AbbVie's TEPKINLY Receives EU Conditional Marketing Authorization for Diffuse Large B-Cell Lymphoma

Strategic Insights -

The European Commission has granted conditional marketing authorization to AbbVie's TEPKINLY (epcoritamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This approval marks a significant milestone in the treatment of DLBCL patients, with TEPKINLY becoming the first subcutaneous T-cell engaging bispecific antibody to receive such approval in the European Union, Liechtenstein, Norway, and Iceland. The conditional approval is supported by data from the pivotal EPCORE NHL-1 Phase 1/2 trial, which demonstrated preliminary efficacy and safety of TEPKINLY in patients with R/R large B-cell lymphoma, including its subtype DLBCL.

Key Takeaways:

  • AbbVie's TEPKINLY (epcoritamab) received conditional marketing authorization from the European Commission for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • TEPKINLY is a subcutaneous T-cell engaging bispecific antibody, making it the first and only approved treatment for DLBCL patients in the European Union, Liechtenstein, Norway, and Iceland.
  • The conditional approval was supported by data from the pivotal EPCORE NHL-1 Phase 1/2 trial, which showed an overall response rate of 62% and a complete response rate of 39% in DLBCL patients treated with TEPKINLY (N=139).
  • The median duration of response was 15.5 months, with a range of 9.7 months to not reached.
  • TEPKINLY demonstrated a manageable safety profile, with common adverse reactions including cytokine release syndrome, fatigue, neutropenia, injection site reaction, musculoskeletal pain, abdominal pain, pyrexia, nausea, and diarrhea.
  • AbbVie and Genmab co-develop TEPKINLY as part of their oncology collaboration, and the companies will share commercial responsibilities in the US and Japan.
  • AbbVie will be responsible for further global commercialization of TEPKINLY.

Statistics:

  • 62% overall response rate in DLBCL patients treated with TEPKINLY (N=139)
  • 39% complete response rate in DLBCL patients treated with TEPKINLY (N=139)
  • Median duration of response was 15.5 months
  • Range of duration of response was 9.7 months to not reached
  • Common adverse reactions included cytokine release syndrome (≥20%), fatigue (≥20%), neutropenia (≥20%), injection site reaction (≥20%), musculoskeletal pain (≥20%), abdominal pain (≥20%), pyrexia (≥20%), nausea (≥20%), and diarrhea (≥20%)

Sources:

  • Abbvie, website: https://www.abbvie.com/ (accessed 25 Sep 2023)