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MajesTEC-4 / EMN30 Trial

Maintenance therapy in transplant-eligible NDMM post-ASCT — Janssen (Johnson & Johnson)

Maintenance therapy in transplant-eligible NDMM post-ASCTTECVAYLIASH 2024
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Top KOLs Discussing MajesTEC-4 / EMN30

Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP
@RahulBanerjeeMD
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Hamza Hashmi
Hamza Hashmi
@hhashmi87
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Samer Al Hadidi, MD,MS,FACP
Samer Al Hadidi, MD,MS,FACP
@HadidiSamer
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Luciano J Costa
Luciano J Costa
@End_myeloma
539 impressions
Ben Derman
Ben Derman
@bdermanmd
493 impressions
Elias K. Mai MD
Elias K. Mai MD
@EliasKarlMai
401 impressions

MajesTEC-4 / EMN30 Key Slides & Visuals

Official trial slides and relevant visuals shared by KOLs at ASH 2024. Click any image to expand.

Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP @RahulBanerjeeMD
MajesTEC-4 / EMN30 Data
1.9K impressions · 11 likes · Mar 1, 2025
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[Slide 1] BCMA-agents for transplant- eligible patients Teclistamab induction in TE patients Teclistamab maintenance in NDMM after ASCT: GMMG-HD10/DSMM-XX (MajesTEC-5) Trial Phase 3 EMN30/MajesTEC-4 study Liby SA) Plane Randomized that Induction cycles" 18 cycles in - Primary enquired IN ABCT ORR NOR M la Beyond b 20 25 Pre-Post-maintenance MRD rates (10-5) in OF-X Am 4t W CANDR Aml 3 . yond Blood 25 20 legathe . N 18,1 100.0 IN legather B.) 0 as legative 0.) I 1 Post Alch nots Gal Got got got our (M) - (x)0) (+2) (M)) (MI) Date Canef 3 boy - Cash X Vader Mard 12g Medan 12m as eduate patients negativity C) IT MRD positive Zamagni E. et al ASH24 Raab M et all ASH24
Samer Al Hadidi, MD,MS,FACP
MajesTEC-4 / EMN30 Data
1.2K impressions · 7 likes · Nov 9, 2024
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[Slide 1] SOCIETY or ASH Annual Meeting & Exposition 494 Phase 3 Study of Teclistamab (Tec) in Combination with Lenalidomide (Len) and Tec Alone Versus Len Alone in Newly Diagnosed Multiple Myeloma (NDMM) As Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT): Safety Run-in (SRI) Results from the Majestec-4/EMN30 Trial Program: Oral and Poster Abstracts Type: Oral Session: 654. Multiple Myeloma: Pharmacologic Therapies: Targeting BCMA Hematology Disease Topics & Pathways: Research, Clinical trials, Bispecific Antibody Therapy, Clinical Research, Plasma Cell Disorders, Diseases, Treatment Considerations, Biological therapies, Lymphoid Malignancies, Adverse Events Sunday, December 8, 2024: 9:45 AM Elena Zamagni, MD¹*, Tobias Silzle, MD²*, Ivan Å piA ka³*, Sabrin Tahri, MD⁴*, Sarah Lonergan⁴, Inger S. Nijhof, MD, PhD⁵*, Antonietta Pia Falcone, MD, PhD⁶*, Evangelos Terpos7*, Jakub Radocha, MD, PhD⁸*, Roberto Mina9*, Guldane Cengiz Seval, MD¹⁰*, Meral Beksac, MD¹¹, Cesar Rodriguez, MD¹²*, Marcelo C. Pasquini, MD, MS¹³,¹⁴, Michel Delforge¹⁵*, Vania Hungria, MD, PhD¹⁶, Donna Reece, MD¹⁷, Philippe Moreau, MD, PhD¹⁸*, Yael C. Cohen¹⁹, Kihyun Kim, MD²⁰*, Dominik Dytfeld2¹*, JiA™ MinaÅ Irene Strass/2³*, Jelena Bila, MD²⁴*, Martin Schreder, MD²⁵*, Janusz Krawczyk, MD²⁶, Fredrik Schjesvold, MD, PhD²⁷, Caroline Cicin-Sain²⁸*, Christoph Driessen²⁹, Gordon Cook³⁰*, Lugui Qiu, MD³¹, Gonzalo Martin Garate, MD³²*, Agoston Gyula Szabo, MD, PhD³³, Roman HÄ¡jek³⁴, Marc S. Raab, M.D.³⁵*, Silvia Mangiacavalli, MD³⁶*, Hermann Einsele, MD³⁷, Andrew Spencer, MBBS³⁸*, Mario Boccadoro, MD³⁹,⁴⁰, Helen Vassalou41*, Lixia Pei42*, Yingqi Shi43*, Maria Krevvata, PhD44*, Ryan Gruber44*, Caline Sakabedoyan⁴⁵*, Margaret Cobb⁴⁶*, Jagoda Jasielec⁴³*, Himal Amin⁴³*, Rachel Kobos, MD⁴³, Pieter Sonneveld, MD⁴⁷ and Niels W.C.J. van de Donk, MD, PhD48*
Ben Derman
Ben Derman @bdermanmd
MajesTEC-4 / EMN30 Data
387 impressions · 7 likes · Dec 8, 2024
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[Slide 1] EMN30/MajesTEC-4: Study Design SRI Phase 3, randomized study Key eligibility criteria: SRI Cohort 1: Tec-Len Tec-Len Dual primary endpoints: PFS NDMM Tec QW Q4W Tec Q4W 12-month MRD-negative CR (by NGF; 10⁻⁵) ECOG PS score of 0-2 Received 4-6 cycles of 1:1:1 randomization Select secondary endpoints: os 3- or 4-drug induction SRI Cohort 2: Tec-Len N=1500 Tec >CR therapy (PI and/or IMiD + Tec Q4W Tec Q4W CR conversion anti-CD38 antibody) and MRD-negative conversion ASCTᵃ ± consolidation MRD negativity/sustained MRD negativity with ≥PR PFS2 SRI Cohort 3: Tec TTNT Len Safety Tec Q4W "Single or tandem ASCT permitted. ASCT, autologous stem cell transplantation; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; E MN, Stichting European Myeloma Network; IMiD, immunomodulatory drug; Len, lenalidomide; MRD, minimal residual disease; NDMM, newy diagnosed multiple myeloma; NGF, next-generation flow cytometry, OS, overall survival; PFS, progression-free survival; PFS2, progression-free survival after next line of therapy, PI, proteosome inhibitor; PR, partial response; QW, weekly, Q4W, every 4 weeks; SRI, safety run-in; Tec, teclistamab; TTNT, time to next treatment. 