(Reuters) – Genmab A/S and Seagen Inc on Monday said that the Phase III trial of Tivdak in recurrent or metastatic cervical cancer patients on or after front-line therapy met its primary endpoint of overall survival.
Tivdak is the brand name for tisotumab vedotin-tftv, the companies’ co-developed antibody-drug conjugate.
They said that an independent data monitoring committee determined that the overall survival crossed the pre-specified efficacy boundary at an interim analysis.
They also said the results of the clinical trial would be submitted for presentation at an upcoming medical congress and discussed with regulatory authorities.
“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,” said Seagen’s Chief Medical Officer Roger Dansey.
The results were from the innovaTV 301 trial, a global, randomized and open-label Phase III trial that evaluates Tivdak versus investigators’ choice of chemotherapy alone in patients with recurrent or metastatic cervical cancer.
In September 2021, the U.S. Food and Drug Administration granted accelerated approval for Tivdak in adult patients suffering from this type of cervical cancer with disease progression on or after chemotherapy.
Pfizer is in the process of acquiring Seagen.
(Reporting by Granth Vanaik in Bengaluru, Editing by Rosalba O’Brien and Cynthia Osterman)
