Genmab reported positive Phase I/II data for its bispecific antibody, which was developed in collaboration with AbbVie at the European Haematology Association (EHA).
The open-label, multinational Phase I/II EPCORE NHL-2 trial (NCT04663347) investigates epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab-lenalidomide (R2).
The companies’ reported an overall response rate (ORR) of 98% and complete metabolic response (CMR) of 87% in response evaluable patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The results will be presented at the European Haematology Association (EHA) congress, being held in Frankfurt from June 8-11, 2023.
Additional findings from the study reported a consistent ORR and CMR across high-risk subgroups, including a 98% ORR and a 75% CMR in patients whose disease progressed within 24 months.
Results from this study were also presented at this year’s American Society of Clinical Oncology (ASCO) Meeting on June 6, 2023.
Updated results from the EPCORE NHL-1 (NCT03625037) large B-cell lymphoma (LBCL) expansion cohort, including longer follow-up (median follow up was 20 months) in challenging-to-treat, relapsed or refractory CD20+ LBCL patients were also reported.
Results reported an ORR of 63.1% and complete response (CR) of 39.5% in patients with R/R LBCL and a 61.9 percent ORR and 39.6 percent CR in patients with R/R diffuse large B-cell lymphoma (DLBCL).
The median overall survival (OS) was 18.5 months for LBCL patients and 19.4 months for DLBCL patients. The median duration of CR in both patient populations was 20.8 months.
OS was not reached among complete responders in both patient populations.
Other epcoritamab trials, Phase III EPCORE DLBCL-2 (NCT05578976) and Phase II EPCORE DLBCL-3 (NCT05660967) have dosed the first patients. The trials have been designed to evaluate the safety and efficacy of epcoritamab as first-line treatment in adult and elderly patients with newly diagnosed DLBCL, respectively.
Epcoritamab-bysp (Epkinly) was approved in the US this May, and is indicated for the treatment of adult patients with relapsed or refractory DLBCL.
GlobalData forecasts that the first-to-market advantage would propel Epkinly sales to $1.8 billion in 2029.
GlobalData is the parent company of Clinical Trials Arena.