3 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA USA --- [Slide 2] EMN30/MajesTEC-4 SRI: Dosing Cycle 1 Cycle 2 Cycles 3-6 Cycles 7-26 Cohort 1: Tec-Len Tec step upᵃ + Tec 1.5 mg/kg QW Tec 3.0 mg/kg Q2W Tec 3.0 mg/kg Q4W Tec 1.5 mg/kg on D8, D15, Tec QW Q4W + Len + Len + Len and D22 Cohort 2: Tec-Len Tec step upᵃ + Tec 3.0 mg/kg Q4W Tec Q4W Tec 1.5 mg/kg on D8 and D15 + Len Cohort 3: Tec Tec step upᵃ + Tec 1.5 mg/kg on D8 and D15 Tec 3.0 mg/kg Q4W Tec Q4W Len was initiated at 10 mg/dayb from Cycles 2 to 4, followed by 15 mg/day in Cycles 5 to 26, if tolerated 2-year fixed-duration maintenance regimenᶜ "Patients received step-up doses of 0.06 and 0.3 mg/kg. in 28-day cycles. Patients who achieved CR on Tec-Len after 1 year discontinued Tec and continued Len for another year. CR, complete response; D, Day; EMN, Stichting European Myeloma Network; Len, lenalidomide; QW, weekly, Q2W, every 2 weeks; Q4W, every 4 weeks; SRI, safety run-in; Tec, teclistamab. 4 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA USA --- [Slide 3] EMN30/MajesTEC-4 SRI: Hematologic TEAEs Cohort 1: Cohort 2: Cohort 3: Cumulative incidence of grade 3/4 Tec-Len Tec-Len Tec neutropenia at 6 months: (QW Q4W) (Q4W) (Q4W) (N=32) (N=32) (N=30) - Cohort 1: 81.3% Median follow-up, mo 21.1 9.2 9.2 - Cohort 2: 56.3% TEAEs,ᵃ n (%) Any grade Grade 3/4 Any grade Grade 3/4 Any grade Grade 3/4 - Cohort 3: 40.0% Any TEAE 32 (100) 32 (100) 32 (100) 27 (84.4) 30 (100) 17 (56.7) Hematologic Aes Median relative dose intensity: Neutropenia 30 (93.8) 30 (93.8) 21 (65.6) 20 (62.5) 17 (56.7) 14 (46.7) - 95.5% to 99.7% for Tec Leukopenia 9 (28.1) 3 (9.4) 1 (3.1) 0 1 (3.3) 1 (3.3) - 58.4% to 61.5% for Len Lymphopenia 2 (6.3) 1 (3.1) 4 (12.5) 4 (12.5) 4 (13.3) 4 (13.3) Thrombocytopenia 6 (18.8) 2 (6.2) 0 0 2 (6.7) 0 Low rates of treatment discontinuation due to TEAEs (5.3% overall) Febrile neutropenia 3 (9.4) 3 (9.4) 3 (9.4) 3 (9.4) 0 0 Anemia 3 (9.4) 0 1 (3.1) 1 (3.1) 1 (3.3) 0 Eosinophilia 1 (3.1) 1 (3.1) 1 (3.1) 1 (3.1) 0 0 Teclistamab every 4 weeks from Cycle 2 had a lower cumulative incidence of grade 3/4 neutropenia than teclistamab weekly every 4 weeks Data cutoff date: September 9, 2024. AEs (graded according to the NCI-CTCAE Version 5.0); any grade occurring in >25% of patients or grade 3/4 in >1 patient. AE, adverse event; EMN, Stichting European Myeloma Network; Len, lenalidomide; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; QW, weekly; Q4W, every 4 weeks; SRI, safety run-in; TEAE, treatment-emergent adverse event; Tec, teclistamab. 7 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual M eeting and Exposition; December 7-10, 2024; San Diego, CA, USA --- [Slide 4] EMN30/MajesTEC-4 SRI: Nonhematologic TEAEs Cohort 1: Cohort 2: Cohort 3: Among the most common Tec-Len Tec-Len Tec nonhematologic TEAEs, rates of (QW Q4W) (Q4W) (Q4W) grade 3/4 events were low (N=32) (N=32) (N=30) All CRS events were grade 1/2, Median follow-up, mo 21.1 9.2 9.2 mostly occurring during Tec step-up TEAEs,ᵃ n (%) Any Any Any dosing grade Grade 3/4 grade Grade 3/4 grade Grade 3/4 - 37.2% after Step-up Dose 1 Nonhematologic AEsb CRS 16 (50.0) 0 13 (40.6) 0 13 (43.3) 0 - 8.5% after Step-up Dose 2 URTI 20 (62.5) 1 (3.1) 13 (40.6) 0 8 (26.7) 0 - 5.3% after Treatment Dose 1 Cough 15 (46.9) 0 6 (18.8) 0 8 (26.7) 0 - No discontinuations due to CRS Diarrhea 13 (40.6) 3 (9.4) 9 (28.1) 1 (3.1) 6 (20.0) 0 No ICANS Injection-site erythema 7 (21.9) 0 12 (37.5) 0 8 (26.7) 0 COVID-19 12 (37.5) 1 (3.1) 5 (15.6) 0 9 (30.0) 1 (3.3) Fatigue 10 (31.3) 1 (3.1) 8 (25.0) 1 (3.1) 5 (16.7) 0 Pneumonia 9 (28.1) 4 (12.5) 3 (9.4) 0 2 (6.7) 1 (3.3) Data cutoff date: September 9, 2024. AEs (graded according to the NCI-CTCAE Version 5.0); any grade occurring in >25% of patients or grade 3/4 in >10% of patients. Hypogammaglobulinemia based on TEAE reporting also met the >25% threshold and is reported separately. AE, adverse event; CRS, cytokine release syndrome; EMN, Stichting European Myeloma Network; ICANS, immune effector cell-associated neurotoxicity syndrome; Len, lenalidomide; QW, weekly; Q4W, every 4 weeks; SRI, safety run-in; TEAE, treatment-emergent adverse event; Tec, tedistamab; URTI, upper respiratory tract infection. 8 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA, USA
