On July 2, 20118 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the Phase III IMpassion130 study met its co-primary endpoint of progression free survival (PFS) (Press release, Genentech, JUL 2, 2018, View Source [SID1234527541]). 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.
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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 View Source Report side effects to Genentech at 1-888-835-2555.