Powerful First-Line Efficacy With a
Well-Established Safety Profile in ALTA 1L
Adverse Reactions in ≥10% (All Gradesa) or ≥2% (Grades 3-4) of Patients by Arm in ALTA 1L (N=273)1
aPer National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
bIncludes abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, and epigastric discomfort.
cIncludes aphthous ulcer, mouth ulceration, oral mucosal blistering and stomatitis.
dIncludes dermatitis, dermatitis acneiform, dermatitis bullous, dermatitis contact, drug eruption, erythema, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, toxic skin eruption, urticaria.
eIncludes pruritus, allergic pruritus, and generalized pruritus.
fIncludes dyspnea and exertional dyspnea.
gIncludes hypertension and systolic hypertension.
hIncludes asthenia and fatigue.
iIncludes angioedema, eye swelling, eyelid edema, face edema, generalized edema, lip swelling, peripheral edema, periorbital edema, peripheral swelling, skin swelling, swelling and swelling face.
jIncludes muscle spasms, muscle twitching, musculoskeletal discomfort, musculoskeletal pain, and myalgia.
kIncludes headache and migraine.
lIncludes burning sensation, dysesthesia, hyperesthesia, hypoesthesia, neuralgia, peripheral neuropathy, paraesthesia, peripheral sensory neuropathy and polyneuropathy.
mIncludes blood cholesterol increased, hypercholesterolemia.
nIncludes bradycardia, heart rate decreased, sinus bradycardia.
oIncludes lower respiratory tract infection, lung infection, pneumonia, aspiration pneumonia, and cryptococcal pneumonia.
pIncludes upper respiratory tract infection and viral upper respiratory tract infection.
qIncludes cataract, glaucoma, hypermetropia, night blindness, papilloedema, photophobia, photopsia, blurred vision, reduced visual acuity, visual field defect, visual impairment, and vitreous floaters.
rIncludes Grade 5 events.
Serious adverse reactions occurred in 33% of patients receiving ALUNBRIG.1
The most common serious adverse reactions in ALTA 1L were pneumonia (4.4%), ILD/pneumonitis (3.7%), pyrexia (2.9%), dyspnea (2.2%), pulmonary embolism (2.2%), and asthenia (2.2%).1
Fatal adverse reactions occurred in 2.9% of patients and included pneumonia (1.5%), cerebrovascular accident (0.7%), and multiple organ dysfunction syndrome (0.7%).1
Laboratory Abnormalities in ≥20% (All Gradesa) of Patients by Arm in ALTA 1L (N=273)1
aPer NCI CTCAE v4.03.
bDenominator for each laboratory parameter may vary and is defined as the number of patients who had both baseline and post-baseline test.
cElevated blood insulin was also observed in both arms.
First-Line Power With Manageable Tolerability
Dose reductions occurred in 38% of patients receiving ALUNBRIG.1
Lab Abnormalities Were the Most Common Adverse Events Leading to Dose Reductions
13% of patients permanently discontinued ALUNBRIG due to adverse reactions.1
The most frequent adverse reactions in ALTA 1L that led to discontinuation were ILD/pneumonitis (3.7%) and pneumonia (2.2%).1
Evaluating the safety profile of ALUNBRIG
Review safety and tolerability data from the ALTA 1L trial with Sarah Karpen, PA, to better understand how ALUNBRIG may support long-term treatment in ALK+ mNSCLC.
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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.
Patient Brochure
Download patient-friendly information to help patients understand their treatment with ALUNBRIG
1L, first-line; ALK, anaplastic lymphoma kinase; ALK+, ALK-positive; CTCAE, Common Terminology Criteria for Adverse Events; ILD, interstitial lung disease; mNSCLC, metastatic NSCLC; NCI, National Cancer Institute; NSCLC, non-small cell lung cancer.