Tecentriq® (atezolizumab)

TECENTRIQ is a cancer immunotherapy, which is a medicine designed to work with the body's own immune system. It is a monoclonal antibody designed to bind with programmed death-ligand 1 (PD-L1). PD-L1 is a protein that plays a role in preventing the body's immune system from fighting cancer. By binding to PD-L1, TECENTRIQ may remove the "stop sign" and activate the immune response.1

Tecentriq
  • TECENTRIQ is the first and only approved anti-PDL1 medicine for people with specific types of advanced urothelial carcinoma (including bladder cancer) and non-small cell lung cancer.2,3
  • It was the first FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years.4,5,6
  • Genentech now has four medicines available to treat various types of lung cancer.
  • Genentech has 17 ongoing or planned Phase III studies with TECENTRIQ across several cancers.

Approved Indications

TECENTRIQ is approved for the treatment of patients with:

Locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy; or, have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.

It is not known if TECENTRIQ is safe and effective in children.

About Urothelial Carcinoma

Bladder cancer is the most common type of urothelial carcinoma. Less common forms include cancers of the urethra, ureters and renal pelvis.7

  • Approximately

    79,000

    people in the U.S. will be diagnosed with bladder cancer in 2017.8

  • 11%

    new diagnoses are made when bladder cancer is in advanced stages.9

  • About

    Half

    of people with advanced bladder cancer may not be eligible to take chemotherapy that contains a medication called cisplatin as an initial treatment.10

Renal Pelvis, Ureter, Bladder, Urethra

About Non-Small Cell Lung Cancer

Approximately 222,500 people in the U.S. will be diagnosed with lung cancer in 2017.8

  • About

    6 in 10

    of lung cancer diagnoses in the U.S. are made when the disease is in the advanced stages.11

  • Up to

    85%

    of all lung cancers are classified as non-small cell lung cancer.12

Approximate number of lung cancer diagnoses in 2016

What is PD-L1?13,14,15

T Cell

The immune system can help protect the body against cancer by sending T cells - a type of white blood cell - to attack tumor cells.

PD-L1 Tumor Cell

However, tumor cells can produce a protein called PD-L1 that works like a "stop sign" to inactivate T cells.

Tumor Infiltrating Immune Cell (IC)

As a tumor grows, many other cells can join and interact with it.

PD-L1

Some of these cells, called tumor-infiltrating immune cells, can also express PD-L1 and inactivate T cells.

How TECENTRIQ May Work1 (Proposed Mechanism of Action)

TECENTRIQ is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells. TECENTRIQ may also affect normal cells.

TECENTRIQ may prevent PD-L1 from binding to other proteins called PD-1 and B7.1, which may remove the "stop sign" that signals to inactivate T-cells.

TECENTRIQ Efficacy Profiles

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 not eligible for cisplatin-based chemotherapy. Cohort 2 included people whose disease progressed during or following previous treatment with a platinum-based chemotherapy regimen. Outcomes were evaluated in all patients and in subgroups based on PD-L1 expression.

ADVERSE EVENTS IN mUC STUDIES


Most common side effects (≥ 20%) in previously-untreated cisplatin-ineligible people with locally advanced or mUC were fatigue, decreased appetite, diarrhea and nausea. Five people (4.2%) who were treated with TECENTRIQ experienced either sepsis, cardiac arrest, myocardial infarction, respiratory failure or respiratory distress, which led to death. One additional patient (0.8%) experienced inflammation of the brain due to the herpes simplex virus (herpetic meningoencephalitis) and disease progression at the time of death. TECENTRIQ was discontinued for adverse reactions in 4.2% (5) of the 119 people.

Most common side effects (≥ 20%) in previously platinum-treated people with locally advanced or mUC were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia (fever) and constipation. Three people (1.0%) who were treated with TECENTRIQ experienced either sepsis, pneumonitis (lung problems) or intestinal obstruction, which led to death. TECENTRIQ was discontinued for adverse reactions in 3.2% (10) of the 310 people.

OAK AND POPLAR STUDIES


The approval of TECENTRIQ for NSCLC was based on results from the global, multicenter, open-label, randomized Phase III OAK and Phase II POPLAR studies that evaluated TECENTRIQ compared with docetaxel in people with metastatic NSCLC whose disease had progressed after platinum-containing chemotherapy. Patients were randomized 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or TECENTRIQ (1200 mg intravenous infusion) every three weeks. OAK enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

STUDY ADVERSE EVENTS IN NSCLC


Most common side effects (20%) in people with metastatic NSCLC in the Phase II POPLAR study were fatigue, decreased appetite, dyspnea (shortness of breath), cough, nausea, musculoskeletal pain, and constipation. Nine people (6.3%) who were treated with TECENTRIQ experienced either pulmonary embolism (2), pneumonia (lung infection, 2), pneumothorax, ulcer hemorrhage (bleeding ulcer), cachexia secondary to dysphagia, myocardial infarction (heart attack), or large intestinal perforation, which led to death. TECENTRIQ was discontinued for adverse reactions in 4% (6) of the 142 people.

Important Safety Information

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. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if a patient has severe side effects.

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, meningitis, encephalitis) - Signs and symptoms 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 - Signs and symptoms may include: blurry vision, double vision, other vision problems, eye pain or redness
  • Severe Infections - Signs and 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, and swelling of the face or lips

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 their 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 their last dose of TECENTRIQ
  • Are breastfeeding or plan to breastfeed
    • It is not known if TECENTRIQ passes into the breastmilk
    • 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
  • shortness of breath
  • cough
  • nausea
  • muscle or bone pain
  • constipation

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.

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.

©2017 Genentech, Inc. All rights reserved. TECENTRIQ® is a trademark of Genentech, Inc. The Genentech logo is a registered trademark of Genentech, Inc.

PDL/122215/0175(2)