Takeda China announced today that its innovative lung cancer drug Ambery® (brigatinib) was officially launched. Brigatinib, a novel selective ALK tyrosine kinase inhibitor, was approved by the China National Medical Products Administration (NMPA) in March 2022 as a single agent for anaplastic lymphoma kinase (ALK)-positive patients. For the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), its launch will further meet the unmet needs of Chinese ALK-positive advanced non-small cell lung cancer patients and help to develop a new treatment pattern in related fields.
The innovative drug Ambery® (brigatinib tablet) in the field of lung cancer was officially launched. Brigatinib, a novel selective ALK tyrosine kinase inhibitor, was approved by the China National Medical Products Administration (NMPA) in March 2022 as a single agent for anaplastic lymphoma kinase (ALK)-positive patients. For the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), its launch will further meet the unmet needs of Chinese ALK-positive advanced non-small cell lung cancer patients and help to develop a new treatment pattern in related fields. During the listing meeting, Takeda China announced on the same day that it would support the two authoritative organizations of the China Medical Education Association and the Chinese Society of Clinical Oncology (CSCO) Non-Small Cell Lung Cancer Special Committee to launch the “Precision Diagnosis and Treatment Project for Rare Targets in Lung Cancer” to jointly promote lung cancer in China Improve the level of precision diagnosis and treatment.
Today’s listing will be held simultaneously in seven places including Shanghai, Beijing, Zhejiang, Jinan, Henan, Fujian and Sichuan. Through offline and online linkage, more than 1,000 experts from nearly 100 hospital departments across the country are invited to participate in the grand event. Several well-known professors in China co-chaired this meeting and conducted in-depth exchanges and discussions with authoritative experts in the field of lung cancer diagnosis and treatment from all over the country on the precise and standardized diagnosis and treatment of ALK-positive advanced non-small cell lung cancer.
Lung cancer is the largest cancer type in China, and its morbidity and mortality rank first among all malignant tumours. Among them, ALK-positive non-small cell lung cancer (ALK+ NSCLC) is a relatively rare and dangerous subtype, with nearly 35,000 new cases in my country every year.
At present, such patients still have urgent clinical needs to be met: the incidence of brain metastases in patients is high, and the quality of life is severely reduced. Data show that about 55% of patients with ALK-positive advanced non-small cell lung cancer will develop brain metastases, which seriously affects the patient’s daily life and even threatens their lives.
Academician of the Chinese Academy of Engineering and President of Shandong Cancer Hospital said: “ALK-positive mutation is known as the ‘diamond mutation’ of non-small cell lung cancer, and patients can achieve the better curative effect with targeted drugs, but currently the type of ALK fusion and drug resistance are targeted. There is still a demand gap for the treatment of mutations, and patients urgently need more innovative and effective therapeutic drugs to prolong survival time and improve quality of life. It is believed that the launch of brigatinib will further enrich the treatment of ALK-positive advanced non-small cell lung cancer in China and promote the precise treatment and whole-process management of lung cancer in China to improve people’s health.”
Including ALK-positive mutations, more and more rare targets and corresponding targeted therapy drugs have been discovered in recent years, which has enabled patients with advanced non-small cell lung cancer to obtain more treatment options, and has also proposed the diagnosis and treatment strategies for non-small cell lung cancer. More precise and individual requirements.
In order to further promote the development of precision diagnosis and treatment of lung cancer, the “Precision Diagnosis and Treatment Project for Rare Targets of Lung Cancer” was launched simultaneously today. The project aims to set up precision diagnosis and treatment centres for rare targets of lung cancer in partner hospitals across the country and establish a regional lung cancer centre with the hospital as the core. Rare target diagnosis and treatment alliance, so as to accumulate and promote the experience of rare target diagnosis and treatment of lung cancer, and jointly promote the improvement of lung cancer diagnosis and treatment level in China.
Director of the Department of Oncology, Shanghai Pulmonary Hospital Affiliated with Tongji University said: “There is a huge base of lung cancer patients in China, so the clinical needs of lung cancer patients with rare gene mutations cannot be ignored. The precision diagnosis and treatment project for rare targets of lung cancer will help more clinicians to use, Using cutting-edge standardized diagnosis and treatment weapons is expected to allow more lung cancer patients with rare mutations to receive corresponding standardized treatment, thereby comprehensively improving the diagnosis and treatment level and efficacy of lung cancer in China.”
As a new ALK tyrosine kinase inhibitor, brigatinib’s unique dimethyl phosphine oxide (DMPO) can ensure high selectivity for ALK and improve drug activity by 7 times; brigatinib has high solubility and The characteristics of high permeability, balanced water solubility and lipid solubility create favourable conditions for penetrating the blood-brain barrier and maintaining the drug concentration in the brain; at the same time, it has a prominent inhibitory effect on the common variants of EML4-ALK.
The ALTA-1L study, a phase III clinical study of brigatinib, also confirmed its efficacy in prolonging patient survival, controlling brain metastases, and improving quality of life.
Professor of Shanghai Chest Hospital said: “The global phase III clinical trial ALTA-1L study confirmed that brigatinib can provide patients with a median progression-free survival (PFS) of 2 years as assessed by an independent review committee. The median PFS is more than 30 months, which fully proves its overall efficacy and is therefore recommended by the NCCN guidelines as the first-line choice for the treatment of ALK-positive advanced NSCLC. It is expected that brigatinib will bring more benefits to Chinese ALK-positive lung cancer patients after the launch. Real clinical benefit.”
For intracranial efficacy, ALTA-1L results showed breakthrough efficacy in patients with baseline brain metastases: intracranial lesion response rate (iORR) of 78% and median duration of response (DoR) of 27.9 months, surpassing controls more than 3 times in the control group (26% and 9.2 months in the control group, respectively); the median PFS assessed by BIRC reached 24 months, and the control group was 5.6 months (HR=0.25, P<0.0001), which means that brigatinib reduced the baseline. Patients with brain metastases have a 75% risk of disease progression or death; first-line treatment with baseline brain metastases has a 3-year OS rate of 74% and a 4-year OS rate as high as 71%.
Brain metastasis is one of the main causes of death and disability in patients with ALK-positive advanced lung cancer, and leads to a significant decrease in the quality of life of patients.
The launch of brigatinib has overcome this clinical problem and can bring deep and durable intracranial disease remission, help nearly 3/4 of the newly treated patients with brain metastases achieve long-term survival of more than 4 years, and is expected to help ALK-positive advanced non-cancer patients. Small cell lung cancer truly achieves long-term controllability and management.
Lung cancer, as the largest cancer in my country, is one of the major public health problems that seriously threaten the health of Chinese residents. Adhering to the “patient first” commitment, Takeda is committed to accelerating the introduction of innovative lung cancer treatment solutions to help address the urgent clinical needs of Chinese patients.
At the same time, we will continue to work with all sectors of society to jointly improve the level of lung cancer diagnosis and treatment, advocate standardized treatment concepts, and improve the management of patients throughout the course of the disease, so as to contribute to the realization of the goal of “Healthy China” to improve the overall 5-year survival rate of cancer.