What were the clinical trial results?

Learning about the clinical trial results for IMFINZI + BCG can help you have an informed discussion with your care team.

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How was IMFINZI studied?

A clinical trial compared two groups of adults with high-risk non-muscle-invasive bladder cancer who had never received treatment with BCG or had not received treatment with BCG in the past 3 years.

339 people

received IMFINZI + BCG

340 people

received BCG alone

A main goal of the study was to find out how long people lived without their bladder cancer coming back, or dying. This is called disease-free survival, or DFS. The study followed each group for approximately 5 years (60.7 months).

In adults with high-risk NMIBC who had not previously been treated with BCG

272 out of 339

people who received IMFINZI + BCG did not see their cancer come back, and were still living

242 out of 340

people who received BCG alone did not see their cancer come back, and were still living

32 %

IMFINZI + BCG, significantly reduced the risk of cancer coming back, or of dying

In a clinical trial, people who received IMFINZI + BCG had a 32% lower risk of their cancer returning, or of dying.

Median disease-free survival was not reached for IMFINZI + BCG or BCG alone. Median DFS is the length of time that half the people did not experience a return of their cancer, or death from any cause. When more than half the people have not had their cancer come back and are still living, median DFS has not been reached. Median is a middle number in a group of numbers arranged from lowest to highest.

Learn more about IMFINZI + BCG treatment

Find out more

Helpful highlights: IMFINZI clinical trial results

Let's review:

  • The clinical trial included adults with high-risk NMIBC that were at high risk for their cancer coming back after treatment, and who had not received treatment with BCG in the last 3 years
  • The trial included 2 groups of people—339 people receiving IMFINZI + BCG, followed by BCG alone, and 340 people receiving BCG alone
  • 272 out of 339 people in the IMFINZI + BCG group were still living and did not see their cancer come back. 242 out of 340 people in the BCG alone group were still living and did not see their cancer come back
  • People who received IMFINZI + BCG, then BCG alone, had a 32% lower risk of their cancer coming back, or of dying

Median disease-free survival was not reached for IMFINZI + BCG or BCG alone.

Median DFS is the length of time that half the people did not experience a return of their cancer, or death from any cause. When more than half the people have not had their cancer come back and are still living, median DFS has not been reached. Median is a middle number in a group of numbers arranged from lowest to highest.

Questions to discuss with your care team:

  • What were the results for IMFINZI + BCG in the clinical trial?
  • What does disease-free survival mean?
  • What does statistical significance mean?
  • How long were the people in the study observed?

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.

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

What is IMFINZI?

IMFINZI is a prescription medicine used in combination with Bacillus Calmette-Guérin (BCG) to treat a type of bladder cancer called high-risk non-muscle invasive bladder cancer (NMIBC) that has not spread into the muscle layer of the bladder, when you have not had prior treatment with BCG.

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

 

  • ISI Lungs Problem Symptoms

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

  • ISI Intestinal Problem Symptoms

    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

  • ISI Liver Problem Symptoms

    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

  • ISI Hormonal Gland Symptoms

    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

  • ISI Kidney Problem Symptoms

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

  • ISI Skin Problem Symptoms

    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

  • ISI Pancreas Problem Symptoms

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

  • ISI Other Organ Problem Symptoms

    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

  • ISI Infusion Reaction Signs and Symptoms

    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

  • ISI Organ or Tissue Transplant Rejection

    Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had

  • ISI Organ or Tissue Transplant Rejection

    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 or tissue transplant, including corneal 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 with Bacillus Calmette-Guérin (BCG) in adults with high-risk NMIBC
include increased liver function tests, urinary tract infection, increased level of potassium in blood, pain or discomfort with urination, decreased red blood cells (anemia), blood in urine, increased level of creatinine in the blood, muscle or bone pain, decreased lymphocyte counts, urinate more often, decreased level of sodium in the blood, feeling tired, rash, and fever.

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 productsReport 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.

Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca productsReport 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.

Please see Full Prescribing Information including Medication Guide for IMFINZI.

What is IMFINZI?

IMFINZI is a prescription medicine used in combination with Bacillus Calmette-Guérin (BCG) to treat a type of bladder cancer called high-risk non-muscle invasive bladder cancer (NMIBC) that has not spread into the muscle layer of the bladder, when you have not had prior treatment with BCG.

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

Please see Full Prescribing Information including Medication Guide for IMFINZI.

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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

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

Read full Important Safety Information

What is IMFINZI?

IMFINZI is a prescription medicine used in combination with Bacillus Calmette-Guérin (BCG) to treat a type of bladder cancer called high-risk non-muscle invasive bladder cancer (NMIBC) that has not spread into the muscle layer of the bladder, when you have not had prior treatment with BCG.

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IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies.

©2026 AstraZeneca. All rights reserved. US-105683 Last Updated 5/26