Genmab Stock Price, News & Analysis

Genmab A/S (Nasdaq: GMAB) announced that AbbVie (NYSE: ABBV) will submit a conditional marketing authorization application (MAA) to the European Medicines Agency for epcoritamab to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in H2 2022. This follows Genmab's intention to submit a biologics license application (BLA) to the FDA for the same drug. The MAA is supported by preliminary efficacy results from the EPCORE™ NHL-1 trial, emphasizing the significant medical need for new treatment options for patients with DLBCL.

Genmab A/S (NASDAQ: GMAB) announced promising results from the EPCORE™ NHL-1 phase 2 trial of epcoritamab for relapsed/refractory large B-cell lymphoma (LBCL). With a total patient population of 157, the study reported an overall response rate (ORR) of 63% and a complete response (CR) of 39%. Notably, CAR T-naïve patients exhibited a 69% ORR, while those previously treated with CAR T had a 54% ORR. Epcoritamab demonstrated a manageable safety profile, with treatment-emergent adverse events primarily occurring in the initial treatment weeks. Results were showcased at the EHA Annual Congress.

Genmab and Seagen presented interim results from the Phase 1b/2 innovaTV 205 trial on June 6, 2022, indicating a 41% objective response rate (ORR) in patients with recurrent or metastatic cervical cancer treated with tisotumab vedotin and pembrolizumab. This study highlights a median progression-free survival of 5.3 months and notable durability of response. Common treatment-related adverse events included alopecia and diarrhea. A new web-based tool was introduced to identify areas needing cervical cancer intervention, reflecting the companies' commitment to addressing healthcare disparities.

Seagen and Genmab have announced interim results from the innovaTV 205 trial, revealing a 41% objective response rate (ORR) for tisotumab vedotin in combination with pembrolizumab among patients with recurrent or metastatic cervical cancer (r/mCC). The data, presented at ASCO 2022, also shows a median progression-free survival of 5.3 months. The trial included 33 patients, with 25% achieving partial responses. Adverse events were primarily manageable, with common occurrences including alopecia and diarrhea. The companies will continue to explore tisotumab vedotin in combination therapies to address unmet needs.

Genmab (Nasdaq: GMAB) announced the acceptance of multiple abstracts for presentation at the 2022 ASCO Annual Meeting, showcasing investigational medicines from its pipeline. Key highlights include data from the phase 1b/2 EPCORE™ NHL-2 trial evaluating epcoritamab (DuoBody-CD3xCD20) in B-cell non-Hodgkin lymphoma and an oral presentation of tisotumab vedotin in recurrent or metastatic cervical cancer. The findings reinforce Genmab's commitment to delivering innovative therapies, with partnerships alongside AbbVie (ABBV) and Seagen (SGEN).

Genmab A/S (Nasdaq: GMAB) announced that multiple abstracts showcasing preliminary efficacy and safety findings of epcoritamab (DuoBody-CD3xCD20) will be presented at the European Hematology Association (EHA) Annual Congress in Vienna, Austria, from June 9-12. The studies include various clinical trials, focusing on B-cell non-Hodgkin lymphoma treatments. Epcoritamab is co-developed with AbbVie (NYSE: ABBV), underscoring a commitment to deliver new treatment options for patients.

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.