Clinical trial results

TAGRISSO results

Changing expectations for treatment

In a clinical study for metastatic (stage 4) non-small cell lung cancer with certain abnormal EGFR genes, TAGRISSO was compared with two other targeted therapies, erlotinib or gefitinib.

Groundbreaking results from TAGRISSO give you more time without your cancer growing or spreading. And now, this once-daily pill is proven to help you live significantly longer than erlotinib or gefitinib.

Proven to give people significantly more time without tumors growing or spreading

The median progression-free survival was 18.9 months vs 10.2 for erlotinib or gefitinib.

People taking TAGRISSO lived significantly longer than people taking erlotinib or gefitinib

The median overall survival was 38.6 months for TAGRISSO vs 31.8 months for erlotinib or gefitinib.

How the trial worked

During the clinical trial, 556 adults with previously untreated stage 4 non-small cell lung cancer with certain abnormal EGFR genes were given treatment with an oral EGFR tyrosine kinase inhibitor (TKI), a type of targeted therapy. Some people were given either erlotinib or gefitinib, while other people were given TAGRISSO® (osimertinib).

The main goal of the clinical trial was to measure the time people were on treatment before their cancer started growing or spreading. This is called progression-free survival (PFS). For people taking TAGRISSO, it took significantly longer for cancer to grow or spread than it did for people taking erlotinib or gefitinib.

The secondary goal of the clinical trial was to measure how long people taking TAGRISSO lived. This is called overall survival (OS). People taking TAGRISSO lived significantly longer than people taking erlotinib or gefitinib.

TAGRISSO for EGFR+ stage 4 NSCLC
Over 21,000 people have treated their EGFR+ stage 4 NSCLC with TAGRISSO*
*Data represent those who have taken TAGRISSO as a first treatment or as a subsequent treatment for lung cancer.

Nearly 8 in 10 people responded to treatment with TAGRISSO

  • 77% of people taking TAGRISSO saw their tumors shrink
  • 69% of those treated with other EGFR-targeted therapies, erlotinib or gefitinib, saw their tumors shrink
77% of people taking TAGRISSO saw their tumors shrink

When cancer had spread to the brain

41 people who had tumors spread to the brain before the study were evaluated. 22 of them were treated with TAGRISSO and 19 were treated with gefitinib or erlotinib to see how it affected their brain tumors. The study found:

  • 77% of those taking TAGRISSO saw their brain tumors shrink. 18% saw their brain tumors completely disappear
  • 63% of those treated with other EGFR-targeted therapies, erlotinib or gefitinib, saw their brain tumors shrink. No one saw their tumors completely disappear
How TAGRISSO treatment may help
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Learn more How to take TAGRISSO

TAGRISSO is a pill that you take once a day, with or without food.

Learn more

Cancer that started in the lungs and has spread to other parts of the body such as the liver or brain. Often referred to as stage 4 cancer.

One of two main types of lung cancer. NSCLC is more common.

A protein found on the surface of some cells. When EGFR mutates, it plays a role in causing cancer cells to grow excessively and spread as tumors. EGFR is one of the stage 4 NSCLC biomarkers.

An abnormal growth of cells that may be benign (not cancer) or malignant (cancer).

The middle number in a group of numbers arranged from lowest to highest.

A disease in which abnormal cells divide out of control, at a very fast rate. These abnormal cells can spread to other nearby organs and tissues.

An abnormal growth of cells that may be benign (not cancer) or malignant (cancer).

A gene carries information about traits passed from parent to child. Most contain instructions for making a specific protein.

For a person living with cancer, the length of time during or after treatment in which cancer does not get worse.

Important Safety Information

TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
  • heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
  • eye problems. TAGRISSO may cause eye problems. Tell your doctor right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
Important Safety Information

TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
  • heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
  • eye problems. TAGRISSO may cause eye problems. Tell your doctor right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO

Before taking TAGRISSO, tell your doctor about all of your medical conditions, including if you:

  • have lung or breathing problems
  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • have a history of eye problems
  • are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
    • Females who are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO
    • Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO
  • are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. Talk to your doctor about the best way to feed your baby during this time

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine

The most common side effects of TAGRISSO are:

  • diarrhea
  • rash
  • dry skin
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails
  • mouth sores
  • tiredness
  • decreased appetite

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-fda-1088.

What is TAGRISSO?

TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used:

  • as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s)
  • or
  • for a certain type of EGFR gene that has been treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working

Your doctor will perform a test to make sure that TAGRISSO is right for you.

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

Please see full Prescribing Information including Patient Information.

You may report side effects related to AstraZeneca products by clicking here.