Teclistamab (Tecvayli) + lenalidomide vs. teclistamab alone vs. lenalidomide alone — maintenance therapy after autologous stem-cell transplant in newly-diagnosed multiple myeloma. Janssen / Johnson & Johnson with the European Myeloma Network (EMN30). Phase 3, investigational; safety run-in presented at ASH 2024 and updated at EHA 2026.
Study-design, efficacy and safety slides shared by KOLs from MAJESTEC-4 (ASH 2024 safety run-in; EHA 2026 update). Click to expand; expand OCR for slide text.
#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
Click to expand
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*
#EHA2026
#nielsvandedonk MajesTEC-4 SRI data
At first glance, shocking that tec (bsAb) dose intensity so much higher than len dose intensity (~90% vs ~50%) 🤯
But honestly not surprising - len maintenance can be tough! Q4W tec with optimal supportive care quite maintainable. https://t.co/Akl05eWwdP
Click to expand
EMN30/MajesTEC-4 SRI: Hematologic TEAEs
Cohort 1:
Cohort 2:
Tec QW Q4W + Len
Cohort 3:
Median relative dose intensityᵇ:
Tec Q4W + Len
Tec Q4W
(n=32)
(n=32)
(n=30)
- Tec: 96-99%c; Len: 55-56%
Median follow-up, mo
32.7
21.2
Discontinuation due to TEAEsd
21.2
TEAEs,ª n (%)
Any
Grade
Any
Grade
Any
Grade
- Cohort 1: 4 (12.5%)
grade
3/4
grade
3/4
grade
3/4
Any TEAE
32 (100)
32 (100)
- Cohort 2: 4 (12.5%)
32 (100)
31 (96.9)
30 (100)
20 (66.7)
Hematologic TEAEs
- Cohort 3: 1 (3.3%)
Neutropenia
30 (93.8)
30 (93.8)
25 (78.1)
25 (78.1)
22 (73.3)
Two Grade 5 TEAEs
19 (63.3)
Leukopenia
8 (25.0)
3 (9.4)
0
0
2 (6.7)
1 (3.3)
- COVID-19 (Cohort 2)
Lymphopenia
2 (6.3)
1 (3.1)
4 (12.5)
4 (12.5)
6 (20.0)
4 (13.3)
- Radiculopathy (Cohort 2)
Thrombocytopenia
6 (18.8)
2 (6.3)
1 (3.1)
1 (3.1)
2 (6.7)
0
Anemia
Two non-TEAE deaths
3 (9.4)
0
2 (6.3)
1 (3.1)
3 (10.0)
0
Febrile neutropenia
3 (9.4)
3 (9.4)
3 (9.4)
3 (9.4)
0
- Complications after allo-SCT (Cohort 1)e
0
Eosinophilia
1 (3.1)
1 (3.1)
1 (3.1)
1 (3.1)
0
0
- Progressive disease (Cohort 3)
High median RDI maintained with Tec and low rates of discontinuation due to TEAEs
allo-SCT, AEs (graded allogenic per NCI-CTCAE stem cell transplant; Version 5.0); MDS, any myelodysplastic grade in >25% syndrome; of patients NCI-CTCAE, or grade 3/4 in National >1 patient. Cancer Ratio Institute of total Common dose actually Terminology received/total Criteria for Adverse Events: RDI, relative dose intensity; TEAE, treatment-emergent adverse event.
are excluded. Includes SUD as well as repeat SUD if Presented applicable. Discontinuation NWCJ of all study treatment. Patient developed MDS and had a fatal planned event due dose to per severe protocol. immunosuppression Planned doses not after received allo-SCT due unrelated to study to drug study discontinuation treatment.
by van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
7
Dr. Niels van de Donk updating MajesTEC-4 at #EHA26 #EHA2026 #mmsm https://t.co/6cAyjdUNYT
Click to expand
Click to expand
Click to expand
Click to expand
EMN30/MajesTEC-4 SRI: Cumulative Incidence
of Grade 3/4 Infections
1.0
0.9
0.8
0.7
Cumulative incidence of
0.6
Tec Q4W + Len
Q4W + Len
grade 3/4 infections
Tec QW
0.5
0.4
0.3
0.2
0.1
Tec Q4W
0
0
3
6
9
12
15
18
21
24
27
30
33
36
Study month
Number at risk
6
5
4
0
32
28
25
25
23
19
14
14
Tec QW > Q4W + Len
Tec Q4W + Len
32
27
24
17
14
12
2
0
0
0
0
27
Tec Q4W
30
24
22
22
22
22
21
1
0
0
0
0
Cumulative incidence of grade 3/4 infections plateaued with Tec Q4W from ~6 months
10
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
|| EMN30/MajesTEC-4 SRI: Response Rates Post-ASCT and
During Maintenance
Efficacy data cutoff: December 8, 2025
60.0%
96.7%
100%
40.6%
96.9%
>CR rate
46.9%
10.0
sCR
100
12.5
CR
31.3
80
VGPR
28.1
50.0
75.0
76.7
PR
60
15.6
Patients (%)
93.8
40
43.8
34.4
23.3
20
21.9
20.0
18.8
15.6
3.1
16.7
3.3
6.3
0
Response
Best response
Response
Best response
Response
Best response
post-ASCT
on maintenance
post-ASCT
on maintenance
post-ASCT
on maintenance
Tec QW > Q4W + Len (n=32)
Tec Q4W + Len (n=32)
Tec Q4W (n=30)
Median follow-up, 35.3 mo
Median follow-up, 23.7 mo
Median follow-up, 23.7 mo
>CR was reached in nearly 100% of patients during maintenance across cohorts
sCR, stringent complete response; VGPR, very good partial response.
