Positive Results from innovaTV301 Study: TIVDAK Shows Promise in Advanced Cervical Cancer Treatment

On October 22nd, Seagen and Genmab, partners in the pharmaceutical industry, jointly announced the results of the global Phase 3 clinical trial, innovaTV301. The study focused on patients with recurrent or metastatic cervical cancer who experienced disease progression during or after first-line treatment. The results showed that patients treated with TIVDAK had a 30% reduction in the risk of death compared to those who received chemotherapy alone. This reduction was statistically significant and clinically meaningful (HR: 0.70, 95% CI: 0.54-0.89, p=0.00381). The study data were presented at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting, specifically during the Presidential Symposium.

Professor Ignace B. Vergote, a primary investigator of the innovaTV301/ENGOTcx-12/GOG3057 clinical trial and a co-initiator of the European Network of Gynaecological Oncological Trial Groups (ENGOT), commented on the positive data obtained from patients with recurrent or metastatic cervical cancer. He stated that once cervical cancer recurs or spreads after initial treatment, subsequent treatment options become very limited. The positive data observed with TIVDAK in this study provide hope for patients in need of innovative treatment options and have the potential to reshape clinical practice.

Compared to chemotherapy, TIVDAK demonstrated the following efficacy in the primary and key secondary endpoints:

1. TIVDAK significantly prolonged overall survival (OS) compared to chemotherapy, with a 30% reduction in the risk of death (HR: 0.70, 95% CI: 0.54-0.89, p=0.00381).

2. TIVDAK showed a statistically significant improvement in progression-free survival (PFS) compared to chemotherapy, with a 33% reduction in the risk of disease progression or death (HR: 0.67, 95% CI: 0.54-0.82, p<0.0001).

3. The confirmed objective response rate (ORR) in patients treated with TIVDAK was 17.8% compared to 5.2% for chemotherapy, showing a statistically significant improvement (OR: 4.0, 95% CI: 2.1-7.6, p<0.0001). Complete response was achieved in patients receiving TIVDAK, indicating no detectable tumor signs within a specific timeframe.

4. The disease control rate (DCR), defined as the percentage of patients achieving complete response, partial response, or stable disease, was 75.9% (95% CI: 70.1-80.0) in the TIVDAK group compared to 58.2% (95% CI: 51.8-64.4) in the chemotherapy group.

The safety profile of TIVDAK observed in the innovaTV301 study was consistent with the information provided in its U.S. prescribing information, and no new safety signals were identified.

Most treatment-related adverse events (TRAEs) in patients treated with TIVDAK were of low grade and controllable through supportive care and dose adjustments. The proportion of patients experiencing Grade 3 or higher TRAEs was 29.2% in the TIVDAK group compared to 45.2% in the chemotherapy group. Grade 3 or higher TRAEs of particular interest in the TIVDAK group included peripheral neuropathy (5.2%), ocular toxicity (3.2%), and bleeding (0.8%).

innovaTV301 is a global, randomized, open-label Phase 3 clinical trial that supplements the results of the innovaTV204 study. Previously, TIVDAK received accelerated conditional approval in the United States based on positive results from the innovaTV204 study for the treatment of adult patients with recurrent or metastatic cervical cancer who experienced disease progression during or after first-line chemotherapy. Discussions with the U.S. regulatory agency have indicated that the results of the innovaTV301 study will serve as a key confirmatory study for the accelerated approval in the United States and support global marketing applications. Seagen has initiated the expansion of the innovaTV301 study in China and is actively enrolling patients.