SOUTH SAN FRANCISCO, CA, USA I August 6, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population.
The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of OS and data were immature at time of analysis. OS follow-up is planned to continue until final analysis. Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified.
In the previous IMpassion130 study, Tecentriq in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension [albumin-bound]; nab-paclitaxel) demonstrated a statistically significant PFS benefit and, while not formally tested, showed clinically meaningful improvements in OS for people with metastatic TNBC and whose tumors express PD-L1 (≥1%). Tecentriq in combination with nab-paclitaxel is approved under accelerated approval by the U.S. Food and Drug Administration for the treatment of adults with unresectable locally advanced or metastatic TNBC and whose tumors express PD-L1 (≥1%).
“While we are disappointed by the results from the IMpassion131 study, we are grateful for all the patients, families and physicians who were involved in the study,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens. We remain committed to finding optimal treatments for all people living with this aggressive disease.”
Full results from IMpassion131 are being discussed with global health authorities and will be presented at a future medical meeting. The insights will also be used to inform existing and future studies in TNBC with Tecentriq in combination with paclitaxel.
Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMpassion131 study
The IMpassion131 study is a Phase III, multi-center, randomized, double-blind study evaluating the efficacy and safety of Tecentriq in combination with paclitaxel, in comparison to placebo plus paclitaxel, in people with previously untreated, inoperable, locally advanced or metastatic TNBC. The study enrolled 651 people who were randomized in a 2:1 ratio to receive Tecentriq or placebo plus paclitaxel. The primary endpoint is PFS per investigator assessment (RECIST 1.1) in the PD-L1-positive population, followed by intention-to-treat (ITT) population. Secondary endpoints include OS, objective response rate, and duration of response in the PD-L1-positive and ITT populations.
About triple-negative breast cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, close to 280,000 people in the United States will be diagnosed with invasive breast cancer, and more than 42,000 will die from the disease in 2020. Breast cancer is not one, but many diseases based on the biology of each tumor. In triple-negative breast cancer, tumor cells lack hormone receptors and do not have excess HER2 protein. Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. It is an aggressive form of the disease with few treatment options.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)
Tecentriq is a prescription medicine used to treat adults with:
A type of bladder and urinary tract cancer called urothelial carcinoma.
Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:
- They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for “PD-L1” or
- They are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status or
- They have tried chemotherapy that contains platinum and it did not work or is no longer working.
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
Tecentriq may be used alone as the first treatment in patients with lung cancer if:
- Their cancer has spread or grown and
- Their cancer tests positive for “high PD-L1”, and
- Their tumor does not have an abnormal “EGFR” or “ALK” gene.
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:
- Their cancer has spread or grown, and
- Is a type called “non-squamous NSCLC”, and
- Their tumor does not have an abnormal “EGFR” or “ALK” gene.
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:
- Their cancer has spread or grown, and
- Is a type called “non-squamous NSCLC”, and
- Their tumor does not have an abnormal “EGFR” or “ALK” gene.
Tecentriq may be used alone in patients with lung cancer if:
- Their cancer has spread or grown and
- They have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
A type of breast cancer called triple-negative breast cancer (TNBC).
Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:
- Has spread or cannot be removed by surgery and
- Their cancer tests positive for “PD-L1”.
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
A type of lung cancer called small cell lung cancer (SCLC).
- Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer is a type of lung cancer called “extensive-stage small cell lung cancer,” which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC).
Tecentriq may be used with the medicine bevacizumab when a patient’s liver cancer:
- Has spread or cannot be removed by surgery, and
- The patient has not received other medicines by mouth or injection through their vein (IV) to treat their cancer.
A type of skin cancer called melanoma.
Tecentriq may be used with the medicines cobimetinib and vemurafenib when a patient’s melanoma:
- Has spread or cannot be removed by surgery, and
- Their cancer has a certain type of abnormal “BRAF” gene. Their healthcare provider will perform a test to make sure this Tecentriq combination is right for them.
It is not known if Tecentriq is safe and effective in children.
Please visit http://www.Tecentriq.com for the full Tecentriq Prescribing Information for additional Important Safety Information.
About Genentech in cancer immunotherapy
Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.
In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.
