Efficacy and Tolerability are Vital for Your Patients1,2


Discover more of what Dr. Zhu has to say about treating patients with ALK+ mNSCLC.

First-line Systemic Efficacy

The efficacy, safety, and tolerability of ALUNBRIG® (brigatinib) was assessed in ALTA 1L, a phase 3, randomized (1:1), open-label, multicenter clinical trial1,2

  • Study design: 275 adult patients with locally advanced or metastatic ALK+ mNSCLC with no prior ALK therapy and ≤1 regimen of prior systematic therapy1. Patients were randomized (1:1) to receive ALUNBRIG (n=137) or crizotinib (n=138).
  • Select exclusion criteria: Patients with a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis
  • Major efficacy outcome measure: PFS according to RECIST v1.1 as evaluated by a BIRC1
  • ALUNBRIG doubled mPFS vs crizotinib: BIRC-assessed median PFS was 24.0 months (n=137; 95% CI: 18.5, NR) for ALUNBRIG vs 11.0 months (n=138; 95% CI: 9.2, 12.9) for crizotinib1
  • Additional efficacy outcome measures: Confirmed ORR, DOR, intracranial ORR, and intracranial DOR as evaluated by BIRC1

In a post hoc subgroup analysis of patients with brain metastases at baseline, the median PFS was longer with ALUNBRIG vs crizotinib2,3

PFS in Patients With Any Brain Metastases at Baseline

Kaplan Meier Plot of PFS in patients with any brain metastases at baseline

23% absolute risk reduction: 50% event rate (n=20/40) for patients taking ALUNBRIG vs 73% event rate (n=30/41) for patients taking crizotinib1

Study Limitation: ALTA 1L was not powered to detect differences across subgroups.

Explore intracranial overall survival data of ALUNBRIG in the ALTA 1L trial

in patients with measurable brain metastases at baseline

A Well-Established Safety Profile

ALUNBRIG has demonstrated long-term tolerability in the ALTA 1L trial1

  • Median follow-up in the ALUNBRIG arm was 40.4 months
  • Median duration of treatment with ALUNBRIG was 24.3 months
  • Median relative dose intensity with ALUNBRIG was 97%
  • The most common serious adverse reactions were pneumonia (4.4%), ILD/pneumonitis (3.7%), pyrexia (2.9%), dyspnea (2.2%), pulmonary embolism (2.2%), and asthenia (2.2%). 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%)

Review the ALUNBRIG safety data and learn more about long-term tolerability1

in first-line patients compared to Crizotinib

ALK, anaplastic lymphoma kinase; ALK+, ALK-positive; BIRC, Blinded independent review committee; Cl, confidence interval; DOR, duration of response; HR, hazard ratio; ILD, interstitial lung disease; mNSCLC, metastatic NSCLC; NR, not reached; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.