Subcutaneous (SC) Epcoritamab (GEN3013; DuoBody-CD3xCD20) in patients with relapsed/refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL): dose-escalation data from a phase I/II Trial
Clausen, M. R.
Linton, Kim M
Oliveri, R. S.
AffiliationRigshospitalet, Copenhagen, Denmark
MetadataShow full item record
AbstractContext: CD3×CD20 bispecifi c antibodies (bsAbs) have demonstrated promising results in R/R B-NHL. Epcoritamab is a novel subcutaneously-administered bsAb with a favorable safety profi le and encouraging preliminary anti-tumor activity in both aggressive and indolent B-NHL in a Phase I/II trial (NCT03625037). Objective: Determine recommended phase 2 dose, safety, and anti-tumor activity of epcoritamab. Participants: Adults with R/R CD20+ B-NHL. Intervention: SC 1 mL injection of fl at-dose epcoritamab (dosing escalation range 0.0128–48 mg preceded by a priming and intermediate dose) administered in 28-day cycles until disease progression or unacceptable toxicity. Results: As of 24 April 2020, 58 patients with a median (range) age 68 (21–84) years were enrolled. Most patients had DLBCL (67.2%) or FL (19.0%) and received a median (range) of 3 (1–6) and 5 (1–18) prior lines of treatment, respectively. No dose-limiting toxicities were observed (median follow-up [range]: 2.7 [ 0.2–16.4] months). MTD has not been reached. Majority of TEAEs were mild (Grade 1–2); the most common TEAEs (>35%) were pyrexia (69.0%), fatigue (41.4%), and injection site reaction (41.4%; all Grade 1). AEs of special interest included CRS (56.9%; no Grade 3 events occurred; all resolved) and neurotoxicity (6.9%; median [range] duration of events: 1 [<1– 3] day). There was no tumor lysis syndrome, neutropenic fever, or treatment-related death. Treatment is ongoing in 20 patients. Antitumor activity (14 May 2020) in evaluable patients with DLBCL (12mg) and FL (0.76mg) are: DLBCL (n=15): ORR 60.0% (CR: 20.0%; PR: 40.0%), SD: 6.7%, PD: 33.3%. FL (n=7): ORR 85.7% (PR: 85.7%), SD: 14.3%, no patients with PD. One patient with DLBCL de novo achieved a response post-data cutoff. Median (range) time to response was 1.6 (1–4) months. Conclusions: The safety, effi cacy, and pharmacokinetics data support epcoritamab 48 mg SC (1 mL, single dose) to be explored in the expansion phase. SC epcoritamab continues to demonstrate a favorable safety profi le consistent with previous reported data. Notably, there were no treatment-related deaths, no febrile neutropenia, tumor lysis syndrome, or Grade 3 CRS events. Epcoritamab has the potential for outpatient administration. Epcoritamab induces rapid, deep responses in heavily pretreated patients across different B-NHL subtypes.
CitationHutchings M, Lugtenburg P, Mous R, Clausen MR, Chamuleau M, Linton KM, et al. Subcutaneous (SC) Epcoritamab (GEN3013; DuoBody-CD3xCD20) in patients with relapsed/refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL): dose-escalation data from a phase I/II Trial. Clinical Lymphoma Myeloma & Leukemia. 2020;20:S274-S.
JournalClinical Lymphoma Myeloma & Leukemia
TypeMeetings and Proceedings