Information offered on the 66th Annual Assembly and Exposition of the American Society of Hematology (ASH)
“These data highlight the potential benefits of epcoritamab in treating patients with relapsed or refractory follicular lymphoma. Moreover, they show that epcoritamab in combination with the commonly used therapy of lenalidomide with rituximab (R2) could offer a potentially strong and durable treatment option,” mentioned Mariana Cota Stirner, M.D., Ph.D., vp, therapeutic space head for hematology, AbbVie. “These data are very encouraging as we continue to further evaluate the potential of epcoritamab in combination with R2 in an ongoing pivotal Phase 3 trial and further establish epcoritamab as a core therapy for the treatment of B-cell malignancies.”
FL is usually an indolent (or slow-growing) type of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second commonest type of NHL accounting for 20-30% of all instances.2,3 About 15,000 individuals develop FL annually in the us4 and it’s thought-about incurable with present customary of care therapies.5 Sufferers typically relapse and, with every relapse the remission and time to subsequent remedy is shorter.6 Over time, transformation to diffuse massive B-cell lymphoma (DLBCL), an aggressive type of NHL related to poor survival outcomes, can happen in additional than 25% of FL sufferers.7
“Because follicular lymphoma is incurable, patients with relapsed or refractory follicular lymphoma need more therapeutic options,” mentioned Lorenzo Falchi, M.D., Lymphoma Specialist, Division of Drugs, Memorial Sloan Kettering Most cancers Middle. “The durable responses seen in the EPCORE NHL-2 trial support the ongoing investigation of epcoritamab in combination with the standard regimen of rituximab plus lenalidomide.”
Overview of Part 1b/2 EPCORE ® NHL-2 Information Outcomes:
This examine’s major endpoint was ORR per Lugano standards, and grownup sufferers with R/R FL acquired subcutaneous epcoritamab + R2 for as much as 12 cycles, adopted by 12 further cycles of epcoritamab monotherapy (28 days every cycle). Amongst 111 sufferers with a median follow-up of over two years, the ORR was 96%, and the CR fee was 87%. At 18 months an estimated 89% of full responders to the mixture remedy remained in CR (period of CR; DoCR), 41 sufferers accomplished remedy per protocol. Minimal residual illness (MRD) evaluation from blood samples confirmed that 88% of sufferers had been MRD detrimental, indicating no detectable illness at 10-6 threshold.8COVID-19 was reported in 57% of sufferers and led to epcoritamab discontinuation in 13% of sufferers. 5 instances of COVID-19 led to deadly treatment-emergent adversarial occasions (TEAEs; COVID-19, n=3; COVID-19 pneumonia, n=2). The opposite commonest TEAEs had been neutropenia (62%) and cytokine launch syndrome (CRS; 51%). CRS occasions with the 2-step step-up dose routine had been largely low grade (38% Grade 1, 12% Grade 2, 2% Grade 3) and primarily occurred following the primary full dose. All CRS instances resolved. One case of immune effector cell-associated neurotoxicity syndrome (ICANS) was reported (Grade 1). The CRS and ICANS instances didn’t result in remedy discontinuation.
Use of epcoritamab + R2 in R/R FL isn’t authorized within the U.S. or within the EU or in another territory. The security and efficacy of epcoritamab to be used as a mixture remedy in FL haven’t been established.
Latest Breakthrough Remedy Designation for Epcoritamab:
The U.S. Meals and Drug Administration (FDA) not too long ago granted a breakthrough remedy designation (BTD) for epcoritamab plus R2 for the remedy of grownup sufferers with R/R FL who’ve acquired a minimum of one prior line of remedy. Epcoritamab together with R2 is being studied additional within the ongoing, randomized, Part 3 EPCORE FL-1 trial (NCT05409066).
Concerning the EPCORE ® NHL-2 TrialEPCORE ® NHL-2 is a Part 1b/2 open-label interventional trial to guage the security, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and together with different customary of care brokers in sufferers with B-cell non-Hodgkin’s lymphoma (B-NHL). The trial consists of two components: Half 1 (Dose Escalation) and Half 2 (Dose Enlargement). The first goal of Half 1 is security, and it contains Arm 1-5 and Arm 10. Half 2 contains all 10 arms (Arm 1-10) and the first aim of all arms, besides Arm 7, is preliminary efficacy. Arm 2 of the trial is epcoritamab + rituximab and lenalidomide (R2) in individuals with relapsed/refractory (R/R) follicular lymphoma (FL). Extra info on this trial could be discovered at https://www.clinicaltrials.gov/ (NCT: 04663347). The first endpoint was total response fee (ORR) based mostly on finest total response per Lugano standards. MRD negativity was assessed as a secondary endpoint.
