Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic cervical cancer that has progressed on or after front-line therapy. According to the interim analysis results, overall survival (OS) has reached its efficacy boundary, with encouraging data also observed in the secondary endpoints of investigator-assessed progression-free survival (PFS) and objective response rate (ORR).
Supporting Global Regulatory Applications and US Accelerated Approval
The positive results from this study will be instrumental in supporting global regulatory applications for Tivdak and will serve as confirmatory evidence for its accelerated approval in the United States. This development is a significant step forward in bringing a new treatment option to patients battling cervical cancer.
Ongoing China Extension Study in Collaboration with Zai Lab
In addition to the global Phase III trial, a China extension study is currently in the recruitment stage, conducted in collaboration with Zai Lab (NASDAQ: ZLAB; HKEX: 9688). This extension study aims to further evaluate the efficacy and safety of Tivdak in the Chinese patient population, potentially expanding access to this treatment for more patients worldwide.-Fineline Info & Tech
