Zai Lab's Tivdak Shows Positive Results in China Subpopulation of Phase 3 Cervical Cancer Trial
核心洞察
Zai Lab's Tivdak demonstrated a 45% reduction in the risk of death compared to chemotherapy in Chinese patients with recurrent or metastatic cervical cancer (搜索).
The China subpopulation results from the innovaTV 301 trial were consistent with global results, showing improved overall survival, PFS, and ORR.
Zai Lab plans to submit a New Drug Application to China’s National Medical Products Administration in the first quarter of 2025.
Zai Lab announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, revealing a clinically meaningful improvement in overall survival (OS) with TIVDAK (tisotumab vedotin) treatment compared to chemotherapy in patients with previously treated recurrent or metastatic cervical cancer (搜索). The results highlight a potential new treatment option for a patient population with limited alternatives after disease progression.
The China subpopulation results mirrored those of the global study, with TIVDAK demonstrating a 45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15]) in patients who had received prior standard systemic therapies. More than half of this Chinese population had received prior anti-PD(L)1 therapy. Median OS for patients treated with TIVDAK was not reached versus 10.7 months for those receiving chemotherapy (95% CI: 6.0-not reached), with a median follow-up of 11.5 months.
Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (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.
Clinical Significance
Dr. Rafael Amado, President and Head of Global Research and Development at Zai Lab, emphasized the significance of these findings, stating, "The consistent and positive results in the China subpopulation of the global Phase 3 study reinforce the potential for TIVDAK, the only ADC therapy in this disease setting, to increase options in this therapeutically unmet clinical setting. If approved, we expect TIVDAK to add to ZEJULA and augment our commercial franchise in women’s tumors."
Dr. Lingying Wu, Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences, noted the limited treatment options for patients whose cancer recurs or spreads after initial treatment. "The promising results from TIVDAK, which demonstrated superior survival extension in patients whose disease progressed after initial treatments, including prior anti-PD(L)1 treatment, offer hope for addressing this critical unmet need," said Dr. Wu.
Regulatory Plans and Market Context
Based on these results, Zai Lab intends to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) in the first quarter of 2025. Zai Lab will leverage its commercial footprint of ZEJULA in women’s cancer to bring the medicine to patients in China if approved.
Cervical cancer (搜索) remains a leading cause of cancer death in women in China, with approximately 150,000 new cases annually. TIVDAK is positioned to provide a new option for previously treated advanced cervical cancer patients who currently have limited treatment options and poor outcomes.
About the innovaTV 301 Trial
The innovaTV 301 trial (NCT04697628) is a global, 1:1 randomized, open-label Phase 3 trial evaluating TIVDAK versus investigator’s choice of single-agent chemotherapy in patients with recurrent or metastatic cervical cancer (搜索) who received chemotherapy. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate.
Patients with recurrent or metastatic cervical cancer (搜索) with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) were included.