Genmab (GMAB) Status Update summary

Strategic pipeline and regulatory milestones

• Achieved multiple regulatory approvals for Epkinly and Tivdak, expanding patient access in key markets such as the U.S. and Japan.

• Five phase III trials for Epkinly are ongoing, including frontline studies in diffuse large B-cell lymphoma and follicular lymphoma.

• Acquisition of ProfoundBio brought Rina-S into the pipeline, enhancing next-generation ADC capabilities.

• Additional regulatory decisions for Epkinly and Tivdak, and data updates for acasunlimab and Rina-S, are anticipated in 2025.

• Submission of HexaBody-CD38 data package to J&J is on track, with a decision expected by Q1 2025.

Clinical data highlights: Rina-S

• Rina-S demonstrated a 50% confirmed objective response rate at 120 mg/m² in heavily pretreated ovarian cancer, with all responses ongoing at data cutoff.

• Responses were observed regardless of folate receptor alpha expression and in patients previously treated with mirvetuximab.

• Safety profile was manageable, with cytopenias and low rates of treatment discontinuation.

• Ongoing studies include phase I expansion and phase III in folate receptor alpha-high populations.

Clinical data highlights: Epkinly (epcoritamab)

• Long-term NHL1 trial data show a 59% overall response rate and 41% complete response rate in relapsed/refractory large B-cell lymphoma, with median complete response duration of 36 months.

• Durable responses and favorable safety profile, with most long-term patients not experiencing serious infections.

• Combination with R-CHOP in first-line high-risk patients yielded 100% response and 80-90% complete response rates, with 83% progression-free survival at 21 months.

• In elderly or frail patients ineligible for anthracycline, single-agent epcoritamab achieved a 70% complete response rate, with manageable safety.

• In newly diagnosed follicular lymphoma, epcoritamab plus bendamustine-rituximab achieved a 96% complete response rate, with 83% progression-free survival at 2.5 years.

• In relapsed/refractory follicular lymphoma, epcoritamab plus R-squared showed a 96% response rate and 87% complete response rate, with 80% progression-free survival at 24 months.

• In relapsed/refractory CLL, single-agent epcoritamab achieved a 61% response rate and 39% complete response rate, with optimized dosing reducing high-grade CRS.