Tivdak, Seagen, and Genmab’s antibody-drug conjugate exceeded expectations. The partners said that a Data Monitoring Committee, independent of either company, noted that Tivdak’s overall survival rating met and even crossed the efficacy boundary at interim analysis. Secondary measurements were equally impressive.

 Treatment Options Are Needed

There are not many treatment options for patients whose cervical cancer has progressed after initial therapy according to Genmab’s CEO Jan van de Winkel and reported in Biospace.

InnovaTV 301

The InnovaTV 301 open-label study enrolled over 500 patients who had not received more than two prior lines of systemic therapies, such as those treating an entire system.

Patients were treated with Tivdak or the investigator’s choice of chemotherapy which may be topotecan, irinotecan, or gemcitabine.

No additional safety issues were uncovered. The adverse event profile for study participants remained as previously disclosed.

The complete analysis of the trial will be presented at an upcoming medical conference.

About Tivdak

Tivdak are hollow fibrous shafts that work by focusing on a protein found on the surface of cervical cancer cells called Tissue Factor.

They primarily support and give shape to a cell and provide routes for organelles (a cellular structure with a specific function) to move through the cells.

The FDA granted accelerated approval to Tivdak in 2021 to treat metastatic cervical cancer after treatment with chemotherapy.

Boxed Warning

The treatment carries a boxed warning to be aware of possible ocular toxicities which may result in vision loss. Patients should have ophthalmic exams prior to each dose.

The partners, Seagen and Genmab, reported Phase Ib/II data obtained from the InnovaTV 205 trial led to an objective response rate of 41%.

The InnovaTV 301 Phase III trial became the confirmatory trial and the conduit for receiving traditional approval. This data will also be used for regulatory applications to the EMA.