Takeda China today announced that its innovative drug in the lung cancer field, Embryo (Bugatinib Tablets/Brigatinib), has officially received approval from the National Pharmaceutical Market Administration (NMPA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is positive for mesenchymal lymphoma kinase (ALK) as a single agent. Bugatinib tablets are a new ALK tyrosine kinase inhibitor with clinically proven efficacy in prolonging patient survival, controlling brain metastases and improving quality of life, and are listed as first-line preferred agents in the NCCN Clinical Practice Guidelines in Oncology and in the CSCO Guidelines for the Management of Non-Small Cell Lung Cancer [1], [2], [3], [4]. The approval of this product marks Takeda China's official entry into the lung cancer treatment field, bringing new treatment options to more Chinese lung cancer patients.

Lung cancer is one of the cancers with the highest incidence and mortality rates in the world. In China, lung cancer is also the number one cancer, with the highest incidence and mortality rate of all malignant tumors every year, which seriously threatens the health of Chinese people [5]. Among them, ALK-positive advanced non-small cell lung cancer (ALK+ mNSCLC) is a relatively rare and aggressive subtype, with the number of new cases approaching 35,000 per year in China [6]. This group of patients commonly suffers from a low mean age of onset and is commonly associated with a high incidence of brain metastases. Data show that 30% of ALK+ mNSCLC patients have brain metastases at the time of initial diagnosis, and 75% of patients will develop brain metastases within two years of treatment, with survival and quality of life severely affected [7], [8], [9]. Therefore, control and prevention of brain metastasis is the focus and difficulty of clinical treatment for ALK+ mNSCLC, and innovative and effective therapeutic agents are urgently needed in the clinic. While improving patient survival, treatment is also very important for the improvement of patients' quality of life. In addition, there is a huge unmet need for treatment against ALK fusion types and drug-resistant mutations.

Professor Cai-Cun Zhou, Director of the Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, said, "The clinical trial results of Bugatinib are very promising, with outstanding efficacy in brain metastases, proving to be effective in prolonging the survival of patients with advanced or metastatic ALK-positive non-small cell cancer and significantly improving their quality of life. As clinicians, we are very much looking forward to the launch of Bugatinib, which is not only a first-line treatment option for such patients, but also brings new treatment options for patients after the progression of other drugs."

Bugatinib tablets mainly act on ALK fusion mutations, and their unique dimethylphosphine oxide (DMPO) structure enhances the binding to ALK proteins, which enhances drug activity and also creates favorable conditions for the drug to cross the blood-brain barrier and maintain blood concentrations in the brain, while broadly inhibiting multiple ALK fusion types and drug-resistant mutations[10],[11],[12],[13],[14] . Bugatinib tablets significantly reduce the risk of disease progression or death, prolong progression-free survival (PFS), and achieve overall survival benefit in ALK+ mNSCLC patients. According to the results of the international multicenter phase III clinical study ALTA-1L, for patients treated with buggitinib tablets, median PFS reached 24 months as assessed by an independent review board, median PFS of 11.1 months for control crizotinib (HR = 0.48, P < 0.0001), and median PFS reached 30.8 months as assessed by the investigator vs. 9.2 months for the control group (HR = 0.43, P < 0.0001), with a 57% reduction in the risk of disease progression or death with bucitinib tablets compared to controls [15].

Data on treatment with burgatinib tablets against brain metastases were outstanding, with ALTA-1L results showing a confirmed objective remission rate (ORR) of 78% for patients with brain metastases at baseline and 26% for controls, and a sustained remission time of up to 27.9 months for patients in remission from intracranial lesions and 9.2 months for controls. Bugatinib tablets prolonged progression-free survival in patients with brain metastases at baseline, reaching a median PFS of 24 months compared with 5.6 months in controls as assessed by an independent review board (HR=0.25, P<0.0001), significantly reducing the risk of disease progression or death by 75% compared with controls [16]. The 4-year overall survival (OS) rate of 71% and reduced risk of death by 57% in patients with baseline brain metastases treated with first-line brigatinib tablets (4-year OS rate of 44% in the control group, HR=0.43, P=0.02). Adverse effects with concomitant use of bucitinib tablets are mostly mild and tolerable with long-term safety [17], [18]. Based on the guarantee of efficacy and safety, Bugatinib tablets are the first ALK inhibitor that has been confirmed by clinical studies [19] to show significant differences in improving or maintaining patients' quality of life compared with controls, truly achieving both patient survival and quality of life benefits.

Currently, Bugatinib tablets have been approved in more than 40 countries and regions worldwide, and have received FDA Breakthrough Therapy Drug Designation and Orphan Drug Designation.

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