Tisotumab vedotin-tftv extends survival in advanced cervical cancer
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Tisotumab vedotin-tftv prolonged OS compared with chemotherapy alone among women with recurrent or metastatic cervical cancer, according to the agent’s manufacturers.
Tisotumab vedotin-tftv (Tivdak; Seagen, Genmab) is an antibody-drug conjugate directed to tissue factor, a protein expressed on cervical cancer cells.
The FDA granted accelerated approval to the agent in 2021 for treatment of women with recurrent or metastatic cervical cancer who progressed on or after chemotherapy.
Findings from the randomized phase 3 innovaTV 301 trial are expected to serve as the pivotal confirmatory trial for the accelerated approval and support other regulatory applications around the world.
The trial included 502 women with recurrent or metastatic cervical cancer who received no more than two prior systemic regimens in the recurrent or metastatic setting, and whose disease progressed on or after front-line therapy.
Study participants received tisotumab vedotin-tftv or investigator’s choice of chemotherapy alone. Chemotherapy options included topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed.
The study met its primary endpoint, with an interim analysis conducted by an independent data monitoring committee showing improved OS among study participants assigned tisotumab vedotin-tftv compared with chemotherapy alone.
The study also met key secondary endpoints of investigator-assessed PFS and objective response rate.
Tisotumab vedotin-tftv exhibited a safety profile consistent with prior reports. Researchers observed no new safety signals.
“Tivdak is the only [FDA]-approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumor histology and prior therapy,” Roger Dansey, MD, president of research and development and chief medical officer at Seagen, said in a company-issued press release. “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.”
Complete results from innovaTV 301 will be submitted for presentation at a medical meeting.
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