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP @RahulBanerjeeMD
MajesTEC-4 / EMN30 Data
225 impressions · 8 likes · Dec 8, 2024
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[Slide 1] EMN Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone vs Lenalidomide Alone in Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation: Safety Run-in Results From the EMN30/MajesTEC-4 Trial* "ClinicalTrials.gov Identifier: NCT05243797; sponsored by EMN in collaboration with Janssen Research & Development, LLC Elena Zamagni1, Tobias Silzle2, Ivan Spicka3, Sabrin Tahri4, Sarah Lonergan⁴, Inger Nijhof6, Antonietta Pia Falcone6, Evangelos Terpos⁷, https://www congresshub. com/ASH2024/Oncology Jakub Radocha8, Roberto Mina9, Guldane Cengiz Seval10, Meral Beksac¹⁰, Cesar Rodriguez¹, Marcelo C Pasquini12, Michel Delforge13, Tedistamab/Zamagni Vania Hungria14, Donna Reece15, Philippe Moreau16, Yael C Cohen17, Kihyun Kim18, Dominik Dytfeld19, Jiri Minarik20, Irene Strass121, The QR code is intended to provide scientific Jelena Bila22, Martin Schreder²³, Janusz Krawczyk24, Fredrik Schjesvold²⁵, Caroline Cicin-Sain26, Christoph Driessen²⁶, Gordon Cook27, information for individual reference. and the information should not be altered or Lugui Qiu²⁸, Gonzalo M Garate29, Agoston Gyula Szabo³⁰, Roman Hajek31, Marc S Raab³², Silvia Mangiacavalli33, Hermann Einsele²⁴, reproduced in anyway. Andrew Spencer³⁵, Mario Boccadoro³⁶, Helen Vassalou³⁷, Lixia Pei38, Yingqi Shi38, Maria Krevvata³⁹, Ryan Gruber³⁹, Caline Sakabedoyan⁴⁰, Margaret Cobb41, Jagoda Jasielec³⁸, Himal Amin38, Rachel Kobos³⁸, Pieter Sonneveld⁴.⁴², Niels WCJ van de Donk43 'IRCCS Azienda Ospedaliero-Universita in di Bologna, stituto di Ematologia agnoli", and Università di Bologna, Bologna, Italy: Cartonal Hospital St. Gallen, St. Gallen, Switzerland; Charl les University and General Hospital, Prague, Czech Republic "Stichting European Myeloma Network, Rotterdam, The Netherlands: St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands: *IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy: University of Athens, School of Medicine, Athers, Greece University Hospital Hradec Kralove and Charles University, Hradec Kralove, Czech Republic PAOU Città della Salute e della Scienza di Torino and University of Torino, Torino, Italy: "Ankara University, Ankara Türkiye: "Icahn School of Medicine at Mount Sinai, New York, NY, USA 12Medical College of Wisconsin, Milwaukee, WI, USA University of Leuven, Leuven, Belgium "Clinica Medica Sao Germano, Sao Paulo, Brazik Princess Margaret Cancer Centre, Toronto, ON, Canada "University Hospital Hôtel-Dieu, Nantes, France "Tel Aviv Sourasky (Ichilov) Medical Center and Tel Aviv University. Tel Awiv, Israel: "Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea: "Poznan University of Medical Sciences, Poznan, Poland; "University Hospital and Palacky University Olomouc Olomouc, Czech Republic; 2'Ordensklinkum Linz Hospital, Linz, Austria; 22University of Belgrade, University Clinical Centre of Serbia, Belgrade, Serbia; 23Klink Ottakring Vienna, Austria "University Hospital Galway, Galway, Ireland and National University of Ireland, Galway, Ireland 25Oslo Myeloma Center and University of Oslo, Oslo, Norway: Kantonsspital St. Gallen, St. Gallen, Switzerland; "University of Leeds, Leeds, UK; "Chinese Academy of Medical Sciences, Blood Diseases Hospital (Institute of Hematology). Tianjin, China: Hospital Aleman Buenos Aires. Argentina Copenhagen University Hospital Rigshospitalet, Copenhagen Denmark; "University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic; University Hospital Heidelberg. Heidelberg. Germany: "Fondazione IRCCS Policinico San Matteo, Pavia, Italy; "University Hospital Würzburg, Würzburg, Germany; 35The Alfred Hospital, Monash University, Melbourne, Australia European Myeloma Network, Torino, Italy: 37Health Data Specialists, Dublin, Ireland; "Janssen Research & Development, LLC, Raritan, NJ, USA; "Janssen Research & Development, LLC, Spring House, PA, USA; "Jarssen Research & Development, LLC, Paris, France "Jarssen Research & Development, LLC, High Wycombe, UK; "Erasmus MC Cancer Institute, Rotterdam, The Netherlands: 43Amsterdam University Medical Center, Vrije Universited Amsterdam, Amsterdam The Netherlands Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA, USA --- [Slide 2] EMN30/MajesTEC-4 SRI: Nonhematologic TEAEs Cohort 1: Cohort 2: Cohort 3: Among the most common Tec-Len Tec-Len