Choose ALUNBRIG® (brigatinib): A Well-Established Safety Profile Post-Crizotinib

Safety and tolerability was studied in 219 patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (mNSCLC)1

The safety of ALUNBRIG was evaluated in 219 patients with locally advanced or metastatic ALK+ NSCLC who received at least 1 dose of ALUNBRIG in ALTA after experiencing disease progression on crizotinib.

  • Serious adverse reactions occurred in 38% of patients in the 90-mg arm and 40% of patients in the 90→180-mg arm. The most common serious adverse reactions were pneumonia (5.5% overall, 3.7% in the 90-mg arm, and 7.3% in the 90→180-mg arm) and interstitial lung disease (ILD)/pneumonitis (4.6% overall, 1.8% in the 90-mg arm, and 7.3% in the 90→180-mg arm)
    • Fatal adverse reactions occurred in 3.7% of patients, consisting of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis, and urosepsis (1 patient each)
  • Most common adverse reactions (≥25% of any grade) in the 90-mg arm were nausea (33%), fatigue (29%), headache (28%), and dyspnea (27%) and in the 90→180-mg arm were nausea (40%), diarrhea (38%), fatigue (36%), cough (34%), and headache (27%)
  • Median duration of treatment was 7.5 and 7.8 months in the 90-mg arm and 90→180-mg arm, respectively

Discontinuation Rates1

  • In ALTA, permanent discontinuation of ALUNBRIG due to adverse reactions occurred in 2.8% of patients in the 90-mg arm and 8.2% of patients in the 90→180-mg arm
  • The most frequent adverse reactions that led to discontinuation were ILD/pneumonitis (0.9% in the 90-mg arm and 1.8% in the 90→180-mg arm) and pneumonia (1.8% in the 90→180-mg arm only)

Dose Modifications1

  • 14% of patients required a dose reduction due to adverse reactions (7.3% in the 90-mg arm and 20% in the 90→180-mg arm)
  • The most common adverse reaction that led to dose reduction was increased creatine phosphokinase (CPK) for both regimens (1.8% in the 90-mg arm and 4.5% in the 90→180-mg arm)

Adverse Reactions in ≥10% (All Gradesa) or ≥2% (Grades 3-4) of Patients by Dose Group in ALTA (N=219)1

Chart showing adverse reactions of patients by dose group in ALTA .
aPer National Cancer Institute Common Terminology Criteria for Adverse Events. Version 4.0 (NCI CTCAE v4.0).
bIncludes abdominal distension, abdominal pain, and epigastric discomfort.
cIncludes asthenia and fatigue.
dIncludes dyspnea and exertional dyspnea.
eIncludes one Grade 5 event.
fIncludes headache and sinus headache.
gIncludes peripheral sensory neuropathy and paresthesia.
hIncludes acneiform dermatitis, exfoliative rash, rash, pruritic rash, and pustular rash.
iIncludes musculoskeletal pain and myalgia.
jIncludes diplopia, photophobia, blurred vision, reduced visual acuity, visual impairment, vitreous floaters, visual field defect, macular edema, and vitreous detachment.

Laboratory Abnormalities With Incidence of ≥20% (All Gradesa) of Patients by Dose Group in ALTA (N=219)1

Chart showing laboratory abnormalities of patients by dose group in ALTA.
aPer NCI CTCAE v4.0.
bElevated blood insulin was also observed in both regimens.

ILD/Pneumonitis1

  • Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG
  • In ALTA, ILD/pneumonitis occurred in 3.7% of patients in the 90-mg arm and 9.1% of patients in the 90→180-mg arm

Early in Treatment2

  • In ALTA, 6.4% (14 of 219 treated patients) experienced reactions consistent with possible ILD within 9 days of initiation of ALUNBRIG (median onset was 2 days). None occurred after escalation to 180 mg, and 7 of the 14 patients were successfully re-treated with ALUNBRIG2
  • 2.7% of patients had Grade 3-4 events within the first 9 days of treatment2

Dose Modifications

Review recommended dose adjustments for adverse reactions

LEARN ABOUT DOSE MODIFICATIONS

Dosing Guide

Helpful information on the one-tablet, once-daily recommended dosage, and modifications for adverse reactions

DOWNLOAD DOSING Guide

ALK+, ALK-positive.

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

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