Concerning the EPCORE ® FL-1 TrialEPCORE ® FL-1 is a Part 3 open-label interventional trial to guage the security and efficacy of epcoritamab + rituximab and lenalidomide (R2) versus R2 alone in sufferers with relapsed/refractory (R/R) follicular lymphoma (FL). The first endpoint is progression-free survival (PFS) assessed by impartial evaluation committee (IRC) per Lugano standards. Further endpoints embody proportion of individuals attaining full response (CR), total survival (OS) and proportion of sufferers attaining minimal residual illness (MRD) negativity. Extra info on this trial could be discovered at https://www.clinicaltrials.gov/ (NCT: 05409066).
About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created utilizing Genmab (NASDAQ:)’s proprietary DuoBody ® know-how and administered subcutaneously. Genmab’s DuoBody-CD3 know-how is designed to direct cytotoxic T cells selectively to elicit an immune response towards goal cell sorts. Epcoritamab is designed to concurrently bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.9 Epcoritamab (authorized below the model title EPKINLY ® within the U.S. and Japan, and TEPKINLY ® within the EU) has acquired regulatory approval in sure lymphoma indications in a number of territories. Epcoritamab is being co-developed by Genmab and AbbVie as a part of the businesses’ oncology collaboration. The businesses share business duties within the U.S. and Japan, with AbbVie answerable for additional world commercialization. Each firms will pursue further worldwide regulatory approvals for the investigational R/R FL indication and extra approvals for the R/R DLBCL indication.
Genmab and AbbVie proceed to guage the usage of epcoritamab as a monotherapy, and together, throughout strains of remedy in a spread of hematologic malignancies. This contains 5 ongoing Part 3, open-label, randomized trials together with a trial evaluating epcoritamab as a monotherapy in sufferers with R/R DLBCL in comparison with investigators alternative chemotherapy (NCT04628494), a trial evaluating epcoritamab together with R-CHOP in grownup sufferers with newly identified DLBCL (NCT05578976), a trial evaluating epcoritamab together with rituximab and lenalidomide (R2) in sufferers with R/R FL (NCT05409066), a trial evaluating epcoritamab together with rituximab and lenalidomide (R2) in comparison with chemoimmunotherapy in sufferers with beforehand untreated FL (NCT06191744), and a trial evaluating epcoritamab together with lenalidomide in comparison with chemotherapy infusion in sufferers with R/R DLBCL (NCT06508658). The security and efficacy of epcoritamab has not been established for these investigational makes use of. Please go to¯www.clinicaltrials.gov¯for extra info.
EPKINLY ® (epcoritamab-bysp) INDICATIONS & U.S. IMPORTANT SAFETY INFORMATION
What’s EPKINLY? EPKINLY is a prescription drugs used to deal with adults with sure forms of diffuse massive B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come again or that didn’t reply to earlier remedy after receiving 2 or extra therapies. EPKINLY is authorized based mostly on affected person response knowledge. Research are ongoing to substantiate the medical advantage of EPKINLY. It isn’t recognized if EPKINLY is secure and efficient in youngsters.
Vital Warnings”EPKINLY may cause critical negative effects, together with:
Cytokine launch syndrome (CRS), which is frequent throughout remedy with EPKINLY and could be critical or life-threatening. To assist scale back your threat of CRS, you’ll obtain EPKINLY on a step-up dosing schedule (if you obtain 2 or 3 smaller step-up doses of EPKINLY earlier than your first full dose throughout your first cycle of remedy), and you may additionally obtain different medicines earlier than and for 3 days after receiving EPKINLY. In case your dose of EPKINLY is delayed for any motive, it’s possible you’ll must repeat the step-up dosing schedule.Neurologic issues that may be life-threatening and result in loss of life. Neurologic issues could occur days or even weeks after you obtain EPKINLY.