Tec nonhematologic TEAEs, rates of (QW Q4W) (Q4W) (Q4W) grade 3/4 events were low (N=32) (N=32) (N=30) All CRS events were grade 1/2, Median follow-up, mo 21.1 9.2 9.2 mostly occurring during Tec step-up TEAEs,ᵃ n (%) Any Any Any dosing grade Grade 3/4 grade Grade 3/4 grade Grade 3/4 - 37.2% after Step-up Dose 1 Nonhematologic AEsb CRS 16 (50.0) 0 13 (40.6) 0 13 (43.3) 0 - 8.5% after Step-up Dose 2 URTI 20 (62.5) 1 (3.1) 13 (40.6) 0 8 (26.7) 0 - 5.3% after Treatment Dose 1 Cough 15 (46.9) 0 6 (18.8) 0 8 (26.7) 0 - No discontinuations due to CRS Diarrhea 13 (40.6) 3 (9.4) 9 (28.1) 1 (3.1) 6 (20.0) 0 No ICANS Injection-site erythema 7 (21.9) 0 12 (37.5) 0 8 (26.7) 0 COVID-19 12 (37.5) 1 (3.1) 5 (15.6) 0 9 (30.0) 1 (3.3) Fatigue 10 (31.3) 1 (3.1) 8 (25.0) 1 (3.1) 5 (16.7) 0 Pneumonia 9 (28.1) 4 (12.5) 3 (9.4) 0 2 (6.7) 1 (3.3) Data cutoff date: September 9, 2024. AEs (graded according to the NCI-CTCAE Version 5.0); any grade occurring in >25% of patients or grade 3/4 in >10% of patients. Hypogammaglobulinemia based on TEAE reporting also met the >25% threshold and is reported separately. AE, adverse event; CRS, cytokine release syndrome; EMN, Stichting European Myeloma Network; ICANS, immune effector cell-associated neurotoxicity syndrome; Len, lenalidomide; QW, weekly; Q4W, every 4 weeks; SRI, safety run-in; TEAE, treatment-emergent adverse event; Tec, tedistamab; URTI, upper respiratory tract infection. 8 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA, USA --- [Slide 3] EMN30/MajesTEC-4 SRI: Infections and Hypogammaglobulinemia Hypogammaglobulinemia® reported in: Cohort 1: Cohort 2: Cohort 3: Tec-Len Tec-Len Tec - Cohort 1: 31 (96.9%) patients (QW Q4W) (Q4W) (Q4W) (N=32) (N=32) (N=30) - Cohort 2: 25 (78.1%) patients Median follow-up, mo 21.1 9.2 9.2 - Cohort 3: 28 (93.3%) patients TEAEs,ᵃ n (%) Any Any Any - All received ≥1 dose of IVIg or SClg grade Grade 3/4 grade Grade 3/4 grade Grade 3/4 One grade 5 COVID-19 TEAE Any infection 30 (93.8) 12 (37.5) 25 (78.1) 9 (28.1) 23 (76.7) 6 (20.0) occurred in Cohort 2 Most common infectionsᵇ Infection prophylaxis, including Ig URTI 20 (62.5) 1 (3.1) 13 (40.6) 0 8 (26.7) 0 replacement, was strongly recommended COVID-19 12 (37.5) 1 (3.1) 5 (15.6) 0 9 (30.0) 1 (3.3) Pneumonia 9 (28.1) 4 (12.5) 3 (9.4) 0 2 (6.7) 1 (3.3) Nasopharyngitis 6 (18.8) 0 0 0 3 (10.0) 0 Data cutoff date: September 9, 2024. AEs (graded according to the NCI-CTCAE Version 5.0). Any grade occurring in >10% of patients in any arm. Includes patients with >1 TEAE of hypogammaglobulinemia or post-baseline IgG value <400 mg/dL. Prophylactic IVIg replacement advised to maintain serum IgG levels of >400 mg/dL. Prophylaxis for Pneumocystis jirovecii pneumonia and herpes zoster reactivation was recommended, as well as routine antibiotic and antiviral prophylaxis. AE, adverse event; EMN, Stichting European Myeloma Network; Ig. immunoglobulin; IgG, immunoglobulin G; IVg, intravenous immunoglobulin; Len, lenalidomide; QW, weekly; Q4W, every 4 weeks; SClg, subcutaneous immunoglobulin; SRI, safety run-in; TEAE, treatment-emergent adverse event; Tec, tedistamab; URTI, upper respiratory tract infection. 9 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual M eeting and Exposition; December 7-10, 2024; San Diego, CA, USA --- [Slide 4] EMN30/MajesTEC-4 SRI: MRD Negativity (10-5) in Evaluable Patients Post-ASCT and During Maintenance 100 80 MRD-negativity rateᵃ (%) 60 100 100 100 40 83.3 73.3 63.0 20 0 Post-ASCTᵇ At 12 months Post-ASCTb At 6 months Post-ASCTb At 6 months (n=27) (n=28) (n=30) (n=26) (n=30) (n=22) Cohort 1: Cohort 2: Cohort 3: Tec (QW -> Q4W)-Len (N=32) Tec (Q4W)-Len (N=32) Tec (Q4W) (N=30) Median follow-up: 21.1 mo Median follow-up: 9.2 mo Median follow-up: 9.2 mo 100% of evaluable patients were MRD negative during maintenance Data cutoff date: September 9, 2024. MRD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10-5), regardless of response. Percentages are out ofevaluable patients. Among 87 evaluable patients, 23 patients were MRD positive at screening (Cohort 1, n=10; Cohort 2, n=5; Cohort 3, n=8). All patients who were MRD positive at study entry and had an assessment during treatment were MRD negative during treatment One patient in Cohort 1 was MRD positive at 18 months. Post-ASCT+ consolidation ASCT, autologous stem cell transplantation; EMN, Stichting European Myeloma Network; Len, lenalidomide; MRD, minimal residual disease; QW, weekly; Q4W, every 4 weeks; SRI, safety run-in; Tec, teclistamab. 11 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual M leeting and Exposition; December 7-10, 2024; San Diego, CA, USA
