Genmab A/S develops antibody medicines for cancer and other serious diseases through therapeutic formats that include bispecific antibodies, antibody-drug conjugates, immune-modulating antibodies and other next-generation modalities. Company news commonly centers on clinical data, regulatory interactions and portfolio decisions for programs such as EPKINLY®/epcoritamab, rinatabart sesutecan (Rina-S®) and petosemtamab.
Recurring updates also cover collaborations and commercialization economics tied to antibody products, including DARZALEX® royalties under the Johnson & Johnson license, EPKINLY development with AbbVie, research partnerships, and capital or shareholder announcements. Genmab’s disclosures frequently connect pipeline progress with hematologic malignancies, solid tumors and the company’s broader antibody-technology strategy.
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.
Seagen and Genmab announced promising interim results for tisotumab vedotin in treating recurrent or metastatic cervical cancer during the ESMO Virtual Congress 2021. In a phase 1b/2 study, tisotumab vedotin combined with carboplatin achieved a 55% objective response rate (ORR) in previously untreated patients, while the combination with pembrolizumab yielded a 38% ORR in previously treated patients. Both treatments demonstrated manageable safety profiles, indicating potential new therapy options for this hard-to-treat cancer.
Genmab (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) announced the publication of results from the phase 1/2 EPCORE™ NHL-1 clinical trial in The Lancet. The trial evaluated the investigational therapy epcoritamab for B-cell non-Hodgkin’s lymphoma (B-NHL). Findings indicate a maximum tolerated dose of 48mg, with an overall response rate (ORR) of 88% and a complete response (CR) of 38% in patients treated with the RP2D. The results were presented at multiple medical congresses, highlighting the drug's potential in hematologic malignancies.
AbbVie and Genmab announced the publication of results from the dose escalation part of the Phase 1/2 EPCORE NHL-1 trial for epcoritamab, an investigational therapy targeting relapsed/refractory B-cell non-Hodgkin's lymphoma. The trial identified a recommended Phase 2 dose of 48mg with an overall response rate of 88% and a complete response rate of 38% in patients with DLBCL. Epcoritamab demonstrated a favorable safety profile, with common adverse events being primarily grade 1-2. The results underline significant interest in new treatment options for patients with hematologic malignancies.
Genmab A/S (Nasdaq: GMAB) and Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) announced a collaboration for oncology research and development. The partnership aims to combine Genmab's antibody technologies with Bolt's Boltbody™ immune-stimulating antibody conjugate platform to develop novel cancer treatments. Genmab will invest USD 10 million upfront and USD 15 million in equity into Bolt, with potential milestone payments of up to USD 285 million per therapeutic candidate. The collaboration will evaluate multiple bispecific antibody concepts.
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced the FDA's acceptance of their Biologics License Application (BLA) for tisotumab vedotin, targeting recurrent or metastatic cervical cancer. This application, filed in February 2021, is under Priority Review, with a decision expected by October 10, 2021. The BLA is based on the innovaTV 204 trial results, highlighting the need for new therapies in a field with low response rates. Both companies aim to enhance treatment options for patients with this severe condition.
Seagen and Genmab submitted a Biologics License Application (BLA) to the FDA for tisotumab vedotin, aimed at treating recurrent or metastatic cervical cancer following chemotherapy. The BLA is based on the innovaTV 204 phase 2 clinical trial, which showed durable responses and a manageable safety profile in patients. Approximately 13,500 women are diagnosed with invasive cervical cancer annually in the U.S., highlighting the need for effective therapies. This milestone could significantly benefit patients with high unmet medical needs.