Two Data Analyses from Clinical Trials Show Epcoritamab (DuoBody® CD3xCD20) Induces Durable, Complete Responses as Monotherapy and Combination Treatment in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
Genmab A/S (Nasdaq: GMAB) today announced new long-term results from two ongoing clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma (DLBCL). Results from Arm 1 of the Phase 1b/2 EPCORE® NHL-2 trial (NCT04663347), evaluating fixed-duration epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), demonstrated an overall response rate (ORR) of 100 percent and a complete response (CR) rate of 87 percent in high-risk patients (n=46) with previously untreated DLBCL. Among complete responders, 83 percent remained in remission after two years. Separately, results from the Phase 2 EPCORE® NHL-1 trial (NCT03625037), evaluating epcoritamab monotherapy in challenging-to-treat adult patients (n=157) with relapsed or refractory (R/R) large B-cell lymphoma (LBCL; including 148 patients with R/R DLBCL), showed that among the 41 percent of patients who achieved a CR, an estimated 52 percent were still responding at three years (median CR duration: 36.1 months). Both analyses were presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH).
Genmab Announces Financial Results for the First Nine Months of 2024November 6, 2024 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2024
Investigational Rinatabart Sesutecan (Rina-S) Shows Promising Anti-Tumor Activity as Single Agent in Heavily Pretreated Patients with Ovarian and Endometrial Cancers in Phase 1/2 Clinical Trial
Genmab A/S (Nasdaq: GMAB) announced today new data from the Phase 1/2 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted, Topo1 antibody-drug conjugate (ADC), demonstrated a confirmed objective response rate (ORR) of 50.0% (95% CI) in ovarian cancer patients treated with Rina-S 120 mg/m2 once every 3 weeks (Q3W), regardless of FRα expression levels. These data were from the dose expansion part of a multi-part study evaluating the safety and efficacy of single-agent Rina-S in ovarian cancer (OC) and endometrial cancer (EC). These results, and additional findings from the study, were presented at the European Society of Medical Oncology Congress 2024 (ESMO) in Barcelona, Spain.
TEPKINLY® (epcoritamab) Receives Second European Commission Approval for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma
Genmab A/S (Nasdaq: GMAB) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.
Genmab Announces Changes to its Executive Committee
Genmab A/S (Nasdaq: GMAB) today announced changes to its Executive Committee to support Genmab’s growth and evolution into a fully integrated biotech innovation powerhouse. Genmab’s Executive Committee will include Rayne Waller in the newly created role of Executive Vice President and Chief Technology Officer and Brad Bailey in the newly created role of Executive Vice President and Chief Commercial Officer. Executive Vice President and Chief Operating Officer Anthony Mancini has decided to leave Genmab to pursue other opportunities.
Genmab Announces Financial Results for the First Half of 2024August 8, 2024 Copenhagen, Denmark; Interim Report for the First Six Months Ended June 30, 2024
Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults with Relapsed/ Refractory Follicular Lymphoma
Genmab A/S (Nasdaq: GMAB) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY®), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The final European Commission decision on this indication for epcoritamab is anticipated later this year.
EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)
Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s).
Investigational Tisotumab Vedotin Phase 2 Data Demonstrates Encouraging Antitumor Activity in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Genmab A/S (Nasdaq: GMAB) announced today that data from the Phase 2 innovaTV 207 trial (NCT03485209) Part C (n=40), investigating tisotumab vedotin, an antibody-drug conjugate directed to tissue factor, demonstrated encouraging antitumor activity as a monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on or after first-line therapy. The study showed 32.5% of patients achieved a confirmed objective response rate (cORR), one patient experienced a complete response (CR) and 12 achieved a partial response (PR). These results were presented in a rapid oral session today at the 2024 ASCO Annual Meeting, being held in Chicago, Illinois, May 31 – June 4, 2024.
Preliminary Analysis of Data Evaluating Investigational Epcoritamab (DuoBody® CD3xCD20) Combination Demonstrates 95% Overall Response Rate in Patients with Previously Untreated Follicular Lymphoma
Genmab A/S (Nasdaq: GMAB) today announced new efficacy and safety data from two ongoing Phase 1/2 clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with certain types of follicular lymphoma (FL). A preliminary analysis of data from the EPCORE™ NHL-2 study (NCT04663347), evaluating epcoritamab in combination with rituximab-lenalidomide (R2), demonstrated an overall response rate (ORR) of 95% and complete response rate (CRR) of 85% in patients with previously untreated FL. The safety and efficacy for this use have not been established. The data were shared during a rapid oral presentation (Abstract #7014) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 4, 2024.
Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in Patients with Previously Treated Metastatic Non-small Cell Lung Cancer (mNSCLC)
Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX) today announced initial data from the Phase 2 GCT1046-04 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PDL(1)-positive mNSCLC who had disease progression following one or more prior lines of anti-PD(L)1 containing treatment. The results showed a 12-month overall survival (OS) rate of 69%, a median overall survival (mOS) of 17.5 months, and a 30% overall response rate (ORR); (confirmed ORR 17%) at time of data cut-off in patients treated with the combination of acasunlimab and pembrolizumab every six weeks. The findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 4, 2024.
Genmab to Showcase Data in Various Patient Populations to be Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting
Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, tisotumab vedotin, an antibody-drug conjugate (ADC), and acasunlimab (also known as GEN1046/BNT311), an investigational bispecific antibody, will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 2, 2024.
Genmab Completes Acquisition of ProfoundBio
Genmab A/S (Nasdaq: GMAB) announced today that it has completed its acquisition of ProfoundBio, Inc., a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADC)s and ADC technologies for the treatment of cancers in an all-cash transaction of USD 1.8 billion (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).
Genmab to Present New and Updated Results From Multiple Clinical Trials Evaluating Epcoritamab Across Various B-Cell Malignancies at the 2024 European Hematology Association (EHA) Congress
Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, will be presented at the 2024 European Hematology Association (EHA) Congress, being held in Madrid, Spain and virtually, June 13-16, 2024.
Genmab Announces Financial Results for the First Quarter of 2024May 2, 2024 Copenhagen, Denmark; Interim Report for the First Quarter Ended March 31, 2024
TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer
Genmab A/S (Nasdaq: GMAB) and Pfizer Inc. (
NYSEPFE) announced today the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval. TIVDAK is the first antibody-drug conjugate (ADC) with demonstrated overall survival data to be granted full FDA approval in this patient population.
Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio
Genmab A/S (Nasdaq: GMAB) and ProfoundBio, Inc. announced today that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction. ProfoundBio is a privately-owned clinical-stage biotechnology company developing next-generation ADCs and ADC technologies for the treatment of certain cancers, including ovarian cancer and other FRα-expressing solid tumors. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).
U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
Genmab A/S (Nasdaq: GMAB) and AbbVie (
NYSEABBV) today announced the U.S. Food and Drug Administration (FDA) granted Priority Review for the supplemental Biologics License Application (sBLA) for epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer
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 metastatic cervical cancer with disease progression on or after systemic therapy. If approved, tisotumab vedotin would be the first ADC granted European Union (EU) marketing authorization for people living with cervical cancer.
TIVDAK® (tisotumab vedotin-tftv) Supplemental Biologics License Application Accepted for Priority Review by U.S. Food and Drug Administration for Patients with Recurrent or Metastatic Cervical Cancer
Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (
NYSEPFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024.
New Pivotal Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Demonstrates High Overall and Complete Responses in Patients with Hard-To-Treat Relapsed/Refractory Follicular Lymphoma (FL)
Genmab A/S (Nasdaq: GMAB) and AbbVie (
NYSEABBV) today announced new data from the ongoing phase 1/2 EPCORE™ NHL-1 clinical trial investigating epcoritamab (DuoBody® CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 82 percent, a complete response (CR) rate of 63 percent and minimal residual disease (MRD) negativity rate of 67 percent in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The presentation included data from an optimized step-up dosing schedule for FL patients showing a reduction in risk and severity of Grade 2+ cytokine release syndrome (CRS), a common side effect of T-cell engaging cancer treatments. These results were presented today at the 2023 65th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in San Diego, California, December 9-12, 2023 (Abstract #1655).
Genmab Announces Positive Regulatory Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma
Genmab A/S (Nasdaq: GMAB) today announced regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. BTD may expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.
Genmab Announces Financial Results for the First Nine Months of 2023November 7, 2023 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2023
Genmab Announces Multiple Abstracts to be Presented at the 65th Annual Meeting and Exposition of the American Society of Hematology (ASH)
Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab (DuoBody®-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, across a variety of treatment settings and hematologic malignancies have been accepted for presentation and publication at the 65th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in San Diego, California, and virtually, December 9-12. The presentations will include two oral and 11 poster presentations highlighting data from several trials evaluating the safety and efficacy of epcoritamab as a monotherapy or in combination for the treatment of patients with various lymphoma subtypes, across lines of therapy including relapsed/refractory (R/R) and newly diagnosed patients.
Genmab Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as Liechtenstein, Norway and Iceland.
