Genmab has secured Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed following chemotherapy.
Tivdak is an antibody-drug conjugate (ADC) co-developed and co-commercialised by Genmab and Pfizer under a collaboration agreement.
The drug combines Genmab’s human monoclonal antibody targeting tissue factor with Pfizer’s ADC technology and is the first ADC approved for cervical cancer in Japan.
The approval is supported by data from the Phase 3 innovaTV 301 clinical trial in 502 patients with advanced or recurrent cervical cancer previously treated with chemotherapy.
The Phase 3 study evaluated Tivdak’s efficacy and safety compared to single-agent chemotherapy chosen by investigators.
The trial showed a 30% reduction in the risk of death for patients treated with Tivdak compared to chemotherapy, meeting its primary endpoint of overall survival (OS).
It also met the secondary endpoints, including progression-free survival and confirmed objective response rate.
The median OS was 11.5 months for Tivdak compared to 9.5 months for chemotherapy.
Common adverse reactions reported in the study include conjunctivitis, nausea, peripheral sensory neuropathy, alopecia, and epistaxis.
The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, the European Network of Gynaecological Oncological Trial Groups, the Gynecologic Oncology Group Foundation, and other global cooperative groups.
Genmab executive vice president and chief development officer Judith Klimovsky said: “This approval marks an important step forward in transforming the treatment paradigm in Japan, ultimately bringing new hope and possibility to patients and their loved ones.”
Jikei University School of Medicine department of obstetrics and gynaecology chief professor Aikou Okamoto said: “Patients with advanced or recurrent cervical cancer, in general, have a poor prognosis. The advent of new treatment options, especially for second-line or later treatment, is much needed.
“Cervical cancer treatment has advanced in recent years, but it is very meaningful that the approval of tisotumab vedotin as an ADC has increased the number of treatment options with a new mechanism of action that is expected to prolong overall survival. This is good news for patients and healthcare professionals.”
