EPKINLY + R2 has a manageable safety profile; generally consistent with the established profiles of EPKINLY and R2 1,2

Most common treatment-related ARs (≥10%)1

Adverse reaction* EPKINLY + R2 R2
  All grades (%) Grade 3 or 4 (%) All grades (%) Grade 3 or 4 (%)
  (n=131)† (n=238)
Cytokine release syndrome 24†‡ 0 0.8 0
  (n=243) (n=238)
Rash§ 46 11II 34 6II
Upper respiratory tract infections§ 33 3.3 18 0.4II
Fatigue§ 31 4.9II 24 2.1II
Injection site reactions 27 0 0.4 0
Constipation 26 0.8II 21 0
Pneumonia§ 24 16II 8 4.6
COVID-19§ 23 5II 13 1.3II
Fever 23 0.4II 11 1.3II
Neurological changes§ 15 1.2II 8 1.3II
Insomnia 14 0 2.9 0
Mucositis§ 12 0 3.4 0
Headache 11 0 3.8 0
Adverse reaction* EPKINLY + R2
  All grades (%) Grade 3 or 4 (%)
  (n=131)‡
Cytokine release syndrome 24†‡ 0
  (n=243)
Rash§ 46 11II
Upper respiratory tract infections§ 33 3.3
Fatigue§ 31 4.9II
Injection site reactions 27 0
Constipation 26 0.8II
Pneumonia§ 24 16II
COVID-19§ 23 5II
Fever 23 0.4II
Neurological changes§ 15 1.2II
Insomnia 14 0
Mucositis§ 12 0
Headache 11 0
Adverse reaction* R2
  All grades (%) Grade 3 or 4 (%)
  (n=238)
Cytokine release syndrome 0.8 0
  (n=238)
Rash§ 34 6II
Upper respiratory tract infections§ 18 0.4II
Fatigue§ 24 2.1II
Injection site reactions 0.4 0
Constipation 21 0
Pneumonia§ 8 4.6
COVID-19§ 13 1.3II
Fever 11 1.3II
Neurological changes§ 8 1.3II
Insomnia 2.9 0
Mucositis§ 3.4 0
Headache 3.8 0

*ARs were graded based on CTCAE Version 5.0. CRS was graded using ASTCT consensus criteria (Lee et al., 2019).

†The frequency of CRS is based on 131 patients who received EPKINLY at the recommended 3-step up dosage schedule. Grade 1 CRS: 19%; Grade 2 CRS: 5%.

‡The frequency of CRS among the 243 patients who received either the 2-step up or 3-step up dosage schedule was the following: any grade CRS 35%; Grade 1 CRS: 28%; Grade 2 CRS: 7%.

§Term includes other related terms. See full Prescribing Information.

IIOnly Grade 3 ARs occurred.

Includes 1 case with a fatal outcome.

In 243 patients who received EPKINLY + R2:

  • The median duration of exposure was 10 cycles for EPKINLY and 9 cycles for lenalidomide
  • Serious ARs occurred in 51% of these patients, including serious infections in 28% of patients and serious CRS in 12% of patients. Fatal adverse reactions within 60 days of last treatment occurred in 0.8% of patients
  • Adverse reactions led to permanent discontinuation of EPKINLY in 6% of patients and dose interruption in 75% of patients, with infection as a leading cause. Adverse reactions leading to interruption of EPKINLY in ≥5% of patients included respiratory tract infections, CRS, and rash
  • In the EPKINLY arm, adverse reactions led to lenalidomide dose interruption in 72%, dose reduction in 22%, and permanent discontinuation in 15%
  • Warnings and precautions include CRS, ICANS, infections, cytopenias, and embryo-fetal toxicity
  • The most common Grade 3 to 4 laboratory abnormalities (≥10%) in the EPKINLY + R2 arm vs the R2 arm, respectively, were decreases in neutrophil count (67% vs 41%), decreases in lymphocyte count (62% vs 15%), and decreases in platelet count (10% vs 7%)

AR=adverse reaction; ASTCT=American Society for Transplantation and Cellular Therapy; CRS=cytokine release syndrome; CTCAE=Common Terminology Criteria for Adverse Events; ICANS=immune effector cell–associated neurotoxicity syndrome; R2=rituximab + lenalidomide.

Connect with a representative to learn more about EPKINLY

GET CONNECTED

Review the CRS and ICANS events that occurred in the clinical trial

FIND OUT MORE