ALUNBRIG^® (brigatinib) Video Library

Sarah: 
When patients are first diagnosed with ALK positive, non-small cell lung cancer, they usually feel like the floor just dropped out beneath them, and they don't know what is going to happen next. 

 

Summer: 
I received my ALK positive lung cancer diagnosis in the summer of 2020, and I went from being a caregiver to my 19-year-old son with cerebral palsy to a patient in the blink of an eye, it was answers to months of debilitating shortness of breath and coughing, but it was also a devastating blow to myself and to my family.

Once I received the ALK positive diagnosis, I dove in headfirst and trying, tried to absorb and obtain all information I could get my hands on. I first went to the ALK positive website. From there, I found an ALK positive support group so I could read articles and also hear from other patients living with the disease. 

 

Dr. Vivek: 
ALK positive metastatic non-small cell lung cancer patients are very unique. It is a rare it's a very rare subset of non-small cell lung cancer.

Treatment for metastatic, non-small cell lung cancer, ALK positive patients can be quite diverse. I like to be involved with the shared decision making, where I tell the patient and the family what different treatment approaches that we have for this type of lung cancer, all the different medications, I like to talk to them about, the side effects, take into account their comorbidities, and then, together with the patient and the family, we come to a conclusion of what is the best treatment for them. 

 

Sarah:
When I present ALUNBRIG to my patients, the number one thing that I tell them first is, this is a pill, and most patients are excited about the option to take a once daily pill.

 

Summer: 
My oncologist and nurse practitioner laid the initial groundwork for getting started on ALUNBRIG, but then I also had a phone call with a specialty pharmacist.

 

Sarah: 
When patients begin ALUNBRIG. It's important to make sure that we monitor them very closely, especially in the beginning of their treatment process. So, 48 hours after starting this medication, we will have a visit with the patient. We'll check their blood pressure, and then we see them one week later. We'll continue seeing them on a weekly cadence for the first month after starting their medication. As long as everything is stable, their labs are normal, and their vital signs are also normal. We can move that to about one month.

In my experience, ALUNBRIG has afforded me to be so close to my baseline with minimal side effects. Of course, my labs have to be monitored and scans, but that's with any treatment option. 

 

Sarah: 
For healthcare providers considering ALUNBRIG, I think the top thing to mention is the ease of dosing. This medication can be given once daily, and it's one pill. The second thing, I think, is very important also to mention is the ramp up dosing that this pill has for patients starting this treatment, they take 90 milligrams for the first seven days, and then 180 milligrams moving forward. This also helps patients stay on treatment.

 

Summer:
For patients considering ALUNBRIG, please remember going with eyes wide open ALUNBRIG is such a great treatment option when we have so many different options in the ALK positive landscape.

Summer: 
Hello. My name is Summer Farman, and today we are going to be talking about shared decision making in the treatment of ALK positive metastatic, non-small cell lung cancer. As a patient living with ALK positive non-small cell lung cancer, shared decision making played an important role in my treatment selection upon diagnosis. But before we begin our discussion. I'd like to provide my fellow panelists with the opportunity to introduce themselves. Sarah, can you go first please?

Sarah:
Thank you, Summer. Hello. My name is Sarah Karpen, and I'm oncology physician assistant in California.

Summer: 
Thank you so much, Dr Taha.

Dr. Taha: 
Hi. My name is Mahdi Taha. I'm a medical oncologist in Southern Florida. 

Summer: 
Thank you. And Dr Vivek?

Dr. Vivek:
Hi, my name is Dr. Abhirami Vivekananadarajah. I'm a community oncologist in New York.

Summer: 
Great. So happy you are all here today for this important discussion. So, thank you. I'd like to begin by sharing my perspective on shared decision making and the important role it played in my treatment journey.

In June of 2020 I received a stage four non-small cell lung cancer diagnosis after months of debilitating cough and shortness of breath. A few weeks later, it was confirmed that I had an ALK positive mutation. 

I had always been a fairly healthy person, active and engaged in all areas of my children's life and my work life, and suddenly I was pretty much bedridden, ridden and very ill. It was important for me to discuss treatment options with my oncologist, to know how this would impact my life and try to get me back to my baseline as much as possible. 

