On April 13, 2022 Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) reported 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 (Press release, Genmab, APR 13, 2022, View Source [SID1234612148]). 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 to determine next steps.

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The topline results from this cohort demonstrated an overall response rate (ORR) of 63.1 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response (DOR) was 12 months. The most common treatment-emergent adverse event was cytokine release syndrome (CRS) with 49.7 percent, including 2.5 percent grade 3. The data will be submitted for presentation at a future medical meeting.

Epcoritamab is being co-developed by Genmab and AbbVie 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 diffuse large B-cell lymphoma (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 of Genmab. "We look forward to sharing the findings at a future medical meeting."

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 DLBCL, which is the most common type of NHL worldwide and accounts for approximately 31 percent of all NHL cases.i,ii,iii,iv

"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.

About the EPCORE NHL-1 Trial

EPCORE NHL-1 an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of two parts: a phase 1 first-in-human, dose escalation part; and a phase 2 expansion part. The trial was designed to evaluate

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Genmab and AbbVie Announce Topline Results for Epcoritamab (DuoBody-CD3xCD20) From Phase 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL)

subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including LBCL and DLBCL. The dose escalation findings, which determined the recommended phase 2 dose RP2D, were published in The Lancet in 2021. In the phase 2 expansion part, additional patients are being treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who had limited therapeutic options.

The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, complete response (CR) rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were evaluated as secondary efficacy endpoints.

About Epcoritamab

Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of lymphoma B cells.v CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.vi,vii Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.