What were the clinical trial results with IMFINZI for limited-stage SCLC?

264 people

were given IMFINZI after cCRT

266 people

were given placebo (no medicine) after cCRT

*Median overall survival (OS) is the length of time that half of the people are still living. The median OS for IMFINZI after cCRT was 55.9 months (4.6 years) compared to 33.4 months (2.8 years) for cCRT alone. Median is the middle number in a group of numbers arranged from lowest to highest.

IMFINZI after cCRT reduced the risk of cancer growing or spreading
In a clinical trial, people receiving IMFINZI after cCRT were 24% less likely to have their cancer grow or spread, compared with people receiving cCRT alone.

People had more time without their cancer growing or spreading^†

The study also measured how long people lived without their cancer growing or spreading when they were given IMFINZI following cCRT, and when given cCRT alone. This is called progression-free survival (PFS). Median progression-free survival is the length of time that half of the people lived before their cancer started growing or spreading.

What should I know before taking IMFINZI?

While on IMFINZI, you may experience side effects. This is because IMFINZI works with your immune system to treat cancer, which can also affect the way normal organs and tissues work. These problems can sometimes become serious or life-threatening and can lead to death in some cases. 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:

• 

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

• 

  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 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), drowsiness, dark urine (tea colored), and bleeding or bruising more easily than normal

• 

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

• 

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

• 

  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

• 

  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

• 

  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

• 

  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

• 

  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

Inflammation in the lungs

Feeling tired or weak

These are not all the possible side effects of IMFINZI.
Please see full Important Safety Information below and Full Prescribing Information including Medication Guide for IMFINZI.