EMA validates AbbVie lymphoma bispecific antibody application

AbbVie’s marketing application for epcoritamab in adults with relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.

EMA validates AbbVie's application for lymphoma bispecific antibody

AbbVie has announced that the European Medicines Agency (EMA) has validated its Marketing Authorisation Application (MAA) for epcoritamab, a bispecific antibody (bsAb) for adults with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after more than two lines of systemic therapy, offering patients a potential new therapy option.

Additionally, Danish biotech Genmab has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for epcoritamab for adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

The submissions are supported by Phase II trial data. The study evaluated the safety and efficacy of the drug in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL).

Dr Mohamed Zaki, Vice President and Head of global oncology development at AbbVie commented: “This achievement represents an initial step… in providing an important treatment option with the potential to become a core therapy for people living with B-cell malignancies such as LBCL and DLBCL.”

Clinical trials for epcoritamab, a bsAb drug

AbbVie and Genmab, which developed epcoritamab, intend to evaluate the medicine as a monotherapy and in combination, across lines of therapy for a variety of haematologic malignancies. An ongoing Phase III, open-label, randomised trial (04628494) is currently evaluating epcoritamab as a monotherapy for patients with these cancers.

The clinical trial comprises of two parts: a first-in-human Phase I and two Phase III parts: dose escalation (which identified the recommended dose for patients) and expansion (which evaluated how the drug affected a larger cohort of patients). Data from the dose escalation section of the investigation was published in The Lancet in 2021.

The primary endpoint for the expansion part was overall response rate (ORR). An independent review committee (IRC) assessed this data point. The secondary efficacy measures observed were:

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