For 3L+ DLBCL

THE POWER FOR DURABLE RESPONSES1

Discover subcutaneous EPKINLY, which demonstrated a remarkable 61% ORR with a mDOR* of 15.6 months.
Granted accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

EPKINLY delivered an ORR of 61%, with 38% of patients achieving a deep response of CR1

61% of patients had a response (n=90/148; 95% CI, 53-69), 38% of patients had a complete response (n=56/148; 95% CI, 30-46), and 23% had a partial response (n=34/148; 95% CI, 17-31). Median DOR was 15.6 months (n=90/148; 95% CI, 9.7 months-NR).
  • The median follow-up for DOR was 9.8 months (range: 0-17.3 months)1
  • mDOCR* was NR (n=56/148; 95% CI, 14.3 mo-NR)2
  • Complete responses were achieved as late as 10.2 months2
  • The median follow-up for DOCR was 9.7 months (range: 8.3-12.1 months)2
  • The efficacy of EPKINLY was evaluated in EPCORE® NHL-1, an open-label, multicohort, multicenter, single-arm trial in 148 patients with R/R DLBCL after 2 or more lines of systemic therapy1

Adverse reactions1

  • EPKINLY can cause serious side effects, including CRS, ICANS, infections, cytopenias, and embryo-fetal toxicity
  • Most common ARs (≥20%) were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea
  • CRS was primarily low grade, predictable, and manageable, with grade 3 (2.5% of patients) and no grade 4 events
  • 3.8% discontinued due to ARs; 34% experienced dosage interruptions

Please see more Important Safety Information.

An off-the-shelf subcutaneous
bispecific antibody for DLBCL1

  • Enables rapid treatment initiation at the moment of relapse3
  • Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia prophylaxis and consider initiating prophylaxis against herpes virus to prevent herpes zoster reactivation

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommended

The NCCN Guidelines® recommend epcoritamab-bysp (EPKINLY) as a NCCN Category 2A treatment option after 2 or more lines of systemic therapy for patients with4‡:

R/R DLBCL CATEGORY 2A PREFERRED

Histological transformation of indolent
lymphoma to DLBCL
CATEGORY 2A RECOMMENDED

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

*Based on Kaplan-Meier estimate.

Efficacy results determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC).

See NCCN Guidelines for the NCCN definitions of Categories of Preference and Categories of Evidence and Consensus.

3L=third line; ARs=adverse reactions; CI=confidence interval; CR=complete response; CRS=cytokine release syndrome; DLBCL=diffuse large B-cell lymphoma; DOR=duration of response; DOCR=duration of complete response; ICANS=immune effector cell-associated neurotoxicity syndrome; mDOCR=median duration of complete response; mDOR=median duration of response; NCCN=National Comprehensive Cancer Network®; NR=not reached; ORR=overall response rate; PR=partial response; R/R=relapsed/refractory.

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Learn more about 3L+ DLBCL

VIEW TREATMENT LANDSCAPE

Review clinical trial results, including subgroup analyses data, for EPKINLY

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