AstraZeneca Announces New Clinical Breakthrough for Tagrisso® in EGFR-Mutated Unresectable Stage III NSCLC at ESMO 2024

During the recently held 2024 European Society for Medical Oncology (ESMO) Annual Meeting, AstraZeneca's Tagrisso® (generic name: Osimertinib) achieved another significant result following the announcement of the primary endpoint, progression-free survival (PFS), from the LAURA Phase III clinical trial at the 2024 American Society of Clinical Oncology (ASCO).

One of the key researchers globally, Professor Lu Shun from the Thoracic Hospital affiliated with Shanghai Jiao Tong University and Director of the Shanghai Pulmonary Tumor Clinical Medical Center, delivered a brief oral presentation on LAURA's reduction in the risk of central nervous system (CNS) and distant progression: Compared to placebo following concurrent chemoradiotherapy, osimertinib as consolidation therapy for EGFR-positive Stage III unresectable non-small cell lung cancer demonstrated clinically significant improvements in CNS progression and median time to distant metastasis (TTDM), further confirming that osimertinib is expected to become a new standard treatment option for such patients.

Professor Lu Shun stated: "The data released from the LAURA study further confirms the clinical benefits of Osimertinib for patients with EGFR-mutated, Stage III unresectable NSCLC (non-small cell lung cancer), which may reshape the future treatment landscape and is expected to become a new standard treatment regimen for such patients. We look forward to the overall survival (OS) benefit of LAURA reaching its endpoint and being approved in China as soon as possible, bringing more survival hope to Chinese patients with Stage III EGFR-mutated NSCLC."

Based on different histopathological characteristics, lung cancer can be divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Among them, NSCLC accounts for about 80%-85%. According to factors such as tumor size, extent of invasion, lymph node metastasis, and distant metastasis, the international TNM staging system classifies NSCLC into stages I, II, III, and IV. In China, approximately 30%-40% of patients are initially diagnosed at stage III. Unlike stage IV advanced lung cancer, at stage III, cancer cells are still confined to a single lung area or have just spread to the lymph nodes in the lung, making radical treatment possible. Currently, the 5-year survival rate for stage III lung cancer is 11%-37%.

At the same time, according to the distribution of patients' tumors, the treatment of stage III lung cancer is divided into three categories: resectable, potentially resectable, and unresectable. Among them, the majority are unresectable stage III NSCLC patients, whose disease progression is the most severe. For unresectable stage III patients, such as some stage IIIA-N2, IIIB, and IIIC patients, although a large number of studies have established that concurrent chemoradiotherapy is the standard treatment for unresectable stage III NSCLC, it has not been able to further improve patient survival rates. Particularly for EGFR-mutant NSCLC patients, these patients also experience a higher incidence of CNS metastases, representing a significant unmet need in clinical treatment.

With the iteration of EGFR inhibitors from the first generation to the second and third generations, as well as the advancement of precise diagnostics, China's precision treatment for lung cancer has entered a brand-new era. Today, the overall five-year survival rate of lung cancer patients in China has significantly increased to 28.7%. In this progress, AstraZeneca introduced the world's first first-generation EGFR-TKI Gefitinib and the first third-generation EGFR-TKI Osimertinib into China, serving as both a witness and contributor to the rise of targeted therapy for lung cancer in China.

It is reported that as the world's first Phase III clinical study exploring targeted therapy for EGFR-mutated, unresectable Stage III NSCLC, the LAURA study is expected to fill the gap in this treatment area. It is understood that the therapy has been granted Priority Review and Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA), and has been included in the priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

Zhang Lingyan, Vice President of AstraZeneca China and Head of the Lung Cancer Division of the Oncology Business Unit, stated: "AstraZeneca is very honored to be able to support this kind of research, helping Chinese experts step onto the global stage, enabling more and more Chinese experiences to play a more significant role in the international academic arena, and gradually becoming a key force driving the transformation of global lung cancer diagnosis and treatment."

Currently, AstraZeneca is continuously expanding its lung cancer product pipeline through four approaches: independent research and development, collaborative development, joint research, and global licensing partnerships. The company aims to launch 9 new products and 26 new indications in China by 2030.