Genmab and Seagen have reported that the Phase III innovaTV 301/ENGOT cx-12/GOG 3057 trial of TIVDAK (tisotumab vedotin-tftv) for the treatment of recurrent or metastatic cervical cancer has met its primary endpoint of overall survival (OS).
Other partners involved in the study are the Gynecologic Oncology Group Foundation and the European Network of Gynaecological Oncological Trial Groups.
The global, open-label, randomised study compared TIVDAK against the investigator’s choice of chemotherapies, including gemcitabine, vinorelbine, topotecan, irinotecan, and pemetrexed.
A total of 502 patients with recurrent or metastatic cervical cancer, and who previously received no more than two systemic treatments, were included in the study.
At interim analysis, an independent data monitoring committee determined that OS crossed the pre-specified efficacy boundary.
The study also met the secondary endpoints of investigator-assessed objective response rate and progression-free survival.
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TIVDAK’s safety profile in the study was found to be consistent with the innovaTV 204 study being carried out in the US.
The results from the study will be used as the pivotal confirmatory trial for the US accelerated approval of TIVDAK and to support global regulatory applications.
An extension study of TIVDAK in China has also been initiated. Patients for this study are being enrolled in collaboration with Zai Lab.
Seagen chief medical officer and research and development president Roger Dansey said: “TIVDAK is the only US Food and Drug Administration-approved therapy in second-line recurrent or metastatic cervical cancer, regardless of biomarker status, tumour histology, and prior therapy.
“Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone in our efforts to ensure more adults living with advanced cervical cancer have an approved treatment option.”
The antibody-drug conjugate TIVDAK is composed of Seagen’s ADC technology and a human monoclonal antibody directed to tissue factor developed by Genmab.