Genmab A/S (GMAB) Stock News, Mar-Sep 2025

Genmab (NASDAQ: GMAB) announced updated results from its Phase 2 EPCORE® NHL-6 trial evaluating epcoritamab monotherapy in relapsed/refractory (R/R) DLBCL patients. The study demonstrated significant success in outpatient treatment, with 92% of patients receiving their first full dose in an outpatient setting.

Key efficacy results showed an overall response rate of 64.3% and complete response rate of 47.6% in patients treated after one prior line of therapy. For patients with two or more prior treatments, the response rates were 60.0% and 38.0% respectively. The safety profile remained consistent with previous studies, with manageable cytokine release syndrome (CRS) occurring in 40.2% of patients, primarily low-grade and resolving within a median of two days.

Genmab (NASDAQ: GMAB) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S®) for treating adult patients with recurrent or progressive endometrial cancer who have disease progression after platinum-containing regimen and PD-(L)1 therapy.

The designation was supported by results from the Phase 1/2 RAINFOL™-01 trial, where 64 heavily pretreated patients with advanced or recurrent EC were treated with Rina-S. The drug is currently being evaluated as a single-agent treatment in the ongoing Phase 1/2 RAINFOL™-01 trial and will be further studied in a planned Phase 3 trial.

Rina-S is a folate receptor alpha-directed, TOPO1-inhibitor antibody-drug conjugate (ADC) that is also being evaluated in other clinical trials, including the Phase 3 RAINFOL-02 trial in ovarian cancer.

Genmab (NASDAQ: GMAB) announced positive results from its Phase 3 EPCORE® FL-1 trial for epcoritamab combined with rituximab and lenalidomide (R2) in treating relapsed/refractory follicular lymphoma. The trial met both primary endpoints with significant improvements in Overall Response Rate (95.7%, p<0.0001) and Progression-Free Survival (HR 0.21, p<0.0001), reducing disease progression risk by 79%.

The FDA has accepted a priority review for the supplemental Biologics License Application (sBLA) with a target action date of November 30, 2025. If approved, this combination would become the first bispecific antibody regimen available as a second-line treatment for R/R FL patients. The safety profile aligned with known individual regimens with no new safety signals observed.

Genmab (GMAB) announced promising results from the Phase 1b/2 EPCORE NHL-2 trial evaluating epcoritamab combination therapy in relapsed/refractory DLBCL patients. The study showed an impressive 87% overall response rate and 65% complete response rate when epcoritamab was combined with R-ICE in patients eligible for autologous stem cell transplantation. At six months, 81% of responses were ongoing, 74% of patients remained progression-free, and patient survival was 100%. The safety profile was manageable, with mainly low-grade adverse events. The therapy demonstrated particularly strong results in high-risk patients who progressed rapidly after initial treatment, achieving an 85% overall response rate. This investigational combination therapy shows potential as a bridge to ASCT, with 65% of patients proceeding to transplantation.

Genmab announced promising Phase 1/2 trial results for rinatabart sesutecan (Rina-S) in treating advanced endometrial cancer. The study showed a 50.0% confirmed objective response rate at 100 mg/m2 dosage, including two complete responses, in heavily pre-treated patients. The median duration of response was not reached after 7.7 months follow-up. The trial involved 64 patients who received either 100 mg/m2 (n=22) or 120 mg/m2 (n=42) doses. The 120 mg/m2 cohort showed a 47.1% response rate. Common side effects included diarrhea, shortness of breath, and urinary tract infection, with serious adverse events occurring in 31.8% of patients at 100 mg/m2 and 50.0% at 120 mg/m2. Notably, no ocular toxicities, neuropathy, or Interstitial Lung Disease were observed, which are typically common with antibody-drug conjugates.

Genmab (GMAB) will present new research data at the 2025 ASCO Annual Meeting from May 30 to June 3 in Chicago. Key highlights include:

- First disclosure of Phase 1/2 trial results for rinatabart sesutecan (Rina-S®), a novel antibody-drug conjugate, in patients with recurrent/advanced endometrial cancer

- Presentation of long-term follow-up data from the Phase 1/2 EPCORE™ NHL-1 study of epcoritamab in patients with relapsed/refractory DLBCL, focusing on patients maintaining complete response at 2 years

The company will host a virtual investor update on June 2 at 4:00 PM CDT to review the Rina-S data. The presentations demonstrate Genmab's commitment to developing alternative treatment options, particularly for endometrial cancer, which has rising mortality rates and limited treatment options.

Genmab (NASDAQ: GMAB) announced the presentation of 14 abstracts evaluating epcoritamab, their T-cell engaging bispecific antibody, at the 2025 European Hematology Association Congress. The presentations will showcase data across multiple treatment settings for diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Key highlights include:

Two oral presentations will feature data from:

• EPCORE NHL-2 trial: evaluating epcoritamab plus R-ICE in relapsed/refractory DLBCL patients
• EPCORE NHL-5 trial: studying epcoritamab plus pola-R-CHP in previously-untreated DLBCL patients

Additional notable presentations include three-year follow-up data from the EPCORE NHL-1 and NHL-3 trials for epcoritamab monotherapy in R/R DLBCL and FL patients. The research will also be presented at the 18th International Conference on Malignant Lymphoma in Lugano, Switzerland.

Genmab (GMAB) plans to submit a supplemental Biologics License Application (sBLA) to the FDA in H1 2025 for epcoritamab in combination with rituximab and lenalidomide (R²) to treat adult patients with relapsed/refractory follicular lymphoma. The submission is backed by positive Phase 3 EPCORE FL-1 trial results, which met one of its dual primary endpoints with a statistically significant overall response rate (p-value < 0.0001). The safety profile was consistent with known profiles of individual treatments, with no new safety signals observed. Epcoritamab is currently FDA-approved as a monotherapy for R/R FL after two or more lines of systemic therapy, but the combination therapy is not yet approved in any territory.

Genmab A/S (NASDAQ: GMAB) announced that the European Commission has approved TIVDAK® (tisotumab vedotin) for treating adult patients with recurrent or metastatic cervical cancer who experienced disease progression after systemic therapy. TIVDAK is the first and only antibody-drug conjugate (ADC) approved for this indication in the EU.

The approval is based on the Phase 3 innovaTV 301 trial results, where TIVDAK demonstrated:

• 30% reduction in death risk compared to chemotherapy
• Median overall survival of 11.5 months vs 9.5 months for chemotherapy
• 33% reduction in disease progression risk

Common adverse reactions (≥25%) included peripheral neuropathy (39%), nausea (37%), epistaxis (33%), conjunctivitis (32%), alopecia (31%), anaemia (27%), and diarrhoea (25%).