Zai Lab's TIVDAK BLA Accepted for Treating Recurrent or Metastatic Cervical Cancer

SHANGHAI & CAMBRIDGE, Mass.—March 12, 2025—Zai Lab Limited has announced that China's National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin-tftv). This application pertains to the treatment of patients with recurrent or metastatic cervical cancer who have experienced disease progression following systemic therapy.

Dr. Rafael Amado, President and Head of Global Research and Development at Zai Lab, highlighted the critical health issue of cervical cancer in China, where approximately 150,000 new cases are diagnosed annually. He emphasized the limited treatment options available for patients whose cancer has recurred or metastasized after initial treatment. TIVDAK stands as the sole antibody-drug conjugate (ADC) therapy targeting cervical cancer, showing significant benefits, including a notable improvement in overall survival (OS) as evidenced by the pivotal innovaTV 301 trial. If approved, TIVDAK will utilize Zai Lab's existing commercial framework for ZEJULA, thereby extending treatment options for women's cancer.

The BLA submission is grounded in results from the global Phase 3 innovaTV 301 clinical trial and the outcomes from the Chinese subset of this study. As reported in January 2025, findings from the Chinese cohort were consistent with the global data. TIVDAK was associated with a 45% reduction in mortality risk compared to chemotherapy in patients who had previously undergone standard systemic therapies. Over half of these Chinese patients had received prior anti-PD(L)1 therapy. Following an 11.5-month median follow-up, the TIVDAK group did not reach median OS, in contrast to 10.7 months for the chemotherapy group. Secondary outcomes such as progression-free survival (PFS) and confirmed objective response rate (ORR) also favored TIVDAK. The safety profile of TIVDAK in the Chinese group was manageable and aligned with global data.

TIVDAK (tisotumab vedotin-tftv) is an ADC combining Genmab’s human monoclonal antibody targeting tissue factor (TF) with Pfizer’s ADC technology, which links monomethyl auristatin E (MMAE) to the antibody using a protease-cleavable linker. Preclinical data suggest that tisotumab vedotin's anticancer efficacy results from the ADC's binding to TF-expressing cancer cells, internalization, and subsequent release of MMAE, leading to cellular apoptosis. Additionally, in vitro studies indicate that tisotumab vedotin facilitates antibody-dependent cellular phagocytosis and cytotoxicity.

TIVDAK received full approval from the U.S. Food and Drug Administration (FDA) in April 2024 for treating adult patients with recurrent or metastatic cervical cancer post-chemotherapy progression. Zai Lab, holding an exclusive license from Seagen Inc. (acquired by Pfizer in 2023), is responsible for developing and commercializing TIVDAK in Greater China, encompassing mainland China, Hong Kong, Macau, and Taiwan.

In China, cervical cancer is a leading cause of cancer mortality among women. With an estimated 150,000 new cases annually, the need for effective treatment options for recurrent or metastatic cervical cancer is urgent. TIVDAK offers a promising new option for patients with limited treatment choices and poor outcomes.

Zai Lab Limited is a biopharmaceutical company with operations in China and the United States, dedicated to discovering, developing, and commercializing innovative products targeting oncology, immunology, neuroscience, and infectious diseases. The company aims to leverage its expertise to address significant unmet medical needs in China and beyond.