A PHASE 3 TRIAL DESIGNED TO DEMONSTRATE FIRST-LINE CLINICAL BENEFIT AND SAFETY1

ALTA 1L Was a Randomized (1:1), Open-Label, Multicenter Trial1

275 ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ALK+ NSCLC

  • No prior treatment with an ALK inhibitor
  • ≤1 regimen of prior systemic therapy in the locally advanced/metastatic setting

ALUNBRIG® (brigatinib) n=137 (ITT population)

180 mg orally once daily with a 7-day lead-in at 90 mg orally once daily

RANDOMIZED 1:1
STRATIFIED BY:

  • Baseline brain metastases (present or absent)
  • Prior chemotherapy in locally advanced/metastatic setting (yes or no)

Crizotinib n=138 (ITT population)

250 mg orally twice daily

Crossover from
crizotinib to
ALUNBRIG was
permitted after
disease progression1

  • 44% of crizotinib
    patients (n=61/138)
    crossed over to
    ALUNBRIG after
    BIRC-assessed
    objective progression1

Patients with a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis were excluded from the trial.

In ALTA 1L, 30% of patients (n=81/275) had CNS metastasis at baseline. Seven of these patients had leptomeningeal involvement at the time of enrollment, including 4 patients in the brigatinib arm and 3 patients in the crizotinib arm.2

Major efficacy outcome measure: Progression-free survival (PFS) as evaluated by Blinded Independent Review Committee (BIRC) according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

Additional efficacy outcome measures: BIRC-assessed confirmed overall response rate (ORR), duration of response (DOR), intracranial ORR, and intracranial DOR.

Median duration of follow-up: Data cutoff was 2 months after the last patient was enrolled, with a median follow-up of 24.9 months for ALUNBRIG and 15.2 months for crizotinib. At the data cutoff, overall survival data were not mature.1,2

The final trial analysis has been conducted, and select efficacy data have been included in the following report. The median follow-up was 40.4 months.3,4

ALTA 1L: Selected Baseline Characteristics4

Demographics and baseline factors were balanced across treatment arms

Baseline Demographics
ALUNBRIG
(n=137)
crizotinib
(n=138)
Median age
(range)
58 years (27-86) 60 years (29-89)
Race 57% White
43% Asian
64% White
36% Asian
Female 50% 59%
ECOG performance status (PS)
PS 0 or 1 96% 96%
PS 2 4% 4%
Disease Characteristics
ALUNBRIG
(n=137)
crizotinib
(n=138)
Stage IV disease 94% 91%
Adenocarcinoma 92% 99%
Prior chemotherapy
in the locally advanced or
metastatic setting
26% 27%
Prior radiation to
the brain
13% 14%
Brain metastases
at baseline
29% 30%

ALK, anaplastic lymphoma kinase; ALK+, ALK-positive; CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; ITT, intention to treat; NSCLC, non-small cell lung cancer.

 


 

References

1. Camidge DR, Kim HR, Ahn MJ, et al. J Clin Oncol. 2020;38(31):3592-3603. 2. Takeda Pharmaceuticals U.S.A., Inc. Data on file. 3. Camidge DR, Kim HR, Ahn MJ, et al. J Thorac Oncol. 2021. doi:10.1016/j.jtho.2021.07.035. 4. Camidge DR, Kim HR, Ahn MJ, et al. N Engl J Med. 2018;379(21):2027-2039.

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In Vitro: ALUNBRIG Inhibited 17
ALK-Inhibitor—Resistant Mutations1,2

ALUNBRIG exhibited in vivo antitumor activity against 4 mutant forms of EML4-ALK, including the G1202R and L1196M mutants identified in NSCLC tumors in patients who had progressed on crizotinib.


 
 

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