Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 35

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 35
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unlimab program under the parties’ existing License and Collaboration Agreement for reasons related to BioNTech’s portfolio strategy. Genmab assumed sole responsibility for the continued development and potential commercialization of acasunlimab and the program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. Acasunlimab is being developed for the treatment of solid tumors using our proprietary DuoBody technology platform and PD-L1 antibody and BioNTech’s 4-1BB antibody. Phase II data was presented at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting of acasunlimab as a single agent or in combination with pembrolizumab for the treatment of relapsed/refractory metastatic NSCLC after 

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treatment with standard of care therapy with an immune checkpoint inhibitor (“CPI”). In PD-L1 positive patients with metastatic NSCLC following progression on prior CPI treatment, acasunlimab plus pembrolizumab dosed every six weeks (“Q6W”) showed a manageable safety profile and promising efficacy, with durable disease control and median overall survival of 17.5 months and a 12-month overall survival rate of 69%.
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Ongoing Phase III Trial
The first Phase III trial of acasunlimab was initiated in November 2024. The objective of this randomized, open-label, multicenter trial is to determine the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in patients with PD-L1-positive metastatic NSCLC who have been treated with PD-1/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the metastatic setting. The trial is currently recruiting. 
Rina-S 
Rina-S, acquired as part of the purchase of ProfoundBio, is a novel folate receptor α (“FRα”)-targeted topoisomerase 1 (“TOPO1”) ADC being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. Dose escalation data suggests that Rina-S has robust single agent activity in various cancers across a broad range of FRα expression levels. 
Platinum-Resistant Ovarian Cancer. In January 2024, Rina-S was granted FTD by the FDA for the treatment of FRα-expressing high-grade serous