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Sunday, Jun 5, 2016

Genentech’s Cancer Immunotherapy Tecentriq™ (atezolizumab) Shrank Tumors in People with Previously Untreated Advanced Bladder Cancer

  • New survival results also reported from study group with previously treated advanced bladder cancer
  • TECENTRIQ is the first and only cancer immunotherapy approved to treat bladder cancer

Chicago -- June 5, 2016 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that in a Phase II study, IMvigor 210, TECENTRIQ™ (atezolizumab) shrank tumors (objective response rate, ORR) in 24 percent (n=28) of people with locally advanced or metastatic urothelial carcinoma (mUC) who have not received a prior treatment (first-line) and who were ineligible for cisplatin-based chemotherapy. Of those people who responded, 75 percent (n=21) continued to respond to treatment and the median duration of response (DOR) had not been reached at the time of analysis. Seven percent (n=8) of all people in the study achieved a complete response (CR). The median overall survival (OS) was 14.8 months. The safety profile of TECENTRIQ was consistent with that observed in an earlier analysis of the study, as well as in other studies of TECENTRIQ as a monotherapy. Full results will be presented in an oral session at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) and highlighted as part of ASCO’s official press program.

"These TECENTRIQ results are highly encouraging because about half of all people with this type of bladder cancer are not able to tolerate a cisplatin-based chemotherapy, and alternative treatments bring very limited duration of response," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "This is why we are particularly pleased that the majority of people who responded to TECENTRIQ continued to respond at the time of analysis."

About the IMvigor 210 study 

IMvigor 210 is an open-label, multicenter, single-arm 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 the study were enrolled into one of two cohorts. Cohort 1 consisted of people who had received no prior therapies for locally advanced or mUC and who were ineligible for first-line cisplatin-based chemotherapy. Cohort 2 included people whose disease progressed during or following previous treatment with a platinum-based chemotherapy regimen (second-line or later). The primary endpoint of the study was ORR. Secondary endpoints included DOR, OS, progression-free survival (PFS) and safety. PD-L1 (programmed death-ligand 1) expression was assessed using an immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. 

Full results from IMvigor 210 Cohort 1 will be presented by Arjun Balar, M.D., director of genitourinary medical oncology at Perlmutter Cancer Center, New York University Langone Medical Center, New York, N.Y. (Abstract #LBA4500, Sunday, June 5, 8:00 – 8:12 A.M. CDT).

Updated data from IMvigor 210 Cohort 1 (previously untreated, first-line) showed:

  • ORR was 24 percent (n=28) (95 percent CI; 16, 32)  
  • 7 percent (n=8) of all people in the study cohort achieved a complete response (CR)
  • Median DOR was not reached with a median follow-up duration of 14.4 months; 75 percent of responses (n=21) were ongoing at the time of analysis
  • Median OS was 14.8 months (95 percent CI; 10.1, not estimable), and the 12-month landmark OS was 57 percent

Fifteen percent of people receiving TECENTRIQ experienced severe (Grade 3 and 4) treatment-related adverse events. Six percent of people experienced an adverse event leading to treatment discontinuation, and 35 percent had an adverse event leading to dose interruption. Treatment-related adverse events (all grades) occurred in 66 percent of people. One Grade 5 treatment-related adverse event occurred (sepsis, or blood infection). Six percent of people had Grade 3-4 immune-mediated adverse events. 

Updated results from IMvigor 210 Cohort 2, the trial upon which TECENTRIQ received U.S. Food and Drug Administration accelerated approval 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 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant), will be presented by Robert Dreicer, associate director of clinical research, hematology and oncology, University of Virginia School of Medicine, Charlottesville, Va. in an oral session (Abstract #4515, Sunday, June 5, 8:36 – 8:48 A.M. CDT).   

Updated data from IMvigor 210 Cohort 2 (previously treated with platinum-based chemotherapy) showed:

  • An ORR of 16 percent (n=49) (95 percent CI; 12, 20)
  • 7 percent (n=21) of people achieved a CR 
  • Median DOR was not reached with a median follow-up duration of 17.5 months; 71 percent of responses were ongoing at the time of analysis
  • Median OS was 7.9 months (95 percent CI; 7, 9), and the 12-month landmark OS was 37 percent

Seventeen percent of people receiving TECENTRIQ experienced severe (Grade 3 and 4) treatment-related adverse events. Three percent of people experienced an adverse event leading to treatment discontinuation, and 31 percent had an adverse event leading to dose interruption. Treatment-related adverse events (all grades) occurred in 70 percent of people. Three Grade 5 adverse events occurred: intestinal obstruction, sepsis (blood infection) and bleeding in the brain (cerebral hemorrhage). 

About metastatic urothelial carcinoma 

According to the American Cancer Society (ACS), it is estimated that more than 76,000 Americans will be diagnosed with bladder cancer in 2016. About 11 percent of new diagnoses are made when bladder cancer 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 about 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. Indications (pronounced ‘tē-SEN-trik’)

TECENTRIQ™ is a prescription medicine used to treat:

  • A type of bladder cancer called urothelial carcinoma. TECENTRIQ may be used when bladder cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma) and,
  • You have tried chemotherapy that contains platinum, 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. The healthcare provider may treat the patient with corticosteroid or hormone replacement medicines. The healthcare provider may delay or completely stop treatment with TECENTRIQ if severe side effects occur.

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, meningoencephalitis) – Signs 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 – Symptoms may include blurry vision, double vision, other vision problems, eye pain or redness
  • Severe Infections – 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, facial swelling 

The most common side effects of TECENTRIQ include:

  • feeling tired
  • decreased appetite
  • nausea
  • urinary tract infection
  • fever
  • constipation

These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.

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 the 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 of the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

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.

Please visit http://www.TECENTRIQ.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.

About Genentech Access Solutions

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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, nine 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 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

 

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