survival (or a hazard ratio of 0.67, which is equivalent to a 33 percent reduction in the risk of death). Survival data continue to mature.
“The reduction in disease recurrence observed in these trials was the largest improvement I’ve seen in breast cancer clinical research. Herceptin plus chemotherapy can potentially stop or delay early-stage HER2-positive breast cancer from relapsing,” said Edith Perez, M.D., professor of medicine at the Mayo Clinic in Jacksonville, Fla., and the lead investigator in one of the two Herceptin trials. “These trials also underscore the importance for every woman diagnosed with breast cancer to receive a HER2 test.”
A preliminary safety analysis showed that adverse events in these studies were consistent with those seen in previous Herceptin clinical trials. Each study had an independent external Data Monitoring Committee (DMC) that reviewed data from the studies, including cardiac safety data on a regular basis. According to the investigators, serious or life-threatening (and in rare cases, fatal) cardiac events, most commonly congestive heart failure (weakening of the heart muscle) occurred approximately 3 to 4 percent more often in the Herceptin plus chemotherapy arms than in the chemotherapy alone arms. Patients in these studies will continue to be followed for any additional side effects.
In these studies, women with early-stage (or cancer that has not spread beyond the breast and the associated lymph nodes) HER2-positive breast cancer received Herceptin plus chemotherapy or chemotherapy alone following initial treatment with surgery and anthracycline and cyclophosphamide (AC). HER2-positive breast cancer is an especially aggressive form of the disease that affects approximately 25 percent of women with breast cancer.
These data were featured in a press briefing at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). More detailed data from the study will be presented to meeting attendees by Edward Romond, M.D., of the University of Kentucky during a scientific symposium (“Advances in Monoclonal Antibodies for Breast Cancer” – Monday, May 16, 1.15 pm EDT).
"These results in early-stage HER2-positive breast cancer suggest that Herceptin may increase the chance of long-term survival by preventing the development of metastatic disease,” said Kapil Dhingra, M.D., Roche’s Vice President, Oncology. “We are also excited about the improvements seen in the adjuvant setting, since patient outcomes are measured in years rather than months. We will work closely with the health authorities to make this medicine accessible to patients with early-stage HER2-positive breast cancer as quickly as possible.”
About the study designs
The National Surgical Adjuvant Breast and Bowel Project (NSABP) study began enrollment in March 2000 and has enrolled 2,085 patients to date; the North Central Cancer Treatment Group (NCCTG) study enrolled its first patient in June 2000 and has enrolled 3,406 patients to date. The joint, interim analysis was based on data from 3,351 patients. Each of the studies was a randomized, controlled trial that evaluated the combination of anthracycline and cyclophosphamide (AC) followed by paclitaxel, with or without Herceptin using different treatment schedules of paclitaxel in women with HER2-positive breast cancer.
About the Herceptin adjuvant clinical trial program
In addition to the NSABP and NCCTG adjuvant studies, Roche and Breast International Group (BIG) announced in April 2005 that the interim analysis of HERA (HERceptin Adjuvant), a large scale, 39-country, phase III study with a wide range of chemotherapy regimens, showed that the addition of Herceptin increased disease-free survival for women with early-stage HER2-positive breast cancer.
Enrollment in the HERA trial began in December 2001, and nearly 5,100 patients have been enrolled at 480 sites in 39 countries worldwide. The interim analysis compared 12 months of Herceptin versus observation and did not include a comparison of 24 months of Herceptin versus observation. These data will become available as the study matures.
The HERA study has an external Independent Data Monitoring Committee (IDMC) that regularly reviews safety data. No safety concerns have been raised by the IDMC to date. Patients in this study will continue to be followed for any side effects.
About breast cancer and Herceptin
Eight to nine percent of women will develop breast cancer during their lifetime, making it one of the most common types of cancer in women. Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year. According to the American Cancer Society, an estimated 211,000 women will be diagnosed with breast cancer and approximately 40,000 women will die of the disease in the United States in 2005. In the United States, breast cancer is the most prevalent form of cancer among women and a woman is diagnosed with breast cancer every three minutes.
In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2 positivity.’ High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20-30% of women with breast cancer.
Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. Herceptin has demonstrated improved survival in the advanced (metastatic) setting, where its addition to chemotherapy allows patients to live up to one-third longer than chemotherapy alone. Herceptin received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein, as first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in second- and third-line therapy. In 2004, it also received approval for use in combination with docetaxel as a first-line therapy in HER2-positive patients who have not received chemotherapy for their metastatic disease. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat over 230,000 HER2-positive breast cancer patients worldwide.
Roche in Oncology
The Roche Group, including its members Genentech in the United States and Chugai in Japan, is the world’s leading provider of cancer care products, including anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products proven to provide survival benefit in different major tumour indications: Avastin, Herceptin, and Xeloda in advanced-stage breast cancer, Herceptin in early-stage HER2-positive breast cancer, MabThera in non-Hodgkin’s lymphoma, Avastin and Xeloda in colorectal cancer, Avastin and Tarceva in non-small cell lung cancer and Tarceva in pancreatic cancer.
In addition to these anti-cancer agents, the Roche oncology portfolio includes a comprehensive collection of medicines that can help improve the quality of life of cancer patients: Bondronat (for prevention of skeletal events in patients with breast cancer and bone metastases, hypercalcaemia of malignancy), Kytril (for chemotherapy and radiotherapy-induced nausea and vomiting), Neupogen (for cancer-related neutropenia), and NeoRecormon (for anaemia in various cancer settings). CERA is the most recent demonstration of Roche’s commitment to anaemia management. Other oncology products include Furtulon (for colorectal cancer) and Roferon-A (for hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). The Roche Group’s cancer medicines generated sales of more than 7.7 billion Swiss francs in 2004.
In addition to the medicines, Roche is developing new diagnostic tests that will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.
The unmatched Roche oncology portfolio as well as an extensive external innovation base through collaborations with companies and academia is what makes it possible for Roche to provide more effective cancer therapies.
In the United States Herceptin, MabThera (Rituxan), Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.
About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is leading clinical development programs for Rituxan® (Rituximab), Herceptin (Trastuzumab), Avastin (bevacizumab) and Tarceva (erlotinib), and markets all four products in the United States alone (Avastin and Herceptin), with Biogen Idec Inc. (Rituxan) or with OSI Pharmaceuticals (Tarceva). Genentech has licensed Rituxan, Herceptin, and Avastin, and OSI Pharmaceuticals has licensed Tarceva to Roche for sale by the Roche Group outside of the United States.
The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e. programmed cell death), the HER pathway and B-cell biology. Potential oncology therapies directed at the HER pathway include a therapeutic antibody currently in Phase II trials. Also in early development are a small molecule directed at the hedgehog pathway, a soluble human protein targeting apoptosis and a humanized anti-CD20 antibody for hematology/oncology indications.
Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from, or are based on, Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit www.gene.com.
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 disease, 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 medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 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 (www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Further information:
- Cancer: www.health-kiosk.ch
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