AbbVie’s Epkinly Enters Follicular Lymphoma Market, Competing with Roche’s Lunsumio

1. FDA Approval: The FDA has granted accelerated approval to AbbVie and Genmab's Epkinly (epcoritamab) for the treatment of relapsed or refractory follicular lymphoma (FL) after at least two prior lines of therapy.
2. Bispecific Antibody: Epkinly is a subcutaneously administered, bispecific antibody targeting CD3 and CD20, which redirects and activates T-cells to CD20-expressing cancer B-cells, resulting in potent and selective T-cell-mediated cytotoxic activity.
3. Competition: Epkinly faces direct competition with Roche's Lunsumio (mosunetuzumab), another bispecific CD20-directed CD3 T-cell engager, which is already approved for FL treatment.
4. Efficacy: Epkinly demonstrated a high overall response rate (82%) and complete response rate (63%) in the Phase I/II EPCORE NHL-1 clinical trial, with a median follow-up of 17.4 months.
5. Safety Profile: Epkinly has a boxed warning for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), but the optimised step-up dose regimen reduced CRS symptoms.
6. Market Potential: Epkinly is projected to increase its sales if a second approval is obtained in the r/r FL setting, despite competition from Lunsumio, which is expected to reach $964 million in global sales by 2029.