So once it was confirmed that I had ALK positive I really dove into the ALK positive website and began lurking on the ALK positive support groups to really equip myself with a foundation of knowledge and others lived experiences so I could have an educated discussion with my oncologist. She really also informed me in any gaps that were missing. So not only was it shared decision making, it was informed decision making. 

So I told you about my experience, but what does shared decision making mean to you as oncologists?

Dr. Vivek: 
So to me as an oncologist, I think shared decision making is very important. When you tell the patient about this, this devastating diagnosis of stage four lung cancer, I think it's very important for the patient to feel empowered and to have the full knowledge to make a decision about their treatment. 

Dr. Taha:

I agree. You know, it's really important on that initial consultation that we build a rapport as a patient, you understood you were probably so scared, and it's important to not only discuss what treatment options you have available, but also to build that rapport so that you trust our connection that we have initially. 

Summer:
It sounds like you're laying out a lot of different options, and then making a collective best, best practice decision or best fit.

Okay, Sarah, as an integral member of the care team, what is your role in patient care and the shared decision-making process for treatment decisions?

Sarah: 
So the first thing that I like to do when I meet a new patient is ask them, what do they want out of their treatment experience? For example, some patients want to know every detail about every treatment and every option available. Some patients say I do not want to know all of that information. It's too much for me. So the first thing that I want to know from a patient is, what do they want from me and how can I help guide them through their treatment experience?

Summer:
So what unique challenges do you face when making treatment decisions and educating patients on next steps?

Dr. Vivek: 
I think from the beginning, when the patient is told about their diagnosis, there's that initial denial that you hear from the patient, the family, they don't want to accept it. So I think that's a very big challenge that I face.

Summer:
Great. Thank you. Sarah, do you want to add anything?

Sarah: 
I think the one thing I would like to add is how timely it it's very important to make sure that these patients are treated, not only in a timely manner, but our physician colleagues have many patients during the day, so I think that having an advanced practice provider like a Nurse Practitioner or Physician Assistant involved can help with patient education.

Summer:
So with shared decision making, do you feel like this is a newer trend that you're seeing, or do you feel like many colleagues, are using shared decision making.

Dr. Vivek:
I mean, depends on the physician, oncologist, I should say, I have started doing this more and more with the patients. Again, it depends on how much the patients know when they come into the office.

Dr. Taha:
Yeah, it also depends on what type of oncologist you are seeing. There's a difference between a community oncologist and an academic oncologist because of the resources they have within their practice. And so a lot of the academic locations have many resources to assist those patients with shared decision making. And so from a private practice, we rely heavily on our team, such as our advanced practitioners, and our teams within the staff, we may have smaller resources, but you also have the continuity with the people that you've already established a relationship with.

Summer: 
So what are the benefits of incorporating the patient into this discussion of their frontline ALK positive treatment plan?

Dr. Vivek: 
So to me, as a physician, I think the most benefit is increasing patient compliance, and establishing the rapport, or basically strengthening the rapport, with the patient and the family.

Dr. Taha:
I think educating the patient about what their experience is going to be like, is important. I often get asked, especially in the beginning, am I going to feel it today? Am I going to feel it tomorrow? And so explaining that to the patients is really key. They want to know about their quality of life while they're on therapy, and having those important initial discussions provides the expectations as to what they're going to go through moving forward.

Summer:
That does successful collaboration in during shared decision making. What does that look like to you?

Dr. Vivek: 
So to me, a successful collaboration is basically having an open line of communication between the patient, the family, the care team, my care team, and also the other different sub specialists that that we have in the case.

Summer:
Great. Sarah, how about you?

Sarah:
I do want to mention the importance of the care team with the family, with friends, family, whoever is supporting the patient, because they also need to understand what to expect with this process. They're going to be the ones seeing that patient on a daily basis, they're going to be the ones taking care of that patient with their side effects and managing their side effects. So I think success not only is with the care team from a medical standpoint, but the care team from a patient centered standpoint.

