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MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Trial

Induction in transplant-eligible NDMM (TE-NDMM) — Janssen + GMMG/DSMM (German myeloma groups)

Induction in transplant-eligible NDMM (TE-NDMM)TECVAYLI + Darzalex + RevlimidASH 2024
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Top KOLs Discussing MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX)

Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP
@RahulBanerjeeMD
12.8K impressions
Jacob Plieth
Jacob Plieth
@JacobPlieth
6.7K impressions
Thilo J. Zander
Thilo J. Zander
@ThiloZander
4.4K impressions
Ben Derman
Ben Derman
@bdermanmd
4.2K impressions
Raj Chakraborty
Raj Chakraborty
@rajshekharucms
3.2K impressions
Hamza Hashmi
Hamza Hashmi
@hhashmi87
3.1K impressions

MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) 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-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Data
9.1K impressions · 76 likes · Sep 17, 2025
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[Slide 1] GMMG-HD10/DSMM-XX/MajesTEC-5: Study Design Key eligibility Induction (6 x 28-day cycles)a Maintenanceᵇ,ᶜ (x 18 cycles) Primary endpoints: criteria: AEs, SAEs Arm A (n=10): TE NDMM Tec (1.5 mg/kg QW)-DR Select secondary ECOG PS score of 0-2 Arm A1 (n=20): HDT + ASCT endpoints: Aged 18-70 years Tec-D MRD negativity Tec (3 mg/kg Q4W)-DR (10-5 and 10-6) ORR >CR Arm B (n=19): >VGPR Tec (3 mg/kg Q4W)-DVR Stem cell yield C1 C2 C3 C4 C5 C6 MRD 10-5 via NGF MRD MRD MRD 10⁻⁶ via NGS Tec (Cycle 1): Tec step-up dosing (0.06 and 0.3 mg/kg on Days 2 and 4) + 1.5 mg/kg on Days 8 and 15e - Tec (Cycles 2-6): 1.5 mg/kg QW on Day 1 (ArmA); 3 mg/kg Q4W on Day 1 (Arm A1 and B) D: 1800 mg SC per label (QW for Cycles 1-2; Q2W for Cycles 3-6) V: 1.3 mg/m² SC QW R: 25 mg PO daily starting in Cycle 2 (Days 1-21) d: 20 mg (PO or IV) in Cycles 1-4 (Arm A) or Cycles 1-2 (Arm A1/B) only "Stem cell collection was planned after 3 cycles of induction Following maintenance therapy. patients could receive additional SoC maintenance treatment per institutional standard and local investigator decision Maintenance treatment can be discontinued when 12 months of sustained MRD negativity (10 have been observed beginning in induction Planned maintenance treatment in Arm Awas Teo-DR. A protocol amendment permitted patients initially assigned to Teo-DR maintenance to receive Tec-D maintenance per investigator's choice (patients who started Tec-DR may have discontinued R to receive Tec- per investigator's choice). "Patients in Arm A received an additional dose of Tec1 1.5 mg/kg on Day 22 AE, adverse event; ASCT, autologous stem cell transplant; CR, complete response D. daratumumab d, dexamethasone; DSMM Deutsche Studiengruppe Multiples Myelom: ECOG PS, Eastern Cooperative Oncology Group performance status: GMMG, German-speaking Myeloma Multicenter Group: HDT, high-dose therapy; MRD. minimal residual disease NDMM newly diagnosed multiple myeloma; NGF, next-generation flow cytometry: NGS, next-generation sequencing ORR, overall response rate; QW. weekly; Q2W. every 2 weeks; Q4W. every 4 weeks; R. lenalidomide; SAE serious adverse event; SoC. standard of care, TE, trans plant-eligible; Tec, teclistamab; V. bortezomib; VGPR, very good partial response 5 Presented by MS Raab at the 22nd International Myeloma Society (IMS) Annual Meeting: September 17-20, 2025; Toronto, Canada --- [Slide 2] GMMG-HD10/DSMM-XX/MajesTEC-5: Response Ratesᵃ ORR ORR ORR 100 100 100 100 90 80 70 ≥CR 60 73.7 73.7 Patients (%) sCR ≥CR ≥VGPR ≥CR ≥VGPR ≥VGPR 50 100 95 CR 100 100 95 95 94.7 VGPR 40 PR 30 20 21.1 10 0 5 5.3 Arm A: Arm A1: Arm B: Tec (QW)-DR Tec (Q4W)-DR Tec (Q4W)-DVR n=10 n=20 n=19 100% of patients responded by the end of induction Response was assessed by investigators based on IMWG criteria, with a confirmed response requiring >2 consecutive identical response assessments ORR was defined as >PR. CR, complete response; D, daratumumab; DSMM, Deutsche Studiengruppe Multiples Myelom; GMMG, German-speaking Myeloma Multicenter Group; IMWG, International Myeloma Working Group; ORR, overall response rate; PR, partial response; QW, weekly, Q4W, every 4 weeks; R, lenalidomide; sCR, stringent complete response; Tec, teclistamab; V, bortezomib; VGPR, very good partial response. 