Genmab (GMAB) Status Update summary

Key clinical data updates

• Tisotumab vedotin showed a 32.5% ORR in heavily pretreated head and neck cancer, with 40% ORR in those with 1–2 prior lines and a durable response of 5.6 months; one complete and 12 partial responses were observed, with a median time-to-response of 1.4 months.

• Epcoritamab in follicular lymphoma demonstrated reduced Grade 2 CRS from 25% to 9% with optimized step-up dosing, no Grade 3 CRS, and maintained high efficacy.

• Epcoritamab plus rituximab and irinotecan in frontline follicular lymphoma achieved an 85% complete response rate and durable responses, supporting ongoing phase III trials.

• Acasunlimab plus pembrolizumab in second-line NSCLC showed a 69% 12-month OS 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 and mostly asymptomatic LFT increases.

Patient population and treatment background

• All 40 patients in the innovaTV207 trial had 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

• Safety profile for tisotumab vedotin was consistent with previous trials, with no new safety signals; Grade ≥3 adverse events occurred in 67.5% of patients, including peripheral neuropathy in 40%.

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