— New fixed-dose combination is administered under the skin in just minutes, significantly reducing the time spent receiving treatment —
— Data will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency —
— Results will be presented at an upcoming medical meeting –
SOUTH SAN FRANCISCO, CA, USA I September 12, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III FeDeriCa study met its primary endpoint. The study showed a new investigational fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) compared to standard IV infusion of Perjeta plus Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC). The safety profile of Perjeta and Herceptin FDC was consistent with that of Perjeta and Herceptin administered intravenously.
“With this single injection under the skin, people with HER2-positive breast cancer receiving Perjeta and Herceptin can have a faster treatment option,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Our medicines have helped millions of people living with HER2-positive breast cancer and this latest development is particularly exciting as, for the first time, we have combined two therapeutic antibodies as a single subcutaneous formulation.”
SC administration of the FDC takes approximately 8 minutes for the initial loading dose, and approximately 5 minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions for the combination.
Full data from the FeDeriCa study will be submitted for presentation at an upcoming medical meeting and to health authorities around the world.
About the FeDeriCa study
FeDeriCa is an international, multi-center, two-arm, randomized, open-label, Phase III study evaluating the pharmacokinetics, efficacy and safety of SC injection of the FDC of Perjeta and Herceptin in combination with chemotherapy, compared with standard IV infusion of Perjeta and Herceptin in combination with chemotherapy in people with HER2-positive eBC who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough). Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pCR, meaning there is no tumor tissue detectable at the time of surgery. The safety profile of Perjeta and Herceptin FDC was consistent with that of Perjeta and Herceptin administered intravenously.
About HER2-positive breast cancer
Breast cancer is one of the most common cancers among women worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20% of breast cancers are HER2-positive based on the result of a diagnostic test.
About the FDC of Perjeta and Herceptin
The FDC of Perjeta and Herceptin is a new SC formulation that combines pertuzumab and trastuzumab with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Trastuzumab in the FDC is the same monoclonal antibody in IV Herceptin, and pertuzumab is the same monoclonal antibody in IV Perjeta. The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signaling pathways.
Halozyme’s Enhanze drug delivery technology may enable and optimize SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.
Current Perjeta and Herceptin IV Indication Statements and Important Safety Information
Perjeta Indication Statements
Perjeta (pertuzumab) is approved for use in combination with Herceptin (trastuzumab) and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
Perjeta is approved for use in combination with Herceptin (trastuzumab) and chemotherapy for:
- use prior to surgery (neoadjuvant treatment) in people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than two centimeters in diameter or node-positive). Perjeta should be used as part of a complete treatment regimen for early breast cancer.
- use after surgery (adjuvant treatment) in people with HER2-positive early breast cancer that has a high likelihood of coming back.
Herceptin Indication Statements
Adjuvant Breast Cancer
Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature. * Herceptin can be used in several different ways:
- As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC→TH.”
- With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH.”
- Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).
Patients are selected for therapy based on an FDA-approved test for Herceptin.
*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.
Metastatic Breast Cancer
Herceptin has two approved uses in metastatic breast cancer:
- Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of HumanEpidermal growth factor Receptor 2-positive (HER2-positive) metastatic breast cancer.
- Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.
Patients are selected for therapy based on an FDA-approved test for Herceptin.
About Genentech in breast cancer
Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 16
— New fixed-dose combination is administered under the skin in just minutes, significantly reducing the time spent receiving treatment —
— Data will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency —
— Results will be presented at an upcoming medical meeting –
SOUTH SAN FRANCISCO, CA, USA I September 12, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III FeDeriCa study met its primary endpoint. The study showed a new investigational fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) compared to standard IV infusion of Perjeta plus Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC). The safety profile of Perjeta and Herceptin FDC was consistent with that of Perjeta and Herceptin administered intravenously.
“With this single injection under the skin, people with HER2-positive breast cancer receiving Perjeta and Herceptin can have a faster treatment option,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Our medicines have helped millions of people living with HER2-positive breast cancer and this latest development is particularly exciting as, for the first time, we have combined two therapeutic antibodies as a single subcutaneous formulation.”
SC administration of the FDC takes approximately 8 minutes for the initial loading dose, and approximately 5 minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions for the combination.
Full data from the FeDeriCa study will be submitted for presentation at an upcoming medical meeting and to health authorities around the world.
About the FeDeriCa study
FeDeriCa is an international, multi-center, two-arm, randomized, open-label, Phase III study evaluating the pharmacokinetics, efficacy and safety of SC injection of the FDC of Perjeta and Herceptin in combination with chemotherapy, compared with standard IV infusion of Perjeta and Herceptin in combination with chemotherapy in people with HER2-positive eBC who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough). Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pCR, meaning there is no tumor tissue detectable at the time of surgery. The safety profile of Perjeta and Herceptin FDC was consistent with that of Perjeta and Herceptin administered intravenously.
About HER2-positive breast cancer
Breast cancer is one of the most common cancers among women worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20% of breast cancers are HER2-positive based on the result of a diagnostic test.
About the FDC of Perjeta and Herceptin
The FDC of Perjeta and Herceptin is a new SC formulation that combines pertuzumab and trastuzumab with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Trastuzumab in the FDC is the same monoclonal antibody in IV Herceptin, and pertuzumab is the same monoclonal antibody in IV Perjeta. The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signaling pathways.
Halozyme’s Enhanze drug delivery technology may enable and optimize SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.
Current Perjeta and Herceptin IV Indication Statements and Important Safety Information
Perjeta Indication Statements
Perjeta (pertuzumab) is approved for use in combination with Herceptin (trastuzumab) and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
Perjeta is approved for use in combination with Herceptin (trastuzumab) and chemotherapy for:
- use prior to surgery (neoadjuvant treatment) in people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than two centimeters in diameter or node-positive). Perjeta should be used as part of a complete treatment regimen for early breast cancer.
- use after surgery (adjuvant treatment) in people with HER2-positive early breast cancer that has a high likelihood of coming back.
Herceptin Indication Statements
Adjuvant Breast Cancer
Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature. * Herceptin can be used in several different ways:
- As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC→TH.”
- With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH.”
- Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).
Patients are selected for therapy based on an FDA-approved test for Herceptin.
*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.
Metastatic Breast Cancer
Herceptin has two approved uses in metastatic breast cancer:
- Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of HumanEpidermal growth factor Receptor 2-positive (HER2-positive) metastatic breast cancer.
- Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.
Patients are selected for therapy based on an FDA-approved test for Herceptin.
About Genentech in breast cancer
Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 16