12 Presented by MS Raab at the 22nd International Myeloma Society (IMS) Annual Meeting: September 17-20, 2025; Toronto, Canada --- [Slide 3] GMMG-HD10/DSMM-XX/MajesTEC-5: MRD Negativity (10-5)a in the MRD-Evaluable Analysis Set MRD-evaluable population: all patients with an available MRD test (positive or negative)b - Only 1 patient was not evaluable for MRD throughout induction (Cycle 3 or 6) due to discontinuation before Cycle 3 Arm A: Tec (QW)-DR Arm A1: Tec (Q4W)-DR Arm B: Tec (Q4W)-DVR 100 90 MRD-evaluable patients (%) 80 70 60 50 100 100 100 100 100 100 40 30 20 10 n=10 n=10 n=19° n=19d n=17e n=17' 0 Cycle 3 Cycle 6 Cycle 3 Cycle 6 Cycle 3 Cycle 6 With completion of induction, 100% MRD negativity (10-5) continues to be observed in MRD-evaluable patients, regardless of depth of response RD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10-5) per NGF, regardless of response (ie, not all patients achieved CR). Excluding those who were not tested, indeterminate, or had no baseline done detected (NGS). One patient was not tested One patient had discontinued after completing Cycle 3. "One patient was not tested, and 1 had discontinued before completing Cycle 3. One patient had discontinued before completing Cycle 3, and 1 had an indeterminate result. CR, complete response; D, daratumumab; DSMM, Deutsche Studiengruppe Multiples Myelom: GMMG, German-speaking Myeloma Multicenter Group; MRD, minimal residual disease; NGF, nexd-generation flow cytometry, NGS, next-generation sequencing; QW, weekly, Q4W, every 4 weeks; R, lenalidomide; Tec, teclistamab; V, bortezomib. 13 Presented by MS Raab at the 22nd International Myeloma Society (IMS) Annual Meeting: September 17-20, 2025; Toronto, Canada --- [Slide 4] GMMG-HD10/DSMM-XX/MajesTEC-5: Infections Arm A: Arm A1: Arm B: 18 (36.7%) patients had Tec (QW)-DR Tec (Q4W)-DR Tec (Q4W)-DVR Total grade 3/4 infectionsᵇ (n=10) (n=20) (n=19) (N=49) All Grade All Grade All Grade All - No discontinuations due to infection Grade 3/4 TEAE, n (%)a grade 3/4 grade 3/4 grade 3/4 grade - No grade 5 infections Any infection 10 (100) 4 (40) 18 (90) 10 (50) 11 (57.9) 4 (21.1)b 39 (79.6) 18 (36.7)b Hypogammaglobulinemia® reported in 45 (91.8%) patients Infections - 44 (89.8%) patients received ≥1 URTI 6 (60) 0 8 (40) 1 (5) 6 (31.6) 0 20 (40.8) 1 (2) dose of IVIg COVID-19 2 (20) 0 4 (20) 1 (5) 3 (15.8) 2 (10.5) 9 (18.4) 3 (6.1) Stringent infection prophylaxis was strongly recommended,e including Nasopharyngitis 3 (30) 0 2 (10) 0 2 (10.5) 0 7 (14.3) 0 Ig replacement Pneumonia 1 (10) 1 (10) 0 0 2 (10.5) 2 (10.5) 3 (6.1) 3 (6.1) Low patient numbers and relatively RTI 0 0 1 (5) 0 2 (10.5) 0 3 (6.1) 0 short follow-up time may account for differing infection rates across Bronchitis 2 (20) 0 0 0 0 0 2 (4.1) 0 arms AEs are graded according to the NCI-CTCAE Version 5.0. The median follow-up was 7.3 (3.1-14.5) months. One patient had a grade 3 "unknown" infection that was reported under the "uncoded" category. Infections reported in > 10% of patients in any arm. "Includes patients with 21 TEAE of hypogammaglobulinemia or a post-baseline IgG value <400 mg/dL. Additional recommended measures included prophylaxis for Pneumocystis jirovecii pneumonia and herpes zoster reactivation as well as routine antibiotic prophylaxis. D, daratumumab; DSMM, Deutsche Studiengruppe Multiples Myelom; GMMG, German-speaking Myeloma Multicenter Group; Ig. immunoglobulin; Mg. intravenous immunoglobulin; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; QW, weekly; Q4W, every 4 weeks; R, lenalidomide; RTI, respiratory tract infection; TEAE, treatment-emergent adverse event; Tec, teclistamab; URTI, upper respiratory tract infection; V. bortezomib. 10 Presented by MS Raab at the 22nd International Myeloma Society (IMS) Annual Meeting: September 17-20, 2025; Toronto, Canada
Thilo J. Zander
Thilo J. Zander @ThiloZander
MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Data
4.3K impressions · 70 likes · Sep 19, 2025
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[Slide 1] GMMG-HD10/DSMM-XX/MajesTEC-5: MRD Negativity (10⁻⁶)a in the MRD-Evaluable Analysis Setb Arm A: Tec (QW)-DR Arm A1: Tec (Q4W)-DR Arm B: Tec (Q4W)-DVR 100 When combining all patients 90 across all arms (n=49), 80 MRD-evaluable patients (%) cumulative MRD-negativity rate 70 by end of induction in the 60 efficacy analysis set was 98.0% 50 100 100 100 85.7% (42/49) of patients 40 achieved >CR and MRD 30 negativity at Cycle 6 (≤10⁻⁵) 20 10 n=10 n=19c n=17d 0 Cycle 6 Cycle 6 Cycle 6 100% of patients in the MRD-evaluable population,ᵇ regardless of depth of response, achieved MRD negativity (10-6) at Cycle 6 MRD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10-6), regardless of response MRD-evaluable population defined as those patients