79%
reduction
in the risk of disease progression or death vs R2
(HR=0.21‡; 95% CI, 0.13-0.33; P<0.0001§)
The efficacy and safety of EPKINLY in combination with R2 vs R2 alone was evaluated in EPCORE® FL-1, an open-label, randomized, multicenter, global trial in 488 patients with R/R FL after 1 prior line of therapy. Efficacy was established based on PFS and ORR.
*Efficacy results determined by Lugano criteria (2014) as assessed by IRC and based on prespecified interim analysis.
†The median duration of study follow-up was 10.4 months in the ITT population. Patients received EPKINLY via subcutaneous injection in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first.
‡Cox proportional hazards hazard ratio stratified by disease history and region.
§Log-rank P-value (one-sided) stratified by disease history and region.
Manageable safety profile; generally consistent with the established profiles of EPKINLY and R2 1,2
- No grade ≥3 CRS events were observed; CRS occurred in 24% of patients (19% grade 1; 5% grade 2)
- Warnings and precautions include CRS, ICANS, infections, cytopenias, and embryo-fetal toxicity
- Most common adverse reactions (≥20%) in patients who received EPKINLY + R2 were rash, upper respiratory tract infections, fatigue, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever
Please see full Important Safety Information, including Boxed Warnings.
Hospitalization is not required for monitoring with EPKINLY administration. Assess each patient.1
- 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 select 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) in combination with lenalidomide and rituximab as an NCCN Category 1 preferred treatment option for patients with relapsed or refractory follicular lymphoma.3||
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.
2L=second line; AR=adverse reaction; Cl=confidence interval; COVID-19=coronavirus disease 2019; CRS=cytokine release syndrome; FL=follicular lymphoma; HR=hazard ratio; ICANS=immune effector cell–associated neurotoxicity syndrome; IRC=Independent Review Committee; ITT=intent to treat; NCCN=National Comprehensive Cancer Network® (NCCN®); ORR=overall response rate; PFS=progression-free survival; R2=rituximab + lenalidomide; R/R=relapsed/refractory.
