South San Francisco, CA May 10, 2017 Genentech Press Release
— IMvigor211 study did not meet its primary endpoint of overall survival (OS) compared to chemotherapy —
–The safety profile was consistent with what has been previously observed for TECENTRIQ–
SOUTH SAN FRANCISCO, CA — 2017-05-09 00:00:00
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMvigor211 study that evaluated TECENTRIQ®(atezolizumab) in people with locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated) did not meet its primary endpoint of overall survival (OS) compared to chemotherapy. The safety profile observed in IMvigor211 was consistent with what has been previously observed for TECENTRIQ.
“While these results are not what we had expected, we believe that TECENTRIQ will continue to play an important role in the treatment of people with advanced bladder cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities.”
The results observed in people treated with TECENTRIQ in IMvigor211 were generally consistent with those observed in a similar group of people in the Phase II IMvigor210 study. The IMvigor211 data will be further examined in an effort to better understand these results, including the initial observation that the chemotherapy arm results were better than study design assumptions. Full data from IMvigor211 will be presented later this year.
TECENTRIQ was granted accelerated approval by the U.S. Food and Drug Administration (FDA) based on tumor response rate and duration of response in IMvigor210 for the treatment of people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 monthsof receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). IMvigor211 was a randomized pivotal study designed to support full approval globally and to serve as the confirmatory study to convert the accelerated approval to full approval in the U.S.
The FDA recently granted accelerated approval to TECENTRIQ as an initial treatment for people with locally advanced or mUC who are not eligible for cisplatin chemotherapy. A Phase III confirmatory study, IMvigor130, is currently ongoing in this population.
Genentech has an extensive clinical trial development program for TECENTRIQ, with more than 30 trials ongoing, 17 of which are ongoing or planned Phase III studies across several kinds of lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder and blood cancers. This includes trials evaluating TECENTRIQ both alone and in combination with other medicines.
About the IMvigor211 study
IMvigor211 is the first randomized Phase III study of TECENTRIQ compared to chemotherapy in people with advanced bladder cancer who were previously treated with a platinum-based chemotherapy. The study evaluated the efficacy and safety of TECENTRIQ compared to chemotherapy (vinflunine, paclitaxel or docetaxel) administered every three weeks in 931 people with previously treated mUC who progressed during or following a platinum-based regimen. Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1, an evaluable tumor sample for centralized PD-L1 testing and had received at least one prior therapeutic regimen for mUC or who had developed mUC within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
The primary efficacy endpoint, overall survival, was to be tested in a successive fashion in study populations defined by PD-L1 expression. The first population tested was people with the highest levels of PD-L1 expression (IC2/3), followed by those with any level of PD-L1 expression (IC1/2/3), followed by the overall study population (Intention-to-Treat; ITT). Statistical significance needed to be achieved in the IC2/3 population in order to evaluate the IC1/2/3 population for statistical significance, and similarly achieved in the IC1/2/3 population in order to evaluate the overall study population for statistical significance.
About the IMvigor210 study
IMvigor210 is an open-label, multicenter, two cohort Phase II study that evaluated the safety and efficacy of TECENTRIQ in people with locally advanced or mUC, regardless of PD-L1 expression. People in a cohort of the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen, or had disease progression within 12 months of treatment with a platinum-based or adjuvant chemotherapy regimen (n=310) received a 1200-mg intravenous dose of TECENTRIQ on day one of 21-day cycles until unacceptable toxicity or either radiographic or clinical progression. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response.
About metastatic urothelial cancer
According to the American Cancer Society (ACS), it is estimated that more than 79,000 Americans will be diagnosed in 2017 with bladder cancer, which is the most common type of urothelial cancer. Less common forms include cancers of the urethra, ureters and renal pelvis. About 11 percent of new diagnoses of bladder cancer are made when the disease is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. Approximately 96 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are three to four times more likely to get bladder cancer during their lifetime than women.
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 activation of T cells. TECENTRIQ may also affect normal cells.
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.
- TECENTRIQ may be used when your bladder cancer:
- has spread or cannot be removed by surgery (advanced urothelial carcinoma), and
- you are not able to take chemotherapy that contains a medicine called cisplatin, 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. There is an ongoing study to confirm clinical benefit.
a type of lung cancer called non-small cell lung cancer (NSCLC)
- TECENTRIQ may be used when your lung cancer:
- has spread or grown, and
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
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:
- Lung Problems (pneumonitis) – Signs and symptoms of pneumonitis may include: new or worsening cough, shortness of breath, or chest pain
- Liver Problems (hepatitis) – Signs and symptoms of hepatitis may include: yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, feeling less hungry than usual
- Intestinal Problems (colitis) – Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual, blood in the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
- Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) – Signs and symptoms that the hormone glands are not working properly may include: headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain
- Nervous System Problems (neuropathy, meningitis, encephalitis) – Signs and symptoms of nervous system problems may include: severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, neck stiffness
- Inflammation of the Eyes – Signs and symptoms may include: blurry vision, double vision, other vision problems, eye pain or redness
- Severe Infections – Signs and symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, pain when urinating
- Severe Infusion Reactions – Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, and swelling of the face or lips
Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:
- Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects their nervous system (such as myasthenia gravis, or Guillain-Barre syndrome); or are being treated for an infection
- Are pregnant or plan to become pregnant
- TECENTRIQ can harm an unborn baby
- If patients are able to become pregnant, they should use an effective method of birth control during treatment and for at least 5 months after the last dose of TECENTRIQ
- Are breastfeeding or plan to breastfeed
- It is not known if TECENTRIQ passes into the breast milk
- Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ
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. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of TECENTRIQ. Ask your healthcare provider or pharmacist for more information.
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, 11 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-
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.