Sunday, Jul 1, 2018
First Phase III immunotherapy study to demonstrate a statistically significant progression-free survival (PFS) improvement in intention-to-treat (ITT) and PD-L1 positive first-line metastatic triple negative breast cancer (TNBC) populations
Encouraging overall survival (OS) benefit for PD-L1 positive population at interim analysis
Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)
South San Francisco, CA -- July 1, 2018 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion130 study met its co-primary endpoint of progression free survival (PFS). Results demonstrated that the combination of TECENTRIQ® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in people with metastatic or unresectable locally advanced triple negative breast cancer (TNBC). Overall survival (OS) is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis.
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. Results will be presented at an upcoming medical meeting and will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
“IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Highly encouraged by these results, we plan to submit to authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible.”
This is the third positive Phase III study that includes TECENTRIQ and nab-paclitaxel as part of a treatment regimen. Currently, Genentech has seven ongoing Phase III studies investigating TECENTRIQ in TNBC.
About the IMpassion130 study
IMpassion130 study is a Phase III multicenter, randomized, double-blind study evaluating the efficacy, safety, and pharmacokinetics of TECENTRIQ and nab-paclitaxel compared with placebo in combination with nab-paclitaxel in people with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer (mBC). The study enrolled 902 people who were randomized equally (1:1). The co-primary endpoints were progression-free survival (PFS) per investigator assessment (RECIST 1.1) and overall survival (OS). PFS and OS were assessed in all randomized participants [intention-to-treat (ITT)] and in those whose disease expressed the PD-L1 protein. Secondary endpoints included objective response rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
During the treatment duration, people in:
About triple negative breast cancer
Breast cancer is the second most common cancer among women in the United States. According to the American Cancer Society, it is estimated that about 266,000 American women will be diagnosed with invasive breast cancer in 2018, and nearly 41,000 will die from the disease. Approximately 10-20 percent of breast cancers are triple negative breast cancer (TNBC). TNBC is an aggressive form of the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines that target HER2.
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.
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:
A type of bladder and urinary tract cancer called urothelial carcinoma.
The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
It is not known if TECENTRIQ is safe and effective in children.
Important Safety Information
What is the most important information about TECENTRIQ?
TECENTRIQ can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
TECENTRIQ can cause serious side effects, including:
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if patients have severe side effects.
Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of TECENTRIQ in people with urothelial carcinoma include:
The most common side effects of TECENTRIQ in people with non-small cell lung cancer include:
TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.
Please visit http://www.Tecentriq.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
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.