How ALUNBRIG^® (brigatinib) May Help as Your First Targeted Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer

Hear From Barbara, a First-Line ALUNBRIG Patient

Barbara's Story

Learn more about Barbara’s ALK+ mNSCLC diagnosis, treatment with ALUNBRIG in the first line, and experience living with lung cancer.

Barbara is a real ALUNBRIG patient

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[Barbara]
When I do watercolor, I don't think about anything else. I just fall into the painting itself and in this way, I don't have to think about anything negative that's happened in my life. I don't think about my cancer. I don't think about the loss of my husband. I just have a wonderful time relaxing and enjoying the moment.

Hi, I'm Barbara. I was diagnosed with ALK positive metastatic non-small cell lung cancer in 2019.
In late 2015, I caught a cold. It developed into a very bad cough, which I thought might be pneumonia, so I went to have an X-ray and they discovered that there was something in my lung. They decided to send me for surgery. I had surgery on my right, upper lung and they discovered that it was a malignant tumor.

It was unbelievable that I had lung cancer because I had never smoked a day in my life. I just didn't understand how that was even possible. Most people in my family have passed away from heart-related diseases. Nobody had cancer in my family, so I was doubly shocked that I had cancer, and particularly that it was lung cancer.

They treated me with four rounds of chemotherapy, which seemed to work for a while.

When my cancer came back, I was absolutely devastated.

I underwent four rounds of chemotherapy concurrently with 37 days of radiation. That was to be followed by immunotherapy. Before the immunotherapy started, my oncologist tested my tumor, and that's when I found out that I had the ALK positive mutation.

The fact that I was ALK positive meant that immunotherapy was not going to be called for in my case, and so I guess I was kind of happy that he discovered that I had this mutation, and that was even before I found out that there was a medication that could benefit me.

My doctor mentioned that there was a pill that I would be eligible to take called Alunbrig.

ALUNBRIG is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC): that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and that has spread to other parts of your body.

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

He said that I would take this once daily in pill form.

When I first started, I was taking 90 milligrams daily. Once I tolerated that, they switched me to 180 milligrams a day, and I've been taking that ever since.

Once I started taking Alunbrig, it just fit so nicely into my lifestyle.

I really like the once daily dosing. I take it in the morning with breakfast and some other medications that I'm taking, and then I don't have to think about it for the rest of the day. That's it.

I have a very active lifestyle. I have loads of hobbies, and I love to travel. Taking one pill once a day works for me.

I have experienced diarrhea, nausea, pains in my legs and hands, as well as changes in the foods I enjoy eating while taking Alunbrig, but these are not all the possible side effects and everyone is different.

Speak to your healthcare provider about all the potential side effects with Alunbrig.

Alunbrig has worked for me, but everyone is different. To anyone living with the same diagnosis, I suggest you speak with your physician to see what would be the best treatment plan for you.

ALUNBRIG was evaluated in a broad range of patients, including those with ALK+ NSCLC that had spread to other parts of their body

The ALUNBRIG study included 275 patients with ALK+ NSCLC whose lung cancer had spread to other parts of their body.

137 patients received the recommended dosing regimen of 90 mg of ALUNBRIG orally once daily for 7 days, followed by an increase to 180 mg orally once daily. The other 138 patients received a different medicine called crizotinib (250 mg orally twice daily).

Patient ages ranged from 27 years to 89 years (median age was 59 years) and about half (55%) were female
58% of patients in the study had never smoked

Patients taking ALUNBRIG lived twice as long without their disease getting worse or spreading versus those taking crizotinib

BLINDED INDEPENDENT REVIEW COMMITTEE RESULTS

MEDIAN^a TIME TO PROGRESSION

Bar chart showing that the median time to progression for patients taking ALUNBRIG® was 24 months versus 11 months for patients taking crizotinib.

^aMedian is not the same as average. Please see glossary for definition

BLINDED INDEPENDENT REVIEW COMMITTEE
This was a group of independent researchers who objectively reviewed and evaluated the results from the trial.

OVERALL TUMOR RESPONSE

Overall, 3 out of 4 patients (74%) taking ALUNBRIG had their tumors shrink, vs 62% of patients taking crizotinib

101 of 137 patients (74%) taking ALUNBRIG had their tumors shrink vs 85 of 138 patients (62%) taking crizotinib.

ALUNBRIG Helped Shrink Tumors in the Brain

Additional Study Results

The Blinded Independent Review Committee also evaluated a smaller group of 41 patients with brain metastases.

Overall, 14 of 18 patients (78%) achieved a response while taking ALUNBRIG vs 6 of 23 patients (26%) taking crizotinib

3 out of every 4 patients with cancer that spread to their brain saw their tumors shrink when they were treated with ALUNBRIG

More than half of all patients (9 out of 14) who responded to ALUNBRIG maintained that response for 2 years or longer

Researchers could not estimate the results for the 6 patients who responded to treatment with crizotinib

During the Same Study, 131 People Completed a Quality of Life^a Questionnaire

ALK+ mNSCLC patients reported on how they functioned physically, emotionally, and socially, and on the severity of their symptoms.

Both groups reported that their cancer eventually impacted their quality of life, but ALUNBRIG patients reported a longer time until their symptoms worsened.

The median time to symptoms getting worse was 26.7 months for patients taking ALUNBRIG compared with 8.3 months for patients taking crizotinib.

The results of this survey weren't originally part of the study. People also knew which medicine they were taking during the study. This means they may have marked their quality-of-life improvements higher than they actually were.

