Zai Lab announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, showing TIVDAK significantly improved OS compared to chemotherapy for patients with recurrent or metastatic cervical cancer

TIVDAK demonstrated a 45% reduction in the risk of death (HR: 0.55) in the China subpopulation, with a mOS not reached versus 10.7 months for chemotherapy, at a median follow-up of 11.5 months

Secondary endpoints, including PFS and confirmed ORR, also favored TIVDAK over chemotherapy in the China subpopulation

The safety profile of TIVDAK in the China subpopulation was manageable and consistent with the global safety profile, with no new safety signals identified

The U.S. FDA approved the sBLA for TIVDAK in April 2024, granting full approval for its use in recurrent or metastatic cervical cancer patients who progress after chemotherapy

Zai Lab plans to submit a NDA for TIVDAK to China’s NMPA in Q1 2025, with full data from the China subpopulation to be presented at a future medical conference in 2025