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: 28
SOUTH SAN FRANCISCO, CA, USA I August 6, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population.
The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of OS and data were immature at time of analysis. OS follow-up is planned to continue until final analysis. Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified.
In the previous IMpassion130 study, Tecentriq in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension [albumin-bound]; nab-paclitaxel) demonstrated a statistically significant PFS benefit and, while not formally tested, showed clinically meaningful improvements in OS for people with metastatic TNBC and whose tumors express PD-L1 (≥1%). Tecentriq in combination with nab-paclitaxel is approved under accelerated approval by the U.S. Food and Drug Administration for the treatment of adults with unresectable locally advanced or metastatic TNBC and whose tumors express PD-L1 (≥1%).
“While we are disappointed by the results from the IMpassion131 study, we are grateful for all the patients, families and physicians who were involved in the study,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens. We remain committed to finding optimal treatments for all people living with this aggressive disease.”
Full results from IMpassion131 are being discussed with global health authorities and will be presented at a future medical meeting. The insights will also be used to inform existing and future studies in TNBC with Tecentriq in combination with paclitaxel.
Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMpassion131 study
The IMpassion131 study is a Phase III, multi-center, randomized, double-blind study evaluating the efficacy and safety of Tecentriq in combination with paclitaxel, in comparison to placebo plus paclitaxel, in people with previously untreated, inoperable, locally advanced or metastatic TNBC. The study enrolled 651 people who were randomized in a 2:1 ratio to receive Tecentriq or placebo plus paclitaxel. The primary endpoint is PFS per investigator assessment (RECIST 1.1) in the PD-L1-positive population, followed by intention-to-treat (ITT) population. Secondary endpoints include OS, objective response rate, and duration of response in the PD-L1-positive and ITT populations.
About triple-negative breast cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, close to 280,000 people in the United States will be diagnosed with invasive breast cancer, and more than 42,000 will die from the disease in 2020. Breast cancer is not one, but many diseases based on the biology of each tumor. In triple-negative breast cancer, tumor cells lack hormone receptors and do not have excess HER2 protein. Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. It is an aggressive form of the disease with few treatment options.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)
Tecentriq is a prescription medicine used to treat adults with:
A type of bladder and urinary tract cancer called urothelial carcinoma.
Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:
- They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for “PD-L1” or
- They are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status or
- They have tried chemotherapy that contains platinum and it did not work or is no longer working.
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
Tecentriq may be used alone as the first treatment in patients with lung cancer if:
- Their cancer has spread or grown and
- Their cancer tests positive for “high PD-L1”, and
- Their tumor does not have an abnormal “EGFR” or “ALK” gene.
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:
- Their cancer has spread or grown, and
- Is a type called “non-squamous NSCLC”, and
- Their tumor does not have an abnormal “EGFR” or “ALK” gene.
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:
- Their cancer has spread or grown, and
- Is a type called “non-squamous NSCLC”, and
- Their tumor does not have an abnormal “EGFR” or “ALK” gene.
Tecentriq may be used alone in patients with lung cancer if:
- Their cancer has spread or grown and
- They have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
A type of breast cancer called triple-negative breast cancer (TNBC).
Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:
- Has spread or cannot be removed by surgery and
- Their cancer tests positive for “PD-L1”.
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
A type of lung cancer called small cell lung cancer (SCLC).
- Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer is a type of lung cancer called “extensive-stage small cell lung cancer,” which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC).
Tecentriq may be used with the medicine bevacizumab when a patient’s liver cancer:
- Has spread or cannot be removed by surgery, and
- The patient has not received other medicines by mouth or injection through their vein (IV) to treat their cancer.
A type of skin cancer called melanoma.
Tecentriq may be used with the medicines cobimetinib and vemurafenib when a patient’s melanoma:
- Has spread or cannot be removed by surgery, and
- Their cancer has a certain type of abnormal “BRAF” gene. Their healthcare provider will perform a test to make sure this Tecentriq combination is right for them.
It is not known if Tecentriq is safe and effective in children.
Please visit http://www.Tecentriq.com for the full Tecentriq Prescribing Information for additional Important Safety Information.
About Genentech in cancer immunotherapy
Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.
In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.
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: 28
