Choose ALUNBRIG^® (brigatinib) for Durable CNS Results¹

Hello. My name is Dr Mahdi Taha. A medical oncologist in Southern Florida. For patients with ALK+ mNSCLC, having a first-line treatment with proven efficacy and a well- established safety profile makes a difference. ALUNBRIG (brigatinib) has demonstrated intracranial activity, an important consideration in treatment decision-making, as well as strong systemic efficacy. In this video, we are going to take a closer look at ALUNBRIG and the ALTA 1L study. Specifically, we will look at a post hoc subgroup analysis that explores intracranial data for patients with or without brain metastases at diagnosis. Before we do, I want to familiarize you with the trial design of the ALTA 1L study.

ALTA 1L was a randomized, Phase 3, open-label study comparing ALUNBRIG to crizotinib in adult patients with advanced ALK+ NSCLC who had not previously received an ALK-targeted therapy. Patients were randomized (1:1) to receive ALUNBRIG 180 mg orally once daily with a 7-day lead-in at 90 mg once daily or crizotinib 250 mg orally twice daily. Patients were stratified by the presence of baseline CNS metastases and prior chemotherapy in the locally advanced and/or metastatic setting. Patients with a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis were excluded from the study. Treatment was continued until disease progression or unacceptable toxicity.

Today we want to focus on ALUNBRIG’s ability to treat patients with brain metastases and delay progression to the brain for those without brain metastases at diagnosis. Brain metastases are a common challenge in ALK+ metastatic NSCLC, affecting up to 35% of patients at diagnosis and up to 75% of patients over the course of their disease. metastases and its impact on patients, choosing an ALK inhibitor with CNS activity is vital to effective disease management.

Let's start by reviewing our overall response data. In a post hoc subgroup analysis of the patients with measurable brain metastases at baseline, ALUNBRIG demonstrated durable intracranial responses compared to crizotinib. 78% of patients achieved a confirmed intracranial response in the ALUNBRIG arm, compared to 26% with crizotinib, who achieved only a partial response. 28% of patients in the ALUNBRIG arm achieved a complete response. Additionally, 64% of responders sustained their intracranial response for at least 2 years. This was not estimable for crizotinib.

Delaying disease progression is also critical in ALK+ NSCLC treatment—especially in the brain. In the ITT population, ALUNBRIG demonstrated prolonged intracranial progression with a median PFS of about 4 years. In patients with any baseline brain metastases, ALUNBRIG was shown to decrease the risk of disease progression or death by 75% vs crizotinib—a substantial improvement. In this data, you can also see the early separation of survival curves.

Overall survival remains a key goal in ALK+ NSCLC treatment. In the ITT population, based on the final analysis with 40.4 months of median follow-up, median overall survival was not reached for both arms. The 3-year OS rate was 71% with ALUNBRIG and 68% with crizotinib. It’s important to note that 47% of patients in the crizotinib arm had crossed over to receive ALUNBRIG. In patients with measurable brain metastases at baseline,  ALUNBRIG reduced the risk of death by 57%. It's important to note the early separation of curves at 3 months. Additionally, 7 out of 10 patients were still alive at 4 years—reinforcing ALUNBRIG as a first-line treatment for those with brain metastases at baseline.

These findings highlight ALUNBRIG's activity in the brain—making it a strong first-line treatment option for your patients with ALK+ mNSCLC.