In short
Brigatinib is an oral tyrosine kinase inhibitor being studied in clinical trials for the treatment of various ALK-positive cancers, particularly non-small cell lung cancer (NSCLC). This article summarizes key information from several clinical trials investigating the safety, efficacy, and optimal dosing of brigatinib in both adult and pediatric patients with ALK-positive cancers.
At a glance
- Drug Name
- Brigatinib (also known as AP26113, ALUNBRIG)
- Drug Class
- Tyrosine Kinase Inhibitor (TKI)
- Primary Target
- ALK (Anaplastic Lymphoma Kinase)
- Main Indications
- ALK-positive Non-Small Cell Lung Cancer (NSCLC), ALK-positive Anaplastic Large Cell Lymphoma, ALK-positive Inflammatory Myofibroblastic Tumors
- Common Dosing Regimen
- 90 mg once daily for 7 days, then 180 mg once daily
- Key Efficacy Measures
- Objective Response Rate (ORR), Progression-Free Survival (PFS), Overall Survival (OS), Intracranial Response Rate
- Safety Monitoring
- Adverse Events, Dose-Limiting Toxicities, Lung-related issues (e.g. pneumonitis), Liver function, Heart rhythm changes
- Patient Populations
- Adults and children with ALK-positive cancers, including treatment-naive and previously treated patients
- Ongoing Research
- Optimal dosing, efficacy in various ALK-positive cancers, use in pediatric patients, real-world effectiveness
What is Brigatinib?
Brigatinib is a medication used to treat certain types of lung cancer. It's also known by the brand names Alunbrig™ and AP26113. Brigatinib belongs to a class of drugs called tyrosine kinase inhibitors (TKIs), which work by blocking specific proteins that contribute to cancer growth.
What Conditions Does Brigatinib Treat?
Brigatinib is primarily used to treat a specific type of non-small cell lung cancer (NSCLC) that is ALK-positive. ALK stands for anaplastic lymphoma kinase, which is a protein that, when abnormally altered, can promote cancer growth. Brigatinib is used in patients with: Advanced or metastatic ALK-positive NSCLC ALK-positive NSCLC that has progressed on or is intolerant to other ALK inhibitors like crizotinib, alectinib, or ceritinib Locally advanced or metastatic NSCLC Additionally, research is ongoing to evaluate brigatinib's effectiveness in treating: ALK-positive anaplastic large cell lymphoma (ALCL) Inflammatory myofibroblastic tumors (IMT) Other ALK-positive solid tumors
How Does Brigatinib Work?
Brigatinib works by targeting and inhibiting the ALK protein. In some lung cancers, the ALK gene is abnormally rearranged, leading to the production of a fusion protein that drives cancer growth. Brigatinib blocks the activity of this abnormal ALK protein, which can slow down or stop the growth of cancer cells.
Dosage and Administration
Brigatinib is typically administered orally in tablet form. The common dosing regimen is: 90 mg once daily for the first 7 days If tolerated, the dose is increased to 180 mg once daily thereafter This dosing schedule is designed to help reduce the risk of early-onset side effects. Your doctor will determine the appropriate dose based on your individual needs and how well you tolerate the medication.
Efficacy of Brigatinib
Clinical trials have shown promising results for brigatinib in treating ALK-positive NSCLC: Objective Response Rate (ORR): This measures how many patients have a significant reduction in tumor size. Studies have shown ORRs ranging from 50% to over 70% in various patient populations. Progression-Free Survival (PFS): This is the length of time during and after treatment that a patient lives with the disease without it worsening. Brigatinib has demonstrated improved PFS compared to some other treatments. Intracranial Response: Brigatinib has shown effectiveness in treating brain metastases, which are common in ALK-positive NSCLC. It's important to note that the effectiveness can vary depending on individual factors and prior treatments.
Side Effects and Safety
Like all medications, brigatinib can cause side effects. Some common side effects include: Nausea and diarrhea Fatigue Headache Cough Muscle and joint pain More serious side effects can include: Interstitial Lung Disease (ILD): This is a group of lung conditions that cause scarring of lung tissue. It's a rare but serious side effect that requires immediate medical attention. High blood pressure Slow heart rate Vision problems Your healthcare team will monitor you closely for these and other potential side effects.
Ongoing Research
Research on brigatinib is ongoing to further understand its effectiveness and expand its use: Pediatric Studies: Clinical trials are evaluating the use of brigatinib in children and young adults with ALK-positive cancers, including ALCL and IMT. First-line Treatment: Studies are investigating brigatinib as a first-line treatment for ALK-positive NSCLC. Blood-based Testing: Research is exploring the use of blood tests to identify patients who might benefit from brigatinib, potentially reducing the need for invasive tissue biopsies. Long-term Efficacy and Safety: Ongoing studies are monitoring the long-term effects and safety of brigatinib in various patient populations. These ongoing studies aim to improve our understanding of brigatinib and potentially expand its use to help more patients.