Zai Lab Announces Approval of AUGTYRO (repotrectinib) for Patients with ROS1-positive NSCLC by China’s NMPA

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for AUGTYRO (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). The approval is based on the pivotal TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated repotrectinib in TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC.

“We are pleased with NMPA’s approval of AUGTYRO for the treatment of patients with ROS1-positive NSCLC in China. There is a significant unmet need for these patients given the limited durability of benefit due to the emergence of resistance with existing therapies, eventually leading to tumor progression,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “We appreciate the NMPA for their thorough assessment of AUGTYRO, recognizing its potential to address the unmet medical need in China.”

“Despite existing earlier generation TKIs for ROS1-positive NSCLC, there remains an unmet need for new treatment options that support important clinical goals, such as durable therapeutic response,” said Dr. Shun Lu, M.D., Ph.D., Chief of Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University. “The TRIDENT-1 study showed that treatment with repotrectinib results in high response rates with promising durability in patients with ROS1-positive NSCLC, across TKI-naïve and TKI-pretreated settings, including in the presence of intracranial disease. Based on this study, repotrectinib has the potential to become a new standard of care for these patients.”

In June 2023, China’s NMPA accepted the NDA for AUGTYRO for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC, with priority review granted in May 2023.

Zai Lab contributed to the pivotal TRIDENT-1 study and dosed the first patient in Greater China in May 2021, and the results were published in the New England Journal of Medicine in January 2024. The topline efficacy and safety data of Chinese subpopulation is consistent with that of global population, demonstrating robust response rates and durable clinical activity in patients with ROS1-positive NSCLC. Treatment with AUGTYRO was generally well tolerated with a manageable safety profile.