NOW APPROVED FOR 3L+ FL

THE POWER FOR DURABLE RESPONSES1

EPKINLY demonstrated a remarkable 82% ORR* with mDOR†
not reached. Granted accelerated approval based on overall
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).

EPKINLY is the first-and-only subcutaneous
bispecific antibody in FL

EPKINLY delivered an ORR of 82%, with 60% of patients achieving a deep response of CR1

82% of patients had an overall response rate (n=104/127; 95% CI, 74-88), 60% of patients had a complete response (n=76/127; 95% CI, 51-68), and 22% had a partial response (n=28/127; 95% CI, 15-30). Median DOR was not reached (n=104/127; 95% Cl, 13.7-NR).

Rapid response1

  • In responders (n=104), the median time to first response was 1.4 months (range: 1-3 months)†

In a prespecified analysis of complete responders (n=76), the median time to complete response was 1.5 months (range: 1.2-11.1).2

*Efficacy results determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC).1

†Median study follow-up was 17.4 months.3

The efficacy results of the 86 patients who received the recommended 3-step up dosage schedule in the EPCORE® NHL-1 dose optimization cohort were comparable to the primary efficacy endpoints.1‡

  • Investigator-assessed efficacy outcomes3,4:
    • ORR: 86% (n=74/86; 95% Cl, 76.9-92.6)
    • CR: 64% (n=55/86; 95% Cl, 52.9-74.0)
    • PR: 22% (n=19/86)

‡Median study follow-up for the dose optimization cohort was 5.7 months.3

Safety profile

  • EPKINLY can cause serious side effects, including CRS, ICANS, infections, cytopenias, and embryo-fetal toxicity
  • Most common ARs (≥20%) were injection site reactions, CRS, COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache
  • CRS was primarily low grade, predictable, and manageable with no grade 3 or higher events§

Please see full Important Safety Information, including Boxed Warnings.

§In 86 patients who received EPKINLY following a 3-step up dosage schedule. The 3-step up dosage schedule is the recommended dosage for patients with R/R FL.

OFF-THE-SHELF SUBCUTANEOUS
OUTPATIENT ADMINISTRATION1

Hospitalization is not required to administer EPKINLY

  • EPKINLY should only be administered by a qualified HCP with appropriate medical support to manage severe reactions such as CRS and ICANS
  • Due to the risk of CRS and ICANS, monitor all patients for signs and symptoms
  • Hospitalization may be needed to manage some ARs

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

The NCCN Guidelines® recommend epcoritamab-bysp (EPKINLY) as an NCCN Category 2A preferred treatment option after 2 or more lines of systemic therapy for patients with relapsed or refractory (R/R) follicular lymphoma.5||

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.

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

3L=third line; AR=adverse reaction; CI=confidence interval; CR=complete response; CRS=cytokine release syndrome; DOR=duration of response; FL=follicular lymphoma; ICANS=immune effector cell-associated neurotoxicity syndrome; mDOR=median duration of response; NCCN=National Comprehensive Cancer Network; NR=not reached; ORR=overall response rate; PR=partial response.

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