The World's First Cervical Cancer ADC Drug, Tivdak, Approved In Macau, Bringing New Hope to Chinese Patients!

On August 12, 2023, the company announced that TIVDAK (tisotumab vedotin-tftv), the world's first antibody to drug conjugate (ADC) drug specifically targeting cervical cancer, was approved in Macau for the treatment of patients with recurrent or metastatic cervical cancer whose disease progresses during or after chemotherapy.

TIVDAK is the first cervical cancer ADC drug approved by the U.S. Food and Drug Administration (FDA). Following accelerated FDA approval in 2021, TIVDAK received full FDA approval in April for the same therapeutic purposes.

TIVDAK's full approval is based on the positive results of the global Phase 3 clinical study innovaTV 301. The study met its primary endpoint, confirming that patients treated with TIVDAK had a significant overall survival (OS) benefit compared to chemotherapy. TIVDAK is also the first ADC to show a clear survival benefit in patients with second and third-line metastatic or recurrent cervical cancer.

Cervical cancer is one of the main killers of women's gynecological diseases. Despite significant progress in cancer prevention and early diagnosis through vaccination and screening, there is still a huge unmet need in the treatment of cervical cancer. It is estimated that there are about 150,000 new cases of cervical cancer in China every year, and about 60,000 patients die from cervical cancer. About 15 percent of adult patients have metastases at diagnosis, and up to 61 percent will relapse even if diagnosed early and treated.

TIVDAK (tisotumab vedotin-tftv), an antibody drug conjugate (ADC) specifically designed for cervical cancer, was carefully developed by Seagen and successfully received accelerated approval from the U.S. Food and Drug Administration (FDA) in September 2021 for the treatment of patients with recurrent or metastatic cervical cancer. As the poster child for ADC drugs, TIVDAK uniquely combines the following two components:

The first is its targeted antibody component, which is highly specific and can accurately recognize and bind to the tissue factor (TF) antigen on the surface of tumor cells to achieve precise localization.

Second, there is A cytotoxic drug component, namely MMAE (monomethoxy tumor necrosis factor A conjugate), which effectively triggers the apoptosis process of tumor cells by interfering with the microtubule structure of tumor cells.

The delicate combination of these two components gives TIVDAK the ability to precisely deliver cytotoxic drugs into TF-expressing tumor cells, significantly improving therapeutic effectiveness while minimizing systemic toxicity.

Clinical trial data showed that TIVDAK achieved an objective response rate of 24% in patients with recurrent or metastatic cervical cancer and a median progression-free survival of 7 months. This is undoubtedly an important new treatment option for patients with refractory cervical cancer.

It is reported that Zai Ding Pharmaceutical participated in the global innovaTV 301 study and plans to submit a listing application to the State Food and Drug Administration in 2024 or the first half of 2025.