Chinanews.com, Beijing, March 25th. The innovative drug in the field of lung cancer, Amberry (Brigatinib), has been approved by the State Drug Administration. The single drug is suitable for anaplastic lymphoma kinase (ALK) Treatment of patients with positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The drug is a new ALK tyrosine kinase inhibitor. Its efficacy in prolonging patient survival, controlling brain metastases, and improving quality of life has been clinically verified, and is listed as first-line by the “NCCN Oncology Clinical Practice Guidelines” The drug is preferred and listed in the “CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer”. The approval of this product will bring new treatment options to more Chinese lung cancer patients.
Lung cancer is one of the most common cancers with the highest morbidity and mortality in the world. In China, the annual incidence and mortality rate of lung cancer ranks first among malignant tumors, which seriously threatens people’s health. Among them, ALK-positive advanced non-small cell lung cancer (ALK+mNSCLC) is a relatively rare and dangerous subtype, with nearly 35,000 new cases each year in China. Such patients generally have a low mean age of onset and a high incidence of brain metastases. Data show that 30% of patients with ALK-positive advanced non-small cell lung cancer have brain metastases at the time of initial diagnosis, and 75% of patients will develop brain progression within two years of treatment, seriously affecting survival and quality of life.
Therefore, the control and prevention of brain metastases is the focus and difficulty of clinical treatment of ALK-positive advanced non-small cell lung cancer. At present, innovative and effective therapeutic drugs are urgently needed in clinical practice. While improving the survival of patients, treatment is also very important for improving the quality of life of patients. In addition, there is a huge unmet need for treatments targeting ALK fusion types and drug resistance mutations.
Professor Lu Shun, director of the Department of Oncology, Shanghai Jiaotong University Chest Hospital, said that although there are some treatment options for ALK-positive non-small cell carcinoma, the existing treatments are insufficient to control brain metastases in patients with ALK-positive non-small cell carcinoma. , drug resistance inevitably occurs during the treatment of patients, and there are still unmet clinical needs. The results of the ALTA-1L study showed that brigatinib has outstanding brain penetration properties, significant intracranial efficacy, and strong inhibitory effect on drug resistance sites. “Both of these are very important to patients, so we are looking forward to this product.”
Amberry (Brigatinib Tablets) mainly acts on ALK fusion mutations, and its unique dimethyl phosphine oxide (DMPO) structure strengthens the binding force with ALK protein, enhances drug activity, and also provides drug penetration. Passing the blood-brain barrier and maintaining the blood concentration of the drug in the brain creates favorable conditions, and at the same time, it can widely inhibit a variety of ALK fusion types and drug resistance mutations. The drug significantly reduces the risk of disease progression or death in patients with ALK-positive advanced non-small cell lung cancer, prolongs progression-free survival (PFS), and achieves an overall survival benefit.
According to the results of the international multi-center phase III clinical study ALTA-1L, for patients treated with Amberry (brigatinib tablets), the median PFS assessed by the independent review committee reached 24 months, and the control group crizole The median PFS of tinib was 11.1 months (HR=0.48, P<0.0001), and the median PFS assessed by the investigator was 30.8 months compared with 9.2 months in the control group (HR=0.43, P<0.0001). gartinib) reduced the risk of disease progression or death by 57% compared to the control group.
In addition, the drug’s treatment data for brain metastases are very outstanding. The ALTA-1L results show that the confirmed objective response rate (ORR) for patients with baseline brain metastases was 78%, and the control group was 26%; for intracranial lesions of patients had a sustained remission of up to 27.9 months compared to 9.2 months in the control group. Amberry (brigatinib) extended baseline progression-free survival in patients with brain metastases, with a median PFS of 24 months as assessed by an independent review committee, compared with 5.6 months in the control group (HR=0.25, P<0.0001), compared with The control group had a 75% lower risk of disease progression or death. The 4-year OS rate of Amberry (brigatinib tablets) first-line treatment for patients with brain metastases at baseline was 71%, and the risk of death was reduced by 57% (the 4-year OS rate in the control group was 44%, HR=0.43, P=0.02).
The adverse reactions of the concomitant use of Amberry (brigatinib tablets) are mostly mild, and long-term use is safe and tolerable. Based on the guarantee of efficacy and safety, the drug is the first ALK inhibitor that has been confirmed by clinical studies and has a significant difference in improving or maintaining the quality of life of patients compared with the control group.
Amberry (brigatinib tablet) is an innovative lung cancer drug under Takeda Pharmaceuticals. It has been approved in more than 40 countries and regions around the world, and has obtained FDA breakthrough therapy drug certification and orphan drug certification. (End)