Phase III IMpassion130 Study Showed Genentech’s TECENTRIQ Plus Abraxane Significantly Reduced the Risk of
Disease Worsening or Death in People With Metastatic or Locally Advanced Triple Negative Breast Cancer
– First Phase III immunotherapy study to demonstrate a statistically significant progression-free survival
(PFS) improvement in intention-to-treat (ITT) and PD-L1 positive first-line metastatic triple negative breast cancer (TNBC)
populations –
– Encouraging overall survival (OS) benefit for PD-L1 positive population at interim analysis –
– Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration
(FDA) and European Medicines Agency (EMA) –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion130 study met
its co-primary endpoint of progression free survival (PFS). Results demonstrated that the combination of TECENTRIQ®
(atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), as an initial
(first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in people with metastatic or
unresectable locally advanced triple negative breast cancer (TNBC). Overall survival (OS) is encouraging in the PD-L1 positive
population at this interim analysis, and 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. Results will be presented at an upcoming medical meeting
and will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines
Agency (EMA).
“IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with
limited treatment options,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Highly
encouraged by these results, we plan to submit to authorities globally with the aim of bringing this combination to people with
triple negative breast cancer as soon as possible.”
This is the third positive Phase III study that includes TECENTRIQ and nab-paclitaxel as part of a treatment regimen.
Currently, Genentech has seven ongoing Phase III studies investigating TECENTRIQ in TNBC.
About the IMpassion130 study
IMpassion130 study is a Phase III multicenter, randomized, double-blind study evaluating the efficacy, safety, and
pharmacokinetics of TECENTRIQ and nab-paclitaxel compared with placebo in combination with nab-paclitaxel in people
with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer (mBC). The study
enrolled 902 people who were randomized equally (1:1). The co-primary endpoints were progression-free survival (PFS) per
investigator assessment (RECIST 1.1) and overall survival (OS). PFS and OS were assessed in all randomized participants
[intention-to-treat (ITT)] and in those whose disease expressed the PD-L1 protein. Secondary endpoints included objective response
rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
During the treatment duration, people in:
- Arm A received TECENTRIQ at a fixed dose of 840 milligrams via intravenous (IV) infusion on
Days 1 and 15 of each 28-day cycle and nab-paclitaxel at a dose of 100 milligrams per square meter via IV infusion on Days
1, 8, and 15 of each 28-day cycle. Nab-paclitaxel was administered for a target of at least 6 cycles, with no maximum.
Participants received both agents until unacceptable toxicity or disease progression.
- Arm B received nab-paclitaxel at a dose of 100 milligrams per square meter via IV
infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-paclitaxel was administered for a target of at least 6 cycles,
with no maximum, and placebo was administered via IV infusion on Days 1 and 15 of each 28-day cycle. Participants received both
agents until unacceptable toxicity or disease progression.
About triple negative breast cancer
Breast cancer is the second most common cancer among women in the United States. According to the American Cancer Society, it is
estimated that about 266,000 American women will be diagnosed with invasive breast cancer in 2018, and nearly 41,000 will die from
the disease. Approximately 10-20 percent of breast cancers are triple negative breast cancer (TNBC). TNBC is an aggressive form of
the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines
that target HER2.
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.
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),
or
- you are not able to take chemotherapy that contains any platinum regardless of the levels of
PD-L1 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 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.
Genentech
Media Contact:
Austine Graff, 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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