Sunday, Dec 10, 2017
South San Francisco, CA -- December 10, 2017 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMmotion151 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) and Avastin ® (bevacizumab) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death (PFS) in people whose disease expressed the PD-L1 (programmed death-ligand 1; PD-L1 expression ≥1 percent) protein compared with sunitinib for the first-line treatment of people who have advanced or metastatic renal cell carcinoma (mRCC).
Observations of a pre-specified subgroup analysis of the TECENTRIQ and Avastin combination indicated that, in people whose disease expressed PD-L1, a numerical difference favoring TECENTRIQ was seen across all patient risk factor groups (favorable, intermediate and poor) compared to sunitinib; however, due to the study design these data could not be assessed for statistical significance and are descriptive only. Assessment of secondary endpoints is ongoing. Safety for the TECENTRIQ and Avastin combination appeared consistent with the known safety profile of the individual medicines and what was previously reported in the Phase II IMmotion150 study. No new safety signals were identified with the combination.
Results will be presented at an upcoming oncology conference in 2018. Top-line results from the co-primary endpoint of overall survival (OS) are not mature.
“We are encouraged by these results as they add to the emerging body of evidence that supports our rationale for this combination. We believe that the regimen of TECENTRIQ and Avastin may enhance the potential of the immune system in the initial treatment of advanced kidney cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We will discuss these data with health authorities globally and hope to bring this combination forward as a potential new treatment option as soon as possible.’’
IMmotion151 is the second successive positive Phase III study of TECENTRIQ that includes an Avastin combination component as an initial treatment. This follows the positive Phase III non-squamous non-small cell lung cancer (NSCLC) IMpower150 study that showed TECENTRIQ and Avastin plus chemotherapy demonstrated a PFS advantage over Avastin plus chemotherapy.
About the IMmotion151 study
IMmotion151 is a Phase III multicenter, randomized, open-label study to evaluate the efficacy and safety of TECENTRIQ and Avastin versus sunitinib in people with inoperable, locally advanced or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy. It enrolled 915 people globally who were randomized 1:1 to receive TECENTRIQ and Avastin, or sunitinib alone.
People in the TECENTRIQ and Avastin arm received TECENTRIQ at a fixed dose of 1200 milligrams (mg) and Avastin at a dose of 15 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 3 weeks until loss of clinical benefit or unacceptable toxicity. People in the sunitinib arm received sunitinib 50 mg orally, once daily for 4 weeks followed by 2 weeks rest until loss of clinical benefit or unacceptable toxicity.
The co-primary endpoints were PFS, as determined by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in people whose tumors expressed PD-L1 [PD-L1 expression ≥1 percent on immune cells (IC)], and OS in the overall study population (intention-to-treat, ITT). PD-L1 expression was prospectively assessed using an immunohistochemistry (IHC) test (SP142) developed by Roche Tissue Diagnostics.
Stratification factors included the presence or absence of liver metastases; level of IC staining for PD-L1 (≥1 percent vs. < 1 percent) and Memorial Sloan-Kettering Cancer Center (Motzer) risk score. The Motzer prognostic scoring system predicts for OS based upon an individual’s baseline clinical and laboratory characteristics. Depending on the presence of one or several of five variables (risk factors), people are classified in one of the three risk groups: “Favorable” with 0 risk factors, “Intermediate” with 1-2 risk factors and “Poor” with ≥ 3 risk factors.
About renal cell carcinoma
According to the American Cancer Society, more than 63,000 people will be diagnosed with kidney cancer in 2017. Renal cell carcinoma (RCC) accounts for approximately 90 percent of all cases. RCC occurs when abnormal cells develop in the tissue of the kidneys, specifically in the small tubes (also known as tubules) where the blood is filtered. Typically, RCC is a single tumor in one kidney but, in rare cases, there can be multiple tumors, which can occur in one or both kidneys. Despite recent progress in the field of kidney cancer, treatment options for people with the disease remains limited.
About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support further investigation of TECENTRIQ plus Avastin in combination. We are investigating this combination in a broad range of cancers, including advanced RCC. Avastin, in addition to its anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumor infiltration and enabling priming and activation of T-cell responses against tumor antigens.
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.
About Avastin® (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). Avastin is the only currently available treatment for people with mRCC that directly inhibits VEGF.
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
Important Information About TECENTRIQ
TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if a patient has severe side effects.
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:
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.
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.
Recurrent ovarian cancer (rOC) . Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments. Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC).
Possible serious side effects
Everyone reacts differently to Avastin therapy. So it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Their doctor will stop treatment if any serious side effects occur. Patients should talk to their doctor if there are any signs of these side effects.
Most serious side effects (not common, but sometimes fatal):
Other possible serious side effects
Side effects seen most often
In clinical studies across different types of cancer, some patients experienced the following side effects:
Avastin is not for everyone
Patients should talk to their doctor if they are:
Patients should talk with their doctor if they have any questions about their condition or treatment.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
For full Prescribing Information on Avastin please visit http://www.avastin.com.
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 or 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.