Japan Approves Genmab's Tivdak for Advanced Cervical Cancer

Genmab has achieved a significant milestone by securing approval from Japan’s Ministry of Health, Labour and Welfare for Tivdak (tisotumab vedotin), a novel treatment for advanced or recurrent cervical cancer that has shown progression after chemotherapy. This marks the first occasion an antibody-drug conjugate (ADC) has been approved for cervical cancer patients within Japan.

The approval is founded on results from the Phase III innovaTV 301 clinical trial, a comprehensive study designed to evaluate Tivdak’s safety and effectiveness compared to chemotherapy. The trial was significant, enrolling a total of 502 participants, including 101 individuals from Japan. The study successfully met its primary endpoint of overall survival (OS), demonstrating a 30% reduction in mortality risk when compared to chemotherapy, thereby underscoring Tivdak’s potential benefits for patients.

Judith Klimovsky, Genmab’s chief development officer and executive vice-president, expressed the company’s awareness of the pressing need for better treatment options for those suffering from advanced cervical cancer. She highlighted that this approval represents a critical advancement in changing treatment practices in Japan, offering renewed hope and opportunities to affected patients and their families.

The clinical trial was a collaborative effort led by Seagen in cooperation with Genmab, along with contributions from the Gynecologic Oncology Group (GOG) Foundation, the European Network of Gynaecological Oncological Trial Groups, and other international gynecological oncology cooperative groups. Notably, in December 2023, Seagen became part of Pfizer through an acquisition.

Tivdak combines Genmab’s human monoclonal antibody targeting tissue factor (TF) with Pfizer’s ADC technology. This technology employs a protease-cleavable linker to connect the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody, enhancing the drug’s therapeutic capabilities.

The development and commercialization of this innovative antibody have been a joint venture between Genmab and Pfizer, with both companies sharing profits and expenses under their collaborative agreement. In Japan, as well as in other global regions excluding China and the United States, Genmab takes the lead in commercializing this treatment for recurrent or metastatic cervical cancer patients who have previously undergone treatment.

This approval not only signifies a breakthrough in the availability of advanced therapies for cervical cancer in Japan but also reflects the effective partnership between Genmab and Pfizer in bringing innovative solutions to the global market. As such, it represents a beacon of hope for patients who have exhausted other treatment options, offering a new lifeline in the fight against this challenging disease.