Seagen Inc (NASDAQ:SGEN) and Genmab A/S (NASDAQ:GMAB) released topline data from the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received Tivdak (tisotumab vedotin-tftv), compared with chemotherapy alone.
The study met its primary endpoint of overall survival (OS).
An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis.
The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance.
The results from innovaTV 301 are intended to serve as the pivotal confirmatory trial for the U.S. accelerated approval and support global regulatory applications for Tivdak.
The innovaTV 301 China extension study has been initiated and continues to enroll patients in collaboration with Zai Lab Limited (NASDAQ:ZLAB).
William Blair analyst Matt Phipps says that while the recent news solidifies Tivdak's approved label for second-line recurrent/metastatic cervical cancer, the pivotal question for the future lies in Tivdak's potential expansion into other medical indications.
The promising data from the innovaTV 207 trial, specifically involving Tivdak as a monotherapy for squamous carcinoma of head and neck cancer patients earlier this year, suggests a strong case for advancing into a pivotal study within this patient group.
Price Action: GMAB shares are up 0.23% at $38.47, and SGEN shares are up 0.89% at $207.91 during the premarket session on the last check Tuesday.
