COPENHAGEN, Denmark / Nov 05, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB): More than 20 abstracts, including four oral presentations, with new clinical data across lines of therapy and subgroups of non-Hodgkin’s lymphoma (NHL) patients New and updated data from EPCORE ® clinical trial program reinforce the potential of epcoritamab as a monotherapy and in combination to treat multiple B-cell malignancies across lines of... Read More

Treatment with rinatabart sesutecan (Rina-S) showed encouraging response rate in heavily pretreated patients with ovarian cancer in dose expansion cohort Responses with Rina-S were observed across FRα expression levels Phase 3 trial will further evaluate the safety and efficacy of Rina-S at 120 mg/m 2 in patients with advanced ovarian cancer COPENHAGEN, Denmark / Sep 15, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB)... Read More

Company Announcement TEPKINLY is the first and only subcutaneous bispecific antibody approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy COPENHAGEN, Denmark / Aug 19, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) today announced that the European Commission (EC) has... Read More

Rayne Waller joins as Executive Vice President and Chief Technology Officer Brad Bailey appointed as Executive Vice President and Chief Commercial Officer Anthony Mancini, Executive Vice President and Chief Operating Officer, will leave Genmab to pursue other opportunities COPENHAGEN, Denmark / Aug 16, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) today announced changes to its Executive Committee to support Genmab’s... Read More

Positive CHMP opinion based on results from the Phase 1/2 EPCORE ® NHL-1 study FL is the second most common type of NHL and accounts for approximately 20-30 percent of all global cases If approved, epcoritamab (TEPKINLY ® ) would become the first and only bispecific antibody conditionally approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large... Read More

Approval based on results from Phase 1/2 EPCORE ® NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with challenging-to-treat R/R FL EPKINLY offers an off-the-shelf, T-cell engaging treatment option that enables treatment across practice settings to address high clinical need EPKINLY is the first and only bispecific antibody approved in the U.S. to treat both relapsed or... Read More

Results from innovaTV207 evaluating tisotumab vedotin, showing 32.5% confirmed objective response rate in patients with recurrent or metastatic HNSCC, presented in a rapid oral session at 2024 ASCO ® Annual Meeting HNSCC is the sixth most common cancer worldwide, with incidence rates expected to increase 30% by 2030 i COPENHAGEN, Denmark / Jun 03, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today that data... Read More

Preliminary analysis of data from the EPCORE™ NHL-2 study demonstrates patients with previously untreated follicular lymphoma (FL) who received epcoritamab in combination with rituximab-lenalidomide (R 2 ) experienced a 95% overall response rate (ORR) Results from the optimization cohort of the EPCORE™ NHL- 1 study show that mitigation strategies led to a clinically significant reduction in rate of cytokine release syndrome... Read More

Initial data from the ongoing Phase 2 trial showed a 12-month overall survival (OS) rate of 69% and median overall survival (mOS) of 17.5 months in patients with previously treated PD-L1-positive mNSCLC treated with combination of acasunlimab with pembrolizumab every six weeks Data from this ongoing Phase 2 study to inform the planned pivotal Phase 3 trial, which is expected to start before the end of 2024 COPENHAGEN,... Read More

Six oral and poster presentations will highlight breadth of clinical program and potential utility of epcoritamab-bysp in patients with difficult-to-treat lymphomas across multiple lines of therapy and histologies where high unmet needs exist Results from two studies evaluating tisotumab vedotin in patients with head and neck squamous cell carcinoma and recurrent or metastatic cervical cancer accepted for oral and poster... Read More

Genmab has completed acquisition of ProfoundBio for USD 1.8 billion in cash Acquisition gives Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate technology platforms COPENHAGEN, Denmark / May 21, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today that it has completed its acquisition of ProfoundBio, Inc.,... Read More

Sixteen abstracts accepted for presentation and publication demonstrate depth and breadth of comprehensive epcoritamab development program Three oral presentations highlight novel data evaluating epcoritamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL), in combination for first-line treatment of diffuse large B-cell lymphoma (DLBCL), and in Richter’s transformation (RT) COPENHAGEN, Denmark / May 14,... Read More

Full approval based on global Phase 3 study demonstrating overall survival benefit of TIVDAK compared to chemotherapy TIVDAK is the first antibody-drug conjugate in this patient population to have positive overall survival data COPENHAGEN, Denmark / Apr 29, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) and Pfizer Inc. (NYSE: PFE) announced today the U.S. Food and Drug Administration (FDA) has approved the supplemental... Read More

Company Announcement Genmab to acquire ProfoundBio for USD 1.8 billion in cash Acquisition will give Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate (ADC) technology platforms Rina-S is a novel, next-generation, potential best-in-class Topo1 ADC targeting folate receptor alpha (FRα) in development for the treatment... Read More

FDA grants Priority Review with target action date of June 28, 2024 Application based on results from Phase 1/2 EPCORE™ NHL-1 trial demonstrating clinically meaningful treatment responses in difficult-to-treat patients with relapsed or refractory (R/R) follicular lymphoma (FL) sBLA submission demonstrates Genmab’s commitment to exploring potential utility of epcoritamab across B-cell malignancies COPENHAGEN, Denmark / Feb... Read More

Validation is supported by data from Phase 3 innovaTV 301 trial COPENHAGEN, Denmark / Feb 02, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or... Read More

