AbbVie (NYSE:ABBV) on Wednesday released new data from a mid-stage trial designed to evaluate how its lymphoma therapy epcoritamab, marketed with Genmab (GMAB), performs when its first full dose is administered in an outpatient setting.
The bispecific antibody is already available in the U.S. as Epkinly for cancerous conditions, including diffuse large B-cell lymphoma (DLBCL), as a late-line option.
Citing updated data from its Phase 2 EPCORE NHL-6 trial, AbbVie (NYSE:ABBV) said that epcoritamab, the first full dose of epcoritamab administered as an injectable for patients with relapsed/refractory DLBCL in the outpatient setting, led to a safety profile in line with its prior studies for R/R DLBCL.
Out of all trial subjects, including those monitored in the inpatient setting, nearly 40% had cytokine release syndrome, most of which were low-grade and resolved within a median time of two days.
The incidence of immune cell-associated neurotoxicity syndrome reached about 8%, and most of the events were low grade and resolved with a median time of three days, the company said, adding that none of the patients dropped out of the trial due to CRS or ICANS events.
AbbVie (NYSE:ABBV) also reported an overall response rate of ~64% and a complete response rate of ~48% in those who received epcoritamab following a single line of systemic therapy with a median follow-up period of 5.8 months.
The results presented at a medical event on Wednesday “suggest that treatment of relapsed/refractory diffuse large B-cell lymphoma with epcoritamab can be safe in the outpatient setting,” said Svetlana Kobina, ABBV’s vice president of oncology medical affairs. “This potential shift to outpatient care could help improve access to treatment.”