Folks with DLBCL or high-grade B-cell lymphoma must be hospitalized for twenty-four hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 because of the threat of CRS and neurologic issues.
Inform (WA:) your healthcare supplier or get medical assist straight away for those who develop a fever of 100.4 °F (38 °C) or increased; dizziness or lightheadedness; hassle respiration; chills; quick heartbeat; feeling anxious; headache; confusion; shaking (tremors); issues with steadiness and motion, reminiscent of hassle strolling; hassle talking or writing; confusion and disorientation; drowsiness, tiredness or lack of vitality; muscle weak spot; seizures; or reminiscence loss. These could also be signs of CRS or neurologic issues. When you’ve got any signs that impair consciousness, don’t drive or use heavy equipment or do different harmful actions till your signs go away.
EPKINLY may cause different critical negative effects, together with:
Infections which will result in loss of life. Your healthcare supplier will verify you for indicators and signs of an infection earlier than and through remedy and deal with you as wanted for those who develop an an infection. It’s best to obtain medicines out of your healthcare supplier earlier than you begin remedy to assist forestall an infection. Inform your healthcare supplier straight away for those who develop any signs of an infection throughout remedy, together with fever of 100.4 °F (38 °C) or increased, cough, chest ache, tiredness, shortness of breath, painful rash, sore throat, ache throughout urination, or feeling weak or typically unwell.Low blood cell counts, which could be critical or extreme. Your healthcare supplier will verify your blood cell counts throughout remedy. EPKINLY could trigger low blood cell counts, together with low white blood cells (neutropenia), which may enhance your threat for an infection; low crimson blood cells (anemia), which may trigger tiredness and shortness of breath; and low platelets (thrombocytopenia), which may trigger bruising or bleeding issues.
Your healthcare supplier will monitor you for signs of CRS, neurologic issues, infections, and low blood cell counts throughout remedy with EPKINLY. Your healthcare supplier could quickly cease or utterly cease remedy with EPKINLY for those who develop sure negative effects.
Earlier than you obtain EPKINLY, inform your healthcare supplier about all of your medical situations, together with you probably have an an infection, are pregnant or plan to develop into pregnant, or are breastfeeding or plan to breastfeed. If you happen to obtain EPKINLY whereas pregnant, it could hurt your unborn child. In case you are a feminine who can develop into pregnant, your healthcare supplier ought to do a being pregnant check earlier than you begin remedy with EPKINLY and you must use efficient contraception (contraception) throughout remedy and for 4 months after your final dose of EPKINLY. Inform your healthcare supplier for those who develop into pregnant or assume that you could be be pregnant throughout remedy with EPKINLY. Don’t breastfeed throughout remedy with EPKINLY and for 4 months after your final dose of EPKINLY.
In DLBCL or high-grade B-cell lymphoma, the most typical negative effects of EPKINLY embody CRS, tiredness, muscle and bone ache, injection website reactions, fever, stomach-area (belly) ache, nausea, and diarrhea. The most typical extreme irregular laboratory check outcomes embody decreased white blood cells, decreased crimson blood cells, and decreased platelets.
In follicular lymphoma the most typical negative effects of EPKINLY embody injection website reactions, CRS, COVID-19, tiredness, higher respiratory tract infections, muscle and bone ache, rash, diarrhea, fever, cough, and headache. The most typical extreme irregular laboratory check outcomes embody decreased white blood cells and decreased crimson blood cells.
These aren’t all the attainable negative effects of EPKINLY. Name your physician for medical recommendation about negative effects. You’re inspired to report negative effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).
Please see Full Prescribing Data and Treatment Information, together with Vital Warnings.
About AbbVie in OncologyAt AbbVie, we’re dedicated to remodeling requirements of take care of a number of blood cancers whereas advancing a dynamic pipeline of investigational therapies throughout a spread of most cancers sorts. Our devoted and skilled staff joins forces with revolutionary companions to speed up the supply of potential breakthrough medicines. We’re evaluating greater than 20 investigational medicines in over 300 medical trials throughout among the world’s most widespread and debilitating cancers. As we work to have a outstanding influence on individuals’s lives, we’re dedicated to exploring options to assist sufferers receive entry to our most cancers medicines. For extra info, please go to http://www.abbvie.com/oncology.
Disclosure: Dr. Falchi has monetary pursuits associated to AbbVie and Genmab.
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