with an available MRD test with a positive or negative result (excluding those who were not tested, were indeterminate or had no baseline clone detected [NGS]). One patient had discontinued after completing Cycle 3. One patient had discontinued before completing Cycle 3, and 1 had no baseline clone detected for NGS *Patients who achieved MRD negativity at 10-⁵ or 10-6 at any time on study (post-induction cycle 3 or cycle 6). D. daratumumab; DSMM, Deutsche Studiengruppe Multiples Myelom; GMMG, German-speaking Myeloma Multicenter Group; MRD, minimal residual disease NGF, next-generation flow cytometry; NGS, next-generation sequencing; QW, weekly; Q4W, every 4 weeks; R. lenalidomide; Tec, teclistamab; V. bortezomib 14 Presented by MS Raab at the 22nd International Myeloma Society (IMS) Annual Meeting: September 17-20. 2025; Toronto, Canada
Ben Derman
Ben Derman @bdermanmd
MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Data
3.7K impressions · 48 likes · Sep 17, 2025
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[Slide 1] GMMG-HD10/DSMM-XX/MajesTEC-5: Study Design Key eligibility Induction (6 x 28-day cycles)a Maintenanceb,ᶜ (x 18 cycles) criteria: Arm A (n=10): TE NDMM Tec (1.5 mg/kg QW)-DR ECOG PS score of 0-2 Arm A1 (n=20): Aged 18-70 years Tec (3 mg/kg Q4W)-DR HDT + ASCT Tec-D Arm B (n=19): Tec (3 mg/kg Q4W)-DVR C1 C2 C3 C4 C5 C6 MRD MRD / . - --- [Slide 2] GMMG-HD10/DSMM-XX/MajesTEC-5: MRD Negativity (10-6)a in the MRD-Evaluable Analysis Setb Arm A: Tec (QW)-DR Arm A1: Tec (Q4W)-DR Arm B: Tec (Q4W)-DVR 100 When combining all patients 90 across all arms (n=49), 80 cumulative MRD-negativity rate MRD-evaluable patients (%) 70 by end of induction in the 60 efficacy analysis set was 98.0% 50 100 100 100 85.7% (42/49) of patients 40 achieved >CR and MRD 30 negativity at Cycle 6 (≤10⁻⁵) 20 10 n=10 n=19c n=17d 0 Cycle 6 Cycle 6 Cycle 6 100% of patients in the MRD-evaluable population,ᵇ regardless of depth of response, achieved MRD negativity (10-6) at Cycle 6 MRD negativity. of nations achieved defined as those patients an available --- [Slide 3] GMMG-HD10/DSMM-XX/MajesTEC-5: Infections Arm A: Arm A1: Arm B: 18 (36.7%) patients had Tec (QW)-DR Tec (Q4W)-DR Tec (Q4W)-DVR Total grade 3/4 infectionsᵇ (n=10) (n=20) (n=19) (N=49) All Grade All Grade All Grade All - No discontinuations due to infection Grade 3/4 TEAE, n (%)a grade 3/4 grade 3/4 grade 3/4 grade - No grade 5 infections Any infection 10 (100) 4 (40) 18 (90) 10 (50) 11 (57.9) 4 (21.1)b 39 (79.6) 18 (36.7)b Hypogammaglobulinemiad reported in 45 (91.8%) patients Infections - 44 (89.8%) patients received ≥1 URTI 6 (60) 0 8 (40) 1 (5) 6 (31.6) 0 20 (40.8) 1 (2) dose of IVIg COVID-19 2 (20) 0 4 (20) 1 (5) 3 (15.8) 2 (10.5) 9 (18.4) 3 (6.1) Stringent infection prophylaxis was strongly recommended,e including Nasopharyngitis 3 (30) 0 2 (10) 0 2 (10.5) 0 7 (14.3) 0 Ig replacement Pneumonia 1 (10) 1 (10) 0 0 2 (10.5) 2 (10.5) 3 (6.1) 3 (6.1) Low patient numbers and relatively RTI 0 0 1 (5) 0 2 (10.5) 0 3 (6.1) 0 short follow-up time may account for differing infection rates across Bronchitis 2 (20) 0 0 0 0 0 2 (4.1) 0 arms
Raj Chakraborty
Raj Chakraborty @rajshekharucms
MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Data
3.2K impressions · 41 likes · Sep 17, 2025
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[Slide 1] GMMG-HD10/DSMM-XX/MajesTEC-5: MRD Negativity (10-6)a in the MRD-Evaluable Analysis Setb Arm A: Tec (QW)-DR Arm A1: Tec (Q4W)-DR Arm B: Tec (Q4W)-DVR 100 When combining all patients 90 across all arms (n=49), 80 cumulative MRD-negativity rate® MRD-evaluable patients (%) 70 by end of induction in the 8 efficacy analysis set was 98.0% 50 100 100 100 85.7% (42/49) of patients 40 achieved >CR and MRD 30 negativity at Cycle 6 (≤10⁻⁵) 20 10 n=10 n=19° n°17° 0 Cycle 6 Cycle 6 Cycle 6 100% of patients in the MRD-evaluable population,ᵇ regardless of depth of response, achieved MRD negativity (10-5) at Cycle 6 and (sicluding - has was who delined - not RI be poporton - of polients who achoved MRS) (10-9) regardless of response. MRD. evaluable population defined as those patients with an available MRD last - 80 Issue Date for NOS Pateras resied, who achieved MRD or had to baseire done detected (NGS) *Doe patient has discontinued after completing Cycle 3. One polient had discontinged before a positive of negative 1 had Group, MRD, registrate a 10⁴ at any time on study (post induction cycle 3 or cycle 6) D, ow. OSMM Deumche Studengruppe Multiples completing Myslom Cycle GMMG, 3, and examal residual