New trial results for patients with Relapsed/Refractory Large B-cell Lymphoma

AbbVie and Genmab A/S today announced topline results from the first cohort of the EPCORE™ NHL-1 phase 1/2 clinical trial evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody. The study cohort includes 157 patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy, including 38.9 percent who received prior treatment with chimeric antigen receptor (CAR) T-cell therapy. Based on the topline results, the companies will engage global regulatory authorities.

LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL) – a cancer that develops in the lymphatic system – that affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally. LBCL includes diffuse large B-cell lymphoma (DLBCL), which is the most common type of NHL worldwide and accounts for approximately 31 percent of all NHL cases.1,2,3,4

“We aim to leverage AbbVie’s strong blood cancer expertise to further develop epcoritamab, alongside Genmab, for certain blood cancer patients who have limited treatment options,” said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie.

The topline results from this cohort demonstrated a confirmed overall response rate (ORR) of 63.1 percent by an independent review committee (IRC). The observed median duration of response (DOR) was 12 months. The mean lines of prior therapy in this cohort were 3.5 (2 to 11 lines of therapy). The most common treatment-emergent adverse events of any grade (greater than or equal to 20 percent) included cytokine release syndrome (CRS) (49.7 percent), pyrexia (23.6 percent), fatigue (22.9 percent), neutropenia (21.7 percent), and diarrhea (20.4 percent). The most common Grade 3 or 4 treatment-emergent adverse events (greater than or equal to 5 percent) included neutropenia (14.6 percent), anemia (10.2 percent), neutrophil count decreased (6.4 percent), and thrombocytopenia (5.7 percent). Additionally, the observed Grade 3 CRS was 2.5 percent. The data will be submitted for presentation at a future medical meeting.

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ broad oncology collaboration. The companies remain committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy for a variety of hematologic malignancies, including an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory DLBCL (NCT: 04628494).

“Together with our partner, AbbVie, we will work with regulatory authorities to determine next steps and continue to evaluate epcoritamab in a variety of clinical trials as a potential treatment option for patients with various hematological malignancies,” said Jan van de Winkel, Ph.D., chief executive officer, Genmab. “We look forward to sharing the findings at a future medical meeting.”