Genmab : Epcoritamab Combo Shows High Response Rates In 1b/2 Trial For R/R Follicular Lymphoma

(RTTNews) - Genmab A/S (GMAB) announced new results from the Phase 1b/2 EPCORE NHL-2 trial evaluating fixed-duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

The results demonstrated an overall response rate (ORR) of 96 percent and a complete response (CR) rate of 87 percent among 111 patients after a median follow-up of two years. Additionally, the study showed an estimated 21-month progression-free survival (PFS) rate of 80 percent and a two-year overall survival (OS) rate of 90 percent.

Additional data from the study showed an estimated 89 percent of complete responders to the combination therapy remained in CR at 18 months.

With the majority of patients being enrolled and treated during the global COVID-19 pandemic, COVID-19 was reported in 57 percent of patients and led to epcoritamab discontinuation in 13 percent of patients. Five cases of COVID-19 led to fatal treatment-emergent adverse events. The other most common treatment-emergent adverse events were neutropenia (62 percent) and cytokine release syndrome (CRS; 51 percent).

Cytokine release syndrome events with the 2-step step-up dose regimen were mostly low grade (38 percent Grade 1, 12 percent Grade 2, 2 percent Grade 3) and primarily occurred following the first full dose. All cytokine release syndrome cases resolved. One case of immune effector cell-associated neurotoxicity syndrome (ICANS) was reported (Grade 1). The cytokine release syndrome and ICANS cases did not lead to treatment discontinuation.

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