Saturday, Oct 20, 2018
Tecentriq combination first immunotherapy regimen to demonstrate positive Phase III results in breast cancer
Tecentriq and nab-paclitaxel significantly reduced the risk of disease worsening or death in both the intention-to-treat and PD-L1-positive populations
Clinically meaningful overall survival improvement in the PD-L1-positive population at this interim analysis
Data are being presented at the European Society for Medical Oncology (ESMO) 2018 Congress, featured in the press program and simultaneously published in the New England Journal of Medicine on October 20, 2018
South San Francisco, CA -- October 20, 2018 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III IMpassion130 study of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The Tecentriq and chemotherapy combination significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in all randomized patients (intention-to-treat [ITT]) (median PFS=7.2 vs. 5.5 months; hazard ratio [HR]=0.80, 95% CI: 0.69-0.92, p=0.0025) and the PD-L1-positive population (median PFS=7.5 vs. 5.0 months; HR=0.62, 95% CI: 0.49-0.78, p<0.0001), a subgroup determined by PD-L1 biomarker testing. At this interim analysis, statistical significance was not met for overall survival (OS) in the ITT population (median OS=21.3 vs. 17.6 months; HR=0.84, 95% CI: 0.69-1.02, p=0.0840), but showed a clinically meaningful 9.5-month OS improvement in the PD-L1-positive population (median OS=25.0 vs. 15.5 months; HR=0.62, 95% CI: 0.45-0.86). Due to the hierarchical statistical design, results in the PD-L1-positive population were not formally tested. 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.
“These important results in people with metastatic triple-negative breast cancer whose disease expresses the PD-L1 protein are highly encouraging and represent a significant step forward in the treatment of this challenging disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We have shared the IMpassion130 results with global health authorities with the hope of bringing this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible.”
These data are being presented today at the European Society for Medical Oncology (ESMO) 2018 Congress Presidential Symposium at 4:30 – 4:45 p.m. CEST (abstract LBA1_PR) and will also be featured in the official ESMO press program at 8:15 – 9:00 a.m. CEST. These results will simultaneously be published in the New England Journal of Medicine.
Currently, Genentech has seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.
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) and OS. PFS and OS were assessed in all randomized patients (ITT) and in the PD-L1-positive population. Secondary endpoints include objective response rate (ORR), duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
A summary of the key study results is included below:
PD-L1-positive population (programmed death-ligand 1 expression ≥1% on IC) | ITT population (intention-to-treat) | |||
Tecentriq + nab-paclitaxel n=185 | Placebo + n=184 | Tecentriq + nab-paclitaxel n=451 | Placebo + n=451 | |
Number of patients | 369 (40.9%) | 902 | ||
PFS (co-primary endpoint) | ||||
Median (months) | 7.5 | 5.0 | 7.2 | 5.5 |
Stratified HR (95% CI) | 0.62 (0.49-0.78) | 0.80 (0.69-0.92) | ||
Stratified p-value | <0.0001 | 0.0025 | ||
OS (co-primary endpoint) | ||||
Median (months) | 25.0 (22.6-NE) | 15.5 (13.1-19.4) | 21.3 (17.3-23.4) | 17.6 (15.9-20.0) |
Stratified HR (95% CI) | 0.62 (0.45-0.86) | 0.84 (0.69-1.02) | ||
Stratified p-value | Results were not formally tested | 0.0840 | ||
ORR (secondary endpoint) | ||||
Responders | 59% | 43% | 56% | 46% |
95% CI | 51%-66% | 35%-50% | 51%-61% | 41%-51% |
Stratified p-value | 0.0016 Not significant (α=0.001) | 0.0021 Not significant (α=0.001) | ||
Adverse events | ||||
The nature and incidence of severe adverse events (SAEs) and Grade 3-4 adverse events (AEs) were consistent with the known safety profile of the individual study drugs or the underlying disease.
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About triple-negative breast cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 269,000 people in the United States will be diagnosed with breast cancer, and more than 41,000 will die from the disease in 2018. 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
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:
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 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.
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.
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