Training Example: ALUNBRIG (Takeda Pharmaceutical Company) – Review the Data, Give Your Score & Compare to the Real AI Evaluation

[H3] If You Are Newly Diagnosed

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[H3] After Treatment With Crizotinib

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[H3] Important Resources for You

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[H2]
Eric & Meghan's Story

Learn about how Eric and Meghan have navigated Eric’s ALK+ mNSCLC diagnosis, their experience with ALUNBRIG, and how together they are living with lung cancer.Eric was diagnosed with ALK+ mNSCLC and was taking ALUNBRIG as prescribed at the time of recording.

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[Meghan]Eric and I have been married for about 10 years, we have a pretty vibrant life. A lung cancer diagnosis made no sense to us. Often people say it's like having the rug pulled out from underneath you, when you get a diagnosis like that. I correct them. And I say it's like the whole floor, coming out from underneath you.When we got that phone call or news from the physician of his cancer diagnosis, I knew it would be a major inflection point in our life.[Eric]Prior to diagnosis, my health started to change in such a way that I was having difficulty breathing. And I was coughing quite a bit.The symptoms that I had, definitely felt like someone standing on my chest. I was also having difficulty sleeping on my back, which led me to a lot more sleepless nights.It came up in a conversation with my wife and after she said, “Hey, I'm concerned that your coughing is becoming uncontrollable. I think it's time for you to visit your primary care physician.”It was a very short period of time, I was able to go from an x-ray to a CT in the same day. And then within two days, I was doing a biopsy.The first time that I heard the word cancer, from my physician. I will never forget those words.At age 41. I was diagnosed with stage four ALK positive non-small cell lung cancer. Receiving a diagnosis of this sort, made no sense to me.[Meghan]We've obviously subsequently learned that anyone with lungs can get lung cancer.[Eric]It took me a while to understand the impact of having brain metastases. And at that point, I was honestly so defeated and downtrodden.As my treatment options were explained to me, I had the choice of a few different TKIs. I consulted with my family, my oncologists and other primary care specialists to pick the best option for me based on the side effects and the dosing. And for me, that choice was 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.The most important factor when selecting ALUNBRIG was how it would impact my life. And I looked at the side effects and the dosage. And those two combined, made it feel that it would be the least impactful to my everyday life.I've experienced bradycardia nausea and stomach pain while taking ALUNBRIG. But these are not all of the possible side effects. And everyone is different.Speak to your healthcare provider about all the potential side effects with ALUNBRIG.[Meghan]The treatment was very easy to incorporate into our lives. Being able to take one pill a day was of a significant benefit to him as well.[Eric]I started ALUNBRIG on the seven-day starter dosage of 90 milligrams, after which I increased to 180 milligrams, which I currently take.[Meghan]From my perspective, Eric has responded really well to ALUNBRIG.Fortunately, it had a rapid reduction in his tumor volume. He was able to tolerate the medicine.[Eric]After reading my scan reports, one of the terms frequently used is “unremarkable”.  That effectively means that while my tumors are still present, they're not growing or spreading. So, I will happily claim to be an “unremarkable cancer patient”.[Meghan]When Eric was first diagnosed with lung cancer, he was given a prognosis of nine to 12 months. That timing then aligned with our 10-year wedding anniversary. So, our goal became to make it to the anniversary.And as we did, we elected to have a vow renewal ceremony with a number of family and friends.We're able to take less of the focus on his treatment and the worry and put it more so into creating memories together.[Eric]The best piece of advice that I've received from my care is that you don't have to hit a homerun your first at bat. You have to get on base. You have to stay healthy enough to take advantage of technology and its advances.And that's what gives me hope.

[H3]
How Does ALUNBRIG Work?

ALUNBRIG, a type of targeted therapy, is a tyrosine kinase inhibitor (TKI) that can inhibit or slow the spread of non-small cell lung cancer by targeting specific proteins that are responsible for cancer cell growth.Tyrosine kinases are proteins that are part of functions like cell signaling, growth, and division. Sometimes, these proteins are too active or are found at high levels in some types of cancer cells.A TKI inhibits or blocks tyrosine kinases and may help keep cancer cells from growing. ALUNBRIG targets a specific type of tyrosine kinase called anaplastic lymphoma kinase (ALK). Although ALK normally helps control cell growth, in 3-5% of patients with NSCLC it becomes abnormal and allows cancerous cells to grow and spread. For these patients, ALUNBRIG blocks ALK to keep cancer cells from growing and spreading in ALK+ mNSCLC.

[H3]
Hear From Greg, an ALUNBRIG Patient

[H2]
Greg’s Story

Learn about Greg’s path to an ALK+ mNSCLC diagnosis, his treatment journey on ALUNBRIG, and how he continues to live an active lifestyle.Greg was diagnosed with ALK+ mNSCLC and was taking ALUNBRIG as prescribed at the time of recording.

