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Genmab A/S (GMAB) is a global biotechnology leader focused on creating differentiated antibody therapies for cancer and autoimmune diseases. This page serves as the definitive source for Genmab news, providing investors and industry professionals with timely updates on clinical developments, regulatory milestones, and strategic partnerships.
Access consolidated information on FDA approvals, collaboration announcements, and clinical trial results across Genmab's pipeline. The company's proprietary platforms like DuoBody and HexaBody underpin its innovative treatments, with key alliances including Johnson & Johnson and AbbVie driving therapeutic advancements.
Bookmark this page for real-time updates on Genmab's progress in antibody engineering and commercialization efforts. Monitor critical updates through verified press releases while gaining insights into how the company addresses complex medical challenges through targeted biologics.
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.
- 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.
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 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%).
TIVDAK® (tisotumab vedotin) has received approval from Japan's Ministry of Health, Labour and Welfare for treating advanced or recurrent cervical cancer that has progressed after chemotherapy. This marks a significant milestone as TIVDAK becomes the first and only antibody-drug conjugate (ADC) approved for cervical cancer patients in Japan.
The approval is supported by the global Phase 3 innovaTV 301 trial results, which demonstrated superior overall survival compared to chemotherapy. The study showed a 30% reduction in risk of death, with median overall survival of 11.5 months for TIVDAK versus 9.5 months for chemotherapy. The trial included 502 patients, with 101 being Japanese.
Common adverse reactions, observed in 87.6% of 250 treated patients, included conjunctivitis (30.4%), nausea (29.2%), peripheral sensory neuropathy (26.8%), alopecia (24.4%), and epistaxis (22.8%).
Genmab A/S (GMAB) reported updated data from Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), showing promising results in treating advanced ovarian cancer. With a median follow-up of 48 weeks, Rina-S at 120 mg/m2 demonstrated:
- Confirmed objective response rate (ORR) of 55.6%
- Disease control rate (DCR) of 88.9%
- Median duration of response (mDOR) not reached
- Complete responses in 4 patients (2 confirmed, 2 unconfirmed)
- Confirmed partial responses in 8 patients (44.4%)
At 100 mg/m2, the study showed a 22.7% ORR and 86.4% DCR. Common side effects included anemia, nausea, and neutropenia. The 120 mg/m2 dose has been selected for further evaluation in ongoing Phase 2 RAINFOL-01 and Phase 3 RAINFOL-02 trials for platinum-resistant ovarian cancer (PROC).