b'With EPKINLY, durable responses are within reach 1-3EPKINLY delivered an ORR of 61%, with 38% of patients achieving a deep response of CR 1 OFF-THE-SHELF SUBQ BsAb FOR DLBCL 1Enables rapid treatment initiation at the moment of relapse 238 Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (n=56/148;prophylaxis and consider initiating prophylaxis against herpes virusFor 3L+ DLBCL 95% CI, 30-46)to prevent herpes zoster reactivationTHE POWER 61 ORR MANAGEABLE ADVERSE REACTIONS 1 EPKINLY can cause serious side effects, including CRS, ICANS, FOR DURABLE(n=90/148;infections, cytopenias, and embryo-fetal toxicity95% CI, 53-69) 3.8% discontinued due to ARs; 34% experienced dosage interruptionsRESPONSES 23 % 15.6Most common ARs (20%) were CRS, fatigue, musculoskeletal PR pain, injection site reactions, pyrexia, abdominal pain, nausea, (n=34/148;months and diarrheaDiscover subcutaneous EPKINLY, which demonstrated95% CI, 17-31) mDOR*CRS was primarily low grade, predictable, and manageable, with a remarkable 61% ORR with a mDOR* of 15.6 months. 1 (n=90/148;grade 3 (2.5% of patients) and no grade 4 eventsGranted accelerated approval based on overall response95% CI, 9.7 months-NR)rate and duration of response. Continued approval for The efficacy of EPKINLY was evaluated in EPCORE NHL-1, an open-label, multicohort, multicenter, single-arm trial in 148 this indication may be contingent upon veri cation and1description of clinical bene t in con rmatory trial(s). patients with R/R DLBCL after 2 or more lines of systemic therapy.* Based on Kaplan-Meier estimate. DISCOVER MORE AT3L=third line; AR=adverse reaction; BsAb=bispecific antibody; CR=complete response; CRS=cytokine release syndrome; DLBCL=diffuse large B-cell EPKINLYhcp.com lymphoma; DOCR=duration of complete response; DOR=duration of response; ICANS=immune effector cell-associated neurotoxicity syndrome; mDOCR=median duration of complete response; mDOR=median duration of response; NHL=non-Hodgkin lymphoma; NR=not reached; ORR=overall response rate; PR=partial response; R/R=relapsed/refractory; subq=subcutaneous.INDICATION CRS Infections Embryo-Fetal ToxicityEPKINLY is indicated for the treatment of adults with relapsed or CRS occurred in 51% of patients in the clinical trial (37% grade 1,EPKINLY can cause serious and fatal infections. In the EPKINLY may cause fetal harm when administered to arefractory diff use large B-cell lymphoma (DLBCL), not otherwise17% grade 2, and 2.5% grade 3) and recurred in 16% of patients.clinical trial, serious infections, including opportunisticpregnant woman. Advise females of reproductive potential tospeci ed (NOS), including DLBCL arising from indolent lymphoma,Most events (92%) occurred during cycle 1, with 61% occurringinfections, were reported in 15% of patients treated withuse effective contraception during treatment with EPKINLY and high-grade B-cell lymphoma (HGBL) after 2 or more lines ofafter the 48 mg dose in cycle 1, day 15. In patients whoEPKINLY at the recommended dose (14% grade 3 or 4,and for 4 months after the last dose. Verify pregnancy statussystemic therapy. experienced CRS, the signs and symptoms included pyrexia,1.3% fatal). in females of reproductive potential prior to initiating EPKINLY.hypotension, hypoxia, dyspnea, chills, and tachycardia. Monitor patients for signs and symptoms of infectionAdverse ReactionsThis indication is approved under accelerated approval based onConcurrent neurological adverse reactions associated withprior to and during treatment and treat appropriately. Most common (20%) adverse reactions were CRS, fatigue, response rate and durability of response. Continued approval forCRS occurred in 2.5% of patients and included headache,Avoid administration in patients with active infections.musculoskeletal pain, injection site reactions, pyrexia, this indication may be contingent upon veri cation and description confusional state, tremors, dizziness, and ataxia. Withhold or consider permanent discontinuation ofabdominal pain, nausea, and diarrhea. Most common grade 3 of clinical bene t in a con rmatory trial(s).Administer pretreatment medications to reduce the risk ofEPKINLY based on severity. Prior to starting EPKINLY, provideto 4 laboratory abnormalities (10%) were decreased CRS. Following administration of therst 48 mg dose, patientsPneumocystis jirovecii pneumonia (PJP) prophylaxis andlymphocytes, decreased neutrophils, decreased white blood IMPORTANT SAFETY INFORMATION should be hospitalized for 24 hours.consider prophylaxis against herpes virus. cells, decreased hemoglobin, and decreased platelets.BOXED WARNINGSMonitor patients for potential CRS. At therst signs orCytopenias Lactation Cytokine release syndrome (CRS), including serious or life- symptoms of CRS, manage per current practice guidelines EPKINLY can cause serious or severe cytopenias. In the clinical Advise women not to breastfeed during treatment and for 4 threatening reactions, can occur in patient receiving EPKINLY.and administer supportive care as appropriate. trial, grade 3 or 4 events occurred in 32% (neutropenia), 12%months after the last dose of EPKINLY.Initiate treatment with the EPKINLY step-up dosing scheduleICANS (anemia), and 12% (thrombocytopenia) of patients. Febrile to reduce the incidence and severity of CRS. Withhold EPKINLY ICANS occurred in 6% of patients in the clinical trial (4.5%neutropenia occurred in 2.5%.until CRS resolves or permanently discontinue based on grade 1, 1.3% grade 2, 0.6% fatal). Of the 10 ICANS events, Monitor complete blood counts throughout treatment. Based 9 occurred in cycle 1 of treatment. The onset of ICANS canon severity of cytopenias, temporarily withhold or permanentlyPlease see accompanying Brief Summary of full severity.be concurrent with CRS, following resolution of CRS, or indiscontinue EPKINLY. Consider prophylactic granulocytePrescribing Information, including Boxed Warnings,Immune eff ector cellassociated neurotoxicity syndrome the absence of CRS. Clinical manifestations of ICANScolony-stimulating factor administration as applicable. on the following pages.(ICANS), including life-threatening and fatal reactions, can included, but were not limited to, confusional state, occur with EPKINLY. Monitor patients for neurological signs orlethargy, tremor, dysgraphia, aphasia, and non-convulsiveReferences: 1. EPKINLY [package insert]. Plainsboro, NJ: Genmab US, Inc. and North Chicago, IL: AbbVie Inc. 2023. 2. Hutchings M, Mous R, Clausen MR, symptoms of ICANS during treatment. Withhold EPKINLY untilstatus epilepticus. et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet doi:10.1016/S0140-6736(21)00889-8 3. Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a novel, ICANS resolves or permanently discontinue based on severity.Monitor patients for potential ICANS. At the first signs or . 2021;398(10306):1157-1169.subcutaneous CD3xCD20 bispecific T-cellengaging antibody, in relapsed or refractory large B-cell lymphoma: dose expansion in a phase I/II trial. symptoms of ICANS, manage per current practice guidelinesJ Clin Oncol. Published online December 22, 2022. doi:10.1200/JCO.22.01725and administer supportive care as appropriate.Distributed and marketed by Genmab US Inc. 777 Scudders Mill Road, Plainsboro, NJ 08536.Distributed and marketed by AbbVie Inc. 1 North Waukegan Road, North Chicago, IL 60064. EPKINLY is a trademark of Genmab A/S2023 Genmab A/S and AbbVie. All rights reserved. 10/2023 COM-US-EPK-0000132'