Summer:
As a patient, of course, I feel that all care teams should be practicing shared decision making. So what do you think is one key takeaway for providers in the importance of shared decision making.

Dr. Vivek: 
Think of the patient as a center. And then basically, every decision, every conversation, has to be centered around them. Because I think that's, that's the number one point that actually, you know, strengthens the relationship between the physician and the patient, the family.

Dr. Taha: 
Yeah, key takeaway is having that really robust communication with your patient and their care team, whatever problems they're going to which will arise throughout their process, you have to address and try to see before it happens. And so that shared decision-making process is what helps mitigate those things.

Sarah:
As part of the care team, as an advanced practice provider, I also want to make sure that my colleagues are empowered to stand up for that practice, because I think patients sometimes only want to see the oncologist because that's who they're used to seeing. But it's also important to understand that the APP does play a big role in shared decision making.

Summer:
There are so many benefits to shared decision making when making treatment decisions, and then along the whole process of being on treatment, establishing trust is huge. Rapport, creating open lines of communication, the benefits are endless, and really you can't go wrong when empowering your patients and making decisions together.

Thank you all so much for being here today and for your role in shared decision making. I think that you can just tell in your responses how you handle shared decision making on a daily basis, and it's such a great model and foundation for other providers and patients to follow and to see what successful collaboration and partnership looks like.

Hello, I’m Dr. Mahdi Taha. A medical oncologist in southern Florida. For patients with ALK+ metastatic NSCLC, managing disease progression is a key consideration when selecting a first-line treatment. ALUNBRIG (brigatinib) has demonstrated strong systemic efficacy with durable intracranial responses, helping to provide durable disease control in these patients with advanced disease. In this video, we’ll take a closer look at the systemic efficacy of ALUNBRIG in the ALTA 1L trial and what it means for patients.

Let’s begin by looking at the design of the study. ALTA 1L was a randomized, Phase 3, open-label study comparing ALUNBRIG to crizotinib in adult patients with advanced ALK+ NSCLC who have not been previously receiving an ALK-targeted therapy. Patients were randomized one-to-one to receive ALUNBRIG 180 mg orally once daily with a 7-day lead-in at 90 mg once daily or crizotinib 250 mg orally twice daily. 

Patients were stratified by the presence of baseline CNS metastases and prior chemotherapy in the locally advanced and/or metastatic setting. Patients with a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis were excluded from the study. Treatment was continued until disease progression or unacceptable toxicity.

In the ALTA 1L trial, ALUNBRIG demonstrated powerful systemic efficacy vs crizotinib. The primary endpoint was Progression-free survival assessed by a Blinded Independent Review Committee. ALUNBRIG more than doubled the median PFS compared to crizotinib demonstrating a median PFS of 24 months vs 11 months. Based on the final analysis, the investigator-assessed median PFS was 30.8 months with ALUNBRIG vs 9.2 months with crizotinib.

The rate and durability of response was also assessed in the ITT population. With ALUNBRIG, we saw a significantly higher overall response rate of 74%, compared to 62% with crizotinib. In those patients that responded, ALUNBRIG demonstrated a durable response nearly 2.5 times longer than crizotinib. The median duration of response was 33.1 months with ALUNBRIG compared to 13.8 months with crizotinib.

ALUNBRIG is a proven first-line treatment choice for patients with ALK+ metastatic NSCLC. With its demonstrated clinical benefits, including durable progression-free survival and sustained responses, ALUNBRIG is a strong option for your next appropriate patient.

Hello. My name is Dr Mahdi Taha. A medical oncologist in Southern Florida. For patients with ALK+ mNSCLC, having a first-line treatment with proven efficacy and a well- established safety profile makes a difference. ALUNBRIG (brigatinib) has demonstrated intracranial activity, an important consideration in treatment decision-making, as well as strong systemic efficacy. In this video, we are going to take a closer look at ALUNBRIG and the ALTA 1L study. Specifically, we will look at a post hoc subgroup analysis that explores intracranial data for patients with or without brain metastases at diagnosis. Before we do, I want to familiarize you with the trial design of the ALTA 1L study.

