Efficacy, Tolerability, and Once-Daily Dosing in ALK+ mNSCLC


Discover an expert perspective on treatment considerations for newly diagnosed patients with ALK+ mNSCLC and brain metastases

First-line Systemic Efficacy

The efficacy, safety, and tolerability of ALUNBRIG 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
  • 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. The median PFS with ALUNBRIG® was 24 months, the median PFS with crizotinib was 5.6 months.

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 first-line 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%)

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.