- Aletinib for advanced ALK-positive NSCLC is uniquely advantageous in patients with advanced NSCLC with brain metastases.
- Recent study data show that aletinib extends median progression-free survival by nearly 3 years.
- Aletinib was approved for marketing in China in August 2018.
Mutations in the mesenchymal lymphoma kinase (ALK) gene are tied to lung cancer development, and this mutation occurs in about 2% to 5% of patients with non-small cell lung cancer (NSCLC).
Alectinib, a second-generation ALK tyrosinase inhibitor for the treatment of ALK-positive NSCLC, overcomes resistance to the first-generation ALK inhibitor crizotinib and has a good efficacy and safety profile.
A successor on the road to lung cancer treatment
Crizotinib and ceritinib remain the first-line agents of choice for targeted therapy in ALK-positive advanced NSCLC. Unfortunately, most patients treated with crizotinib are resistant to the drug within 1-2 years, and crizotinib is less effective in patients with brain metastases.
In response to these shortcomings, scientists developed a second-generation ALK inhibitor, and aletinib was born.
Aletinib is more effective and has a unique advantage for brain metastases
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In 2015, the U.S. Food and Drug Administration (FDA) approved aletinib for patients with ALK-positive advanced NSCLC whose disease has progressed or developed resistance after treatment with crizotinib. on November 7, 2017, the FDA further approved aletinib for first-line treatment of ALK-positive metastatic NSCLC patients. The FDA further approved aletinib for the first-line treatment of patients with ALK-positive metastatic NSCLC.
Aletinib has shown good efficacy and safety compared to the first-generation targeted drug crizotinib:
(1) The J-Alex study was conducted in Japanese patients and found that among patients with ALK-positive NSCLC, the objective remission rate was 85.4% in the aletinib group and 70.2% in the crizotinib group. In addition, more serious adverse reactions occurred in 52% of patients in the crizotinib group compared with 26% in the alaitinib group.
(2) The ALEX study, on the other hand, showed that alectinib, a first-line treatment for patients with ALK-positive advanced NSCLC, reduced the risk of disease progression or death in patients by more than half (53%) compared with crizotinib.
Control of brain metastases is the biggest benefit of alectinib, which was shown in the ALEX study to reduce the risk of progression of brain metastases by 84%. The incidence of brain metastasis progression within 12 months was only 9.4% in patients taking alectinib compared with 41.4% in the crizotinib group. In patients with brain metastases, oral aletinib was 81% effective compared with 50% in the crizotinib group.
Significantly prolonged progression-free survival, aletinib ushers in a new era
In June, the ALEX study was updated with good news: patients in the aletinib group had a median progression-free survival of 34.8 months compared with 10.9 months for crizotinib, meaning that half of the patients with ALK-positive advanced lung cancer taking aletinib had their disease under control for nearly 3 years. This is an unprecedentedly good result!
In August 2018, the highly anticipated aletinib (trade name: Ansonia) landed in China.
Conclusion
Looking at the clinical studies published so far, aletinib has a pivotal role in the treatment of advanced ALK-positive NSCLC. It is unique in patients with advanced NSCLC with brain metastases and has a broad application prospect with significant effect in prolonging progression-free survival. When it enters China, we expect it to bring benefits to more Chinese patients!