ALTA 1L was a randomized, Phase 3, open-label study comparing ALUNBRIG to crizotinib in adult patients with advanced ALK+ NSCLC who had not previously received an ALK-targeted therapy. Patients were randomized (1:1) to receive ALUNBRIG 180 mg orally once daily with a 7-day lead-in at 90 mg once daily or crizotinib 250 mg orally twice daily. Patients were stratified by the presence of baseline CNS metastases and prior chemotherapy in the locally advanced and/or metastatic setting. Patients with a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis were excluded from the study. Treatment was continued until disease progression or unacceptable toxicity.

Today we want to focus on ALUNBRIG’s ability to treat patients with brain metastases and delay progression to the brain for those without brain metastases at diagnosis. Brain metastases are a common challenge in ALK+ metastatic NSCLC, affecting up to 35% of patients at diagnosis and up to 75% of patients over the course of their disease. metastases and its impact on patients, choosing an ALK inhibitor with CNS activity is vital to effective disease management.

Let's start by reviewing our overall response data. In a post hoc subgroup analysis of the patients with measurable brain metastases at baseline, ALUNBRIG demonstrated durable intracranial responses compared to crizotinib. 78% of patients achieved a confirmed intracranial response in the ALUNBRIG arm, compared to 26% with crizotinib, who achieved only a partial response. 28% of patients in the ALUNBRIG arm achieved a complete response. Additionally, 64% of responders sustained their intracranial response for at least 2 years. This was not estimable for crizotinib.

Delaying disease progression is also critical in ALK+ NSCLC treatment—especially in the brain. In the ITT population, ALUNBRIG demonstrated prolonged intracranial progression with a median PFS of about 4 years. In patients with any baseline brain metastases, ALUNBRIG was shown to decrease the risk of disease progression or death by 75% vs crizotinib—a substantial improvement. In this data, you can also see the early separation of survival curves.

Overall survival remains a key goal in ALK+ NSCLC treatment. In the ITT population, based on the final analysis with 40.4 months of median follow-up, median overall survival was not reached for both arms. The 3-year OS rate was 71% with ALUNBRIG and 68% with crizotinib. It’s important to note that 47% of patients in the crizotinib arm had crossed over to receive ALUNBRIG. In patients with measurable brain metastases at baseline,  ALUNBRIG reduced the risk of death by 57%. It's important to note the early separation of curves at 3 months. Additionally, 7 out of 10 patients were still alive at 4 years—reinforcing ALUNBRIG as a first-line treatment for those with brain metastases at baseline.

These findings highlight ALUNBRIG's activity in the brain—making it a strong first-line treatment option for your patients with ALK+ mNSCLC.

Evaluating the safety profile of ALUNBRIG

Hello, I’m Sarah Karpen. An oncology physician’s assistant from San Diego, California. When considering treatment options for ALK+ metastatic non-small cell lung cancer, it is important to understand the clinical and safety profile of your first-line treatment. The ALK-positive NSCLC patient population tends to be younger than the average NSCLC patient. Additionally, they may stay on therapy longer, increasing the importance of long-term tolerability as it can impact patient outcomes, adherence, and quality of life.

ALTA 1L was a randomized, Phase 3, open-label study comparing ALUNBRIG to crizotinib in adult patients with advanced ALK+ NSCLC who had not previously received an ALK-targeted therapy. In the ALTA 1L trial, ALUNBRIG (brigatinib) demonstrated a well-established safety profile with most adverse reactions being grades 1-2. Proactive monitoring and dose adjustments may help mitigate adverse events and help patients remain on ALUNBRIG.

In the ALTA 1L trial, adverse reactions occurring in at least 20% of patients receiving ALUNBRIG included diarrhea, rash, cough, hypertension, fatigue, nausea, myalgia, dyspnea, headache, and vomiting. The incidence of grade 3 and 4 events was generally low across both arms in ALTA 1L. The most common serious adverse reactions included pneumonia, ILD/pneumonitis, and pyrexia. Fatal adverse reactions occurred in 2.9% of patients and included pneumonia, cerebrovascular accident, and multiple organ dysfunction syndrome.

