Investor Update
Basel, 17 May 2005
Twice as many long-term survivors with HER2-positive metastatic breast cancer following treatment with Herceptin
Two-year follow-up results show powerful new evidence for Herceptin as the foundation of care in HER2-positive metastatic breast cancer
New two-year follow-up data presented today at the American Society of Clinical Oncology (ASCO) annual meeting shows that the targeted anti-cancer therapy Herceptin (trastuzumab) doubles the number of long-term survivors with an aggressive form of metastatic breast cancer, known as HER2-positive, which affects 20 – 30% of women with breast cancer.
The randomised study
“These data confirm the impressive durability of response with Herceptin in the treatment of metastatic breast cancer and will provide great hope to thousands of patients,” said principal study investigator, Professor Michel Marty, Head of Therapeutic Innovation in Onco Haematology at Saint Louis University Hospital, Paris, France. “There is now firm evidence from two large randomised studies that Herceptin provides significant survival benefit for women with HER2-positive metastatic breast cancer.”
Further ASCO news: ER/HER2 co-positive metastatic breast cancer
Other data published at ASCO reported on the incidence of metastatic breast tumours which overexpress both HER2 and oestrogen receptors (ER). The French National Epidemiological Study (ESTHER)
Whilst the majority of patients with ER/HER2 co-positive metastatic breast cancer is currently treated with hormonal therapy alone, preclinical data suggest that the addition of Herceptin to standard hormonal therapy may provide additional benefits to this patient subgroup. The medical community now eagerly awaits the results from the phase III TAnDEM study, which investigates Herceptin in combination with the hormonal therapy anastrozole (an aromatase inhibitor). Results from the TAnDEM study are expected near the end of 2005 or early 2006.
About the M77001 study
188 patients were recruited into the study (M77001), 94 patients randomised to receive Herceptin plus Taxotere and 94 randomised to receive Taxotere alone. Two patients in the combination arm did not receive study drug and were excluded from the final analysis. Taxotere was scheduled at a dose of 100 mg/m2 every 3 weeks for at least 6 cycles. Herceptin was administered in 2mg/kg weekly doses until disease progression (after an initial loading dose of 4mg/kg). Patients in the Taxotere arm of the study were given the option to cross over to receive Herceptin, following disease progression.
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.
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.’ HER2-positive breast cancer is a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that 20-30% of breast cancers are HER2 positive.
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 both the advanced (metastatic) and early-stage breast cancer setting. In the advanced setting, the addition of Herceptin 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 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
Twice as many long-term survivors with HER2-positive metastatic breast cancer following treatment with Herceptin
Two-year follow-up results show powerful new evidence for Herceptin as the foundation of care in HER2-positive metastatic breast cancer
New two-year follow-up data presented today at the American Society of Clinical Oncology (ASCO) annual meeting shows that the targeted anti-cancer therapy Herceptin (trastuzumab) doubles the number of long-term survivors with an aggressive form of metastatic breast cancer, known as HER2-positive, which affects 20 – 30% of women with breast cancer.
1
The randomised study
2
investigated Herceptin in combination with Taxotere versus Taxotere alone as a first-line treatment in HER2-positive patients with metastatic disease. Long-term follow-up now shows that twice as many patients who received the combination therapy are still alive three years after starting therapy (33% vs. 16%). Notably, as patients in the chemotherapy alone arm were allowed to cross over to receive Herceptin following disease progression, 91% of all long-term survivors had received Herceptin. The combination also significantly prolonged life by more than one-third (31 months vs. 23 months), which is highly statistically significant in this patient population. This news strongly supports the first-line use of Herceptin plus taxanes in patients with HER2-positive metastatic breast cancer and confirms that establishing HER2 status is an essential step in the management of the disease.“These data confirm the impressive durability of response with Herceptin in the treatment of metastatic breast cancer and will provide great hope to thousands of patients,” said principal study investigator, Professor Michel Marty, Head of Therapeutic Innovation in Onco Haematology at Saint Louis University Hospital, Paris, France. “There is now firm evidence from two large randomised studies that Herceptin provides significant survival benefit for women with HER2-positive metastatic breast cancer.”
Further ASCO news: ER/HER2 co-positive metastatic breast cancer
Other data published at ASCO reported on the incidence of metastatic breast tumours which overexpress both HER2 and oestrogen receptors (ER). The French National Epidemiological Study (ESTHER)
3
demonstrated that nearly two-thirds (61%) of breast cancer tumours are ER-positive, and a significant group of patients have tumours that are both ER- and HER2-positive (14%). ER/HER2 co-positive breast cancer is a distinct subgroup with a relatively poor prognosis because of the HER2-positivity.Whilst the majority of patients with ER/HER2 co-positive metastatic breast cancer is currently treated with hormonal therapy alone, preclinical data suggest that the addition of Herceptin to standard hormonal therapy may provide additional benefits to this patient subgroup. The medical community now eagerly awaits the results from the phase III TAnDEM study, which investigates Herceptin in combination with the hormonal therapy anastrozole (an aromatase inhibitor). Results from the TAnDEM study are expected near the end of 2005 or early 2006.
About the M77001 study
188 patients were recruited into the study (M77001), 94 patients randomised to receive Herceptin plus Taxotere and 94 randomised to receive Taxotere alone. Two patients in the combination arm did not receive study drug and were excluded from the final analysis. Taxotere was scheduled at a dose of 100 mg/m2 every 3 weeks for at least 6 cycles. Herceptin was administered in 2mg/kg weekly doses until disease progression (after an initial loading dose of 4mg/kg). Patients in the Taxotere arm of the study were given the option to cross over to receive Herceptin, following disease progression.
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.
4
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.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.’ HER2-positive breast cancer is a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that 20-30% of breast cancers are HER2 positive.
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 both the advanced (metastatic) and early-stage breast cancer setting. In the advanced setting, the addition of Herceptin 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 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.
References
1.
Harries M, Smith I., Endocr Relat Cancer 9: 75-85, 2002.
2. Extra JM, Cognetti
F, Maraninchi D et al. Long-term survival demonstrated with trastuzumab plus docetaxel: 24-month data
from a randomised trial (M77001) in HER2-positive metastatic breast cancer. Abstract #555, American
Society for Clinical Oncology (ASCO) Annual Meeting 2005
3. Penault–Llorca F, Vincent-Salomon
A, Mathieu MC et al. Incidence and implications of HER2 and hormonal receptor overexpression in newly
diagnosed metastatic breast cancer (MBC). Abstract #764 American Society for Clinical Oncology (ASCO)
Annual Meeting 2005
4. World Health Organization, 2000
Further information:
- Cancer: www.health-kiosk.ch