Zai Lab Announces FDA Approval of Repotrectinib (Augtyro™) for ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Adults

On November 16, 2023, Zai Lab's partner Bristol-Myers Squibb Company announced that repotrectinib (Repotrectinib, Augtyro™) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

The approval was based on the TRIDENT-1 study, an open-label Phase 1/2 trial that evaluated Repotrectinib in both TKI-naïve and TKI-pretreated patients. In TKI-naïve patients (n=71), the objective response rate (ORR) was 79%, progression-free survival (PFS) was 35.7 months, and median duration of response (mDOR) was 34.1 months. In patients previously treated with one ROS1 TKI and no chemotherapy (n=56), the ORR was 38% and mDOR was 14.8 months. Among patients with measurable brain metastases at baseline, intracranial responses were observed in 7 out of 8 TKI-naïve patients and in 5 out of 12 TKI-pretreated patients.

Jessica J. Lin, MD, primary investigator of TRIDENT-1, attending physician at the Thoracic Oncology Center of Massachusetts General Hospital, and assistant professor of medicine at Harvard Medical School, said:

Patients with ROS1 fusion-positive non-small cell lung cancer still need new treatment options to support critical clinical goals, including achieving durable treatment responses.

Based on the data we have seen in the TRIDENT-1 study, repotrectinib has the potential to become a new standard treatment option for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.

In June 2023, China's National Medical Products Administration (NMPA) accepted the new drug application for Repotrectinib for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer. In May 2023, Repotrectinib was granted priority review by the NMPA. Currently, Repotrectinib has received four Breakthrough Therapy Designations in China.

*The drugs and related indications mentioned in this article have not been approved/launched in China.

About Non-Small Cell Lung Cancer in China

Lung cancer is the most common type of cancer in China and a leading cause of cancer-related deaths. In 2022, there were approximately 871,000 new cases of lung cancer and about 767,000 deaths in China1. Non-small cell lung cancer accounts for about 85% of lung cancer cases, with approximately 70% of non-small cell lung cancer patients presenting with locally advanced or metastatic disease at initial diagnosis. In China, ROS1 rearrangements occur in approximately 2%-3% of patients with advanced non-small cell lung cancer2.

1.ChangfaXia,etal.CancerstatisticsinChinaandUnitedStates,2022:profiles,trends,anddeterminants.

2.Zhangetal.PrevalenceofROS1fusioninChinesepatientswithnon-smallcelllungcancer,ThoracicCancerJanuary2019.

About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovation-driven biopharmaceutical company with a focus on research and development, and is currently in the commercialization stage. Headquartered in China and the United States, we are committed to addressing significant unmet medical needs in the fields of oncology, autoimmune diseases, infectious diseases, and central nervous system disorders through the discovery, development, and commercialization of innovative products. Our goal is to leverage our capabilities and resources to promote the health and well-being of people in China and around the world.

Editor: Bai Ji

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