TIVDAK sBLA accepted for priority review, FDA action date is May 9, 2024 Submission based on positive results from global phase 3 innovaTV 301 trial demonstrating overall survival benefit of tisotumab vedotin-tftv over chemotherapy COPENHAGEN, Denmark / Jan 09, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the... Read More

Data from the pivotal phase 1/2 EPCORE™ NHL-1 study showed 82 percent overall response rate (ORR), 63 percent complete response (CR) and 67 percent minimal residual disease (MRD) negativity in patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with subcutaneous epcoritamab Results presented at the 65 th American Society of Hematology (ASH) Annual Meeting and Exposition include data from an optimized... Read More

U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation (BTD) for epcoritamab-bysp for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy European Medicines Agency (EMA) validates regulatory application for epcoritamab for the same indication The regulatory actions are supported by data from the phase 1/2 EPCORE™ NHL-1 trial COPENHAGEN,... Read More

Eighteen total abstracts accepted for presentation and publication, including results from four clinical trials evaluating epcoritamab in multiple treatment settings and patient populations Oral presentations highlighting new findings from a clinical trial of epcoritamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and a real-world analysis of patients with R/R large B-cell lymphoma (LBCL)... Read More

Company Announcement TEPKINLY ® (epcoritamab) is the first and only subcutaneous bispecific antibody approved as a monotherapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy Conditional marketing authorization approval from the European Commission is supported by data from the pivotal phase 1/2 EPCORE™ NHL-1 clinical trial, which... Read More

Subcutaneous EPKINLY ™ (epcoritamab) is the first and only bispecific antibody approved in Japan to treat adult patients with certain types of relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy Approval based on results of EPCORE ™ NHL-3 and EPCORE ™ NHL-1 clinical trials, evaluating EPKINLY in patients with certain types of R/R LBCL LBCL is a common form of non-Hodgkin’s... Read More

Phase 3 innovaTV 301 confirmatory trial met its primary endpoint of improved overall survival (OS) at predetermined, independent interim analysis Trial results to be submitted for presentation at a future medical meeting Genmab and Seagen to engage in discussions with regulatory authorities COPENHAGEN, Denmark & BOTHELL, Wash. / Sep 04, 2023 / Business Wire / Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced... Read More

Company Announcement The positive CHMP opinion is supported by results from the EPCORE™ NHL-1 phase 1/2 trial evaluating the preliminary efficacy and safety of epcoritamab in patients with non-Hodgkin’s lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) DLBCL is an aggressive subtype of NHL and accounts for approximately 30 percent of all global cases If approved, epcoritamab (TEPKINLY ® ) would become the first... Read More

Company Announcement Based on the topline results from the EPCORE™ NHL-1 clinical trial, Genmab and AbbVie will engage with global regulatory authorities to discuss next steps Data from the clinical trial will be presented at a future medical meeting Follicular Lymphoma is a common form of non-Hodgkin’s lymphoma (NHL) and currently has limited treatment options, particularly in the relapsed/refractory setting COPENHAGEN,... Read More

COPENHAGEN, Denmark / Jun 22, 2023 / Business Wire / 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),... Read More

Results from phase 1/2 EPCORE™ NHL-2 trial investigating epcoritamab in combination with rituximab-lenalidomide (R2) showed a 98 percent overall response rate (ORR), 87 percent complete metabolic response (CMR) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) Results from the EPCORE™ NHL-1 expansion cohort, including longer follow-up in challenging-to-treat large B-cell lymphoma (LBCL) patients, also... Read More

Oral presentations will highlight epcoritamab-bysp in combination with rituximab-lenalidomide (R2) in high-risk follicular lymphoma Poster presentations will highlight epcoritamab in lymphoma across multiple lines of therapy and histologies where high unmet needs exist COPENHAGEN, Denmark / May 25, 2023 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab, a T-cell... Read More

Results from phase 2 clinical trial demonstrated EPKINLY™ (epcoritamab-bysp) delivered 61 percent overall response rate, 38 percent complete response, and 15.6-month median duration of response in challenging-to-treat R/R DLBCL patients EPKINLY represents the seventh approved medicine incorporating Genmab innovation and third created via Genmab’s DuoBody ® technology platform COPENHAGEN, Denmark / May 19, 2023 / Business... Read More

Genmab and argenx have entered a multiyear collaboration bringing together capabilities to jointly discover, develop and commercialize antibody therapies Discovery programs against two differentiated targets are underway COPENHAGEN, Denmark / Apr 17, 2023 / Business Wire / Genmab A/S (Nasdaq: GMAB) and argenx (Euronext & Nasdaq: ARGX) announced today that Genmab and argenx have entered into a collaboration agreement to... Read More

JNDA submission supported by results of Japanese and global phase 2 clinical trials evaluating epcoritamab in patients with mature B-cell non-Hodgkin’s lymphoma (NHL), including relapsed/refractory large B-cell lymphoma (LBCL) Genmab A/S ( Nasdaq: GMAB) today announced that the company has submitted a Japan new drug application (JNDA) to the Ministry of Health, Labor and Welfare (MHLW) of Japan for subcutaneous epcoritamab... Read More

COPENHAGEN, Denmark; December 11, 2022 Epcoritamab featured in multiple data disclosures , including four oral presentations R esults presented from the phase 1 b /2 EPCORE™ NHL-2 trial of e pcoritamab combined with standard salvage therapy in patients with transplant eligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Additional r esults also presented from the phase 1 b /2 EPCORE NHL-2 trial evaluating... Read More