Genmab A/S (NASDAQ:GMAB) today announced the results from multiple clinical trials evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, alone or in combination with other therapies for the treatment of patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), previously untreated FL, and Richter’s Syndrome (RS). These data, along with additional results from the phase 1/2 EPCORE NHL-1 clinical trial, evaluating the safety and efficacy of epcoritamab in patients with R/R large B-cell lymphoma (LBCL), are being presented at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in New Orleans, Louisiana, and virtually, December 10-13, 2022.
“The breadth of clinical data for epcoritamab presented at ASH demonstrates Genmab’s commitment to addressing treatment needs for people living with a variety of B-cell lymphomas,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Together with AbbVie, we continue to evaluate epcoritamab in various treatment settings and patient populations to unlock its potential to become a core therapy for B-cell malignancies.”
Notably, results from the phase 1b/2 EPCORE NHL-2 arm (Abstract #443) evaluating 27 patients with R/R DLBCL who were eligible for autologous stem cell transplant, showed an 85 percent (23/27) overall response rate (ORR) and a 67 percent (18/27) complete metabolic response (CMR) rate, following treatment with the combination of subcutaneous epcoritamab plus standard rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin (R-DHAX/C) salvage therapy. The most common treatment-emergent adverse events (TEAEs) of any grade were thrombocytopenia (69 percent), anemia (51 percent), neutropenia (44 percent), cytokine release syndrome (CRS) (41 percent), nausea (31 percent), fatigue (28 percent), constipation, diarrhea, headache, pyrexia (all at 24 percent), and increased aspartate aminotransferase (AST) (21 percent). These results were highlighted during an oral presentation on Sunday, December 11, 2022, at 10:30 a.m. CST.
Results from two additional arms of the EPCORE NHL-2 study, evaluating subcutaneous epcoritamab in combination with rituximab and lenalidomide, one arm in patients with R/R FL and the other arm in previously untreated FL, will be presented during an oral session on Sunday, December 11, 2022, beginning at 4:30 p.m. CST.
In the R/R FL arm (Abstract #609), 95 percent (63/66) of efficacy evaluable patients treated with subcutaneous epcoritamab in combination with rituximab and lenalidomide achieved an overall response. Among these patients, 80 percent (53/66) achieved a CMR, and 15 percent (10/66) achieved a partial metabolic response (PMR). The majority of patients achieved a response at the first tumor response assessment and most continued to respond through the latest assessment at the time of data collection. The most common TEAEs of any grade were neutropenia (47 percent), CRS (43 percent), injection-site reactions (32 percent), fatigue (31 percent), constipation, COVID-19, pyrexia (all at 25 percent), and infusion-related reaction (21 percent).
In the previously untreated FL patient arm (Abstract #611), 94 percent (34/36) of efficacy evaluable patients who received subcutaneous epcoritamab in combination with rituximab and lenalidomide achieved an overall response, including 86 percent (31/36) achieving a CMR as their best overall response. The most common TEAEs of any grade were CRS (54 percent), neutropenia (47 percent), pyrexia (44 percent), fatigue (37 percent), injection site reaction (37 percent), headache (34 percent), COVID-19 (33 percent), diarrhea (32 percent), constipation (29 percent), rash (27 percent), increased alanine aminotransferase (ALT) (22 percent), and vomiting (22 percent).
Preliminary results from the phase 1b/2 open-label, multi-center safety and efficacy EPCORE CLL-1 trial (Abstract #348) showed that treatment with investigational subcutaneous epcoritamab monotherapy had promising antitumor activity in 10 patients with Richter’s Syndrome, with a 60 percent ORR and a 50 percent CMR rate. Most responses were observed by the first assessment at week six. The most common related TEAEs of any grade percent were CRS (90 percent), anemia (50 percent), neutropenia (50 percent), injection-site reaction (40 percent), thrombocytopenia (40 percent), and hypophosphatemia, hypokalemia, hyperglycemia, COVID-19, diarrhea, fatigue, and nausea (all at 30 percent). These results were highlighted during an oral session on Saturday, December 10, 2022, at 5:15 p.m. CST.