Samer Al Hadidi, MD,MS,FACP
MajesTEC-4 / EMN30 Data
187 impressions · 4 likes · Dec 8, 2024
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[Slide 1] EMN30/MajesTEC-4 SRI: Demographic and Disease Characteristics Cohort 1: Cohort 2: Cohort 3: The median time from ASCT to Tec-Len Tec-Len Tec maintenance treatment for all (QW +> Q4W) (Q4W) (Q4W) Characteristic (N=32) (N=32) (N=30) patients was 4.7 months (range, 1.8-7.4) Median age, y (range) 58.5 (31-73) 58.0 (38-73) 58.5 (34-72) >65, n (%) 12 (37.5) 5 (15.6) 9 (30.0) All patients had an ECOG PS score of 0 or 1 Male, n (%) 21 (65.6) 21 (65.6) 22 (73.3) White race, n (%) 32 (100) 32 (100) 30 (100) More patients in Cohorts 2 and 3 ISS disease stage at diagnosis, n/N (%) received anti-CD38 during induction I 18/32 (56.3) 8/32 (25.0) 9/28 (32.1) compared with in Cohort 1 II 7/32 (21.9) 9/32 (28.1) 11/28 (39.3) III 7/32 (21.9) 15/32 (46.9) 8/28 (28.6) High cytogenetic risk at diagnosis, n/N (%) 7/25 (28.0) 5/29 (17.2) 6/25 (24.0) Induction regimen for MM, n (%) Plb + IMiDc 28 (87.5) 28 (87.5) 30 (100) Plb + IMiDc + anti-CD38 11 (34.4) 19 (59.4) 20 (66.7) Prior consolidation, n (%) 6 (18.8) 12 (37.5) 10 (33.3) High cylogenetic risk is defined as the presence of a1 of the following abnormalities del(17p). 1(4;14) or 1(14;16) 93/94 (98 9%) received bortezomb, 3/94 (3.2%) cartilzomb 53/94 (56 4%) received Len, 39/94 (41 5%) thalidomide 1/94 1%) pomalidomide 49/94 (52 1%) received daratumumab and 1/94 (1 1%) isatuximab as part of triplet regimen; 1/94 (1 1%) received daratumumab with lenalidomide as part of a doublet regimen ASCT, autologous stem cell transplantation ECOG PS, Eastern Cooperative Oncology Group performance status, EMN, Stichting European Myeloma Network IMD, immunomodulatory drug, ISS, International Staging System, Len, lenalidomide, MM, multiple myeloma, PI, proteasome inhibitor; QW, weekly, Q4W, every 4 weeks SRI, safety run-in, Tec, teclistamab 6 Presented by E Zamagni at the 66th American Society of Homatology (ASH) Annual Meeting and Exposition December 7-10, 2024; San Diego, CA USA --- [Slide 2] EMN30/MajesTEC-4 SRI: Treatment Disposition and Exposure Cohort 1: Tec-Len Cohort 2: Tec-Len Cohort 3: Tec (Tec QW -> Q4W) (Tec Q4W) (Tec Q4W) N=32 N=32 N=30 Discontinued, n=7 Discontinued, n=1 Discontinued, n=4 AE, n=3 AE, n=1 AE, n=1 Patient withdrawal, n=2 Patient withdrawal, n=1 Physician decision, n=1 Progressive disease, n=1 Progressive disease, n=1 Other,ᵃ n=1 Ongoing, n=25 Ongoing, n=31 Ongoing, n=26 Median follow-up, Median follow-up, Median follow-up, 21.1 months (range, 14.8-23.8) 9.2 months (range, 1.2*-12.2) 9.2 months (range, 3.7-11.5) As of September 9, 2024, 81 of 94 patients (86.2%) remained on treatment + consored observation *Patient decision AE, adverse event, EMN, Stichting European Myeloma Network Len, lenalidomide, QW, weekly, Q4W. every 4 weeks, SRI, safety run-in, Tec, teclistamab. 6 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition December 7-10, 2024 San Diego, CA USA --- [Slide 3] EMN30/MajesTEC-4 SRI: Hematologic TEAEs Cohort 1: Cohort 2: Cohort 3: Cumulative incidence of grade 3/4 Tec-Len Tec-Len Tec neutropenia at 6 months: (QW Q4W) (Q4W) (Q4W) (N=32) (N=32) (N=30) - Cohort 1: 81.3% Median follow-up, mo 21.1 9.2 9.2 - Cohort 2: 56.3% TEAEs,ᵃ n (%) Any grade Grade 3/4 Any grade Grade 3/4 Any grade Grade 3/4 - Cohort 3: 40.0% Any TEAE 32 (100) 32 (100) 32 (100) 27 (84.4) 30 (100) 17 (56.7) Hematologic Aes Median relative dose intensity: Neutropenia 30 (93.8) 30 (93.8) 21 (65.6) 20 (62.5) 17 (56.7) 14 (46.7) - 95.5% to 99.7% for Tec Leukopenia 9 (28.1) 3 (9.4) 1 (3.1) 0 1 (3.3) 1 (3.3) - 58.4% to 61.5% for Len Lymphopenia 2 (6.3) 1 (3.1) 4 (12.5) 4 (12.5) 4 (13.3) 4 (13.3) Thrombocytopenia 6 (18.8) 2 (6.2) 0 0 2 (6.7) 0 Low rates of treatment discontinuation due to TEAEs (5.3% overall) Febrile neutropenia 3 (9.4) 3 (9.4) 3 (9.4) 3 (9.4) 0 0 Anemia 3 (9.4) 0 1 (3.1) 1 (3.1) 1 (3.3) 0 Eosinophilia 1 (3.1) 1 (3.1) 1 (3.1) 1 (3.1) 0 0 Teclistamab every 4 weeks from Cycle 2 had a lower cumulative incidence of grade 3/4 neutropenia than teclistamab weekly every 4 weeks Data cutoff date: September 9. 2024 AEs (graded according to the NCI-CTCAE Version 5 0). any grade occurring in >25% of patients or grade 3/4 in >1 patient AE adverse event EMN Stichting European Myeloma Network Len lenalidomide; NCI-CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events; QW, weekly; Q4W every 4 weeks; SRI, safety run-in; TEAE, treatment emergent adverse event; Tec, teclistamab 7 Presented by E Zamagni at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition December 7-10, 2024 San Diego, CA USA

