Genentech’s Tecentriq in Combination With Abraxane Improves Outcomes as an Initial Treatment for People With PD-L1-Positive Metastatic Triple-Negative Breast Cancer

– 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, Calif.–(BUSINESS WIRE)–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 +
nab-paclitaxel
n=184

 

 

Tecentriq +
nab-paclitaxel
n=451

 

 

Placebo +
nab-paclitaxel
n=451

 

Number of patients   369 (40.9%)   902
PFS (co-primary endpoint)
Median (months)
(95% CI)
  7.5
(6.7-9.2)
  5.0
(3.8-5.6)
  7.2
(5.6-7.5)
  5.5
(5.3-5.6)
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)
(95% CI)
  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.

 

  • SAEs were reported in 23 percent of people receiving Tecentriq
    plus nab-paclitaxel compared to 18 percent of people
    receiving chemotherapy alone. SAEs occurring in one percent or
    more of people receiving Tecentriq plus nab-paclitaxel
    were pneumonia (2 percent), urinary tract infection (1 percent),
    difficulty breathing (dyspnea, 1 percent) and fever (pyrexia, 1
    percent).
  • Grade 3-4 AEs were reported in 49 percent of people receiving
    Tecentriq plus nab-paclitaxel compared to 42 percent of
    people receiving chemotherapy alone. The most common Grade 3-4
    AEs in people receiving Tecentriq plus nab-paclitaxel
    were an abnormal low count of a certain type of white blood cell
    (neutropenia, 8 percent); decreased neutrophil count (5
    percent); numbness, tingling or pain in the hands or feet
    (peripheral neuropathy, 6 percent); fatigue (4 percent); and
    decrease in red blood cells (anemia, 3 percent). Peripheral
    neuropathy was the only Grade 3-4 AE reported with a two percent
    or higher incidence in people receiving Tecentriq plus nab-paclitaxel
    compared to people receiving chemotherapy alone (6 percent vs. 3
    percent).
 

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.

  • Tecentriq may be used when your bladder cancer:

    • has spread or cannot be removed by surgery, and if you have any
      one of the following conditions
      :
    • you are not able to take chemotherapy that contains a medicine
      called cisplatin, and your doctor has tested your cancer and found
      high levels of a specific protein on your cancer called programmed
      death-ligand 1 (PD-L1), as determined by an FDA-approved test, or
    • you are not able to take chemotherapy that contains any platinum
      regardless of PD-L1 status on your cancer, 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

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:

  • Lung problems (pneumonitis)–signs and symptoms may include new
    or worsening cough, shortness of breath, and 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, and 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 or mucous in the stools or dark, tarry, sticky stools, and
    severe stomach area (abdomen) pain or tenderness
  • Hormone gland problems (especially the thyroid, adrenal glands,
    pancreas, and pituitary)
    –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,
    the voice gets deeper, urinating more often than usual, nausea or
    vomiting, and stomach area (abdomen) pain
  • Problems in other organs–signs and symptoms may include severe
    muscle weakness, numbness or tingling in hands or feet, confusion,
    blurry vision, double vision, or other vision problems, changes in
    mood or behavior, extreme sensitivity to light, neck stiffness, eye
    pain or redness, skin blisters or peeling, chest pain, irregular
    heartbeat, shortness of breath, or swelling of the ankles
  • Severe infections–signs and symptoms of infection may include
    fever, cough, flu-like symptoms, pain when urinating, and frequent
    urination or back pain
  • Severe infusion reactions–signs and symptoms of infusion
    reactions may include chills or shaking, itching or rash, flushing,
    shortness of breath or wheezing, swelling of the face or lips,
    dizziness, fever, feeling like passing out, and back or neck pain

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:

  • 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. Patients should tell their healthcare provider right away if
    they become pregnant or think they may be pregnant during treatment
    with Tecentriq. If patients are able to become pregnant:

    • A healthcare provider should do a pregnancy test before they start
      treatment with Tecentriq.
    • They should use an effective method of birth control during their
      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:

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

The most common side effects of Tecentriq in people with non-small
cell lung cancer include:

  • feeling tired
  • decreased appetite
  • muscle pain
  • cough
  • shortness of breath

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.

Contacts

Genentech
Media Contact:
Courtney Aberbach, 650-467-6800
or
Advocacy
Contact:
Katie Creme Henry, 202-258-8228
or
Investor
Contacts:
Loren Kalm, 650-225-3217
Karl Mahler, 011 41 61 687
8503

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