Epcoritamab From AbbVie, Genmab Shows Positive Topline Results in Phase 1/2 Trial

DuoBody, for treatment of relapsed/refractory large B-cell lymphoma, demonstrates an overall response rate of 63.1%.

AbbVie and Genmab A/S announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2 trial, evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody.

“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,” Mohamed Zaki, MD, PhD, vice president and head of global oncology development at AbbVie, said in a statement.

The study cohort included 157 individuals with relapsed or refractory large B-cell lymphoma (LBCL) who received at least 2 prior lines of systemic therapy. Approximately 38.9% of individuals received prior treatment with chimeric antigen receptor (CAR) T-cell therapy.

It consisted of 2 parts: a phase 1 first-in-human dose escalation and a phase 2 expansion.

The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL. The dose escalation findings, which are data recommended from the phase 2 dose, were published in The Lancet in 2021.

In the expansion part, additional individuals were treated with epcoritamab to further examine the efficacy and safety of the drug in 3 cohorts of individuals with different types of relapsed or refractory B-NHLs who had limited therapeutic options.

The results showed a confirmed overall response rate of 63.1%. The observed median duration was 12 months, and the mean lines of prior therapy of this cohort was 3.5, with the range being 2 to 11 lines of prior therapy.

The most common adverse events (AEs) of any grade included cytokine release syndrome (CRS), diarrhea, fatigue, neutropenia, and pyrexia.

The most common grade 3 or 4 AEs included anemia, decreased neutrophil count, neutropenia, anemia, and thrombocytopenia. Additionally, the observed grade CRS was 2.5%.

Based on the topline results, the companies will seek approval from global regulatory authorities. The data will also be submitted for presentation at a future medical meeting.

“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,” Jan van de Winkel, PhD, CEO of Genmab, said in the statement. “We look forward to sharing the findings at a future medical meeting.”

Epcoritamab is being co-developed by both companies as part of their broad oncology collaboration. The companies continue to evaluate epcoritamab as a monotherapy and as a combination therapy across lines of therapy for a variety of hematologic malignancies. They have an ongoing open-label, phase 3 randomized trial evaluating epcoritamab as a monotherapy in individuals with relapsed or refractory diffused large B-cell lymphoma (DLBCL).

LBCL is a fast-growing type of non-Hodgkin lymphoma (NHL) that affects B-cell lymphocytes, a type of white blood cell, according to the statement.

It also includes DLBCL, which is the most common type of NHL and accounts for approximately 31% of all NHL cases.

Reference

AbbVie and Genmab announce topline results for epcoritamab (DuoBody®-CD3xCD20) from phase 1/2 trial in patients with relapsed/refractory large B-cell lymphoma (LBCL). AbbVie. News release. April 13, 2022. Accessed April 20, 2022. https://news.abbvie.com/news/press-releases/abbvie-and-genmab-announce-topline-results-for-epcoritamab-duobody-cd3xcd20-from-phase-12-trial-in-patients-with-relapsedrefractory-large-b-cell-lymphoma-lbcl.htm