MajesTEC-4 / EMN30 Top Tweets

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Hamza Hashmi
Hamza Hashmi@hhashmi87

@RahulBanerjeeMD @DrGPrakash @DrPMPGI I like that Teclistamab was used as maintenance post ASCT for pt#2. With uncontrolled chemo refractory EMD, going straight to ASCT often leads to relapse &lt;60…

👁 2.9K ♡ 2 ↻ 2 Mar 4, 2026
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP@RahulBanerjeeMD

Very good point - kudos to team for investigating it!

I totally agree: once MajesTEC-4 approved, this will probably be the best use case for indefinite bsAb maintenance in #MMsm.

And as…

👁 1.9K ♡ 8 ↻ 0 Mar 4, 2026
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP@RahulBanerjeeMD

#BeyondBlood in Mexico City - @RobertoMinaMD giving an excellent talk about transplant-eligible myeloma in 2025.

First time with these evergreen #MMsm talks that BCMA is now being added in after…

👁 1.9K ♡ 11 ↻ 4 Mar 1, 2025
Samer Al Hadidi, MD,MS,FACP
Samer Al Hadidi, MD,MS,FACP@HadidiSamer

#ASH24 #mmsm
1️⃣0️⃣ Majestec-4/EMN30 Trial
➡️ https://t.co/gAOFjnxR4S

✅Multiple cohorts comparing Tec alone, Tec-Len vs Len alone post ASCT- time limited maintenance in all pts

Will be interesting…

👁 1.2K ♡ 7 ↻ 0 Nov 9, 2024
Luciano J Costa
Luciano J Costa@End_myeloma

5- MajesTEC-4, Less is more with teclistamab in low burden settings.

https://t.co/lfzuPA2ooY

👁 539 ♡ 7 ↻ 1 Nov 29, 2024
Elias K. Mai MD
Elias K. Mai MD@EliasKarlMai

#ASH24 #mmsm

Anti-BCMA bispecifics arriving in firstline! Curious to see the follow up! @EMN_EuMMnet https://t.co/58UwvjXROR

