Genmab, Seagen say Tivdak cervical cancer trial met overall survival
endpoint
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[September 05, 2023]
(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.
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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)
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