donese, NOF, not-generation for cytomosy, NOS NEXT monthly, Q4W every & weeks; R Imalidomida Tec. --- [Slide 2] GMMG-HD10/DSMM-XX/MajesTEC-51 MRD Negativity (10-⁵)ᵃ in the MRD-Evaluable Analysis Set MRD-evaluable population: all patients with an available MRD test (positive or negative)ᵇ - Only 1 patient was not evaluable for MRD throughout induction (Cycle 3 or 6) due to discontinuation before Cycle 3 Arm A: Tec (QW)-DR Arm A1: Tec (Q4W)-DR Arm B: Tec (Q4W)-DVR 100 90 MRD-evaluable patients (%) 80 70 60 50 100 100 100 100 100 100 40 30 20 10 n=10 0 n=10 n=19° n=19d n=17° n=17' Cycle 3 Cycle 6 Cycle 3 Cycle 6 Cycle 3 Cycle 6 With completion of induction, 100% MRD negativity (10-5) continues to be observed in MRD-evaluable patients, regardless of depth of response Insure SED regative - was adinat Cen as the provide proportion - not of Instad patients One was belowed achieved had MRD regalizity (189) per NOF, regardiess of - Fax not at patents actived CR) "Excluding Thosa who --- [Slide 3] GMMG-HD10/DSMM-XX/MajesTEC-5: Infections Arm A: Arm A1: Arm B: 18 (36.7%) patients had Tec (QW)-DR Tec (Q4W)-DR Tec (Q4W)-DVR Total grade 3/4 infectionsᵇ (n=10) (п=20) (n=19) (N=49) All Grade All Grade All Grade All - No discontinuations due to Infection Grade 3/4 TEAE, n (%)* grade 3/4 grade 3/4 grade 3/4 grade - No grade 5 infections Any Infection 10 (100) 4 (40) 18 (90) 10 (50) 11 (57.9) 4 (21.1) 39 (79.6) 18 (36.7)b Hypogammaglobulinemia® reported in 45 (91.8%) patients Infectionsᶜ - 44 (89.8%) patients received ≥1 URTI 6 (60) 0 8 (40) 1 (5) 6 (31.6) 0 20 (40.8) 1 (2) dose of IVlg COVID-19 2 (20) 0 4 (20) 1 (5) 3 (15.8) 2 (10.5) 9 (18.4) 3 (6.1) Stringent infection prophylaxis was Nasopharyngitis 3 (30) 0 2 (10) 0 2(10.5) 0 7 (14.3) 0 strongly recommended, including Ig replacement Pneumonia 1 (10) 1 (10) 0 0 2(10.5) 2 (10.5) 3(6.1) 3 (6.1) Low patient numbers and relatively RTI 0 0 1 (5) 0 2 (10.5) 0 3 (6.1) 0 short follow-up time may account Bronchitis 2 (20) 0 0 0 0 0 2 (4.1) 0 for differing infection rates across arms ALA 10% - . graded patents according n any - to the Recludes NO-CTORE patients Version with at 10 TEAE The median of blow-up - 73 or I-14.5) a post months baseine One g0 patient value <00 had a mg/dl grade Additional 3 'ustrown' recommended infection that measures was reported included under prophytics the uncoded Ry Promocysts calogory Infections reported
Hamza Hashmi
Hamza Hashmi @hhashmi87
MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Data
3.1K impressions · 13 likes · Sep 17, 2025
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[Slide 1] Post-Induction Outcomes and Updated Minimal Residual Disease Analysis From GM MG GMMG-HD10/DSMM-XX (MajesTEC-5): a Study deutsche studiengruppe of Teclistamab-Based Induction Regimens in multiples envelops Newly Diagnosed Multiple Myeloma (NDMM)* dsmm mong mudes - *ClinicalTrials.gov Identifier: NCT05695508; sponsored by the University of Heidelberg Medical Center and in collaboration with Johnson & Johnson Marc S Raab1, Niels Weinhold1, K Martin Kortüm², Jan Krönke³, Lilli Podola¹, Uta Bertsch1, hops Julia Mersi², Stefanie Huhn1, Michael Hundemer1, Roland Fenk4, Katja Weisel⁵, Alexander Brobeil°, The OR code is intended 33 provide scientific Elias K Mai1, Natalie Schub⁷, Florian Bassermann8, Monika Engelhardt9, Mathias Hänel10, information for individual and the information should not be attered or Hans Salwender11, Raphael Teipel¹², Mohamed Amine Bayar13, Elena Ershova14, reproduced as any way Bas D Koster¹⁵, Hartmut Goldschmidt1, Hermann Einsele², Leo Rasche² 'Heidelberg Myeloma Center, Department of Medicine V. Heldelberg University Hospital and Medical Faculty Heldelberg, Heldelberg, Germany; Department of Internal Medicine 11, University Hospital of Würzburg, Würzburg, Germany; Department for Hematology, Oncology, and Tumor immunology, Charité Universitätsmedizin Bertin, Germany; Department for Hematology, Oncology and Clinical Immunology, Medical Faculty, Heinrich Heine University Dusseldorf, Moorenstr 5, 40225, Dusseldorf, Germany: University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Institute of Pathology, University Hospital Heldelberg, Heldelberg, Germany: Department of Internal Medicine 11, Division of Stem Cell Transplantation and Immunotherapy, UKSH Campus Kiel, Kiel, Germany; Department of Medicine III, TUM Klinikum, Technische Universität München, München, Germany; German Cancer Consortium (OKTK), German Cancer Research Center (DKFZ), Heldelberg, Germany; Department of Hematology, Oncology and Stem Cell