👁 401 ♡ 5 ↻ 3 Dec 8, 2024
Ben Derman
Ben Derman@bdermanmd

Tec-Len safety run in as post-ASCT maintenance #ASH24 #mmsm #mmMRD
- Convenient dosing schedule
- Nearly everyone got significant neutropenia (94% G3+)
- CRS rates are lower overall in this…

👁 387 ♡ 7 ↻ 3 Dec 8, 2024
Mike Thompson, MD, PhD, FASCO
Mike Thompson, MD, PhD, FASCO@mtmdphd

Ph3 Teclistamab (Tec) + Lenalidomide (R) and Tec Alone vs R Alone in NDMM As Maintenance Tx Following ASCT: Safety Run-in (SRI) Results from the Majestec-4/EMN30 Trial [Dec 8, 2024] Zamagni et al.…

👁 349 ♡ 0 ↻ 0 Nov 10, 2024
Beth Faiman PhD
Beth Faiman PhD@Bethfaiman

@DrRakeshPopat I agree - impressive and rapid #MRD negative rates!! #ASH24 https://t.co/Kli0aR9VNc

👁 345 ♡ 4 ↻ 1 Dec 8, 2024
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP@RahulBanerjeeMD

#ASH24 MajesTEC-4! Zamagni et al: Safety run-in for tec + len maintenance after ASCT.

First time we&#x27;re seeing bsAb maintenance data in #MMsm 👏 Bottom line: it works!

But important to see: Tec as…

👁 225 ♡ 8 ↻ 2 Dec 8, 2024

About the MajesTEC-4 / EMN30 Trial

First phase 3 evaluating BCMA bispecific as post-transplant maintenance. 100% MRD negativity in SRI cohorts is unprecedented. Will compete with continued lenalidomide monotherapy (current SOC) and complement CARTITUDE-6 (CAR-T front-line) for the transplant-eligible NDMM landscape.

Trial Methodology & Results

MRD Negativity + PFS — Safety Run-In (SRI) — Primary Analysis Pending

Unprecedented efficacy in the SRI portion: 100% of patients achieved MRD negativity (10⁻⁵ by NGF) at 12 months in Cohort 1 (Tec-Len weekly) and at 6 months in Cohorts 2 and 3. All patients upgraded their response during maintenance to ≥CR. Tec-Len in Cohort 1 showed 100% MRD-negative CR at 12 months in evaluable patients. PFS endpoint readout pending primary analysis.

✓ 100% MRD-neg at 10⁻⁵ in SRI

📄 Source: KOL commentary on X →

Overall Survival (OS)

OS data pending primary analysis.


📄 Source →

Safety & Tolerability

Grade ≥3 adverse events: 100.0% (Tec-Len (Cohort 1)) vs. 84.4% (Tec-Len (Cohort 2)) vs. 56.7% (Tec alone (Cohort 3)). Key AEs: infections (G3/4: 37.5% / 28.1% / 20.0%), neutropenia G3/4 cumulative at 6 mo: 81.3% / 56.3% / 40.0%, CRS 43.6% overall (grade 1/2 only, no high-grade). Infections are the dominant safety signal — requires robust prophylaxis. CRS is low-grade and manageable. Overall TEAE discontinuation 5.3%.

Infection prophylaxis mandatory; CRS manageable (G1/2 only)

📄 Source →

Clinical Implications

⚠️ SRI-phase signal — potential paradigm-shifting maintenance approach. First phase 3 evaluating BCMA bispecific as post-transplant maintenance. 100% MRD negativity in SRI cohorts is unprecedented. Will compete with continued lenalidomide monotherapy (current SOC) and complement CARTITUDE-6 (CAR-T front-line) for the transplant-eligible NDMM landscape.

