Genmab A/S - GMAB STOCK NEWS

The U.S. FDA has approved EPKINLY® (epcoritamab-bysp) for adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This makes EPKINLY the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. for this patient group. Approval is based on data from the Phase 1/2 EPCORE® NHL-1 study, which showed an overall response rate of 82% and a complete response rate of 60%. EPKINLY is also approved for treating R/R diffuse large B-cell lymphoma (DLBCL). Common adverse events include injection site reactions, cytokine release syndrome (CRS), fatigue, and upper respiratory tract infections. The National Comprehensive Cancer Network (NCCN) has included EPKINLY in their guidelines as a preferred option for third-line and subsequent therapies for FL.

Genmab announced Phase 2 results from the innovaTV 207 trial, showing that tisotumab vedotin demonstrated encouraging antitumor activity in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The study, presented at the 2024 ASCO Annual Meeting, revealed a 32.5% confirmed objective response rate (cORR) with one complete response and 12 partial responses. Median duration of response was 5.6 months, and median time-to-response was 1.4 months. The study highlighted treatment options for these patients, emphasizing the need for further clinical development. Safety findings were consistent with previous trials, with the most common Grade ≥3 treatment-emergent adverse events being peripheral neuropathy (40%).

Genmab announced new data from Phase 1/2 trials evaluating epcoritamab, a T-cell engaging bispecific antibody for follicular lymphoma (FL).

The EPCORE™ NHL-2 study showed a 95% overall response rate (ORR) and 85% complete response rate (CRR) in patients with untreated FL.

The EPCORE™ NHL-1 study demonstrated a reduction in cytokine release syndrome (CRS) and no high-grade CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) in relapsed/refractory (R/R) FL patients.

These results were presented at the 2024 ASCO Annual Meeting. Epcoritamab is not yet approved for FL in the U.S. or EU.

Genmab will present multiple abstracts at the 2024 ASCO Annual Meeting. These include studies on epcoritamab, tisotumab vedotin, and acasunlimab, showcasing their efficacy and safety across different cancers.

The presentations will cover six oral and poster sessions, including the first Phase 2 study of acasunlimab in metastatic non-small cell lung cancer (mNSCLC).

Genmab’s Chief Development Officer, Dr. Judith Klimovsky, highlighted the significant progress in developing antibody therapies.

The meeting will be held from May 31 to June 2, 2024, in Chicago, IL, and virtually.

Genmab (Nasdaq: GMAB) has completed the acquisition of ProfoundBio, a clinical-stage biotech firm, for USD 1.8 billion in cash. This acquisition grants Genmab global rights to three clinical candidates, including rinatabart sesutecan (Rina-S), and ProfoundBio's novel antibody-drug conjugate (ADC) technology platforms.

Rina-S is a potential best-in-class ADC currently in part 2 of a Phase 1/2 trial for ovarian cancer and other FRα-expressing tumors. The U.S. FDA has granted Fast Track designation for Rina-S in treating high-grade serous or endometrioid platinum-resistant ovarian cancer.

Genmab expects increased operating expenses due to this acquisition but maintains its revenue guidance. The combination of both companies' ADC technology platforms aims to enhance the development of innovative cancer treatments.

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.