ALK in Lung Cancer Trial of AP26113 (ALTA): evaluating the efficacy and safety of ALUNBRIG (brigatinib)
ALTA: a phase 2, global, randomised, open-label, multicentre trial.
Objective: to access the efficacy and safety of two ALUNBRIG dosing regimens.
ALTA was not a controlled trial and not designed for statistical comparisons between dosing regimens.
Primary endpoint was confirmed ORR according to Response Evaluation Criteria In Solid Tumours (RECIST v1.1) as evaluated by investigator.
aPatients in the 90 mg arm were allowed to escalate to 180 mg after RECIST progression.
Locally advanced or
metastatic ALK+ NSCLC
Progressed on crizotinib
180 mg regimen
180 mg once daily with a 7-day lead-in at 90 mg once daily
90 mg once daily regimen
Brain metastases at baseline (absent or present)
Best responses to prior crizotinib treatment
Disease progression requiring an alternate therapya
Other reasons for discontinuation
More than half of patients on ALUNBRIG achieved a responsea with the 180 mg regimenb,3
Two thirds of patients with measurablea brain metastases at baseline (n=18) achieved an intracranial responseb with ALUNBRIG1,3,4
Exceeds 1 year median PFS in ALK+ aNSCLC patients post crizotinib3
Intracranial protection extending out to one and a half yearsa,3-6
ALUNBRIG demonstrated median OS of more than 2.5 years3
- Kim DW, et al. J Clin Oncol 2017;35:2490–8.
- US clinical trial record NCT02094573. Available from https://clinicaltrials.gov/ct2/show/NCT02094573. Last accessed January 2019.
- Huber RM, et al. Poster presentation at ASCO Annual Meeting 2018, Poster 384.
- Ahn M-J, et al. Oral presentation at IASLC 18th World Conference on Lung Cancer, 2017
- Camidge DR, et al. J Clin Oncol 2018;36:3693-2701.
- Ou S-HI, et al. Oral presentation at ESMO 2017, poster 1345P.
Additional trial information1,2
Secondary endpoints: confirmed ORR as evaluated by an IRC, time to response, PFS, DOR, overall survival; and intracranial ORR, intracranial PFSa and intracranial DOR as evaluated by an IRC
Key inclusion criteria
- Adults with ALK+ aNSCLC who had progressed on crizotinib
- Documented ALK rearrangement with at least one measurable lesion per RECIST v1.1
- No restrictions on number of prior chemotherapy regimens
- ECOG performance status 0-2
- Life expectancy ≥3 months
Key exclusion criteria
- Prior ALK-targeted TKI other than crizotinib
- Received crizotinib within 3 days of the first dose of brigatinib
- Had symptomatic CNS metastases that were neurologically unstable or required an increasing dose of corticosteroids
- Patients with a history or presence of pulmonary interstitial disease, drug-related pneumonitis, or with significant, uncontrolled or active cardiovascular disease
aIntracranial PFS does not include systemic (non-cranial) disease progression events.
Baseline characteristics in ALTA (N=222)1
a With 7-day lead-in at 90 mg once daily
b As assessed by the investigator