Tivdak, First Cervical Cancer ADC Drug, Approved in Macau, Offers New Hope to Chinese Patients

On August 12, 2023, it was announced that TIVDAK (tisotumab vedotin-tftv), a pioneering antibody-drug conjugate (ADC) designed specifically to target cervical cancer, received approval in Macau for treating patients with recurrent or metastatic cervical cancer who have experienced disease progression during or following chemotherapy.

TIVDAK holds the distinction of being the first ADC drug approved by the U.S. Food and Drug Administration (FDA) for cervical cancer. Initially granted accelerated FDA approval in 2021, TIVDAK received full FDA approval in April for the same patient population.

The full approval of TIVDAK was based on promising results from the global Phase 3 clinical trial known as innovaTV 301. This study achieved its primary endpoint, demonstrating a significant overall survival benefit for patients treated with TIVDAK compared to those receiving chemotherapy. Notably, TIVDAK is the first ADC to show a clear survival advantage in patients undergoing second and third-line treatments for metastatic or recurrent cervical cancer.

Cervical cancer remains a major threat to women's health globally. Despite advancements in prevention and early detection through vaccination and screening, a significant treatment gap persists. In China alone, it is estimated that 150,000 new cases of cervical cancer are diagnosed annually, resulting in around 60,000 deaths. Approximately 15 percent of adult patients present with metastatic disease at diagnosis, and up to 61 percent of those diagnosed early will experience a recurrence despite initial treatment.

TIVDAK, an ADC specifically engineered for cervical cancer, was developed by Seagen. It was granted accelerated approval by the FDA in September 2021 for the treatment of patients with recurrent or metastatic cervical cancer. TIVDAK exemplifies the unique potential of ADC drugs, combining targeted and cytotoxic components.

The targeted antibody component of TIVDAK is highly specific, allowing it to recognize and bind to the tissue factor (TF) antigen present on the surface of tumor cells, ensuring precise localization. The cytotoxic component, monomethoxy tumor necrosis factor A conjugate (MMAE), induces tumor cell apoptosis by disrupting the microtubule structure within the cells. This combination allows TIVDAK to deliver cytotoxic drugs directly to TF-expressing tumor cells, significantly enhancing therapeutic efficacy while reducing systemic toxicity.

Clinical studies have shown that TIVDAK achieved an objective response rate of 24% in patients with recurrent or metastatic cervical cancer, with a median progression-free survival of 7 months. These results offer a promising new treatment avenue for patients with refractory cervical cancer.

It has been reported that Zai Ding Pharmaceutical participated in the global innovaTV 301 study. The company plans to submit an application for listing TIVDAK with the State Food and Drug Administration in 2024 or the first half of 2025.