How safe and effective is epcoritamab for the treatment of patients with relapsed or refractory B-cell non-Hodgkin lymphoma?

The authors investigated the safety and effectiveness of epcoritamab (DuoBody-CD3xCD20) for the treatment of patients with relapsed or refractory (r/r) CD20+ B-cell non-Hodgkin lymphoma (B-NHL).

The study showed that this medication has promising effectiveness and safety in these patients. 

B-NHL is a type of blood cancer. CD20 is a protein found on cells of the immune system called B cells (CD20 positive B cells; CD20⁺). High-dose chemotherapy and autologous stem-cell transplantation (ASCT) have been the standard treatment of r/r B-NHL. However, there are patients that do not respond to standard therapy or relapse (cancer returns) sooner.

Many new therapies targeting CD20, called monoclonal antibodies, are emerging. Epcoritamab targets CD20 and another protein found on B cells called CD3. However, the safety and tolerated dose of epcoritamab in the treatment of r/r B-NHL remain under investigation.

This study included 69 patients with r/r CD20⁺ B-NHL. All patients received epicoritamab treatment in increasing doses up to 60 mg administered subcutaneously (inder the skin injection). The average follow up period was 9.2 months. 

68% of patients with r/r B-NHL responded to treatment and 45% had a complete response (complete disappearance of cancer) at doses of 12 – 50 mg. At 48 mg (the recommended dose), 88% of patients responded to treatment and 38% had a complete response.

90% of patients with r/r follicular lymphoma (a type of NHL) responded to treatment and 40% had a complete response at doses of 0.76 – 48 mg.

The most common side effects were fever (69%), cytokine release syndrome (59%; when inflammatory cells are rapidly released in the body causing fever and other organ dysfunction), and injection site reactions (47%).

This study showed that epcoritamab has promising safety and effectiveness in the treatment of patients with r/r CD20⁺ B-NHL. The recommended dose of 48 mg was identified for future clinical trials.

This study is funded by Genmab and AbbVie who manufacture epcoritamab. This was a phase I/II clinical trial. It had a small number of participants, short follow-up period and did not have any comparison group. Further studies are needed.