Takeda's Innovative Drug Brigatinib Tablet Officially Launched in China, Pioneering a New Era in the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer

2022Year8Month13Day,Takeda China announced today that its innovative lung cancer drug, Ambray^®(Brigatinib Tablets) Officially Launched. Brigatinib is a novel selectiveALKTyrosine kinase inhibitor, has been2022Year3Monthly acquisition of approval from the National Medical Products Administration (NMPA) of ChinaNMPA) approved, as monotherapy for anaplastic lymphoma kinase (ALK) Positive locally advanced or metastatic non-small cell lung cancer (NSCLC) treatment, its market launch will further meet the needs of ChinaALKPatients with positive advanced non-small cell lung cancer currently have unmet needs that urgently need to be addressed, helping to open up a new pattern of treatment in related fields. During the product launch conference, Takeda China announced on the same day that it would support the Chinese Pharmaceutical Education Association and the Chinese Society of Clinical Oncology (CSCO) Two major authoritative institutions of the Non-Small Cell Lung Cancer Committee, launched“Precision Diagnosis and Treatment Project for Rare Targets in Lung Cancer”, jointly promote the improvement of precision diagnosis and treatment levels for lung cancer in China.

The meeting was held simultaneously in seven locations, including Shanghai, Beijing, Zhejiang, Jinan, Henan, Fujian, and Sichuan, with online and offline participation. Nearly a hundred hospital departments and more than a thousand experts from across China were invited to this grand event. Academician Jinming Yu, an academician of the Chinese Academy of Engineering and director of Shandong Cancer HospitalProf. Cai-Cun Zhou from Shanghai Pulmonary Hospital affiliated to Tongji University, Prof. Bao-Hui Han from Shanghai Chest Hospital, Prof. Chang-Li Wang from Tianjin Medical University Cancer Institute and Hospital, Prof. Jian-Ying Zhou from the First Affiliated Hospital of Zhejiang University School of Medicine, Prof. Yun Fan from Cancer Hospital of University of Chinese Academy of Sciences, Prof. Zhe-Hai Wang from Shandong Cancer Hospital, Prof. Xiu-Wen Wang from Qilu Hospital of Shandong University, Prof. Qing-Hua Zhou from Lung Cancer Institute of West China Hospital Sichuan University, Prof. Zhi-Yong Ma from Cancer Hospital Affiliated to Zhengzhou University, Prof. Guo-Jun Zhang from the First Affiliated Hospital of Zhengzhou University, Prof. Tong-Jian Cui from Fujian Provincial Hospital, Prof. Jian-Cheng Li from Fujian Cancer Hospital, etc.Co-chaired this meeting, with authoritative experts in the field of lung cancer diagnosis and treatment from across China.ALKIn-depth exchanges and discussions were conducted on the precise and standardized diagnosis and treatment of advanced non-small cell lung cancer with positive mutations.

Lung cancer is the leading type of cancer in China, with the highest incidence and mortality rates among all malignant tumors. Among these,ALKPositive Non-Small Cell Lung Cancer (ALK+ NSCLC) is a relatively rare and dangerous subtype, with nearly35000Example. Currently, there remains an urgent unmet clinical need for such patients: a high incidence of brain metastases significantly reduces their quality of life. Data shows that approximately55%OfALKPatients with positive advanced non-small cell lung cancer may experience brain metastasis.^,,，seriously affecting the daily life of patients, and even threatening their lives.

Academician Jinming Yu, President of Shandong Cancer Hospital and an academician of the Chinese Academy of Engineering, stated:“ALKPositive mutations are referred to as non-small cell lung cancer‘Diamond Mutation’, patients can achieve better efficacy through targeted drugs, but currently forALKThere is still an unmet need for the treatment of fusion types and drug-resistant mutations, and patients are in urgent need of more innovative and effective therapies to prolong survival and improve quality of life. The launch of brigatinib this time is believed to further enrich China'sALKTreatment options for positive advanced non-small cell lung cancer, and promote the precise treatment and whole-process management of lung cancer in China, improving the health level of the people.”

