Takeda China announced today that ALUNBRIG® (brigatinib) has been approved by the National Medical Products Administration (NMPA) of China as a monotherapy for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung cancer (NSCLC). As the new tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations, ALUNBRIG® (brigatinib) has shown clinical efficacy in prolonging patient survival, controlling brain metastases, and improving the quality of life. It has been listed as a preferred first-line therapy by the NCCN Clinical Practice Guidelines in Oncology and also listed in the CSCO Guidelines for Diagnosis and Treatment of Non-Small Cell Lung Cancer. As Takeda’s first drug for Chinese patients with lung cancer, the approval of ALUNBRIG® (brigatinib) marks the company’s official entry into the field of lung cancer treatment in China.
In China, lung cancer is the most commonly diagnosed cancer, with the highest incidence and mortality rates among all malignant tumors, thus posing serious threats to the health of Chinese people. Among them, ALK-positive non-small cell lung cancer (ALK+ NSCLC) is a smaller but dangerous subtype, with nearly 35,000 new cases in China every year. These patients generally have early onset and are more likely to develop metastases. Data showed that 30% of ALK+ NSCLC patients already had brain metastases while firstly diagnosed, and 75% of them will develop brain metastases within two years after initial diagnosis, which causes a significant negative impact on their survival and quality of life. Control and prevention of brain metastases is both a priority and challenge in clinical treatment of ALK+ advanced NSCLC, and innovative and effective therapeutic drugs are urgently needed in clinical practice. While extending the survival, treatment is also essential for improving the quality of life. In addition, there is a huge unmet need among patients with ALK fusion and drug resistance mutations.
ALUNBRIG mainly acts on ALK fusion-positive mutations. Its unique dimethylphosphine oxide (DMPO) structure creates a positive condition for the drug to pass through the blood-brain barrier and maintain plasma concentration in the brain. It can inhibit a variety of ALK fusions and drug resistance mutations. ALUNBRIG significantly reduced the risk of disease progression or death in patients with ALK+ advanced NSCLC, prolonged progression-free survival (PFS), and demonstrated overall survival benefits. Results from the global multicenter Phase 3 ALTA 1L trial showed that ALUNBRIG demonstrated a 24-month median PFS as assessed by a blinded independent review committee versus 11 months for crizotinib (HR=0.48, P<0.0001). The investigator-assessed median PFS was 30.8 months vs 9.2 months (HR=0.43, P<0.0001). ALUNBRIG demonstrated a 57% decline in the risk of disease progression or death compared with crizotinib.
ALUNBRIG demonstrated a confirmed intracranial overall response rate (ORR) of 78% in patients with measurable brain metastases at baseline, compared with 26% in patients treated with crizotinib, while the duration of remission was 27.9 months versus 9.2 months. ALUNBRIG prolonged PFS in patients with measurable brain metastases at baseline, with a median PFS of 24 months as assessed by an independent review committee, compared with 5.6 months in the crizotinib group (HR=0.25, P<0.0001), thereby significantly reducing the risk of disease progression or death by 75%. ALUNBRIG demonstrated a 4-year overall survival (OS) rate of 71% in patients with measurable brain metastases at baseline, and lowered the risk of death by 57% (4-year OS rate in the crizotinib group was 44%, HR=0.43, P=0.02). The adverse reactions were mostly mild, with a well-tolerated safety profile in long-term use. Based on the efficacy and safety data, ALUNBRIG is the first ALK inhibitor that has been clinically proven to significantly improve and maintain the quality of life for patients compared with the control group. It brought benefits to patients in both survival and quality of life.
“Today’s approval of ALUNBRIG is an important milestone in expanding treatment options for patients with ALK+NSCLC in China,” said Awny Farajallah, MD, Head, Global Medical Affairs Oncology, Takeda Oncology. “Takeda is proud to deliver on our commitment to people living with lung cancer in China as we strive to bring new oncology therapies to patients around the globe.”
Sean Shan, President of Takeda China, said, “We appreciate the Chinese government’s strong support which enabling us to launch ALUNBRIG® (brigatinib) in China quickly to benefit patients with ALK-positive non-small cell lung cancer. ALUNBRIG® (brigatinib) is our first therapy for Chinese patients with lung cancer, and this approval marks another milestone for us in the field of oncology in China. As a patient-first, values-based, R&D-driven global biopharmaceutical company, Takeda will continue to accelerate the access to innovative treatments, and work with all partners to address the unmet medical needs, and contribute to the ‘Healthy China 2030 initiative’.”
"At Takeda, our commitment to our patients drives us to explore innovative treatments." Lin Wang, Head of Takeda Development Center Asia, said, "So, facing the still existing unmet medical needs of the patients with ALK-positive advanced NSCLC, the whole team worked together to achieve the early NDA submission and received approval. In the future, Takeda will further combine its expertise advantages with research and development capabilities to accelerate the delivery of transformative medicines to patients in China through simultaneous drug development, enabling Chinese patients to obtain the access to global innovation simultaneously."
So far, ALUNBRIG has been approved in more than 40 countries and regions, and has obtained the Breakthrough Therapy Designation and Orphan Drug Designation granted by the FDA.