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LEARN ABOUT THE CLINICAL TRIAL RESULTS FOR IMFINZI

HOW WAS IMFINZI STUDIED?

A clinical trial compared 2 groups of patients with unresectable Stage 3 non-small cell lung cancer (NSCLC) who completed at least 2 cycles of platinum-based chemotherapy and radiation therapy given together. This is also known as chemoradiation therapy, or CRT.

GROUP 1

Group 1 Patients Received IMFINZI

476 patients received IMFINZI

after CRT for up to 12 months or until disease progression or serious side effects occurred.

GROUP 2

Group 2 Patients Received Placebo

237 patients received placebo

(no medicine) after CRT, which was standard treatment at the time of the study.

TREATMENT SET UP

Cycles of Chemotherapy and Radiation Therapy

BEFORE STUDY

PATIENTS WERE FIRST ON THE STANDARD OF CARE CHEMORADIATION THERAPY (CRT)

For about 6 weeks
(at least 2 cycles of chemotherapy and radiation therapy)

Patients Started Treatment with IMFINZI or Placebo

STUDY START

PATIENTS STARTED TREATMENT
WITH IMFINZI OR PLACEBO within 6 weeks (42 days)

Every 2 weeks (for up to 12
months or until disease progression or side effects became intolerable)

Patients in the study had good performance status, meaning a World Health Organization (WHO) grade of 0 or 1. A grade of 0 means they were able to do all activities they were able to do before their disease. A grade of 1 means they were not able to carry out physically strenuous activities, but were still able to do light work.

IMFINZI was tested against placebo (no medicine). There were 2 main goals of the trial. The first was to measure how long people lived (called overall survival). The second was to measure the length of time they survived without their cancer growing or spreading (called progression-free survival).

IMFINZI HELPED PEOPLE LIVE LONGER AFTER CRT VS PLACEBO (NO MEDICINE)*

PEOPLE LIVING AT 2 YEARS*:

66%
of people taking IMFINZI were living

VS

56%
of those taking placebo (no medicine) were living

*Median overall survival (OS) was not reached with IMFINZI and was 28.7 months with placebo. Median OS is the length of time that half of the people are living. When more than half are living, median OS has not been reached. Median is the middle number in a group of numbers arranged from lowest to highest.

IMFINZI Reached a 5-Year Milestone

IMFINZI REACHED A 5-YEAR MILESTONE

In a follow-up analysis† at 5 years, 43% of people taking IMFINZI and 33%
of people taking placebo were living.

†Called a post-hoc analysis. Based on the limitations of the analysis, results are descriptive and your experience may differ. The post-hoc analysis was conducted approximately 5 years after the last patient started treatment in this study.

IMFINZI SIGNIFICANTLY REDUCED THE CHANCE OF LUNG CANCER SPREADING VS PLACEBO

3x More Time Without Cancer Growing or Spreading

3x

more time without cancer growing or spreading

IMFINZI was proven to give people 3x more time without their lung cancer growing or spreading compared with people receiving placebo.‡§

‡The median time tumors did not grow or spread was 16.8 months for the 476 patients receiving IMFINZI compared with 5.6 months for the 237 patients receiving placebo. IMFINZI may not work for everyone. Individual results may vary.

§The median amount of time patients were followed was 14.5 months for this analysis.

48% Lower Chance of Cancer Growing or Spreading

48%

lower chance of cancer growing or spreading

People receiving IMFINZI had a 48% lower chance of their lung cancer growing or spreading than people receiving placebo.

‡The median time tumors did not grow or spread was 16.8 months for the 476 patients receiving IMFINZI compared with 5.6 months for the 237 patients receiving placebo. IMFINZI may not work for everyone. Individual results may vary.

§The median amount of time patients were followed was 14.5 months for this analysis.

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Important Safety Information

What is the most important information I should know about IMFINZI® (durvalumab)?

IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

What is IMFINZI?

IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

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

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

  • Lung Icon

    Lung problems: cough, shortness of breath, and chest pain

  • Intestine Icon

    Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area (abdomen) pain or tenderness

  • Liver Icon

    Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), and bleeding or bruising more easily than normal

  • Hormone Gland Icon

    Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

  • Kidney Icon

    Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, and loss of appetite

  • Skin Irritation Icon

    Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in mouth or nose, throat, or genital area; fever or flu-like symptoms; and swollen lymph nodes

  • Pancreas Problems Icon

    Pancreas problems: pain in your upper stomach area (abdomen), severe nausea or vomiting, and loss of appetite

  • Patient with Other Health Issues Icon

    Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: Chest pain, irregular heartbeats, shortness of breath or swelling of ankles; confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems; tingling, numbness or weakness of the arms or legs; double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight; persistent or severe muscle pain or weakness, muscle cramps, joint pain, joint stiffness or swelling; and low red blood cells and bruising

  • Hospital Drips Icon

    Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, and back or neck pain

  • Organ Transplant Complications Icon

    Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with IMFINZI. Your healthcare provider will monitor you for these complications

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with IMFINZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with IMFINZI if you have severe side effects

Before you receive IMFINZI, tell your healthcare provider about all of your medical conditions, including if you:

  • have immune system problems such as Crohn's disease, ulcerative colitis, or lupus
  • have received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. IMFINZI can harm your unborn baby

Females who are able to become pregnant:

    • Your healthcare provider will give you a pregnancy test before you start treatment with IMFINZI.
    • You should use an effective method of birth control during your treatment and for 3 months after the last dose of IMFINZI. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with IMFINZI.
  • are breastfeeding or plan to breastfeed. It is not known if IMFINZI passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of IMFINZI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of IMFINZI?

IMFINZI can cause serious side effects (see above):

The most common side effects of IMFINZI when used alone in adults with non-small cell lung cancer (NSCLC) that cannot be removed by surgery include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMFINZI. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

What is IMFINZI?

IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

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

Please see Full Prescribing Information including Medication Guide for IMFINZI.

+

Important Safety Information +

What is the most important information I should know about IMFINZI® (durvalumab)?

IMFINZI is a medicine that may treat certain cancers by working with your immune system.

What is IMFINZI?

IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

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