South San Francisco, CA — March 8, 2019 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.
“The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.”
“The Tecentriq regimen is an exciting new treatment option for certain people living with metastatic triple-negative breast cancer, a difficult-to-treat form of the disease,” said Hayley Dinerman, executive director of the Triple Negative Breast Cancer Foundation. “Chemotherapy alone has been the mainstay of treatment for many years, so it’s encouraging to now have an immunotherapy combination available for people with PD-L1-positive disease.”
This accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 40 percent compared with nab- paclitaxel alone (median PFS=7.4 vs. 4.8 months; HR=0.60, 95% CI: 0.48-0.77, p<0.0001) in
PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. Overall survival (OS) results were immature with 43 percent of events in all randomized patients (intent-to-treat; ITT), and further data will be shared with the FDA and presented at an upcoming medical meeting.
Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The most common Grade 3-4 side effects (≥2 percent) with Tecentriq plus nab-paclitaxel were low white blood cells, tingling or numbness in the hands and feet, neutrophil count decreased, feeling tired, low red blood cells, low blood potassium level, pneumonia and increased blood level of a liver enzyme (AST). The most common side effects (≥20 percent) were hair loss, feeling tired, tingling or numbness in the hands and feet, nausea, diarrhea, low red blood cells, constipation, cough, headache, low white blood cells, decreased appetite and vomiting.
For those who qualify, Genentech offers patient assistance programs for people prescribed Tecentriq by their doctor through Genentech Access Solutions. Please contact Genentech Access Solutions at (866) 422-2377 or visit http://www.Genentech-Access.com/Tecentriq for more information.
About the IMpassion130 study
The IMpassion130 study is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomized equally (1:1). The
co-primary endpoints are PFS per investigator assessment (RECIST 1.1) in the ITT population and in the PD-L1-positive population and OS in the ITT population. OS results were immature in the ITT population. Secondary endpoints include objective response rate and duration of response.
About triple-negative breast cancer
Breast cancer is the most common cancer 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 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.
Tecentriq is a monoclonal antibody designed to bind with a protein called 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.
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
Tecentriq U.S. Indication (pronounced ‘tē-SEN-trik’)
Tecentriq is a prescription medicine used to treat adults with:
A type of breast cancer called triple-negative breast cancer (TNBC).
Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:
- has spread or cannot be removed by surgery, and
- your cancer tests positive for “PD-L1.”
The approval of Tecentriq in these patients is based on a study that measured progression-free survival. There is an ongoing study to confirm clinical benefit.
It is not known if Tecentriq is safe and effective in children.
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 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 20 investigational medicines, 10 of which are in clinical trials. 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-immunotherapy.
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.
Posted: March 2019
- FDA Approves Genentech’s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer – December 6, 2018
- FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer – April 17, 2017
- FDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer – October 18, 2016
- FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma – May 18, 2016
Tecentriq (atezolizumab) FDA Approval History
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