Genmab A/S ADS - GMAB STOCK NEWS

AbbVie and Genmab announced topline results from the EPCORE™ NHL-1 clinical trial for epcoritamab (DuoBody®-CD3xCD20), targeting relapsed/refractory large B-cell lymphoma (LBCL). The trial involved 157 patients with a confirmed overall response rate (ORR) of 63.1% and a median duration of response (DOR) of 12 months. Common adverse events included cytokine release syndrome (49.7%) and neutropenia (21.7%). The companies plan to engage global regulatory authorities and present data at a future medical conference.

Genmab (NASDAQ: GMAB) and AbbVie (NYSE: ABBV) announced positive topline results from the EPCORE™ NHL-1 clinical trial for epcoritamab, a bispecific antibody targeting large B-cell lymphoma (LBCL). The trial, involving 157 patients, demonstrated an overall response rate (ORR) of 63.1%, surpassing efficacy benchmarks, with a median duration of response (DOR) of 12 months. The companies will engage global regulatory authorities to determine next steps and plan to present detailed data at an upcoming medical meeting.

Genmab A/S (NASDAQ: GMAB) announced that the FDA has granted orphan-drug designation to epcoritamab (DuoBody®-CD3xCD20) for treating follicular lymphoma (FL). This designation aids the development of treatments for rare diseases affecting fewer than 200,000 people annually. FL is the second most common form of non-Hodgkin’s lymphoma, impacting approximately 2.7 per 100,000 people in the U.S. Epcoritamab is currently in multiple clinical trials, providing hope for patients who are refractory to conventional therapies.

Genmab A/S (NASDAQ: GMAB) and Seagen Inc. (NASDAQ: SGEN) announced preliminary results from the innovaTV 207 phase 2 trial of tisotumab vedotin (TIVDAK®) for squamous cell carcinoma of the head and neck. Of 31 patients treated, a 16% objective response rate was observed. Secondary endpoints showed a disease control rate of 58.1% and median progression-free survival of 4.2 months. Safety data indicated a manageable profile, with 67.7% experiencing Grade ≥3 adverse events. The findings will be presented at the ASTRO 2022 symposium on February 25.

Seagen and Genmab will present preliminary data from the innovaTV 207 phase 2 trial of tisotumab vedotin (TIVDAK) for patients with squamous cell carcinoma of the head and neck at the ASTRO 2022 symposium. Results indicate a 16% confirmed objective response rate, with 58.1% disease control rate and a median progression-free survival of 4.2 months. Noteworthy adverse events included Grade ≥3 treatment-emergent adverse events in 67.7% of patients. The data underscores the potential of tisotumab vedotin in treating this high-need patient group, with ongoing trials planned.

Genmab A/S (GMAB) announced several abstract presentations at the 63rd Annual ASH Meeting, showcasing the efficacy of epcoritamab (DuoBody®-CD3xCD20) for treating B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Over 20 abstracts from Genmab and its partners, including AbbVie (ABBV) and Janssen, will be shared, highlighting clinical trial results. A virtual R&D Update and ASH Data Review is scheduled for December 14, focusing on these advancements in oncology.

Genmab A/S (NASDAQ: GMAB) announced multiple presentations at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021), held November 10-14 in Washington, DC. The highlights include a mini-oral presentation of the first-in-human trial for DuoBody®-CD40×4-1BB (GEN1042) and a poster on DuoBody®-PD-L1×4-1BB (GEN1046). Both investigational bispecific antibodies are co-developed with BioNTech (NASDAQ: BNTX). Genmab emphasizes its commitment to advancing cancer treatment through these innovative therapies.

The FDA has granted accelerated approval to TIVDAK (tisotumab vedotin-tftv), the first antibody-drug conjugate for adult patients with recurrent or metastatic cervical cancer after chemotherapy. This decision is based on the innovaTV 204 clinical trial, which showed a 24% confirmed objective response rate and a median duration of response of 8.3 months. However, continuous approval is contingent on further verification of clinical benefits. The drug carries significant safety warnings, including ocular toxicity.

TIVDAK (tisotumab vedotin-tftv) has received accelerated approval from the FDA as the first approved antibody-drug conjugate for adults with recurrent or metastatic cervical cancer after chemotherapy. This decision is based on tumor response and its duration, with ongoing trials for further verification. The innovaTV 204 trial showed a confirmed objective response rate of 24% among 101 patients, with a median duration of response of 8.3 months. The approval includes warnings for serious adverse effects, particularly ocular toxicity.