Articles from Genmab

Genmab A/S (Nasdaq: GMAB) announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels. With a median on-study follow-up of 48 weeks, 1 out of 10 patients experienced disease progression and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). The data are from the dose expansion cohort of the multi-part study evaluating the safety and efficacy of Rina-S as a single agent in solid tumors that are known to express FRα and were presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer® (SGO) in Seattle, Washington.

Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced topline results from the follicular lymphoma (FL) cohort of the phase 1/2 EPCORE™ NHL-1 clinical trial evaluating epcoritamab (DuoBody® CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously. The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy. 70.3 percent of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. Based on the topline results, the companies will engage with global regulatory authorities to determine next steps. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

Genmab A/S (Nasdaq: GMAB) today announced that epcoritamab, a T-cell engaging bispecific antibody, has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for “B-cell Lymphomas” (Version 4.2023) for third-line and subsequent therapy for patients with diffuse large B-cell lymphoma (DLBCL), including patients with disease progression after transplant or chimeric antigen receptor (CAR) T-cell therapy and as a Category 2A, preferred regimen for patients with histologic transformation of indolent lymphomas to DLBCL and no intention to proceed to transplant, including patients with disease progression after transplant or CAR T-cell therapy. This recommendation is based on uniform NCCN consensus that the intervention is appropriate.i Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies' oncology collaboration.

Genmab A/S (Nasdaq: GMAB) today announced data from its ongoing phase 1/2 EPCORE™ NHL-2 trial investigating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab-lenalidomide (R2) showed an overall response rate (ORR) of 98 percent and complete metabolic response (CMR) of 87 percent in response evaluable patients (n=104) with relapsed or refractory (R/R) follicular lymphoma (FL). These preliminary results will be presented today during an oral presentation at the 2023 European Hematology Association (EHA) Congress, being held in Frankfurt, Germany and virtually, June 8-11, 2023 (Abstract #S222). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies' oncology collaboration.

Genmab A/S (Nasdaq: GMAB) and argenx (Euronext & Nasdaq: ARGX) announced today that Genmab and argenx have entered into a collaboration agreement to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas. The multiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer.

Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 21, 2023.

Genmab A/S (Nasdaq: GMAB) announced today primary results from the large B-cell lymphoma (LBCL) expansion cohort in the EPCORE™ NHL-1 phase 2 clinical trial evaluating subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody. In the study, treatment with epcoritamab demonstrated deep and durable responses with an overall response rate (ORR) of 63 percent and a complete response rate (CR) of 39 percent in patients who had previously received at least two prior lines of systemic anti-lymphoma therapy. Additionally, patients naïve to treatment with chimeric antigen receptor (CAR) T-cell therapy achieved 69 percent ORR and 42 percent CR and patients previously treated with CAR T achieved a 54 percent ORR and 34 percent CR. Data were presented in a late-breaking oral presentation as a part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA2022) in Vienna, Austria (Abstract #LB2364).

Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating several investigational medicines in the company’s pipeline, or created using Genmab’s innovative drug development platforms, will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held at McCormick Place, in Chicago, IL, and virtually, June 3-7. The presentations will include data from multiple arms of the phase 1b/2 EPCORE™ NHL-2 clinical trial, evaluating the safety and preliminary efficacy of epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, in combination with standard-of-care therapies for the treatment of various types of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, will be presented at the European Hematology Association (EHA) Annual Congress, being held in Vienna, Austria, and virtually, June 9-12. The presentations will include data from various clinical trials, including multiple arms of the phase 1b/2 EPCORE™ NHL-2 trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating several investigational therapies and technologies in the company’s solid tumor product pipeline will be presented at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021), being held in Washington, DC, and virtually, November 10-14. The presentations will include a mini-oral session featuring the results of the first-in-human (FIH) phase 1/2 trial evaluating the safety and initial clinical activity of the investigational bispecific antibody, DuoBody®-CD40×4-1BB (GEN1042), in patients with advanced solid tumors. Data from another FIH phase 1/2a trial, evaluating the investigational bispecific antibody, DuoBody®-PD-L1×4-1BB (GEN1046) in patients with advanced solid tumors, will be presented as a poster. In addition, four posters will be presented, including one evaluating DuoBody®-CD3xB7H4 (GEN1047), an investigational therapy in Genmab’s early-stage solid tumor product pipeline.