FDA priority review for AbbVie lymphoma bispecific antibody

The US Food and Drug Administration (FDA) has accepted priority review of AbbVie’s Biologics License Application of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody (BsAb), for adults with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

The application is supported by results from the LBCL cohort of the EPCORE™ NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL).

Epcoritamab is developed by AbbVie and Genmab and is being evaluated as a monotherapy and in combination, across lines of therapy in a range of haematologic malignancies. This includes an ongoing Phase III, open-label, randomised clinical trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (04628494) and a Phase III, open-label clinical trial evaluating epcoritamab in combination for relapsed/refractory follicular lymphoma (05409066).

EPCORE™ NHL-1 Trial of epcoritamab 

EPCORE™ NHL-1 is an open-label, multi-centre safety and preliminary efficacy trial of epcoritamab. The research programme includes a first-in-human Phase I, dose escalation part; a Phase II expansion part; and an optimisation part, to evaluate epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including LBCL and DLBCL. Data from the dose escalation part of the study, to determine the recommended Phase II dose, was published in The Lancet in 2021. In the Phase II expansion part, additional patients, with different types of relapsed/refractory B-cell NHLs with otherwise limited therapeutic options, are grouped into three cohorts.

The primary endpoint for the Phase II expansion part of the trial was overall response rate. Secondary efficacy endpoints included:

• Duration of response
• Complete response rate
• Progression-free survival
• Overall survival
• Time to response
• Time to next therapy
• Rate of minimal residual disease negativity.

The European Medicines Agency (EMA) recently validated a Marketing Authorisation Application (MAA) for epcoritamab for adults with relapsed/refractory DLBCL – a major subtype of LBCL – after two or more lines of systemic therapy.

“This milestone signals an early step in our hope to develop a core therapy for people living with B-cell malignancies,” commented Dr Mohamed Zaki, PhD, Vice President and Head of Global Oncology Development at AbbVie.