Genmab, Seagen say Tivdak cervical cancer trial met overall survival endpoint (updated)
04/09/2023 21:37
(Adds details from release in paragraphs 3-5, background in
paragraphs 6-8)
Sept 4 (Reuters) - Genmab A/S GMAB.CO GMAB.O and
Seagen Inc SGEN.O 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 PFE.N is in
the process
of acquiring Seagen.
(Reporting by Granth Vanaik in Bengaluru, Editing by Rosalba
O'Brien and Cynthia Osterman)
((Granth.Vanaik@thomsonreuters.com; Twitter: https://twitter.com/Vanaik_Granth;))