Genentech's TECENTRIQ in Combination with Chemotherapy Helped People with Previously-Untreated Extensive-Stage Small Cell Lung Cancer Live Significantly Longer Compared to Chemotherapy | Financial Buzz

Genentechs TECENTRIQ in Combination with Chemotherapy Helped People with Previously-Untreated Extensive-Stage Small Cell Lung Cancer Live Significantly Longer Compared to Chemotherapy

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the Phase III IMpower133 study met its co-primary
endpoints of overall survival (OS) and progression-free survival (PFS)
at its first interim analysis. The study demonstrated that initial
(first-line) treatment with the combination of TECENTRIQ®
(atezolizumab) plus chemotherapy (carboplatin and etoposide) helped
people with extensive-stage small cell lung cancer (ES-SCLC) live
significantly longer compared to chemotherapy alone. The TECENTRIQ-based
combination also reduced the risk of disease worsening or death (PFS)
compared to chemotherapy alone. Safety for the TECENTRIQ and
chemotherapy combination appeared consistent with the known safety
profile of the individual medicines, and no new safety signals were
identified with the combination. These data will be presented at an
upcoming medical meeting.

“These are the first positive Phase III survival results for any
immunotherapy-based combination in the initial treatment of
extensive-stage small cell lung cancer, a particularly
difficult-to-treat type of disease,” said Sandra Horning, M.D., chief
medical officer and head of Global Product Development. “The clinically
meaningful results from the IMpower133 study add to the growing body of
evidence demonstrating that TECENTRIQ-based combinations may be an
effective treatment for different types of advanced lung cancer. We look
forward to working with health authorities globally to bring this
potential treatment option to people with this type of disease as soon
as possible.”

This is the fourth positive Phase III lung cancer study evaluating a
TECENTRIQ-based combination to read out this year and the fifth positive
study overall. Currently, Genentech has eight Phase III lung cancer
studies underway evaluating TECENTRIQ alone or in combination with other
medicines across different types of lung cancer.

About the IMpower133 study

IMpower133 is a Phase III, multicenter, double-blinded, randomized
placebo-controlled study evaluating the efficacy and safety of TECENTRIQ
in combination with carboplatin and etoposide versus chemotherapy
(carboplatin plus etoposide) alone in chemotherapy-naïve people with
ES-SCLC. The study enrolled 403 people who were randomized equally (1:1)
to receive:

During the treatment-induction phase, people received treatment on
21-day cycles for four cycles, followed by maintenance with TECENTRIQ or
placebo until progressive disease (PD) as assessed by the investigator
using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST
v1.1). Treatment could be continued until persistent radiographic PD or
symptomatic deterioration was observed.

The co-primary endpoints were:

IMpower133 met its OS and PFS co-primary endpoints as per the study
protocol.

About lung cancer

According to the American Cancer Society, it is estimated that more than
234,000 Americans will be diagnosed with lung cancer in 2018, and SCLC
accounts for approximately 15 percent of all lung cancers. It is
estimated that approximately 60 percent of lung cancer diagnoses in the
United States are made when the disease is in the advanced stages.

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.

TECENTRIQ U.S. Indication (pronounced ‘t?-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

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:

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:

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.
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 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 in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and
we are committed to developing new approaches, medicines and tests that
can help people with this deadly disease. Our goal is to provide an
effective treatment option for every person diagnosed with lung cancer.
We currently have four approved medicines to treat certain kinds of lung
cancer and more than 10 medicines being developed to target the most
common genetic drivers of lung cancer or to boost the immune system to
combat the disease.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180624005074/en/