Takeda's Innovative Lung Cancer Drug Brigatinib Tablet Receives First Prescription in China, Marking Clinical Launch for ALK-Positive NSCLC Patients

Accelerate the realization of medication in China, providing protection for patients with ALK-positive advanced non-small cell lung cancer

ShanghaiJuly 28, 2022/PR Newswire/ -- Today,Professor Bao-Hui Han, Department of Respiratory Medicine, Shanghai Chest HospitalBrand New^[1]ALK Tyrosine Kinase InhibitorBrigatinib TabletsThe first prescription in China marks the official entry of this globally innovative lung cancer treatment drug into clinical application, offering new options and hope for patients with ALK fusion-positive advanced non-small cell lung cancer.

Professor Han Baohui"ALK-positive advanced non-small cell lung cancer is a relatively rare and aggressive subtype, with patients having a lower average age of onset and a high incidence of brain metastasis. Therefore, in clinical practice, it is important to control brain metastases to achieve long-term survival when treating this type of patient, while also selecting drugs with good tolerability and safety to ensure the quality of life for patients. Clinical research data shows that treatment with brigatinib can significantly reduce the risk of disease progression or death due to brain metastases, and its safety is tolerable, offering hope for prolonged survival. This contributes to further realizing the chronic disease management of lung cancer, significantly improving the quality of life for patients."

Lung cancer is the leading type of cancer in China, with the highest incidence and mortality rates among all malignant tumors.^[2]Among them, ALK-positive non-small cell lung cancer (ALK+ NSCLC) is a relatively rare and aggressive subtype, with approximately 35,000 new cases annually in China.^[3]Currently, there remains an urgent unmet clinical need for such patients: a low average age of onset, a high incidence of brain metastases, and gaps in treatment options for ALK fusion types and drug-resistant mutations. Data shows that approximately 55% of ALK-positive advanced non-small cell lung cancer patients will develop brain metastases.^[4],[5],[6]. Symptoms such as headaches, nausea, vomiting, limb motor and sensory disturbances, aphasia, dizziness, and memory loss caused by brain metastases [7] seriously affect patients' daily lives and even threaten their lives. Therefore, patients urgently need more innovative and effective therapeutic drugs to revolutionize traditional treatment methods, prolong survival time, and improve quality of life.

As a novel ALK tyrosine kinase inhibitor, brigatinib tablets primarily target ALK fusion-positive cases. Their unique dimethyl sulfoxide (DMSO) structure enhances binding affinity with the ALK protein, increases drug activity, and facilitates the drug's ability to cross the blood-brain barrier while maintaining effective concentrations in the brain. Additionally, it broadly inhibits various ALK fusion types and drug-resistant mutations.^[8],[9],[10]The latest reported results from the global Phase III clinical trial ALTA-1L confirmed that, for patients treated with brigatinib tablets, the median PFS assessed by the Independent Review Committee reached 24 months, compared to 11.1 months in the control group (HR=0.48, P<0.0001). The investigator-assessed median PFS reached 30.8 months versus 9.2 months in the control group (HR=0.43, P<0.0001), reducing the risk of disease progression or death by 57% compared to the control group.^[11]。

In addition, the research results show that the brain metastasis data of Brigatinib tablets are very prominent. The ALTA-1L results show breakthrough efficacy for patients with baseline brain metastases: the median PFS assessed by the Independent Review Committee reached 24 months, compared to 5.6 months in the control group (HR=0.25, P＜0.0001), significantly reducing the risk of disease progression or death by 75% compared to the control group. The 4-year OS rate of Brigatinib tablets as a first-line treatment for patients with baseline brain metastases was 71%, reducing the risk of death by 57% (the 4-year OS rate in the control group was 44%, HR=0.43, P=0.02), meaning that nearly three-quarters of brain metastasis patients could achieve long-term survival of 4 years or more.^[12], achieving significant benefits in clinical efficacy and quality of life^[10]。

Takeda China also announced today that within the next week, brigatinib tablets will be simultaneously launched in major hospitals across more than twenty provinces and municipalities in China, including Beijing, Guangzhou, Tianjin, Fujian, Jiangsu, Zhejiang, Sichuan, Shandong, Henan, and Hunan, allowing patients in various regions to benefit simultaneously.

Statement:

1. This article aims to convey cutting-edge pharmaceutical information and does not constitute a recommendation or promotion of any drug or treatment plan.

2. If you want to learn more about disease knowledge or drug and treatment-related information, please consult a healthcare professional.

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[2] Zhang Xuchao, Liu Xiaoqing, Wang Jie, et al. Guidelines for the Diagnosis and Treatment of Anaplastic Lymphoma Kinase-Positive and ROS1-Positive Non-Small Cell Lung Cancer in China[J]. Chinese Journal of Pathology, 2018, 47(4):7.

[3] Zhang Xuchao, Lu Shun, Zhang Li, et al. Guidelines for the Diagnosis and Treatment of Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer in China[J]. Chinese Journal of Pathology, 2015, 44(10): 696-703.

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[8] Ando K, et al. Cancers (Basel) , 2020.

[9] Banks WA, et al. BMC Neurol. 2009

[10] Bedi S, et al. Saudi Pharm J. 2018

[11] Camidge DR, et al. J Clin Oncol. 2020

[12] Camidge DR, et al. J Clin Oncol. 2021