Transplantation, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; "Department of internal Medicine 111, Klinikum Chemnitz, Chemnitz, Germany; "Asklepios Tumorzentrum Hamburg, AK Altona and AK St Georg, Hamburg, Germany; Medizinische Klinik und Poliklinik 1, Universitätsklinikums Carl Gustav Carus an der TU Dresden, Dresden, Germany; PJohnson & Johnson, Parts, France; "Johnson & Johnson, Beerse, Belgium; "Johnson 5 Johnson, Leiden, The Netherlands. Presented by MS Raab at the 22nd International Myeloma Society (IMS) Annual Meeting: September 17-20, 2025; Toronto, Canada --- [Slide 2] GMMG-HD10/DSMM-XX/MajesTEC-5: Study Design Key eligibility Induction (6 x 28-day cycles)a Maintenanceᵇ,ᶜ (x 18 cycles) Primary endpoints: criteria: Arm A (n=10): AEs, SAEs TE NDMM Tec (1.5 mg/kg QW)-DR Select secondary ECOG PS score of 0-2 Arm A1 (n=20): Tec (3 mg/kg Q4W)-DR HDT + ASCT endpoints: Aged 18-70 years Tec-D MRD negativity (10⁻⁵ and 10⁻⁶) ORR Arm B (n=19): >CR >VGPR Tec (3 mg/kg Q4W)-DVR Stem cell yield C1 C2 C3 C4 C5 C6 MRD 10⁻⁵ via NGF MRD MRD MRD 10⁻⁶ via NGS Tec (Cycle 1): Tec step-up dosing (0.06 and 0.3 mg/kg on Days 2 and 4) + 1.5 mg/kg on Days 8 and 15ᵉ - Tec (Cycles 2-6): 1.5 mg/kg QW on Day 1 (Arm A); 3 mg/kg Q4W on Day 1 (Arm A1 and B) D: 1800 mg SC per label (QW for Cycles 1-2; Q2W for Cycles 3-6) V: 1.3 mg/m2 SC QW R: 25 mg PO daily starting in Cycle 2 (Days 1-21) d: 20 mg (PO or IV) in Cycles 1-4 (Arm A) or Cycles 1-2 (Arm A1/B) only Stem cell collection was planned after 3 cycles of induction. Following maintenance therapy, patients could receive additional SoC maintenance treatment per institutional standard and local investigator decision. Maintenance treatment an be discontinued when 12 months of sustained MRD negativity (10-4) have been observed, beginning in induction Planned maintenance treatment in Arm A was Tec-DR A protocol amendment permitted patients initially assigned to Tec-DR saintenance to receive Tec-D maintenance per investigator's choice (patients who started Tec-DR may have discontinued R to receive Tec-D per investigator's choice). Patients in Arm A received an additional dose of Tec 1.5 mg/kg on Day 22. E, adverse event; ASCT, autologous stem cell transplant; CR, complete response, D, daratumumab; d, dexamethasone; DSMM, Deutsche Studiengruppe Multiples Myelom; ECOG PS, Eastern Cooperative Oncology Group performance status; MMG, German-speaking Myeloma Multicenter Group; HDT, high-dose therapy, MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; NGF, next-generation flow cytometry; NGS, next-generation sequencing ORR, overall esponse rate; QW, weekly; Q2W, every 2 weeks; Q4W, every 4 weeks; R, lenalidomide; SAE, serious adverse event, SoC, standard of care; TE, transplant-eligible; Tec, teclistamab; V, bortezomib; VGPR, very good partial response 5 Presented by MS Raab at the 22nd International Myoloma Society (IMS) Annual Meeting: September 17-20. 2025; Toronto, Canada --- [Slide 3] GMMG-HD10/DSMM-XX/MajesTEC-5: MRD Negativity (10-6)a in the MRD-Evaluable Analysis Setb Arm A: Tec (QW)-DR Arm A1: Tec (Q4W)-DR Arm B: Tec (Q4W)-DVR 100 When combining all patients 90 across all arms (n=49), 80 cumulative MRD-negativity rate® MRD-evaluable patients (%) 70 by end of induction in the 60 efficacy analysis set was 98.0% 50 100 100 100 85.7% (42/49) of patients 40 achieved ≥CR and MRD 30 negativity at Cycle 6 (≤10⁻⁵) 20 10 n=10 n=19° n=17d 0 Cycle 6 Cycle 6 Cycle 6 100% of patients in the MRD-evaluable population,ᵇ regardless of depth of response, achieved MRD negativity (10-6) at Cycle 6 MRD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10-4). regardless of response. MRD-evaluable population defined as those patients with an available MRD test with a positive or negative result (excluding those who were not tested, were indeterminate, or had no baseline clone detected [NGS]). One patient had discontinued after completing Cycle 3. One patient had discontinued before completing Cycle 3, and 1 had no baseline clone detected for NGS. *Patients who achieved MRD negativity at 10-⁵ or 10-4 at any time on study (post-induction cycle 3 or cycle 6). D, daratumumab; DSMM, Deutsche Studiengruppe Multiples Myelom; GMMG, German-speaking Myeloma Multicenter Group; MRD, minimal residual disease; NGF, next-generation flow cytometry; NGS, next-generation sequencing; QW, weekly, Q4W, every 4 weeks; R, lenalidomide; Tec, teclistamab; V, bortezomib. 14 Presented by MS Raab at the 22nd International Myeloma Society (IMS) Annual Meeting: September 17-20, 2025; Toronto, Canada

MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Top Tweets

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Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP@RahulBanerjeeMD

#IMS25 In my mind, this will be the slayer of ASCT more than any other #MMsm regimen...

Excellent Tec-DVR &amp; Tec-DR data [1x weekly Velcade &amp; lots of IVIG 👏] in NDMM from MajesTEC-5 @RaabMarc

👁 9.1K ♡ 76 ↻ 26 Sep 17, 2025
Jacob Plieth
Jacob Plieth@JacobPlieth

Why is everyone so excited about this? #ASH24 https://t.co/HFHaxODnxg

👁 5.5K ♡ 7 ↻ 1 Dec 8, 2024
Thilo J. Zander
Thilo J. Zander@ThiloZander

‼️100% MRD Negativity after 6 cycles of Teclistamab-based induction in NDMM is something we will remember @RaabMarc #myeloma #IMS2025 https://t.co/0PU0a1tjmg

👁 4.3K ♡ 70 ↻ 15 Sep 19, 2025
Ben Derman
Ben Derman@bdermanmd

Updates from MajesTEC-5:
Continue to see unprecedented mrd negativity rates after just 6 cycles of teclistamab + Dara-R and +\- bortezomib.
Pretty clear that bortezomib thus far not offering benefit.…

👁 3.7K ♡ 48 ↻ 16 Sep 17, 2025
Raj Chakraborty
Raj Chakraborty@rajshekharucms

Exciting data from MajesTEC-5 by Dr. Raab. Tec-Dara based induction leading to ~100% MRD-negativity rate by NGS at 10^-6 post Cycle#6. At ~7 mo f/u risk of Grade 3 or higher infection ~37% (no deaths…

👁 3.2K ♡ 41 ↻ 12 Sep 17, 2025
Hamza Hashmi
Hamza Hashmi@hhashmi87

#IMS25 MajesTEC_5: Tec+DaraRV for TE NDMM:
N=50, 100% MRD neg by NGS 10-6 after C6, all pts collected stem cells
G3 infection 33%, hypogamma 90%
MRD neg much higher than SOC DRVd
Id this Rx for…

👁 3.1K ♡ 13 ↻ 5 Sep 17, 2025
Rafael Fonseca MD
Rafael Fonseca MD@Rfonsi1

MjesTEC-5 ORR 100%, 95-100 CR, MRD- 100% including 10-6.
#IMS2025 #mmsm https://t.co/IuQ8LHZJNj

👁 2.7K ♡ 40 ↻ 8 Sep 17, 2025
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
Jacob Plieth
Jacob Plieth@JacobPlieth

$JNJ&#x27;s shot at 1st-line multiple myeloma: Tecvayli in Majestec-5 study in transplant-eligible patients. Note Pomalyst + Revlimid (+Velcade) combo and uncontrolled study #ASH24 https://t.co/u4Kwk3vH8e

👁 1.3K ♡ 0 ↻ 1 Dec 8, 2024
Luciano J Costa
Luciano J Costa@End_myeloma

@Rfonsi1 Is this a year 2000, STI571 moment?

👁 1.1K ♡ 7 ↻ 1 Sep 19, 2025

About the MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) Trial

MajesTEC-5 positions teclistamab + DR ± bortezomib as a potential new induction regimen in TE-NDMM with unprecedented MRD negativity rates. Phase 3 confirmation pending. Direct competitor: CARTITUDE-6 (cilta-cel front-line) for the TE-NDMM landscape.

