Genmab’s TIVDAK Approved In Japan, First ADC For Advanced Cervical Cancer Shows 30% Survival Rate In Phase 3 Trial

Today, the Japanese Ministry of Health, Labour, and Welfare approved Genmab’s TIVDAK® (tisotumab vedotin) to treat patients with recurrent cervical cancer whose disease worsened after chemotherapy. Japan establishes its first antibody-drug conjugate (ADC) drug approval for cervical cancer treatment in patients. 

“As a company, we understand the urgent need for patients with advanced cervical cancer whose disease has progressed,” said Judith Klimovsky, M.D., Executive Vice President and chief development officer of Genmab. “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.”

The cases of cervical cancer-related deaths continue to increase in the Japanese female population under 50 years old. The available treatments for recurrent or metastatic cervical cancer patients are limited. TIVDAK received approval from Japanese authorities based on the findings of the innovaTV 301 Phase 3 clinical trial, which had 502 participants and 101 Japanese patients. The study results demonstrated that TIVDAK was superior to chemotherapy because it decreased mortality rates by 30%, leading to an 11.5-month median overall survival rate compared with chemotherapy's 9.5-month median overall survival. The drug achieved both primary secondary outcomes of progression-free survival (PFS) and objective response rate (ORR).

Aikou Okamoto, M.D., Ph.D., Chief Professor, Department of Obstetrics and Gynecology at The Jikei University School of Medicine, commented, “Patients with advanced or recurrent cervical cancer generally 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. Still, it is significant that the approval of tisotumab vedotin as an ADC has increased the number of treatment options with a new mechanism of action to prolong overall survival. This is good news for patients and healthcare professionals.”

Safety data from the trial indicated adverse drug reactions in 87.6% of TIVDAK-treated patients. The most common side effects included conjunctivitis (30.4%), nausea (29.2%), peripheral sensory neuropathy (26.8%), alopecia (24.4%), and epistaxis (22.8%). These findings were based on data collected as of July 24, 2023.