Efficacy
Study Design

ALTA Study

The safety and efficacy of ALUNBRIG® (brigatinib) were evaluated in a global, two-arm, open-label, multicenter trial.

 

222 Adult Patients

Locally advanced or metastatic ALK+ NSCLC
Progressed on crizotinib

Randomized 1:1

n=110

ALUNBRIG
90180-mg arm
180 mg once daily with a 7-day lead-in dose at 90 mg once daily

STRATIFIED BY:

Brain metastases at baseline (absent or present)

Best responses to prior crizotinib treatment

n=112

ALUNBRIG
90-mg once-daily arm

Median duration of follow-up of 8 months (RANGE: 0.1-20.2) For All Patients

Efficacy Endpoints

Major efficacy outcome measure was confirmed overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1) as evaluated by an Independent Review Committee (IRC).


Additional Efficacy Outcome Measures

  • Investigator-assessed ORR
  • Duration of response (DOR)
  • Intracranial ORR
  • Intracranial DOR

Selected Baseline Characteristics in ALTA (N=222)

  • Patients who had prior systemic chemotherapy treatment: 74%
  • Patients who had brain metastasis: 69%
    • 61% of these patients had received prior radiation to the brain
  • 64% of patients had an objective response to prior crizotinib

 

Patient Demographics

Patient Characteristics at Entry Total Patients (N=222)
Median age 54 years old (range, 18-82; 23% aged ≥65)
Race
White 67%
Asian 31%
Sex
Female 57%
ECOG performance status
0 36%
1 57%
Smoking history
Never or former 95%
Cancer stage at study entry
IV 98%
Tumor histology
Adenocarcinoma 97%
Prior systemic chemotherapy 74%
Most common sites of metastases
Brain 69%
Prior radiation to the brain 61% (of those with brain metastasis)
Bone 39%
Liver 26%
Objective response to prior crizotinib 64%

ALK+, anaplastic lymphoma kinase-positive; ECOG, Eastern Cooperative Oncology Group; NSCLC, non-small cell lung cancer.

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