FOR 3L+ FL

THE POWER FOR DURABLE RESPONSES1

EPKINLY demonstrated a remarkable 82% ORR* with mDOR*† not reached.

Approved under accelerated approval. Continued approval contingent
upon clinical benefit verification in confirmatory trial(s).

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

 

Even with a high enrollment of patients with difficult-to-treat disease,‡ 60% CR was observed in EPCORE® NHL-11-4

82% of patients had an overall response rate (n equals 104 out of 127; 95% CI, 74 to 88), 60% of patients had a complete response (n equals 76 out of 127; 95% CI, 51­ to 68), and 22% had a partial response (n equals 28 out of 127; 95% CI, 15­ to 30). Median duration of response or mDOR was not reached (n equals 104 out of 127; 95% Cl, 13.7­ to Not Reached).

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).5*

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

†Based on Kaplan-Meier estimate. The median follow-up for DOR was 14.8 months.5

‡Difficult-to-treat disease characteristics included age >65, double refractory, refractory to ≥2 consecutive lines of antilymphoma therapy, and POD24.1-4

§Median study follow-up was 17.4 months.6

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 outcomes6,7:
    • 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.6

Manageable Safety Profile1

  • With the 3-step up dosage schedule:
    • No grade ≥3 CRS events were observed; CRS occurred in 49% of patients (45% grade 1; 9% grade 2)
  • Warnings and precautions include CRS, ICANS, infections, cytopenias, and embryo-fetal toxicity
  • Most common adverse reactions (≥20%) were injection site reactions, CRS, COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache

Please see full Important Safety Information, including Boxed Warnings.

In 86 patients who received EPKINLY following the recommended 3-step up dosage schedule.

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 adverse reactions

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 follicular lymphoma.8#

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; POD24=progression of disease within 24 months; PR=partial response.

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