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

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  • 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–(BUSINESS WIRE)–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 duration of response (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

Access Solutions is part of Genentech’s commitment to helping people
access the Genentech medicines they are prescribed, regardless of their
ability to pay. The team of 350 in-house specialists at Access Solutions
is dedicated to helping people navigate the access and reimbursement
process, and to providing assistance to eligible patients in the United
States who are uninsured or cannot afford the out-of-pocket costs for
their medicine. To date, the team has helped more than 1.4 million
patients access the medicines they need. Please contact Access Solutions
(866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com
for more 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, 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.

Contacts

Genentech
Media Contact:
Austine Graff, 650-255-9212
Advocacy
Contact:
Nicole Martin, 650-826-9223
Investor Contacts:
Nina
Goworek, 650-467-8737
Karl Mahler, 011 41 61 687 8503