Brigatinib Approved, but Treatment Role Uncertain

Area of Science:

• Oncology
• Pharmacology

Background:

• Metastatic non-small cell lung cancer (NSCLC) remains a significant health challenge.
• Anaplastic Lymphoma Kinase (ALK) inhibitors have transformed treatment for ALK-positive NSCLC.
• Crizotinib is a first-generation ALK inhibitor, but resistance and intolerance necessitate alternative therapies.

Purpose of the Study:

• To evaluate the efficacy and safety of brigatinib, an ALK inhibitor, in patients with metastatic ALK-positive NSCLC.
• To assess brigatinib in patients who were previously treated with or intolerant to crizotinib.

Main Methods:

• A phase II clinical study was conducted to assess two different doses of brigatinib.
• The study population comprised patients with metastatic ALK-positive NSCLC.
• Efficacy endpoints included overall response rate (ORR).

Main Results:

• Brigatinib demonstrated significant efficacy, with overall response rates of 45% and 56% observed for the two assessed doses.
• The study provided data supporting the FDA approval of brigatinib for this patient population.

Conclusions:

• Brigatinib is an effective treatment option for patients with metastatic ALK-positive NSCLC who cannot tolerate crizotinib or whose disease progressed on crizotinib.
• Further research is needed to clarify brigatinib's impact on overall survival and its optimal sequencing with other ALK inhibitors.