LAURA Phase III Clinical Trial: Chinese Cohort Data Confirms Consistent Clinical Benefit of Osimertinib in EGFR-Mutated Unresectable Stage III NSCLC

China Finance and Economics News, September 18 — During the 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain from September 13 to 17, AstraZeneca's Tagrisso (generic name: Osimertinib) released the efficacy and safety data of the Chinese cohort from the LAURA Phase III clinical trial, following the announcement of the primary endpoint, progression-free survival (PFS), at the 2024 American Society of Clinical Oncology (ASCO).

Professor Dong Xiaorong, Director of the Department of Thoracic Oncology at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, as one of the Principal Investigators (PI) of the China Clinical Research Center, presented this achievement in a poster: Compared with placebo after radical radiotherapy and chemotherapy, the clinical benefits and safety of Osimertinib in treating Chinese patients with EGFR-mutated stage III unresectable non-small cell lung cancer (NSCLC) are consistent with those observed globally.

Among 216 randomized subjects globally, 40 (19%) were Chinese (27 in the osimertinib group and 13 in the placebo group). According to the assessment by the blinded independent central review (BICR), the 12-month and 24-month PFS rates in the osimertinib-treated group were 80% and 71%, respectively, compared to only 17% and 8% in the placebo group. The OS data is not yet mature. These results support the use of osimertinib as maintenance therapy following curative chemoradiotherapy in patients with stage III unresectable NSCLC harboring EGFR mutations, which is expected to become the new standard treatment for both global and Chinese patients.

EGFR is one of the most common driver genes in non-small cell lung cancer. Data shows that the EGFR mutation rate in Chinese lung cancer patients is around 50%, much higher than in Europe and America. This year marks the 20th anniversary of the discovery of the EGFR gene mutation. Over the past two decades, with the iterative development and successive introduction of first-, second-, and third-generation EGFR-TKIs, the quality of life and survival time of Chinese non-small cell lung cancer patients with EGFR mutations have continuously improved.

As the world's first Phase III clinical study demonstrating PFS benefit with targeted therapy for EGFR-mutated, unresectable Stage III non-small cell lung cancer (NSCLC), LAURA undoubtedly represents a milestone breakthrough. Statistics show that in China, approximately 30%-40% of patients are initially diagnosed at Stage III, with the majority being unresectable Stage III NSCLC patients who face the most severe disease progression. However, it is regrettable that the current treatment strategy—"concurrent chemoradiotherapy plus immunotherapy consolidation"—still results in an overall 5-year survival rate of less than 20%, showing poor efficacy and leaving significant unmet treatment needs. The LARUA study will fill this therapeutic gap, bringing renewed hope to Chinese patients with this type of lung cancer.

Previously, the article on the first-phase results of the LAURA study was published in The New England Journal of Medicine. Professor Lu Shun from the Shanghai Chest Hospital affiliated with Shanghai Jiao Tong University and the Shanghai Lung Tumor Clinical Medical Center, one of the leading Principal Investigators (PI) globally, is the first author and corresponding author of the article. Professor Dong Xiaorong, Professor Huang Meijuan, Deputy Director of the Thoracic Oncology Department at West China Hospital of Sichuan University, and Professor Chen Ming, Director of the Radiation Oncology Department at Sun Yat-sen University Cancer Center, are also among the authors of the article. Additionally, the safety data of the LAURA study was recently presented at the just-concluded World Conference on Lung Cancer (WCLC). With the release of this series of significant data, it has been granted Priority Review and Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and included in the priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.

Professor Dong Xiaorong stated: "It is a great honor that China has the largest number of participants in this study and has become the world's second-largest clinical research center. The release of the Chinese cohort data signifies that China's experience is playing a significant role and value in global clinical research, helping to usher in the era of targeted therapy for patients with Stage III unresectable non-small cell lung cancer in China and even globally. In the future, we look forward to China’s innovation continuing to contribute to global innovation, and sincerely hope that LAURA will be approved in China as soon as possible, allowing more patients to benefit from breakthrough achievements brought by medical innovation."

Against the backdrop of global cooperation in innovative drug development, with the further enhancement of China's drug R&D capabilities, China's innovative technologies, models, experts, and experiences are becoming key forces driving the transformation of global cancer diagnosis and treatment. In this process, multinational pharmaceutical companies have also played a bridging role. The success of the LAURA Phase III study is one of the best examples, which focuses on cancer types that are highly prevalent in China, allowing China-driven R&D to lead the global R&D process, and empowering the global R&D pipeline with Chinese clinical data. By creating East-West integrated innovations, it injects sustainable momentum into the globalization of China’s healthcare industry.

"I am very pleased that AstraZeneca, by supporting relevant research, has enabled more Chinese experts to stand on the global scientific stage and has also allowed the world to see the powerful strength and resilience of China's innovation," said Zhang Lingyan, Vice President of AstraZeneca China and Head of the Oncology Business Unit for Lung Cancer. "For a long time, AstraZeneca China has adhered to a 'patient-centered' approach, upheld science as the guiding principle, and over the 20 years of dedication in the field of lung cancer, we have achieved treatment coverage across the entire disease cycle of lung cancer through targeted and immunotherapy drugs, continuously changing clinical treatment standards and improving patients' overall survival. This transformative power stems from our relentless acceleration in the development of innovative drugs, allowing advanced and highly effective therapies to benefit lung cancer patients faster. In the future, we will expand into broader and more comprehensive disruptive innovative therapies, including ADC drugs targeting TROP2 and HER2, immunotherapy combined with targeted therapy, monoclonal antibodies, and bispecific antibodies. By 2030, we aim to launch nine new products and 26 new indications in China, illuminating the light of life for Chinese lung cancer patients."