Zai Lab announces results from innovaTV 301 study

Zai Lab (ZLAB) announced topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. The China subpopulation results were consistent with those in the global population: TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy in the China subpopulation who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. Median OS for patients treated with TIVDAK was not reached versus chemotherapy 10.7 months with a median follow-up of 11.5 months. Secondary endpoints of PFS and confirmed ORR also favored treatment with TIVDAK compared to chemotherapy. The safety profile of TIVDAK in the China subpopulation was manageable and consistent with the global profile. Based on these results, Zai Lab intends to submit an NDA for TIVDAK to China’s National Medical Products Administration in the first quarter of 2025. The full China subpopulation data will be presented at a future medical conference in 2025.