FDA Grants Priority Review to Subcutaneous Epcoritamab for Previously Treated R/R LBCL

Based on positive findings from the phase 2 pivotal EPCORE NHL-1, the FDA will conduct a speedy review of the biologics license application for subcutaneous epcoritamab for the treatment of patients with relapsed/refractory large B-cell lymphoma after 2 or more lines of systemic therapy an granted it priority review.

The FDA has accepted the biologics license application for subcutaneous epcoritamab (DuoBody-CD3xCD20) for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after 2 or more lines of systemic therapy an granted it priority review.1

The BLA for subcutaneous epcoritamab was supported by findings from the LBCL cohort of the open-label, multi-center phase 2 pivotal EPCORE NHL-1 (NCT03625037). Results presented that the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA 2022), showed that the subcutaneous epcoritamab achieved deep and durable response in the patients with relapsed/refractory LBCL.1,2

As previously reported by Targeted Oncology™, the confirmed overall response rate (ORR) observed with epcoritamab in EPCORE™ NHL-1 in patients with LBCL treated with at least 3 prior lines of therapy was 63% with a complete response (CR) rate of 39% in the overall population. Investigator assessed response in patients who were naïve to chimeric antigen receptor (CAR) T cells and those who were refractory to CAR T cells. In the CAR T-naïve population, the ORR was 60% with a 42% CR rate. In patients who failed on CAR T-cell therapy, the ORR with epcoritamab was 54% with a CR rate of 34%. At a median follow-up of 10.7 months, epcoritamab achieved a median duration of response (DOR) of 12 months.2

In terms of safety, the most common any-grade treatment-emergent adverse events (TEAEs) included cytokine release syndrome (CRS; 49.7%), pyrexia (23.6%), fatigue (22.9%), neutropenia (21.7%), and diarrhea (20.4%). TEAEs of any-grade occurred in 20% of patients. The grade 3 or 4 TEAEs most commonly observed were neutropenia (14.6%), anemia (10.2%), neutrophil count decreased (6.4%), and thrombocytopenia (5.7%). Grade 3/4 TEAEs occurred in 5% of patients in the study. There were also cases of grade 3 CRS in 2.5% of patients.

EPCORE NHL-1 is includes patients with relapsed/refractory LBCL who are heavily pretreated and have an ECOG performance status of 0-2, detectable disease on PET scan. adequate liver and renal function, and a life expectancy of at least 2 months. Patients enrolled will be assessed for the primary end point of overall survival, and secondary efficacy end points including, progression-free survival, ORR, complete response rate, duration of response, time to response, rate and duration of minimal residual disease (MRD) negative status, time to next anti-lymphoma therapy, and anti-epcoritamab antibody response.3

Secondary safety end points being explored in the study include the incidence and severity of AEs, the incidence and severity of changes in laboratory values, incidence of dose delays, and health-related quality of life.

REFERENCES:

1. Genmab announces U.S. Food and Drug Administration accepts for priority review biologics license application (BLA) for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large b-cell lymphoma (LBCL). New release. November 21, 2022. Accessed November 21, 2022. https://bit.ly/3Vebi3D

2. Genmab announces late-breaking phase 2 trial results of investigational epcoritamab (DuoBody®-CD3xCD20) in relapsed/refractory large b-cell lymphoma (LBCL) patients presented at European Hematology Association (EHA) Presidential Symposium. Genmab A/S. June 11, 2022. Accessed October 28, 2022. https://bit.ly/3gRxVMx

3. A phase 3 trial of epcoritamab vs investigator's choice chemotherapy in r/r DLBCL (EPCORE™DLBCL-1), ClinicalTrials.gov. Updated September 16, 2022. Accessed October 28, 2022. https://clinicaltrials.gov/ct2/show/NCT04628494?term=epcoritamab&draw=2