Genmab Stock Price, News & Analysis

- 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).

Genmab (Nasdaq: GMAB) announced that Johnson & Johnson (J&J) has declined to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38. Following this decision and a portfolio evaluation, Genmab will discontinue further clinical development of the drug.

The Phase 2 expansion study comparing HexaBody-CD38 with DARZALEX FASPRO® in multiple myeloma patients showed an overall response rate (ORR) of 55% for HexaBody-CD38 versus 52% for daratumumab. Very good partial response rates were 29% vs. 17%, and complete response rates were 7% vs. 2%. Common treatment emergent adverse events included neutropenia, infusion-related reactions, anemia, and thrombocytopenia.

Despite promising clinical data validating the HexaBody platform's potential, Genmab will focus on its existing pipeline, including EPKINLY® and two wholly owned assets in Phase 3 development: rinatabart sesutecan and acasunlimab. The company maintains its 2025 Financial Guidance.

Genmab A/S (Nasdaq: GMAB) announced that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for treating patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior lines of therapy. This approval is based on results from two Phase 1/2 EPCORE® clinical trials, which demonstrated strong and durable efficacy in patients.

EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in Japan to treat both R/R FL and R/R large B-cell lymphomas. FL accounts for 20-30% of non-Hodgkin’s lymphoma (NHL) cases, with approximately 19,000 patients living with FL in Japan. FL is considered incurable with current therapies, and patients often relapse, leading to shorter remission periods.

The approval is supported by data from the EPCORE NHL-1 and EPCORE NHL-3 trials. In the global EPCORE NHL-1 trial, the overall response rate (ORR) was 82%, with a complete response (CR) rate of 62.5%. In the Japanese EPCORE NHL-3 trial, the ORR was 95.2%, with a CR rate of 76.2%. Common adverse events included cytokine release syndrome (CRS) and injection site reactions.

EPKINLY is the only bispecific antibody approved in the U.S., European Union, and Japan for dual indications in treating B-cell malignancies.