How ALUNBRIG^® (brigatinib) May Help if You’ve Already Tried Another ALK+ Targeted Treatment

Why Did My Doctor Recommend That I Start a New Treatment?

Unfortunately, despite treatment—even with a targeted therapy—ALK+ non-small cell lung cancer (NSCLC) can still progress (worsen) over time. This may mean that your cancer has developed resistance to your current treatment, and it is no longer working. It's important to know that this may be expected, and you still have options. That’s why your healthcare provider has recommend switching to ALUNBRIG.

Your doctor may also talk to you about switching to ALUNBRIG if, while on your current treatment, you experience side effects you may not be able to tolerate.

ALUNBRIG study design featured 222 patients with ALK+ metastatic NSCLC who progressed after crizotinib treatment. They were split into 2 groups, with 112 patients taking 90 mg and 110 patients starting with 90 mg and increasing to 180 mg.

ALUNBRIG Was Shown to Shrink Tumors After Crizotinib Treatment in Patients with ALK+ NSCLC Whose Cancer Had Spread to Other Parts of the Body

In a previous ALUNBRIG study, researchers followed 222 patients with ALK+ NSCLC whose cancer had spread to other parts of the body, who had taken the medicine crizotinib, and whose disease had worsened.

112 patients received 90 mg of ALUNBRIG orally once daily (90-mg group).

The other group of 110 patients received the recommended ALUNBRIG dosing regimen of 90 mg orally once daily for 7 days, followed by an increase to 180 mg orally once daily thereafter (90→180-mg group).

Study Results for the Recommended Dosing Regimen (90→180-mg Group)

More than half (53%) of patients achieved a response, meaning their tumors either shrank or disappeared while taking ALUNBRIG.

Pie chart showing that 53% of patients achieved an overall response rate in the 90 mg→180 mg group.

Overall, 58 out of 110 achieved a response

5 out of 110 (4.5%) patients achieved a complete response
53 out of 110 (48%) patients achieved a partial response

Additional Study Results

In the same study, 112 patients received 90 mg of ALUNBRIG orally once daily (90-mg group) without having their dose increased.

54 out of 112 (48%) patients achieved a response
- 4 out of 112 (3.6%) patients achieved a complete response
- 50 out of 112 (45%) patients achieved a partial response

Responses lasted a median of 13.8 months for both dosing groups.

Additional Second-Line Study Results

ALUNBRIG also showed results in the brain

Study Results for the Recommended Dosing Regimen (90→180-mg Group)
In the same study, 18 patients receiving the recommended dosing regimen had measurable tumors that had spread to the brain.

67% of patients' brain tumors shrank
Nearly 2 out of every 3 patients saw their brain tumors shrink.

None of the patients had a complete response in the brain
67% (12 out of 18) had a partial response in the brain

Of the 12 patients who responded to treatment with ALUNBRIG:

6 patients responded for 6 months or longer, and
3 patients responded for 12 months or longer

Additional Study Results for the 90-mg Group

26 patients with ALK+ NSCLC in the 90-mg group had measurable tumors that had spread to the brain.

Overall, brain tumors shrank in 11 out of 26 (42%) patients

2 out of 26 (7.7%) patients had a complete response in the brain
9 out of 26 (35%) patients had a partial response in the brain

Of the 11 patients who responded to treatment with ALUNBRIG:

7 patients responded for 6 months or longer, and
4 patients responded for 12 months or longer

How to Take ALUNBRIG

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

ALK gene - A gene that makes a protein called anaplastic lymphoma kinase or ALK, which is involved in cell growth. Mutated or genetically changed forms of the ALK gene and protein have been found in some types of cancer, such as NSCLC.

Complete response - The disappearance of tumors in response to a given treatment. This is not the same as a cure.
Median - The middle number in a set of measurements arranged from lowest to highest.
Partial response - The decrease in size and spread of tumors in response to a given treatment.
Resistance - When cancer cells do not respond to a drug used to destroy or weaken them. Drug resistance may happen at the beginning of a treatment or may happen over time.

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.