Every patient is different. Always talk to your doctor if you have any questions about ALUNBRIG.

How to Take ALUNBRIG

^aQuality of life was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, or EORTC QLQ-C30. This 30-item questionnaire is used to measure health-related quality of life in people with cancer—specifically, how their disease and treatment are affecting them physically (eg, side effects and ability to be active), psychologically (eg, mental and emotional challenges), and socially (eg, impact on interacting with family and friends).

It's normal to have questions as you begin your treatment on ALUNBRIG.

We have additional resources for you to discuss with your healthcare provider as you get started.

See Additional Resources

Glossary

Median – The middle number in a set of measurements arranged from lowest to highest.

IMPORTANT SAFETY INFORMATION

ALUNBRIG can cause serious side effects, including:

Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms. including:

trouble breathing or shortness of breath
chest pain
cough with or without mucus
fever

High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.

Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your healthcare provider if you take any heart or blood pressure medicines.

Vision problems. ALUNBRIG may cause vision problems. Your healthcare provider may stop ALUNBRIG and refer you to an eye specialist if you develop severe vision problems during treatment with ALUNBRIG. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:

double vision
seeing flashes of light
blurry vision
light hurting your eyes
new or increased floaters

Muscle pain, tenderness, and weakness (myalgia). ALUNBRIG may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your blood levels of CPK during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Inflammation of the pancreas (pancreatitis). ALUNBRIG may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of pancreatitis, including upper abdominal pain that may spread to the back and get worse with eating, weight loss, or nausea.

Liver problems (hepatotoxicity). ALUNBRIG may increase the levels of bilirubin in your blood and enzymes called aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in your blood, which may be a sign of liver problems. Your healthcare provider will do blood tests to check your liver during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs or symptoms, including:

yellowing of your skin or the white part of your eyes
dark or brown (tea color) urine
nausea or vomiting
pain on the right side of your stomach area
bleed or bruise more easily than normal
itchy skin
decreased appetite
feeling tired

High blood sugar (hyperglycemia). ALUNBRIG may increase your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with ALUNBRIG. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of hyperglycemia, including:

feeling very thirsty
needing to urinate more than usual
feeling very hungry
feeling sick to your stomach
feeling weak or tired
feeling confused

The most common side effects of ALUNBRIG include diarrhea, fatigue, nausea, rash, cough, muscle pain, headache, high blood pressure, vomiting and difficulty breathing.

ALUNBRIG may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of ALUNBRIG. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What should I avoid while taking ALUNBRIG?

Limit your time in the sun during treatment with ALUNBRIG and for at least 5 days after your final dose. ALUNBRIG may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn.

Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.

Before you take ALUNBRIG, tell your healthcare provider about all of your medical conditions, including if you have lung or breathing problems, high blood pressure, a slow heartbeat, or any vision problems, have or have had pancreatitis, have liver problems, have diabetes mellitus or glucose intolerance, have kidney problems or are on dialysis, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

ALUNBRIG can harm your unborn baby. Your healthcare provider will determine whether or not you are pregnant before you start treatment with ALUNBRIG. Tell your healthcare provider right away if you become pregnant during treatment with ALUNBRIG or think you may be pregnant.

Females who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 4 months after the final dose of ALUNBRIG. Talk to your healthcare provider about birth control choices that are right for you during treatment with ALUNBRIG.
Males who have female partners who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 3 months after the final dose of ALUNBRIG.

It is not known if ALUNBRIG passes into your breast milk. Do not breastfeed during treatment with ALUNBRIG and for 1 week after the final dose of ALUNBRIG.

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

How ALUNBRIG^® (brigatinib) May Help as Your First Targeted Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer

Hear From Barbara, a First-Line ALUNBRIG Patient

Barbara's Story

ALUNBRIG was evaluated in a broad range of patients, including those with ALK+ NSCLC that had spread to other parts of their body

Patients taking ALUNBRIG lived twice as long without their disease getting worse or spreading versus those taking crizotinib

BLINDED INDEPENDENT REVIEW COMMITTEE RESULTS

MEDIAN^a TIME TO PROGRESSION

OVERALL TUMOR RESPONSE

Overall, 3 out of 4 patients (74%) taking ALUNBRIG had their tumors shrink, vs 62% of patients taking crizotinib

ALUNBRIG Helped Shrink Tumors in the Brain

During the Same Study, 131 People Completed a Quality of Life^a Questionnaire

It's normal to have questions as you begin your treatment on ALUNBRIG.

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

ALUNBRIG can cause serious side effects, including:

What should I avoid while taking ALUNBRIG?

What is ALUNBRIG?

Hear From Barbara, a First-Line ALUNBRIG Patient

Barbara's Story

ALUNBRIG was evaluated in a broad range of patients, including those with ALK+ NSCLC that had spread to other parts of their body

Patients taking ALUNBRIG lived twice as long without their disease getting worse or spreading versus those taking crizotinib

BLINDED INDEPENDENT REVIEW COMMITTEE RESULTS

MEDIANa TIME TO PROGRESSION

OVERALL TUMOR RESPONSE

Overall, 3 out of 4 patients (74%) taking ALUNBRIG had their tumors shrink, vs 62% of patients taking crizotinib

ALUNBRIG Helped Shrink Tumors in the Brain

During the Same Study, 131 People Completed a Quality of Lifea Questionnaire

It's normal to have questions as you begin your treatment on ALUNBRIG.

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

MEDIAN^a TIME TO PROGRESSION

During the Same Study, 131 People Completed a Quality of Life^a Questionnaire