ALUNBRIG is indicated as monotherapy for the treatment of adult patients with:1
- anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (aNSCLC) previously not treated with an ALK inhibitor
- ALK+ aNSCLC previously treated with crizotinib
Superior systemic and intracranial efficacy versus crizotinib with ALUNBRIG2
The final analysis of ALTA-1L – a randomised, phase III, open-label trial comparing the efficacy and safety of ALUNBRIG versus crizotinib in ALK+ aNSCLC participants previously untreated with ALK inhibitors – revealed:2
ALTA-1L: a phase III clinical trial designed to be applicable to your practice2
ALTA-1L was a phase III, open-label, randomised, multicentre study aimed to compare the efficacy and safety profile of ALUNBRIG versus crizotinib in ALK+ aNSCLC participants who have not previously been treated with an ALK inhibitor.
*As confirmed by local testing.
†In the crizotinib arm, crossover to ALUNBRIG was permitted at BIRC-assessed progressive disease.2
Adapted from Camidge R et al, 20212
Primary endpoint:2
- PFS, as assessed by BIRC, according to RECIST v1.1
Secondary endpoints:3
As assessed by BIRC:
- Confirmed ORR per RECIST v1.1
- Confirmed intracranial ORR
- Intracranial PFS
- Duration of response
- Time to response
- Disease control rate
- Overall survival
- Safety and tolerability
- Patient-reported symptoms and HRQoL scores, assessed with the EORTC QLQ-C30 (v3.0)
Baseline characteristics2
The median age of participants (n=275) in the intention-to-treat population was 59 years (range: 27‑89 years) and 45% were male. 93% had stage IV disease at trial entry, and 96% had adenocarcinoma. Brain metastases were present in 29% of patients. 27% of patients with locally advanced or metastatic disease has previously completed at least one full cycle of chemotherapy.
Study completion2
The study was completed on 29 January 2021, 42 months after the last patient enrolled. The median follow up was 40.4 months for patients receiving ALUNBRIG and 15.2 months for patients receiving crizotinib.
Systemic efficacy of ALUNBRIG versus crizotinib2
Click the tab above to view information for OS.
Patients (N=275) with locally advanced or metastatic ALK+ aNSCLC randomised 1:1 to ALUNBRIG (n=137) or crizotinib (n=138)2
(Median follow up 40.4 months for ALUNBRIG and 15.2 months for crizotinib)2
BIRC-assessed PFS for ALUNBRIG vs crizotinib (primary endpoint; ITT population)2
Adapted from Camidge R et al, 20212
The 4-year BIRC-assessed PFS probability was 36% for ALUNBRIG (95% CI: 26–46) compared with 18% for crizotinib (95% CI: 11–26)2
Click the tab above to view information for PFS.
Patients (N=275) with locally advanced or metastatic ALK+ aNSCLC randomised 1:1 to ALUNBRIG (n=137) or crizotinib (n=138)2
(Median follow up 40.4 months for ALUNBRIG and 15.2 months for crizotinib)2
Median OS had not been reached in either trial arm at study completion.
The 4-year OS probability was 66% for ALUNBRIG (95% CI: 56–74) compared with 60% for crizotinib (95% CI: 51–68)2
Crossover from crizotinib to ALUNBRIG was permitted; 47% crossed over at disease progression.
OS in patients with or without brain metastases (post-hoc analysis)
Adapted from Camidge R et al, 20212
The 4-year OS probability in patients with brain metastases at baseline was 71% for ALUNBRIG (95% CI: 53–83) compared with 44% for crizotinib (95% CI: 28–59)2
The 4-year OS probability in patients without brain metastases at baseline was 64% for ALUNBRIG (95% CI: 52–74) compared with 67% for crizotinib (95% CI: 56–76)2
Professor Samreen Ahmed explains:
Systemic efficacy data in ALTA-1L:
Time to watch: 10 mins 8 secs
Intracranial efficacy of ALUNBRIG versus crizotinib
Intracranial PFS‡
BIRC-assessed intracranial PFS in patients with any brain metastases at baseline2
Adapted from Camidge R et al, 20212
BIRC-assessed intracranial PFS probability in 3 years was:2
The 4-year intracranial PFS probability in patients with any brain metastases at baseline was 22% (95% CI: 9–39) for ALUNBRIG compared with NE for crizotinib2
BIRC-assessed intracranial PFS in patients in the ITT population2
Adapted from Camidge R et al, 20212
The 3-year intracranial PFS probability was 56% in patients receiving ALUNBRIG (95% CI: 47-66) and 38% in patients receiving crizotinib (95% CI: 27-49)
The 4-year intracranial PFS probability was 46% for ALUNBRIG (95% CI: 34–57) compared with 33% for crizotinib (95% CI: 19–47)2
‡Only brain lesions were reviewed. Intracranial progression was defined as radiological progression, or death, or an event requiring brain radiotherapy.2
Professor Samreen Ahmed explains:
Intracranial efficacy data in ALTA-1L:
Time to watch: 10 mins 8 secs
Intracranial response rates in patients with any brain metastases at baseline2
BIRC-assessed intracranial PFS in patients in the ITT population2
*Lesion diameter ≥ 10 mm
ALK, anaplastic lymphoma kinase; aNSCLC, advanced non‑small cell lung cancer; BIRC, blinded independent review committee; EORTC QLQ‑C30, European Organisation for Research and Treatment of Cancer Quality‑of‑life Questionnaire Core 30; HRQoL, health‑related quality of life; ORR, objective response rate; PFS, progression‑free survival rate; RECIST, response evaluation criteria in solid tumours; CI, confidence interval; NE, not estimable; HR, hazard ratio; ITT, intention to treat; OS, overall survival; PFS, progression‑free survival.
1. ALUNBRIG (brigatinib) Summary of Product Characteristics. Available at: medicines.org.uk. Accessed June 2026; 2. Camidge D R, Kim H R et al. Brigatinib versus crizotinib in ALK inhibitor‑naive advanced ALK‑positive NSCLC: final results of phase 3 ALTA-1L trial. J Thorac Oncol 2021;16:2091-2108 (+ suppl); 3. Camidge D R, Kim H R et al. Brigatinib versus crizotinib in ALK‑positive non‑small‑cell lung cancer: study protocol. N Engl J Med 2018;379:2027-2039
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