Genmab A/S develops antibody medicines for cancer and other serious diseases through therapeutic formats that include bispecific antibodies, antibody-drug conjugates, immune-modulating antibodies and other next-generation modalities. Company news commonly centers on clinical data, regulatory interactions and portfolio decisions for programs such as EPKINLY®/epcoritamab, rinatabart sesutecan (Rina-S®) and petosemtamab.
Recurring updates also cover collaborations and commercialization economics tied to antibody products, including DARZALEX® royalties under the Johnson & Johnson license, EPKINLY development with AbbVie, research partnerships, and capital or shareholder announcements. Genmab’s disclosures frequently connect pipeline progress with hematologic malignancies, solid tumors and the company’s broader antibody-technology strategy.
Genmab (GMAB) reported that petosemtamab plus pembrolizumab met both primary endpoints in the Phase 3 LiGeR-HN1 head and neck cancer trial.
At the first interim analysis, the combination reduced the risk of death by 50% versus pembrolizumab alone, with a hazard ratio of 0.50 (95% confidence interval: 0.37–0.67; p<0.0001). Objective response rate, the proportion of patients whose tumors shrink, also improved, with an odds ratio of 3.17 (95% confidence interval: 2.06–4.89; p<0.0001). The trial evaluates first-line treatment of PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma; results met both endpoints regardless of HPV status.
No new safety signals were identified. Genmab plans to engage global regulatory authorities and submit full results for presentation at a future medical meeting. Petosemtamab remains investigational.
Genmab (GMAB) reported median overall survival of 28.2 months with petosemtamab plus pembrolizumab in a Phase 2 head-and-neck cancer trial.
The first-line combination arm enrolled patients with recurrent or metastatic PD-L1-positive head and neck squamous cell carcinoma. Among 43 efficacy-evaluable patients, the response rate was 63%, including 19% complete responses; median progression-free survival, the time without disease worsening, was 9.0 months. At the May 15, 2026 cutoff, median follow-up was 25.5 months. Median response duration was not reached, with an estimated 55% of responders maintaining a response at 24 months.
The open-label arm treated 45 patients. Infusion-related reactions occurred in 38%, including 7% Grade 3–4, and all resolved. No Grade 5 events or treatment-related deaths were reported. Genmab anticipates first-line Phase 3 topline data later in 2026.
Genmab (GMAB) reported updated Phase 2 results for petosemtamab plus chemotherapy in metastatic colorectal cancer, with responses across both treatment settings. Among efficacy-evaluable patients, confirmed and unconfirmed objective response rates, measuring tumor shrinkage, were 75% in first-line and 67% in second-line treatment. Median follow-up was 5.9 and 7.1 months, respectively; most previously unconfirmed responses were subsequently confirmed with longer follow-up.
As of May 15, 2026, 79 patients had received treatment. Response rates reached 81% among first-line patients with left-sided tumors. Petosemtamab-related adverse events led to discontinuation in 5% receiving mFOLFOX6 and 3% receiving FOLFIRI; no adverse events arising during treatment led to death. Grade 3 infusion reactions occurred in 7% and 3%, respectively. Global Phase 3 colorectal cancer trials are actively enrolling.
Incyte (INCY) and Genmab (GMAB) announced a clinical trial collaboration to evaluate a combination treatment for metastatic colorectal cancer. The planned Phase 1/2 study will evaluate Incyte’s INCB161734 with Genmab’s petosemtamab and standard-of-care chemotherapy as first-line treatment for patients whose cancers carry the KRAS G12D mutation.
Genmab will conduct the study, while Incyte will co-fund it and supply INCB161734. The companies aim to investigate whether combining agents with different mechanisms and chemotherapy could provide a new treatment approach. INCB161734 targets KRAS G12D; petosemtamab targets EGFR and LGR5, proteins involved in cancer biology. Separately, petosemtamab is being evaluated with chemotherapy in two Phase 3 trials in first- and second-line metastatic colorectal cancer without RAS/BRAF mutations.
Genmab (GMAB) reported that Rina-S improved progression-free and overall survival versus investigator’s choice chemotherapy in the Phase 3 RAINFOL-02 trial.