Trial Methodology & Results

ORR + MRD Negativity — Induction Phase — Multi-Cohort

Arm A (Tec-DR weekly, n=10): ORR 100%, sCR/≥CR 100%, 100% MRD-negative by NGS. Arm A1 (Tec-DR Q4W, n=20): ORR 90-100%, ≥CR 95%, 100% MRD-neg. Arm B (Tec-DVR Q4W with bortezomib, n=19): ORR 89.5-100%, ≥CR 73.7%, 100% MRD-neg. Unprecedented depth of response during induction alone.

✓ ORR 90-100%; 100% MRD-neg at Cycle 3/end of induction

📄 Source: KOL commentary on X →

Overall Survival (OS)

OS data immature; primary analysis includes post-induction/ASCT + maintenance phases (ongoing).


📄 Source →

Safety & Tolerability

Key AEs: infections (require stringent prophylaxis), peripheral neuropathy (G≥2: 16% with weekly bortezomib), CRS (low-grade). Weekly bortezomib scheduling reduces peripheral neuropathy vs. twice-weekly. Tolerable in early NDMM cohorts with maturing data. Infection prophylaxis critical given bispecific activity.

Manageable with infection prophylaxis

📄 Source →

Clinical Implications

⚠️ Phase 2 signal — potential new induction standard. MajesTEC-5 positions teclistamab + DR ± bortezomib as a potential new induction regimen in TE-NDMM with unprecedented MRD negativity rates. Phase 3 confirmation pending. Direct competitor: CARTITUDE-6 (cilta-cel front-line) for the TE-NDMM landscape.

MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX) in the News

Key KOL Sentiments — MajesTEC-5 (MMY2003 / GMMG-HD10 / DSMM-XX)