IncludingALKIncluding positive mutations, in recent yearsThe discovery of an increasing number of rare targets and corresponding targeted therapeutic drugs has provided more treatment options for patients with advanced non-small cell lung cancer (NSCLC) and has also placed more precise and individualized demands on the diagnosis and treatment strategies for NSCLC. To further promote the development of precision diagnosis and treatment for lung cancer,“Precision Diagnosis and Treatment Project for Rare Targets in Lung Cancer”Launched in synchronization today, this project aims to establish precision diagnosis and treatment centers for rare lung cancer targets at cooperative hospitals across China, and to build regional alliances for the diagnosis and treatment of rare lung cancer targets centered around these hospitals, thereby accumulating and promoting experience in the diagnosis and treatment of rare lung cancer targets, and jointly advancing the level of lung cancer diagnosis and treatment in China.

Professor Cai-Cun Zhou, Director of the Department of Oncology at Shanghai Pulmonary Hospital, Tongji University, stated:“China has a large base of lung cancer patients, so the clinical needs of lung cancer patients with rare genetic mutations should not be overlooked.The Precision Diagnosis and Treatment Project for Rare Targets in Lung Cancer will help more clinicians utilize and effectively apply cutting-edge standardized diagnostic and treatment tools, with the potential to enable more lung cancer patients with rare mutations to receive corresponding standardized treatment. This, in turn, is expected to comprehensively enhance the diagnostic and treatment standards and outcomes of lung cancer in China.”

As a brand-newALKTyrosine Kinase Inhibitor, Brigatinib Unique Dimethyl Phosphine Oxide (DMPO) can ensure forALKHigh selectivity and enhanced drug activity up to7Times; Brigatinib is characterized by high solubility and high permeability, and its balanced water solubility and lipid solubility create favorable conditions for crossing the blood-brain barrier and maintaining drug concentration in the brain; at the same time, itEML4-ALKAll common variants have a prominent inhibitory effect.^,,Brigatinib Phase III Clinical StudyALTA-1LThe study also confirmed its efficacy in extending patient survival, controlling brain metastases, and improving quality of life.

Professor Han Baohui from Shanghai Chest Hospital said:“GlobalIIIPhase Clinical TrialALTA-1LThe study confirmed that brigatinib increased the median progression-free survival (PFS) as assessed by an independent review committee.PFS) Takeda2Year, median assessed by researchersPFSExceed30months, fully demonstrating its overall efficacy, and thus beingNCCNGuidelines asALK Positive Advanced StageNSCLCThe first-line preferred recommendation for treatment. It is expected that after Brigatinib is launched in China, it will...ALKPositive lung cancer patients bring more tangible clinical benefits.”

For intracranial efficacy,ALTA-1LThe results showed its breakthrough efficacy for patients with baseline brain metastases: intracranial lesion response rate (iORR) Takeda78%, Median Duration of Response (DoR) Takeda27.9Months, surpassing the control group3More than double (control groups were26%、9.2Months);BIRCMedian AssessmentPFSAchieve24Months, Control Group5.6Months (HR=0.25，P＜0.0001), which means brigatinib reduces baseline brain metastases in patients75%Risk of Disease Progression or Death; Baseline Brain Metastases in First-Line Treatment Patients3YearOSRate of74%，4YearOSAs high as71% 。

Brain Metastasis isALKOne of the main causes of death and disability in patients with advanced lung cancer, leading to a significant decline in their quality of life.Is a key and challenging aspect of current clinical diagnosis and treatment;And the previous treatment drugs have limitations in controlling brain metastases. The launch of Brigatinib has overcome this clinical challenge, providing deep and lasting relief of intracranial lesions, helping nearly3/4The initial treatment of brain metastasis patients achieved4Long-term survival of more than a year is expected to helpALKLong-term Controllability and Manageability Achieved for Positive Advanced Non-small Cell Lung Cancer¹⁰。

Takeda China President Shan Guohong stated:“Lung cancer, as the leading type of cancer in China, is one of the major public health issues that seriously threaten the health of our residents. Following’Patient First’'s commitment, Takeda is dedicated to accelerating the introduction of innovative lung cancer treatment solutions to help address the urgent clinical needs of patients in China. At the same time, we will continue to collaborate with all sectors of society to jointly improve the level of lung cancer diagnosis and treatment, promote standardized treatment concepts, and enhance comprehensive patient management throughout the course of the disease, in order to achieve‘Healthy China’Improve Overall Cancer5Objective of the X-Year Survival RateContribute strength.”

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