Genmab A/S ADS - GMAB STOCK NEWS

Genmab announced that it will present new and updated results from clinical trials evaluating epcoritamab at the 2024 EHA Congress. Sixteen abstracts will be presented, showcasing the depth of their epcoritamab development program. The data includes safety and efficacy results across various B-cell malignancies, such as relapsed/refractory follicular lymphoma, diffuse large B-cell lymphoma, and Richter’s transformation.

Three oral presentations will highlight key findings: single-agent epcoritamab results in Richter’s Transformation, epcoritamab combined with Pola-R-CHP for first-line treatment in diffuse large B-cell lymphoma, and epcoritamab's impact on relapsed/refractory follicular lymphoma. The presentations will occur in Madrid and virtually from June 13-16, 2024.

Genmab, in collaboration with AbbVie, continues to advance epcoritamab's development as both a monotherapy and combination therapy. The abstracts are available via the EHA Open Access Library.

The FDA has granted full approval for TIVDAK® for the treatment of recurrent or metastatic cervical cancer. TIVDAK is the first antibody-drug conjugate with positive overall survival data for patients with previously treated disease. The approval is based on results from a Phase 3 study showing an overall survival benefit compared to chemotherapy. The safety profile of TIVDAK was consistent with known information, with no new safety issues identified. Common adverse reactions included decreased hemoglobin, peripheral neuropathy, and conjunctival adverse reactions. The approval of TIVDAK brings new treatment options for patients with advanced cervical cancer and addresses the high unmet need in this patient population.

Genmab A/S and Pfizer Inc. announced that the U.S. FDA has approved TIVDAK® for recurrent or metastatic cervical cancer treatment, converting its accelerated approval to a full approval. This is the first ADC with positive overall survival data in this patient population. The approval is based on Phase 3 data showing a 30% risk reduction in death compared to chemotherapy.

Genmab to acquire ProfoundBio for USD 1.8 billion in cash, gaining rights to three clinical candidates and ADC technology platforms. The acquisition will expand Genmab's pipeline and enhance its cancer treatment capabilities, with Rina-S as a potential best-in-class ADC targeting ovarian cancer and solid tumors.

Genmab A/S (GMAB) and AbbVie (ABBV) receive FDA Priority Review for epcoritamab in R/R follicular lymphoma, with a target action date of June 28, 2024. The sBLA submission is based on positive Phase 1/2 EPCORE™ NHL-1 trial results, showing promising treatment responses. Epcoritamab aims to address the unmet needs of difficult-to-treat FL patients, with potential utility across B-cell malignancies.

Genmab A/S and Pfizer, Inc. announced that the European Medicines Agency has validated the marketing authorization application of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer. The application is based on data from the Phase 3 innovaTV 301 trial, demonstrating superior overall survival, progression-free survival, and objective response rate compared to chemotherapy. The safety profile was consistent with previous data. If approved, tisotumab vedotin would be the first ADC granted EU marketing authorization for cervical cancer.

Genmab A/S (GMAB) and Pfizer, Inc. (PFE) announced that the FDA has accepted the sBLA for TIVDAK, with a PDUFA action date of May 9, 2024. This is based on positive results from the global phase 3 innovaTV 301 trial, demonstrating an overall survival benefit of tisotumab vedotin-tftv over chemotherapy for the treatment of patients with recurrent or metastatic cervical cancer.

Pfizer Inc. (PFE) and Genmab A/S (GMAB) announced the FDA's acceptance of the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression. The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, progression-free survival, and confirmed objective response rate in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.

Genmab A/S (GMAB) and AbbVie (ABBV) reported new data from the phase 1/2 EPCORE™ NHL-1 clinical trial for epcoritamab, showing an 82% overall response rate, 63% complete response rate, and 67% minimal residual disease negativity in patients with relapsed/refractory follicular lymphoma. The study presented at the 65th ASH Annual Meeting and Exposition also highlighted an optimized dosing schedule for FL patients, reducing the risk and severity of cytokine release syndrome.