DoctorSentimentComment
Rahul Banerjee, MD, FACP ● POSITIVE #IMS25 In my mind, this will be the slayer of ASCT more than any other #MMsm regimen... Excellent Tec-DVR &amp; Tec-DR data [1x weekly Velcade &amp; lots of IVIG 👏] in NDMM from MajesTEC-5 @RaabMarc 100% ORR, 100% MRD neg across the board. This is what we hope for with induction! https://t.co/H5s9c2rRj8
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
Marc-A. Bärtsch ● POSITIVE The overflow rooms were overflowing! Important contributions from German study groups GMMG and DSMM in NDMM: impressive 100% MRD negativity with Teclistamab based regimens in HD10 presented by @RaabMarc and significant PFS benefit with Isa-VRd induction reported by @EliasKarlMai https://t.co/A23UIPR5jV
Gareth Morgan ● POSITIVE These combinations are safe and hugely effective and are going to get most patients to have no detectable disease great work from my German friends https://t.co/PeSH8t8QId
Rahul Banerjee, MD, FACP ● POSITIVE And #IMS25 @RaabMarc adding that they even switched from NGF to NGS at 10^-6 to be sure... still 100% MRD neg across the board. Truly remains the best induction data in #MMsm the world has ever seen... and my guess is that IVIG is helping to lower AE profile substantially! https://t.co/WYxqZ3lujw
Peter Forsberg MD ● POSITIVE This is the start of a revolution. Still lots of work to do but the future of myeloma therapy is clear to see and it couldn’t be more exciting. https://t.co/GVm0TlEu0K
Murali Janakiram ● POSITIVE @RahulBanerjeeMD @RaabMarc This is encouraging Rahul no issues with collection
Bhuvan Kishore ● POSITIVE @RahulBanerjeeMD @RaabMarc These are amazing results. Probably sets the bar quite high if MRD 💯 is to be beaten. The only way forward from here is deescalation or deferred ASCT. Sustained MRD hopefully will be as good.
Rahul Banerjee, MD, FACP ● POSITIVE @bdermanmd I could not agree more! If 100% of patients are expected to be MRD negative within 3 months of induction, should ASCT be the norm or the exception? We obviously don't know yet, but fascinating to see how far the #MMsm world has come! #ASH24
Teresa Miceli. &4 ● POSITIVE Response impressive. #ASH24 #mmsm #myeloma https://t.co/bop6YuvFoq
Jacob Plieth ● NEUTRAL Why is everyone so excited about this? #ASH24 https://t.co/HFHaxODnxg
Thilo J. Zander ● NEUTRAL ‼️100% MRD Negativity after 6 cycles of Teclistamab-based induction in NDMM is something we will remember @RaabMarc #myeloma #IMS2025 https://t.co/0PU0a1tjmg
Raj Chakraborty ● NEUTRAL Exciting data from MajesTEC-5 by Dr. Raab. Tec-Dara based induction leading to ~100% MRD-negativity rate by NGS at 10^-6 post Cycle#6. At ~7 mo f/u risk of Grade 3 or higher infection ~37% (no deaths from infection yet). My thoughts: Is ASCT necessary with such deep response https://t.co/YsTmQAxaRl
Hamza Hashmi ● NEUTRAL #IMS25 MajesTEC_5: Tec+DaraRV for TE NDMM: N=50, 100% MRD neg by NGS 10-6 after C6, all pts collected stem cells G3 infection 33%, hypogamma 90% MRD neg much higher than SOC DRVd Id this Rx for ‘Time limited therapy’,? Role of ASCT with such high MRD neg rates https://t.co/PhjmUt3Yda
Rafael Fonseca MD ● NEUTRAL MjesTEC-5 ORR 100%, 95-100 CR, MRD- 100% including 10-6. #IMS2025 #mmsm https://t.co/IuQ8LHZJNj
Jacob Plieth ● NEUTRAL $JNJ's shot at 1st-line multiple myeloma: Tecvayli in Majestec-5 study in transplant-eligible patients. Note Pomalyst + Revlimid (+Velcade) combo and uncontrolled study #ASH24 https://t.co/u4Kwk3vH8e
Luciano J Costa ● NEUTRAL @Rfonsi1 Is this a year 2000, STI571 moment?
Multiple Myeloma RF ● NEUTRAL Tecvayli is approved for later line therapies in relapsed/refractory patients. However, studies at #IMS2025 are highlighting the impact bispecifics like Tecvayli can have for newly diagnosed patients. Efficacy results are still very early, but encouraging. https://t.co/hywBR5HskB
Luciano J Costa ● NEUTRAL 4- MajesTEC-5, NDMM, early and intriguing. The question to me is not to what regimen to add an anti-BCMA TCE, but rather when you have agents with this high activity, what other agent do you still need? https://t.co/Je06Fh4Nqk
OncLive.com ● NEUTRAL We spoke with @RaabMarc of @HDMyeloma about post-induction outcomes and updated minimal residual disease analysis from MajesTEC-5, of teclistamab-based induction regimens in newly diagnosed multiple myeloma 🧬 Tune in for the latest updates from #IMS25: https://t.co/ilUu43Kxi7 https://t.co/FGJnxWB8wk
Rahul Banerjee, MD, FACP ● NEUTRAL @RaabMarc #ASH24 Small n, but this is great to see - 100% MRD negativity in all arms with tec-based induction in #MMsm. Now of course the question will be, if you achieve 100% MRD negativity in all patients with induction, should you even go to ASCT? 🤔 Exciting data to see! https://t.co/g4vTnGMpTf
Ben Derman ● NEUTRAL MajesTEC-5 - Arm A/A1: Teclistamab + Dara + Len --&gt; ASCT --&gt; Tec-Dara Arm B: Tec-Dara-V-R Toxicity: 60-70% CRS, G1-2; 35% G3+ infections (everybody getting some infections) Efficacy (amazing!) Everybody is MRD negative after just 3 cycles! Stem cell yields not affected To me,… https://t.co/HuUY1RANU5 https://t.co/ohdyIxkkJ5
Blood Cancers Today ● NEUTRAL ➕ Teclistamab plus daratumumab-based regimens is effective as induction therapy for patients with transplant-eligible, newly diagnosed #myeloma. 📰 Read more from the MajesTEC-5 trial presented at #IMS25 by @RaabMarc of @HDMyeloma. ➡️ https://t.co/4CZYTmg80E https://t.co/psgzA1gf0V
Rahul Banerjee, MD, FACP ● NEUTRAL #ASH24 just for context - in DETERMINATION published just a few years ago, MRD neg (10^-5) AFTER ASCT was ~54%. In MajesTEC-5, small n, but 100% MRD negativity BEFORE ASCT (after only 3 cycles)... + 1x-wkly V and #downwithdex! Amazing #MMsm data by @RaabMarc @RascheLeo et al! https://t.co/EuvLm1jf9k https://t.co/hN3IMLfKix
Rahul Banerjee, MD, FACP ● NEUTRAL #ASH24 @RaabMarc presenting MajesTEC-5 (frontline bsAb) now! Obviously will talk about efficacy next, but 👏 look 👏 at 👏 this!! 1️⃣ V only once-weekly even in ASCT-eligible (cc @GKaurMD) 2️⃣ #downwithdex after 2 cycles (cc @jmikhaelmd) EVERY #MMsm study should be this way! https://t.co/0UaofOJVvM
Rafael Fonseca MD ● NEUTRAL @End_myeloma I think so
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL @ASH_hematology #ASH24 #mmsm @ASH_hematology Oral myeloma: GMMG-HD10/DSMM-XX (MajesTEC-5) Responses are high and deep with ongoing follow up 100% MRD -ve and sCR in Arm A and other arms follow up ongoing (very nice to see such responses) Vaccines were recommended not mandated Prophylaxis… https://t.co/q5QtbhzISq https://t.co/yRK1LnKDY7
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH24 #mmsm @ASH_hematology Oral myeloma: GMMG-HD10/DSMM-XX (MajesTEC-5) Notice AEs and pt desposition One patient fail to harvest stem cells (prior XRT) Infections G3/4 in 1 out of 3 pts Data on G2 CRS will be important Elevated lipase reported with one patient with… https://t.co/5ZHYJ2DWNW https://t.co/QyEK0zJx9X
Thilo J. Zander ● NEUTRAL Study Design &amp; Infections https://t.co/H9Yuw5m466
Ben Derman ● NEGATIVE Updates from MajesTEC-5: Continue to see unprecedented mrd negativity rates after just 6 cycles of teclistamab + Dara-R and +\- bortezomib. Pretty clear that bortezomib thus far not offering benefit. Is transplant really needed either? Infection rates a bit concerning with short https://t.co/cEuVQ8fsFt