The ALUNBRIG Prescribing Information provides recommendations for dosage modifications of ALUNBRIG for the management of adverse reactions. As you can see in the table, ALUNBRIG dose adjustments provide a structured approach to managing adverse reactions, helping patients remain on treatment whenever possible. For patients taking 180 mg once daily, the first recommended reduction is 120 mg, followed by 90 mg, and if needed, 60 mg once daily. It’s important to remember—once a dose is reduced, it should not be increased again. And if a patient cannot tolerate 60 mg once daily, ALUNBRIG should be permanently discontinued. By following the recommended guidelines in the Prescribing Information, dose adjustments may help manage certain adverse reactions while allowing patients to continue benefiting from treatment.

The median duration of treatment with ALUNBRIG was 24.3 months – when administered orally, once daily – 90 mg for the first 7 days then increased to 180 mg. The median relative dose intensity was 97%. Additionally, ALUNBRIG was permanently discontinued in 13% of patients due to adverse reactions in ALTA 1L. The most frequent adverse reactions that led to discontinuation were ILD/pneumonitis and pneumonia.

Choosing a first-line treatment option with a proven safety profile and long-term tolerability is key in managing ALK+ metastatic NSCLC.* ALUNBRIG offers an established safety profile for these patients and has been shown to be generally well tolerated—supporting consistent dosing over time.

*Long-term tolerability is based on the median follow-up in the ALUNBRIG arm of ALTA 1L: 40.4 months.
 

Hello, I’m Sarah Karpen. An oncology physician’s assistant from San Diego, California. In this video, we’ll walk through the recommended dosage for ALUNBRIG (brigatinib) and how to initiate treatment for patients with ALK+ metastatic non-small cell lung cancer. Please refer to the full ALUNBRIG Prescribing Information for complete dosage guidance, including drug interactions, use in special populations, and recommended dosage modifications, as these will not be covered in this video.

ALUNBRIG is designed with patients in mind, offering the convenience of once-daily oral dosing and an Initiation Pack to support a smooth start to treatment.

Let’s start by taking a closer look at the recommended dosing regimen.

ALUNBRIG’s recommended dosing follows a 2-step approach to help patients effectively initiate treatment and mitigate the potential of early-onset adverse reactions.

Patients begin with 90 mg once daily for the first 7 days. After this lead-in period, the dose is increased to 180 mg once daily for continuous treatment. ALUNBRIG can be taken with or without food. Patients should be instructed to swallow the tablets whole—never crushed, split, or chewed—to ensure proper absorption.

Administer ALUNBRIG until disease progression or unacceptable toxicity. If a dose of ALUNBRIG is missed or vomiting occurs after taking a dose, do not administer an additional dose, and instruct the patient to take the next dose of ALUNBRIG at the regular time. If treatment is interrupted for 14 days or longer for reasons other than adverse reactions, resume at 90 mg once daily for 7 days before increasing to the previously tolerated dose.

A once daily dosing regimen may substantially reduce pill burden for patients. For example, treatments requiring eight doses a day means nearly 3,000 pills every year. With ALUNBRIG, there's just 1 pill, once a day—365 pills per year—allowing patients to spend less time worrying about taking their next dose.

Getting started should be easy, which is why ALUNBRIG offers an Initiation Pack to guide patients through the first month of treatment. The pack contains a bottle of seven 90-mg tablets for the first week and a bottle of twenty-three 180-mg tablets for the remainder of the month. It is important to note that patients are not automatically started with the Initiation Pack. The Starter Pack must be ordered by the prescribing physician for the first month’s treatment. Upon completion, the patient will then transition to the regular 180-mg dosing. This ensures that patients receive the correct starting dose and allows prescribers to initiate therapy with confidence.

For patients, ALUNBRIG’s once-daily dosing may offer a more consistent daily routine, less
disruption to daily life, and a reduced pill burden. ALUNBRIG supports providers and their patients in getting started with a convenient and easy-to-take ALK+ mNSCLC treatment.