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[Greg]My name is Greg. My wife's name is Amy. We live in Boston, Massachusetts. We like to go out and experience different things and travel a lot together whenever we have time.I was diagnosed with ALK Positive, metastatic, non-small cell lung cancer in September of 2021 at the age of 39.Before I was diagnosed, I was very active, almost on a daily basis. I really didn't stop moving from the time I woke up between 4:45, and 5:15 until I went to bed.Around Memorial Day in 2021, after I was doing workouts, it was taking me longer to recover. And steadily deteriorated, which gave me a rise to suspect something else was going on.The journey to diagnosis was actually a very long and stressful one. I got a lymph node that bulged from my neck on the left side, and during that time, I developed a persistent cough. I couldn't even walk my dog around the apartment building without feeling like I had run 10 plus miles or even a full race.That all led to this day when I got up and went to work and I couldn't speak, and that was kind of the beginning of what I'll call the diagnosis process that took 11 days of being hospitalized.But it wasn’t until the neurologist came in and noticed I had lost the ability to speak. She said to the nurse you need to get him down to an MRI. That’s when the result came back that showed 13 lesions in my head.That's where the confirmation came that it's cancer. What type we did not know at this point.And during the course of radiation, after we got the biopsy that was sent off for next generation sequencing to see if there were any biomarkers, we got the panel report back that confirmed and diagnosed me with ALK Positive metastatic, non-small cell lung cancer.It really didn't make any sense to me. It doesn't matter your fitness level. It doesn't matter your lifestyle. I mean, one of the things that I've learned over the past four years now, is that if you have lungs, you can get lung cancer.The decision to choose an ALK TKI as our first treatment option was because it works directly on the ALK mutation.My oncologist discussed the variety of options in terms of the ALK TKI’s. We went over, you know, the pros, the cons, the side effects, the potential for response versus nonresponse.It was a collaborative conversation. But ultimately, the decision was mine to make.I was only on that first line of treatment for about a month. I had a significant downturn in my health and was hospitalized.Although this was my experience on that treatment, each patient will be different.I first learned about ALUNBRIG during the selection process of the first TKI. It wasn't until we decided to switch one month later to a second TKI that I really dug into the efficacy and the safety profile of ALUNBRIG. Deciding on ALUNBRIG for the second treatment option was a very quick decision.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 is not spread to other parts of your body. It is not known if ALUNBRIG is safe and effective in children.Before starting ALUNBRIG, my doctor explained that I may experience side effects. The ones that were pointed out were specifically fatigue in my situation. He also shared that these can sometimes be serious, so it's important for me to understand this before we began treatment. While I've not experienced side effects while being treated by ALUNBRIG, please remember that's my experience, and others may experience something different.Please speak with your healthcare provider about possible side effects with ALUNBRIG.I started ALUNBRIG at 90 milligrams once a day for seven days, and then moved to 180 milligrams once a day, which is the recommended dose, and I've been on that ever since.I think treatment with ALUNBRIG has impacted my life in a very positive way. The doctors use the term N.E.D. or “no evidence of disease” to describe my current state from the neck down.Even when you're in a place that seems completely hopeless, there is hope, there is a possibility for things to change and for you to fight for it.I'm really enjoying just being in the moment. I've checked a lot of things off my bucket list that I would not have thought I was able to do four years ago. I plan to live life unapologetically and the fullest, every day for however long I can.ALUNBRIG (brigatinib) 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 bodyIt is not known if ALUNBRIG is safe and effective in children.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:   o trouble breathing or shortness of breath   o chest pain   o cough with or without mucus   o 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:   o double vision   o seeing flashes of light   o blurry vision   o light hurting your eyes   o 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:   o yellowing of your skin or the white part of your eyes   o dark or brown (tea color) urine   o nausea or vomiting   o pain on the right side of your stomach area   o bleed or bruise more   o itchy skin   o decreased appetite   o 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:   o feeling very thirsty   o needing to urinate more than usual   o feeling very hungry   o feeling sick to your stomach   o feeling weak or tired   o feeling confusedThe 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.While taking ALUNBRIG you should:• 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.o 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.o 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.Talk to your healthcare provider about ALUNBRIG, a once-daily oral prescription medication that may help treat adults with ALK-positive metastatic non-small cell lung cancer.

[H3]
Who Can Be Treated With ALUNBRIG?

ALUNBRIG is approved to treat adults with NSCLC:

that has an abnormal ALK gene, and
that has spread to other parts of the body

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

[IMG: Man and woman standing together.]

[H3] Learn More About ALUNBRIG as a First Treatment

Clinical Study Results

[H3] Learn More About ALUNBRIG After Another Treatment

After Treatment with Crizotinib

[H3] 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.

Targeted therapy - A type of treatment that can inhibit or slow the disease growth, progression, and spread of cancer by targeting specific molecules that are responsible for cancer cell growth. Some targeted therapies block the action of certain enzymes, proteins, or other molecules involved in the growth and spread of cancer cells.

