Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 34

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 34
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 progression on or after front-line therapy who received tisotumab vedotin, compared with chemotherapy alone. Favorable top line results from the innovaTV 301 trial were announced in September 2023. An Independent Data Monitoring Committee determined that overall survival (“OS”) crossed the pre-specified efficacy boundary at the interim analysis. The key secondary endpoints of investigator-assessed progression-free survival and ORR also demonstrated statistical significance. The safety profile of tisotumab vedotin in innovaTV 301 was consistent with the known safety profile of tisotumab vedotin as presented in the U.S. prescribing information, and no new safety signals were observed. Based on these results, regulatory submissions were also made in Europe and Japan in 2024. In December 2024, the U.S. NCCN updated its Clinical Practice Guidelines in Oncology for Cervical Cancer with tisotumab vedotin-tftv changing from a category 2A to a category 1. Tisotumab vedotin-tftv plus pembrolizumab was also added as an option for PD-L1 positive tumors. 
Acasunlimab (GEN1046, DuoBody-PD-L1x4-1BB)
Acasunlimab is a proprietary bispecific antibody designed to target programmed death ligand 1 (“PD-L1”)-and 4-1BB. PD-L1 is a validated target that is expressed on tumor cells. 4-1BB is a trans-membrane receptor belonging to the tumor necrosis factor (“TNF”) receptor super-family and is expressed predominantly on activated T-cells. In pre-clinical settings, acasunlimab promoted conditional T-cell activation in a tumor-specific manner by simultaneous activation and release of the key inhibitory brake. Pre-clinical trials also indicated a release of T-cell inhibition through the programmed cell death protein (“PD-1”)//PD-L1 axis, including in the absence of 4-1BB, strong co-stimulation via the agonistic activity of 4-1BB and T-cell clonal expansion. Acasunlimab was co-developed in collaboration with BioNTech SE (“BioNTech”) under an agreement in which the companies shared all costs and future potential profits for acasunlimab on a 50:50 basis. In August 2024, BioNTech opted not to participate in the further development of the acas