The study enrolled patients with platinum-resistant ovarian cancer regardless of folate receptor alpha expression. Among all 584 randomized patients, Rina-S reduced the risk of disease progression or death by 71%; the reduction was 67% in the 492-patient primary analysis subset. Overall survival also improved, with hazard ratios of 0.43 and 0.44, respectively; values below one favor Rina-S. Both survival endpoints were statistically significant in both populations, with p<0.0001. No new safety signals or unexpected safety concerns were identified.
Genmab plans to discuss potential next steps with regulatory authorities worldwide and submit the data for presentation at a future medical meeting. Rina-S remains investigational.
AbbVie (ABBV) and Genmab (GMAB) announced Phase 3 results showing epcoritamab plus R-CHOP improved progression-free survival in newly diagnosed diffuse large B-cell lymphoma.
In EPCORE DLBCL-2, the combination reduced the risk of disease progression or death by 51% versus R-CHOP alone among patients with International Prognostic Index risk scores of 2–5. The primary endpoint population, with scores of 3–5, also had a 51% reduction; both results had p-values below 0.0001. Progression-free survival measures time without disease worsening or death. AbbVie and Genmab described the combination as generally well tolerated, with safety consistent with the individual agents.
The results came from the first planned efficacy interim analysis; independent monitors recommended unblinding. The trial remains ongoing. The combination is not approved, and the companies plan to engage global regulators on next steps.
AbbVie (ABBV) and Genmab (GMAB) reported improved progression-free survival with epcoritamab plus R-CHOP in newly diagnosed diffuse large B-cell lymphoma.
The Phase 3 EPCORE DLBCL-2 trial compared the combination with R-CHOP, a standard chemotherapy and antibody regimen, alone. In patients with International Prognostic Index (IPI) scores of 2–5, the risk of disease progression or death fell 51% (hazard ratio 0.49; p-value <0.0001). The primary endpoint population, with IPI scores of 3–5, also showed a 51% reduction. Progression-free survival measures time without disease worsening or death.
The companies described the combination as generally well tolerated, with safety consistent with the individual agents. They will engage global regulatory authorities to determine next steps and submit data for a future medical meeting. The trial remains ongoing; epcoritamab plus R-CHOP is not approved.
Genmab (GMAB) reported a confirmed response rate of 45.9% for investigational Rina-S in patients with platinum-resistant ovarian cancer in RAINFOL-01.
Part C of the Phase 1/2 trial treated 109 patients with 120 mg/m² every three weeks. Responses included five complete responses. Median response duration was 12.1 months, with 51% of responders remaining in response at one year. Median progression-free survival, the time without disease progression or death, was 9.5 months. Activity was observed across folate receptor alpha expression levels and regardless of prior mirvetuximab treatment.
Serious adverse events occurred in approximately one-third of participants; 5.5% discontinued treatment because of treatment-emergent adverse events. No safety signals for ocular toxicity, peripheral neuropathy, interstitial lung disease or stomatitis were observed. Genmab's development program includes four Phase 3 trials.
Genmab (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) clarified that in the global Phase 3 EPCORE® DLBCL-1 trial of subcutaneous epcoritamab monotherapy versus investigator’s choice chemoimmunotherapy in adults with relapsed/refractory DLBCL ineligible for autologous stem cell transplant, overall survival (OS) was the sole U.S. primary endpoint and was not met, as the study did not show a statistically significant OS improvement.
The trial remains ongoing with region-specific primary endpoints and further data planned for peer‑reviewed publication. Epcoritamab, co-developed by Genmab and AbbVie, already holds FDA accelerated approval for certain R/R DLBCL and follicular lymphoma indications and is approved in more than 65 territories under the EPKINLY®/TEPKINLY® brands.
Genmab (Nasdaq: GMAB) received European Commission marketing authorization for TEPKINLY (epcoritamab) + lenalidomide and rituximab (R2) to treat adult patients with relapsed or refractory follicular lymphoma. This fixed-duration, chemotherapy-free, bispecific-based regimen is approved in the second-line setting, supported by pivotal Phase 3 EPCORE FL-1 results.
TEPKINLY + R2 reduced risk of progression or death by 79% versus R2, achieved a 96% overall response rate and 74% complete response rate, with a safety profile consistent with the individual regimens.