Genmab (GMAB) R&D Update summary

Clinical efficacy and differentiation

• Rina-S® achieved a confirmed ORR of 55.6% at 120 mg/m² in advanced ovarian cancer; median duration of response was not reached at 48 weeks of follow-up.

• In advanced or recurrent endometrial cancer, confirmed ORRs were 50.0% at 100 mg/m², including two complete responses, and 47.1% at 120 mg/m²; median duration of response was not reached in either cohort.

• Endometrial cancer patients had received a median of three prior therapy lines (range 1–8) and had progressed on or after platinum-based chemotherapy and anti-PD-(L)1 treatment.

• Antitumor activity was observed across a broad range of FRα expression, supporting development without biomarker-based patient selection.

Safety

• Treatment-emergent adverse events were mainly cytopenias and gastrointestinal events; hematologic events were manageable, with low treatment discontinuation rates.

• Grade ≥3 TEAEs occurred in 77.2% of patients at 100 mg/m² and 76.1% at 120 mg/m²; serious TEAEs occurred in 31.8% and 50.0%, respectively, with two fatal events in the higher-dose cohort.

• No ocular toxicity, neuropathy or interstitial lung disease was observed.

Development and expansion plans

• Phase 3 trials are planned or enrolling in platinum-resistant ovarian cancer, platinum-sensitive ovarian cancer maintenance and second-line endometrial cancer; endometrial dosing in a new study is expected by year-end.

• Rina-S® 100 mg/m² Q3W was selected for further monotherapy evaluation in advanced, recurrent or metastatic endometrial cancer, including ongoing Phase 2 and planned Phase 3 studies.

• A Phase 2 NSCLC trial is planned to start by year-end, exploring EGFR-mutated and broader adenocarcinoma populations.

• Combination studies with standard-of-care agents are underway in ovarian and endometrial cancers; expansion into additional solid tumors is planned.