MajesTEC-4 / EMN30 in the News

Key KOL Sentiments — MajesTEC-4 / EMN30

DoctorSentimentComment
Rahul Banerjee, MD, FACP ● POSITIVE Very good point - kudos to team for investigating it! I totally agree: once MajesTEC-4 approved, this will probably be the best use case for indefinite bsAb maintenance in #MMsm. And as time-limited bsAb maintenance becomes the norm, we’ll see it for even more subgroups! https://t.co/pwEEq3XfGM
Rahul Banerjee, MD, FACP ● POSITIVE #BeyondBlood in Mexico City - @RobertoMinaMD giving an excellent talk about transplant-eligible myeloma in 2025. First time with these evergreen #MMsm talks that BCMA is now being added in after #ASH24 - very nice discussion of TEC-5 and TEC-4! https://t.co/1Q4n4BwFR5
Beth Faiman PhD ● POSITIVE @DrRakeshPopat I agree - impressive and rapid #MRD negative rates!! #ASH24 https://t.co/Kli0aR9VNc
Hamza Hashmi ● NEUTRAL @RahulBanerjeeMD @DrGPrakash @DrPMPGI I like that Teclistamab was used as maintenance post ASCT for pt#2. With uncontrolled chemo refractory EMD, going straight to ASCT often leads to relapse &lt;60 days post ASCT. For EMD with primary ref disease, I do not think Len, D+Len lead to durable remissions. Good to see there
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH24 #mmsm 1️⃣0️⃣ Majestec-4/EMN30 Trial ➡️ https://t.co/gAOFjnxR4S ✅Multiple cohorts comparing Tec alone, Tec-Len vs Len alone post ASCT- time limited maintenance in all pts Will be interesting to see if intensifying maintenance for 2 yrs will improve efficacy/safety https://t.co/KclSGJQAU1
Luciano J Costa ● NEUTRAL 5- MajesTEC-4, Less is more with teclistamab in low burden settings. https://t.co/lfzuPA2ooY
Elias K. Mai MD ● NEUTRAL #ASH24 #mmsm Anti-BCMA bispecifics arriving in firstline! Curious to see the follow up! @EMN_EuMMnet https://t.co/58UwvjXROR
Ben Derman ● NEUTRAL Tec-Len safety run in as post-ASCT maintenance #ASH24 #mmsm #mmMRD - Convenient dosing schedule - Nearly everyone got significant neutropenia (94% G3+) - CRS rates are lower overall in this low-disease burden setting (40-50%) https://t.co/S7DrmBTN0X
Mike Thompson, MD, PhD, FASCO ● NEUTRAL Ph3 Teclistamab (Tec) + Lenalidomide (R) and Tec Alone vs R Alone in NDMM As Maintenance Tx Following ASCT: Safety Run-in (SRI) Results from the Majestec-4/EMN30 Trial [Dec 8, 2024] Zamagni et al. #ASH24 Abst 494 https://t.co/ex2Nv2jVXc #mmsm #caxtx
Rahul Banerjee, MD, FACP ● NEUTRAL #ASH24 MajesTEC-4! Zamagni et al: Safety run-in for tec + len maintenance after ASCT. First time we're seeing bsAb maintenance data in #MMsm 👏 Bottom line: it works! But important to see: Tec as maintenance is same as tec in RRMM: CRS and infections can happen. Use IVIG! https://t.co/1oQVujS3je
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH24 #mmsm @ASH_hematology Oral Myeloma: Majestec-4/EMN30 Young patients overall In cohort 1 high levels of discontinuation High rates of cytopenia/neutropenia https://t.co/aNlsVKgpeq
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL @ASH_hematology #ASH24 #mmsm @ASH_hematology Oral Myeloma: Majestec-4/EMN30 Deep responses 1 out of 3 pts had G3/4 infections Neutropenia was better with 3 mg/kg Q4 weeks dosing The utility of such approaches maybe to do very short duration of maintenance (why not 6 months or 12 months) and… https://t.co/zJAgsAZYsp https://t.co/uUyaPLCWPJ
Ben Derman ● NEUTRAL Infection rates were high, though grade 3+ around 30% with perhaps a little lower rate in patients who got teclistamab alone. Significant deepening of response and once again, Tec acts like an 'MRD erase' - everyone was MRD negative at 12 months. Questions I have: Do we… https://t.co/TKoZaqqPP8 https://t.co/0RkXSwB9wE
Rakesh Popat ● NEUTRAL Majestec 4 - safety lead in for Tec or Tec Len maintenance post ASCT. High MRD conversion rates. Key is going to be balancing the toxicity profile with ongoing treatment. #ASH24 mmsm https://t.co/1QRxtTrqZu
Hamza Hashmi ● NEUTRAL MAJESTEC 4: Early safety data on Tec+ Len vs Tec alone as maintenance post ASCT CRS ~50%, hypogamma 90%, G3 infections 30% All eval pts achieved MRD neg remission, Tec q4 weeks better than Tec weekly, Future strategy for limited duration guided by MRD negativity #mmsm #ash24
Becky Bosley ● NEUTRAL Abstract #494 Phase 3 study of Tec in combo w/ Len and Tec alone vs Len alone in NDMM as maint after ASCT: SRI results from the MajesTEC-4 / EMN30 trial #IMFASH24 #ASH24 We love the possibility of a fixed duration of maintenance! https://t.co/l2I9y61mX6
Bertrand Delsuc ● NEUTRAL TECVAYLI (teclistamab) demonstrates potential as frontline combination therapy for patients with NDMM (MAJECTEC-4/5) $JNJ $GMAB #ASH24 MAJECTEC-5 - n=49 TE NDMM - Tec-DRd or Tec-DVRd as induction therapy "unprecedented MRD- rates": MRD negativity (at 10e-5) after C3 of… https://t.co/jlLF0wE5uB https://t.co/2Bl9fuvoP6
J&J Medical Affairs Oncology ● NEUTRAL For US #HCPs at #ASH24: see Dr. Elena Zamagni (@ElenaZamagni) present safety run-in results from Phase 3 MajesTEC-4 study evaluating BCMAxCD3 bispecific antibody ± IMiD as maintenance therapy in patients with newly diagnosed #MultipleMyeloma following ASCT https://t.co/5yUIHsMgTp
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH24 #mmsm @ASH_hematology Oral Myeloma: Majestec-4/EMN30 Schema 👇 Pts got 3-4 drugs with 1-2 transplants and needed to have at least partial response Maintenance study Dosing intensity per 3 cohorts 👇 Tec can be stopped after 1 year if in CR and at 2 years regardless,… https://t.co/sAAj5gfnHg https://t.co/h8l1rqE0YA
Teresa Miceli. &4 ● NEUTRAL #ASH24 #mmsm Hypogam continues to be expected AE in Bi-specifics. IVIG important supportive care. @IMFMyeloma #IMFASH24 #myeloma https://t.co/RFrBiqbpo8