Choose ALUNBRIG® (brigatinib) Which Offers First-Line Systemic Efficacy
ALUNBRIG doubled median progression-free survival compared to crizotinib in ALK+ mNSCLC patients, including those with brain metastases1,2
A Phase 3 Trial Designed to Assess the Efficacy, Safety, and Tolerability of ALUNBRIG1,3
ALTA 1L Was a Randomized (1:1), Open-Label, Multicenter Trial1,3
Select exclusion criteria: Patients with a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis.1
Treatment was continued until disease progression or unacceptable toxicity.3
Crossover from crizotinib to ALUNBRIG was permitted after disease progression. After BIRC-assessed objective progression, 44% of patients taking crizotinib (n=61/138) crossed over to the ALUNBRIG arm.3
Major efficacy outcome measure: PFS according to RECIST v1.1 as evaluated by a BIRC.1
Additional efficacy outcome measures: Confirmed ORR, DOR, intracranial ORR, and intracranial DOR as evaluated by a BIRC.1
Median duration of follow-up: At the time of the second interim analysis, data cutoff was 22 months after the last patient was enrolled,4 with a median follow-up of 24.9 months for ALUNBRIG and 15.2 months for crizotinib.3
The median follow-up for ALUNBRIG was 40.4 months at final analysis.5
Select Baseline Characteristics
ALTA 1L included a population reflective of real-world patientsa with brain metastases at baseline and those who were treated with prior chemotherapy2,a
Demographics and baseline factors were balanced across treatment arms2
30% of patients had brain metastases at baseline. Seven patients had leptomeningeal involvement (4 patients in the ALUNBRIG arm and 3 patients in the crizotinib arm).2,4
aPatients in ALTA 1L exhibited characteristics that were common among real-world ALK+ mNSCLC patients, including high rates of adenocarcinoma, presence of brain metastases at baseline, and a preponderance of patients in their 50s.
ITT Population
Doubled median PFS vs crizotinib1
Significantly Longer Median PFS as Assessed by a BIRC (Primary Endpoint)1
Investigator assessed: ALUNBRIG extended median PFS by 20 months vs crizotinib; median PFS of 29.4 months for ALUNBRIG vs 9.2 months for crizotinib (HR=0.43; 95% CI: 0.31, 0.61; P<0.0001)3,c
bStratified by presence of brain metastases at baseline and prior chemotherapy for locally advanced or metastatic disease for log-rank test and Cochran Mantel-Haenszel test, respectively.
cInvestigator-assessed PFS did not include a formal hypothesis test with Type I error control. In addition, ALTA 1L was an open-label trial, so there may be bias that contributed to the estimation of benefit from the investigator-assessed PFS.
High Response Rates and Durable Responses1
Significantly Higher Confirmed ORR vs Crizotinib1
ALUNBRIG
(n=101/137)
15% complete response
(95% CI: 9, 22)
P=0.0342b
crizotinib
(n=85/138)
9% complete response
(95% CI: 5, 15)
P=0.0342b
bStratified by presence of brain metastases at baseline and prior chemotherapy for locally advanced or metastatic disease for log-rank test and Cochran Mantel-Haenszel test, respectively.
Final analysis with 40.4 months of median follow-up in the ITT population5
ALUNBRIG Demonstrated ~2.5x Longer Median DOR vs Crizotinib1
Median DOR was nearly 20 months longer with ALUNBRIG vs crizotinib1
- ALUNBRIG 33.1 months (95% CI: 22.0, NR) vs crizotinib 13.8 months (95% CI: 10.4, 20.8)1
Overall Survival1
Median OS not reached for either arm1:
- 30% of patients (n=41/137) died in the ALUNBRIG® (brigatinib) arm vs 37% of patients (n=51/138) in the crizotinib arm1,5
- The 3-year OS rate was 71% (95% CI: 62, 78) with ALUNBRIG and 68% (95% CI: 59, 75) with crizotinib (HR=0.81; 95% CI: 0.53, 1.22; P=0.331)5
47% of patients (n=65) in the crizotinib arm had crossed over to receive ALUNBRIG.5
Exploring Systemic Efficacy Results
Dr Alex Spira, Director of the Virginia Cancer Specialists Research Institute, talks through key efficacy outcomes comparing ALUNBRIG vs crizotinib.
Dr. Alex Spira Presents: Systemic Efficacy Results from ALTA 1L Trial
1L, first line; ALK, anaplastic lymphoma kinase; ALK+, ALK-positive; BIRC, blinded independent review committee; CI, confidence interval; CNS, central nervous system; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; ITT, intention to treat; NE, not estimable; 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.