EPKINLY™ (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare as the First Bispecific Antibody to Treat Adults Patients with Certain Types of Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)
Genmab A/S (Nasdaq: GMAB) announced today that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY™ (epcoritamab) as the first and only T-cell engaging bispecific antibody treatment in Japan of adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.
Genmab and Seagen Announce That TIVDAK® (tisotumab vedotin-tftv) Met its Primary Endpoint of Improved Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared to Chemotherapy
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced today that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK® (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS). An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of TIVDAK in innovaTV 301 is consistent with the known safety profile of TIVDAK as presented in the U.S. prescribing information, and no new safety signals were observed.
Genmab Announces Financial Results for the First Half of 2023August 3, 2023 Copenhagen, Denmark; Interim Report for the First Six Months Ended June 30, 2023
Genmab Announces AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Genmab A/S (Nasdaq: GMAB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization for epcoritamab (TEPKINLY®) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The final European Commission decision on the indication for epcoritamab is anticipated later this year.
Genmab Announces Multiple Abstracts to be Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) Congress
Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, June 2-6, 2023, and at the 2023 European Hematology Association (EHA) Congress, being held in Frankfurt, Germany and virtually, June 8-11, 2023.
EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY™ (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy. EPKINLY was approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s). EPKINLY is being co-developed and co-commercialized by Genmab and AbbVie (
NYSEABBV) as part of the companies’ oncology collaboration.
Genmab Announces Financial Results for the First Quarter of 2023May 10, 2023 Copenhagen, Denmark; Interim Report for the First Quarter Ended March 31, 2023
Genmab Showcases Data From Robust Development Program Evaluating Epcoritamab (DuoBody®-CD3xCD20) in Patients Across a Broad Range of B-Cell Lymphomas at the 64th Annual ASH Meeting
Genmab A/S (Nasdaq: GMAB) today announced the results from multiple clinical trials evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, alone or in combination with other therapies for the treatment of patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), previously untreated FL, and Richter’s Syndrome (RS). These data, along with additional results from the phase 1/2 EPCORE NHL-1 clinical trial, evaluating the safety and efficacy of epcoritamab in patients with R/R large B-cell lymphoma (LBCL), are being presented at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in New Orleans, Louisiana, and virtually, December 10-13, 2022.
Genmab Announces Financial Results for the First Nine Months of 2022November 9, 2022 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2022
Genmab Announces Multiple Abstracts to be Presented at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH)
Genmab A/S (Nasdaq: GMAB) announced today that 19 abstracts evaluating various investigational medicines in its pipeline have been accepted for presentation at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held at the Ernest N. Morial Convention Center in New Orleans, Louisiana, and virtually, December 10-13. The presentations will include four oral and six poster presentations highlighting data from several clinical trials evaluating the safety and efficacy of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology, alone or in combination for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), previously untreated FL and Richter’s syndrome.
Genmab Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL) and Diffuse Large B-Cell Lymphoma (DLBCL)
Genmab A/S (Nasdaq: GMAB) today announced that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) 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. Additionally, Genmab announced that AbbVie (
NYSEABBV) submitted a Marketing Authorization Application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, which has been validated by the European Medicines Agency (EMA).
Genmab and BioNTech Expand Global Strategic Collaboration to Develop and Commercialize Novel Immunotherapy Candidates
Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced an expansion of their global strategic collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients. Under the expansion, Genmab and BioNTech will jointly work to research, develop, and commercialize novel monospecific antibody candidates for various cancer indications. Since 2015, the companies have been working on the joint development of bispecific cancer antibodies aimed at improving immunotherapy options for cancer patients.
Genmab Announces That AbbVie Will Submit Marketing Authorization Application to European Medicines Agency for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Genmab A/S (Nasdaq: GMAB) today announced that AbbVie (
NYSEABBV) will submit a conditional marketing authorization application (MAA) with the European Medicines Agency (EMA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), in the second half of 2022. Genmab recently announced that the company will submit a biologics license application (BLA) for epcoritamab with the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), also in the second half of 2022.
Genmab and Seagen Present Data from Tisotumab Vedotin (TIVDAK®) Clinical Development Program and Additional Cervical Cancer Research at ASCO 2022 Annual Meeting
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced interim data from the innovaTV 205 trial, which included data evaluating tisotumab vedotin (TIVDAK®) in combination with pembrolizumab (Cohort E) in patients with recurrent or metastatic cervical cancer (r/mCC) who have not received prior systemic therapy, with a confirmed objective response rate (ORR) of 41% (95% Confidence Interval [CI]: 24% to 59%) and median durability of response that was not reached within almost 19 months of median follow up. Data were presented during an oral session at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting on June 6.