[H3]
Listen to Katie’s Story and Her Experience With ALUNBRIG

[H2]
Katie's Story

Katie is a wife and mother of two. Learn about her path to an ALK+ mNSCLC diagnosis, and why ALUNBRIG was the best treatment option for her.Katie was diagnosed with ALK+ mNSCLC and was taking ALUNBRIG as prescribed at the time of recording.

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[Katie]Before my diagnosis, I really thought of myself as a pretty healthy person. I took care of myself. I have never been a smoker. I never had any major health issue or problem.My name is Katie. I live in a suburb of Chicago. I'm married to my wonderful husband, Tom, and I have two great kids, Wilson and Opal.I was diagnosed with ALK positive, metastatic non-small cell lung cancer in January of 2022. About a year before I was actually diagnosed, I developed a cough and it would not go away. I tried everything. I went and sought out my doctor, and at first she thought that it was possibly allergies. And she said, “Let's just keep an eye on it, and we'll follow up after the holidays.”And at that appointment, I learned that they were able to see a mass in my lower left lung. My doctor tried to reassure me this could be so many things. But just in case, we should do a PET scan. And on the PET scan, it lights up in areas that could be metastatic. I had light up along my spine, in my left shoulder, in my lymph nodes, in my left lung, my lower back.20 minutes or so after I woke up from surgery, the surgeon came in and confirmed that it was stage four, non-small cell lung cancer. People around me were trying so hard to be positive, I didn't understand what had happened. I didn't understand why it had happened. I was really clutching for answers that just really aren't there. We talked about the possibility, because I was young and a non-smoker, there was a higher likelihood that I would have a targetable mutation that was driving the cancer.Instead of traditional chemotherapy and radiation, there are certain mutations that just require an oral pill.So we're waiting for the phone call from the doctor to let me know if I have this mutation or not.The phone rang, and it was the doctor, and she said, I have great news. You have a mutation called ALK.There is a treatment path available to you. The sense of relief I had was just unlike anything I had felt.In a cancer diagnosis a second opinion is everything. My doctor sat down with my husband and myself and actually went over three possible options for my treatment. My doctor and I both decided that ALUNBRIG would be the best choice for me. I have a busy life and taking one pill a day doesn't seem to be very intrusive to my life.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. I started ALUNBRIG with 90 milligrams once a day for seven days, and then I increased it to 180 milligrams once a day, which is the recommended dose, and that's the dose I continue to be on. Since being on ALUNBRIG, I have not had too many side effects, but I have experienced some GI side effects, which I've been able to manage with my doctor and with over-the-counter medication. But these are not all of the possible side effects and everyone is different. Speak to your health care provider about the potential side effects with ALUNBRIG.After my one-year PET scan on ALUNBRIG, my doctor just gave me the biggest hug, and she said, I have to tell you, you have had a complete metabolic response… and you have no evidence of disease currently in your body. Being able to just continue with what I did as a mom, as a wife, that's meant everything. My husband has held me up through all of it. My kids have inspired me to keep going. I saw my son graduate high school. I moved my son into his dorm room. That was big. My daughter, Sweet 16. I'm going to be 50 this year.I want to travel. I want to see things. I want to visit places that I've always wanted to go. Today, I feel healthy, I feel confident, I feel grateful.For me, ALUNBRIG means hope.ALUNBRIG (brigatinib) 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 bodyIt is not known if ALUNBRIG is safe and effective in children.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• feverHigh 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 floatersMuscle 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• itchy skin• decreased appetite• feeling tiredHigh 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 confusedThe 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.While taking ALUNBRIG you should:• 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.Talk to your healthcare provider about ALUNBRIG, a once-daily oral prescription medication that may help treat adults with ALK-positive metastatic non-small cell lung cancer.

[IMG: People walking in a park.]

[H3]
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 female58% of patients in the study had never smoked

[H2]
Patients taking ALUNBRIG lived twice as long without their disease getting worse or spreading versus those taking crizotinib

[H4]
BLINDED INDEPENDENT REVIEW COMMITTEE RESULTS

[H4]
MEDIANa TIME TO PROGRESSION

[IMG: 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.

[H3]
OVERALL TUMOR RESPONSE

[IMG: 3 out of 4.]

[H3]
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.

[H3]
ALUNBRIG Helped Shrink Tumors in the Brain

Additional Study ResultsThe 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 crizotinib3 out of every 4 patients with cancer that spread to their brain saw their tumors shrink when they were treated with ALUNBRIGMore than half of all patients (9 out of 14) who responded to ALUNBRIG maintained that response for 2 years or longerResearchers could not estimate the results for the 6 patients who responded to treatment with crizotinib

How to Take ALUNBRIG

[H3] 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.

[H3]
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.

[IMG: 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.]

[H3]
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).

[H3]
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.

[IMG: 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.

[H3]
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

[H3]
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

[H3] 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.