How effective is brigatinib in treating lung cancer?

Brigatinib (Brigatinib) is an oral targeted therapy drug that is widely used to treat non-small cell lung cancer (NSCLC), especially for patients who are ALK fusion positive. It effectively controls the development of lung cancer by inhibiting the growth and spread of cancer cells, providing patients with a better quality of life.

The ALTA-2 trial is a prospective, multicenter Phase 2 clinical trial investigating the efficacy of brigatinib in patients with advanced ALKpositive NSCLC after prior treatment with ceritinib or alectinib. The trial was conducted at 54 centers in 15 countries and included eligible patients with cytologically or histologically confirmed advanced ALK-positive NSCLC.

In theALTA-2 trial, patients who had progressed on alectinib or ceritinib were treated with brigatinib. The brigatinib dosing regimen was 180 mg once daily, but patients received 90 mg for the first 7 days. This dosing strategy is designed to improve patient tolerability and ensure the safety of the treatment.

The primary endpoint of the trial is overall response rate (ORR) as assessed by an independent review committee (IRC). ORR is an important indicator of treatment effectiveness. It represents the proportion of patients whose tumors shrink or disappear. Confirmation of the IRC-assessed intention-to-treat population in the ALTA-2 trial ORR It is26.2% (out of 10327 people). This means that more than a quarter of patients achieved tumor shrinkage or disappearance after receiving brigatinib treatment.

In addition to ORR, the researchers also analyzed other efficacy measures, such as disease control rate (DCR), median duration of response (DOR), and progression-free survival (PFS). DCR represents the proportion of patients who achieve tumor remission or stable disease. In the ALTA-2 trial, the IRC-assessed DCR was 54.4% (56 out of 103 cases), indicating that more than half of the patients had their disease effectively controlled after receiving brigatinib treatment.

MedianDOR is a measure of the durability of treatment effects. In the ALTA-2 trial, the median DOR was 6.3 months. This means that half of the patients who received brigatinib had tumor responses that lasted longer than 6.3 months. This result further confirms the potential of brigatinib in extending patient survival.

PFSRepresents the time from the start of treatment to disease progression or death. In the ALTA-2 trial, the median PFS assessed by the IRC was 3.8 months. Although this number is relatively low, this result still has certain clinical significance considering that the patient had previously been treated with other ALK inhibitors and the disease had progressed. It shows that brigatinib can delay the progression of the disease to a certain extent and provide patients with more survival time.

In terms of safety, brigatinib demonstrated acceptable safety in theALTA-2 trial. The most common treatment-related adverse events (TRAE) include elevated creatine phosphokinase, diarrhea, and nausea. Most of these adverse events were mild to moderate and could be mitigated with appropriate management. A few patients experienced serious adverse events that required discontinuation of brigatinib, such as pneumonia and hypertension, but the overall incidence was low.

References:

https://www.sciencedirect.com/science/article/pii/S1556086422015842