SOUTH SAN FRANCISCO, CA, USA I January 23, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMvigor010 study evaluating Tecentriq ® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body. More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within two years of surgery.
In addition to ongoing Phase III studies in early and advanced bladder cancer, Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across 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 IMvigor010 study
IMvigor010 is a global Phase III, open-label, randomized, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared with observation in 809 people with MIUC, who are at high risk for recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomization to invasive urothelial cancer recurrence or death.
About bladder cancer
According to the American Cancer Society (ACS), it is estimated that more than 81,000 Americans will be diagnosed with bladder cancer in 2020. Urothelial cancer is the most common type of bladder cancer, accounting for about 90-95% of all cases. MIUC is a type of urothelial cancer that has spread into the muscle wall of the bladder, ureter, or renal pelvis. Approximately 25% of people newly diagnosed with bladder cancer are diagnosed with muscle-invasive disease, which is associated with a poorer prognosis than non-MIUC.
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. Bladder Indications
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 when your bladder cancer:
- has spread or cannot be removed by surgery, and if you have any one of the following conditions:
- you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for “PD-L1”, or
- you are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status, or
- you 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 response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
It is not known if Tecentriq is safe and effective in children.
About Genentech in personalized cancer immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotheray.
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: 25
SOUTH SAN FRANCISCO, CA, USA I January 23, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMvigor010 study evaluating Tecentriq ® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body. More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within two years of surgery.
In addition to ongoing Phase III studies in early and advanced bladder cancer, Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across 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 IMvigor010 study
IMvigor010 is a global Phase III, open-label, randomized, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared with observation in 809 people with MIUC, who are at high risk for recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomization to invasive urothelial cancer recurrence or death.
About bladder cancer
According to the American Cancer Society (ACS), it is estimated that more than 81,000 Americans will be diagnosed with bladder cancer in 2020. Urothelial cancer is the most common type of bladder cancer, accounting for about 90-95% of all cases. MIUC is a type of urothelial cancer that has spread into the muscle wall of the bladder, ureter, or renal pelvis. Approximately 25% of people newly diagnosed with bladder cancer are diagnosed with muscle-invasive disease, which is associated with a poorer prognosis than non-MIUC.
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. Bladder Indications
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 when your bladder cancer:
- has spread or cannot be removed by surgery, and if you have any one of the following conditions:
- you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for “PD-L1”, or
- you are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status, or
- you 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 response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
It is not known if Tecentriq is safe and effective in children.
About Genentech in personalized cancer immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotheray.
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: 25
