Genmab (GMAB) Status Update summary

Key clinical data updates

• Tisotumab vedotin demonstrated a 32.5% objective response rate in heavily pretreated head and neck cancer patients, with a 40% response rate in those with 1–2 prior lines and a median duration of response of 5.6 months; safety profile was consistent with previous trials and no new safety signals were observed.

• Epcoritamab step-up dosing in follicular lymphoma reduced Grade 2 CRS from 25% to 9%, with no Grade 3 CRS, maintaining high efficacy and safety, supporting outpatient use.

• Epcoritamab in combination with rituximab and irinotecan in frontline follicular lymphoma achieved an 85% complete response rate and durable outcomes, informing ongoing phase III trials.

• Acasunlimab plus pembrolizumab in second-line NSCLC demonstrated a 69% 12-month overall survival and median OS of 17 months, with improved safety and efficacy using a Q6-week dosing schedule.

• Safety mitigation strategies for acasunlimab have reduced treatment discontinuations due to liver enzyme elevations, with manageable safety in real-world settings.

Patient population and treatment background

• All 40 patients in the innovaTV207 trial had received prior platinum-based therapy and checkpoint inhibitors if eligible; 80% had prior platinum, 100% prior CPI, 57.5% prior taxane, and 67.5% prior cetuximab.

• Primary tumor sites included oropharynx, larynx, and oral cavity.

Safety and adverse events

• Grade ≥3 treatment-emergent adverse events occurred in 67.5% of patients treated with tisotumab vedotin, with peripheral neuropathy in 40%.

• Adverse events of special interest included ocular (52.5%), peripheral neuropathy (47.5%), and bleeding events (40%).