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Cash figures as of 2025-12-31. Database snapshot: 2026-11-07.
Cap table as of 2025-12-31.
Pembrolizumab Phase 3 Positive · 2026-10-28
PD-L1
Primary: Overall survival (OS) and objective response rate (ORR), the dual primary endpoints of the Phase 3 LiGeR-HN1 trial (NCT06525220), at the first interim analysis — OS: HR 0.50 (95% CI, 0.37, 0.67); p<0.0001; ORR: odds ratio 3.17 (95% CI, 2.06, 4.89; p<0.0001) — both dual primary endpoints met
· Petosemtamab in combination with pembrolizumab reduced the risk of death by 50% versus pembrolizumab alone
· Benefit regardless of HPV status, in first-line PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
· First interim analysis assessed by an independent data monitoring committee (IDMC)
· Patients randomized 1:1 to petosemtamab plus pembrolizumab or pembrolizumab alone
· Petosemtamab has U.S. FDA Breakthrough Therapy Designation for the first-line treatment of patients with recurrent or metastatic PD-L1-positive HNSCC in combination with pembrolizumab
· Genmab plans to engage global regulatory authorities and will submit full results for presentation at a future medical meeting
Safety: The safety profile of petosemtamab when administered in combination with pembrolizumab was generally well tolerated and consistent with the previously reported safety profiles of the individual agents; no new safety signals were identified.
pembrolizumab Phase 2 Positive · 2026-10-26
PD-L1
Primary: Objective response rate (ORR) and safety in the Phase 2 trial (NCT03526835) — Median overall survival of 28.2 months, associated with an overall response rate (ORR) of 63% and median progression free survival (mPFS) of 9.0 months in efficacy-evaluable patients (n=43), including a complete response (CR) rate of 19%
· 12-month OS rate, 79%
· Median duration of response (mDOR) was not reached, with an estimated 55% of responders maintaining a response at 24 months
· Median PFS was 9.0 months (95% CI, 5.2–12.9; 12-month PFS rate, 40%)
· Median duration of follow-up was 25.5 months as of May 15, 2026
· 45 patients were treated in the first-line combination arm with 1500 mg of petosemtamab every two weeks plus 400 mg of pembrolizumab every six weeks
· Responses were observed across HPV-positive and HPV-negative disease and across combined positive PD L-1 expression levels and p16 subgroups
Safety: Most common treatment-emergent adverse events (all grade/Grade 3-4) were asthenia (51%/7%), acneiform dermatitis (51%/7%), and rash (49%/2%); infusion-related reactions occurred in 38% of patients (7% Grade 3-4), and all resolved; no Grade 5 events nor treatment-related deaths were reported
Petosemtamab Phase 2 Positive · 2026-10-25
Metastatic colorectal cancer (mCRC)
Rina-S Phase 3 Positive · 2026-10-23
RAINFOL-02
Primary: Progression-free survival (PFS) — Trial met its primary endpoint: Rina-S demonstrated a 71% reduction in the risk of disease progression or death in the intent-to-treat (ITT) population (HR 0.29; 95% CI, 0.23-0.37; p<0.0001); in the primary analysis set (PAS) population, HR 0.33 (95% CI, 0.26–0.42; p<0.0001)
· Key secondary endpoint overall survival (OS) also met: HR 0.43 (95% CI, 0.31–0.59; p<0.0001) in the ITT population
· OS in the PAS population: HR 0.44 (95% CI, 0.31–0.63; p<0.0001)
· ITT population N=584, all randomized patients with platinum-resistant ovarian cancer regardless of FRα expression
· PAS population N=492; mandated patients with FRα expression ≥75% PS2+ to have been treated with mirvetuximab
· Population: platinum-resistant ovarian cancer regardless of FRα expression level or prior treatment with mirvetuximab, versus investigator's choice chemotherapy
· Data will be submitted for presentation at a future medical meeting and discussed with regulatory authorities worldwide
Safety: Observed safety profile was consistent with the known profile of Rina-S, with no new safety signals or unexpected safety concerns identified
Epcoritamab Phase 3 Positive · 2026-10-05
DLBCL-2