For 3L+ DLBCL

THE POWER OF SUSTAINED REMISSION

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

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% of patients 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).
  • PR: 23% (n=34/148; 95% CI, 17-31)
  • 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
  • The median follow-up for DOR was 9.8 months (range: 0-17.3 months)1

Manageable safety profile1

  • 3.8% discontinued due to ARs; 34% experienced dosage interruptions
  • 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 events occurring in 2.5% of patients and no grade 4 events
  • Warnings and precautions include CRS, ICANS, infections, cytopenias, and embryo-fetal toxicity

Please see full Important Safety Information, including Boxed Warnings.

Hospitalization is not required for monitoring with EPKINLY administration. Assess each patient.

  • Due to the risk of CRS and ICANS, monitor all patients for signs and symptoms
    • Assess whether hospitalization or outpatient monitoring for the first 48 mg dose is appropriate based on comorbidities or other situational factors
    • During outpatient monitoring after the first 48 mg dose, patients should remain in proximity to a healthcare facility that can assess and manage CRS
  • Hospitalization may be needed to manage some adverse reactions

Please see Dosing and Administration for more information.

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 with2‡:

R/R DLBCL NCCN CATEGORY 2A PREFERRED

Histological transformation of indolent
lymphoma to DLBCL NCCN 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.

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

†Based on Kaplan-Meier estimate. The median follow-up for DOR was 9.8 months (range: 0-17.3 months).

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

2L=second line; 3L=third line; AR=adverse reaction; 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® (NCCN®); NR=not reached; ORR=overall response rate; PR=partial response; R/R=relapsed/refractory.

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