30May

Epcoritamab (GEN3013) to induce CR in pts with R/R B-NHL: Complete dose escalation data and efficacy results from a phase I/II trial

Epcoritamab (GEN3013; DuoBody-CD33CD20) to induce complete response in patientswith relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL): Complete dose esca-lation data and efficacy results from a phase I/II trial


Abstract No : 8009

Abstract Type : Oral Abstract Session

Indication : NHL (DLBCL/FL)

Intervention : Epcoritamab

Company : Genmab

Technology : Bispecefic Antibody


Results:

As of 8 Jan 2020, 41 pts with median age of 66 (range: 21–82) were enrolled. Most pts had DLBCL/HGBCL (73%) or FL (20%) and received a median (range) of 3 (1–6) and 5 (2–18) prior lines of treatment. No DLTs were observed (median follow-up: 4.7 mo; range: 3.7– 5.6). MTD has not been reached. Most common TEAEs (>35%) were pyrexia (71%), fatigue (46%), and injection site reaction (39%; all Gr 1). AEs of special interest included cytokine release syndrome (59%; all Gr 1/2; all resolved) and cytokine release-related decreased CARTOX-10 score (n=1). There was no clinical tumor lysis syndrome or treatment-related deaths. Treatment is ongoing in 13 pts. Anti-tumor activity was observed at minimal efficacy threshold (based on PK modelling) for DLBCL/HGBCL and FL (Table). Complete dose escalation data and RP2D will be presented.


Conclusion:

SC epcoritamab continues to demonstrate a favorable safety profile across all doses with no ≥Gr 3 CRS and no DLTs. Dose escalation data show improved efficacy as doses reach above the modeled predicted exposure threshold, inducing CRs in heavily pretreated DLBCL pts. All pts achieving CRs remain in remission


Commentary:

Pcoritamab demonstrates efficacy (ORR 50%) in R/R patients who failed multiple previous line of therapies.


Refer to Diffuse Large B-Cell Lymphoma Market report for detailed Insights.