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Immunotherapy Gives Certain Patients Hope

(BPT) - On Christmas morning 2017, while lugging his children’s new gift – a 16-foot trampoline – up the basement steps, Wayne hurt his back. He had a history of back problems due to osteoporosis, but this time the pain was worse. Wayne woke up the next morning to even more pain and knew he had to go to the hospital. X-rays detected five fractures, as well as a mass in Wayne’s left lung. Doctors ran additional tests, including a biopsy of the mass. The results confirmed a diagnosis of Stage 3 non-small cell lung cancer.

“When I heard the news, I was really frightened. I thought it was the end of my life,” Wayne recalls. “I know that Stage 4 cancer is considered the most advanced stage, and here I was with Stage 3. I didn’t think I was going to make it.”

Wayne lives in Taylorsville, Kentucky, where he is a volunteer youth counselor and a pillar of the community. He works with teens as part of a motorcycle ministry that helps teach religion throughout the town – a position that he dearly loves. He couldn’t bear the thought of letting down all the people he supports through his ministry and swore to fight back against his lung cancer.

Understanding Stage 3 Non-Small Cell Lung Cancer and Treatment Options

Non-small cell lung cancer (NSCLC) accounts for most lung cancer diagnoses. Stage 3 NSCLC is diagnosed when the cancer has spread to nearby tissue or lymph nodes within the chest but has not spread to other parts of the body. Most of the estimated 43,000 Americans who are diagnosed with Stage 3 NSCLC each year have unresectable tumors, meaning the cancer cannot be removed by surgery. This was the case for Wayne, who had already suffered permanent lung damage from chronic obstructive pulmonary disease (COPD), rendering the tumors medically inoperable.

Wayne met with his medical team to discuss treatment options. His doctors recommended that he start on radiation therapy and chemotherapy given at the same time – known as concurrent chemoradiation therapy, or cCRT. cCRT is typically the first choice of treatment for patients with Wayne’s type of cancer. One small study showed that up to 89 percent of patients progressed to Stage 4 lung cancer within a year of receiving cCRT. By then the disease has already spread outside the chest to other areas of the body, lowering the chances of long-term survival. In fact, only about 6 percent of patients survive five years at Stage 4.

Treatment Advances Raise Hope

IMFINZI® (durvalumab) is a prescription medicine approved for patients with unresectable Stage 3 NSCLC whose disease has not progressed following cCRT. In addition to fighting tumors, IMFINZI can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. Side effects for IMFINZI include but not limited to chest pain, diarrhea, severe stomach pain, nausea, headache and irregular heartbeat. These side effects can be serious. See full safety information below.

“It was just about one decade ago that patients with unresectable Stage 3 non-small cell lung cancer had very few meaningful options beyond chemotherapy and radiation,” said Kristin Higgins, MD, Radiation Oncologist at Winship Cancer Institute of Emory University. “Fortunately, treatment options have improved significantly in recent years. I would encourage patients to ask their doctor or another member of the care team to help them better understand their lung cancer diagnosis and your treatment options.”

In addition to this survival benefit, the same trial previously showed that people receiving IMFINZI had a 48 percent lower chance of lung cancer growing or spreading than people receiving placebo (after a median* follow-up time of 14.5 months). It was also proven to give people 3 times more time without their lung cancer growing or spreading compared with people receiving placebo. The median amount of time that people lived without their tumors growing or spreading was 16.8 months for the patients receiving IMFINZI compared with 5.6 months for the patients receiving placebo.

Wayne Charts a New Course for Himself and His Family

Wayne has completed cCRT and IMFINZI treatment.

Having been treated with chemotherapy and radiation, and now with IMFINZI, Wayne’s outlook on life is completely different. Wayne says, “I’ve got a big family that still needs me. I’m grateful for the chance to live longer.”

Important Safety Information

What is the most important information I should know about IMFINZI?

IMFINZI is a medicine that may treat a type of lung cancer by working with your immune system.

IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms may include new or worsening cough, shortness of breath, and chest pain.

Liver problems (hepatitis). Signs and symptoms may include 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), bleeding or bruising more easily than normal, and feeling less hungry than usual.

Intestinal problems (colitis). Signs and symptoms may include diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.

Hormone gland problems (especially the thyroid, adrenals, pituitary, and pancreas). Signs and symptoms that your 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; feeling cold; constipation; your voice gets deeper; urinating more often than usual; nausea or vomiting; stomach-area (abdomen) pain; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include decrease in the amount of urine, blood in your urine, swelling of your ankles, and loss of appetite.

Skin problems. Signs may include rash, itching, and skin blistering.

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Problems in other organs. Signs and symptoms may include neck stiffness; headache; confusion; fever; chest pain, shortness of breath, or irregular heartbeat (myocarditis); changes in mood or behavior; low red blood cells (anemia); excessive bleeding or bruising; muscle weakness or muscle pain; blurry vision, double vision, or other vision problems; and eye pain or redness.

Severe infections. Signs and symptoms may include fever, cough, frequent urination, pain when urinating, and flu-like symptoms.

Severe infusion reactions. Signs and symptoms 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 facial swelling.

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 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 had an organ transplant; have lung or breathing problems; have liver problems; or are being treated for an infection.

If you are pregnant or plan to become pregnant, tell your healthcare provider. IMFINZI can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. Talk to your healthcare provider about which birth control methods to use. Tell your healthcare provider right away if you become pregnant during treatment with IMFINZI.

If you are breastfeeding or plan to breastfeed, tell your healthcare provider. It is not known if IMFINZI passes into breast milk. Do not breastfeed during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.

Tell your healthcare provider about all the medicines you take. This includes 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 in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs (pneumonitis), 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 healthcare provider for medical advice about side effects.

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

Please see complete Prescribing Information, including Patient Information (Medication Guide).

Who is IMFINZI for?

IMFINZI® (durvalumab) is a prescription medicine used to treat 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.

*The value at the midpoint of a frequency distribution

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