Response based on investigator assessment *Post-ASCT consolidation.
11
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
|| EMN30/MajesTEC-4 SRI: Progression-Free Survival
Estimated 18-mo Estimated 24-mo
96.4%
96.6%
100
Cohort 3:
Median PFS was not
90
Cohort 2:
Tec Q4W
93.8%
Cohort 1:
Tec Q4W +Len
Tec QW > Q4W +
reached in any cohort
80
Len
% of patients progression
70
Only 3 patients progressed
free and alive
60
- 2 in Cohort 1
50
40
- 1 in Cohort 3
30
20
10
0
0
3
6
9
12
15
18
21
24
27
30
33
Number at risk
PFS (months)
Tec QW + Q4W + Len
32
32
32
32
31
29
28
28
28
25
2
0
31
31
31
31
26
5
0
0
0
0
0
Tec Q4W + Len
32
Tec Q4W
30
29
28
27
26
26
6
0
0
0
0
0
Estimated 18- and 24-month PFS rates were 94%-97%, with only 3 progression events
Clinical cutoff date: May 7, 2025.
13
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
|| EMN30/Majes TEC-4 SRI: Tec ± Len as Maintenance
Therapy Post-ASCT in NDMM
Tec and Tec-Len were safety administered as 2-year fixed-duration post-ASCT maintenance, with convenient
Tec Q4W dosing after cycle 1 (median follow-up ~2-3 years)
CRS and infections were manageable via established protocols, supporting use across practice settings
Tec-based maintenance delivered remarkable depth of response post-ASCT, which deepened over time:
- -97%-100% of patients achieved >CR post-ASCT
- 90%-100% of evaluable patients achieved MRD-negative CR at 12 months
Estimated 18- and 24-mo PFS rates were 94%-97%, with only 3 progression events
The randomized portion is open and evaluating Tec-Len, Tec, and Len as maintenance with monthly Tec dosing
Tec + Len as post-ASCT maintenance in NDMM is a promising new maintenance approach
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
14
MajesTEC-4: Trial using Tec vs Tec+Len in maintenance post ASCT !
This is early, but the P3 trial of BCMA bispecifics is going to be a huge change in how we manage NDMM.
Globally ~180K NDMM are diagnosed, and about ~30-40% are potentially transplant eligible. Having a therapy https://t.co/4DXqTuWtvk
Click to expand
Click to expand
Click to expand
EMN30/MajesTEC-4: Study Design
SRI
Phase 3, randomized study
Key eligibility criteria:
SRI Cohort 1
Tec-Lenb
Dual primary end points:
NDMM
Tec QW
Q4W
PFS
Tec Q4W
12-month MRD-negative CR (by NGF; 10⁻⁵)
+
ECOG PS score of 0-2
Len
Key secondary end point:
Received 4-6 cycles of
SRI Cohort 2
3- or 4-drug induction therapy
Tec Q4W
antibody) and
N=1500
ASCT + consolidation
+
Len
with >PR
1:1:1 randomization
OS
(PI and/or IMiD ± anti-CD38
Tec
Select secondary end points:
>CR
Tec Q4W
CR conversion
MRD-negative CR
SRI Cohort 3
MRD-negative conversion
Sustained MRD-negative CR
PFS2
Tec Q4W
Lenb
TTNT
Safety
CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; MRD, minimal residual disease; 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; TTNT. time to next treatment.
"Single or tandem ASCT permitted. Len dose: 10 mg once daily; may increase to 15 mg once daily on Day 1 of Cycle 4 (Len) or Cycle 5 (Tec-Len) if 10 mg was tolerated
3
Presented by NWC van de Donk at the 31st European Hematology Association (FHA) Annual Meeting: June 11-14 2026 Stockholm Sweden
|| EMN30/MajesTEC-4 SRI: Dosing
28-day cycles
Cycle 1
Cycle 2
Cycles 3-6
Cycles 7-26c
Tec SUDᵃ +
Tec QW Q4W
Tec 1.5 mg/kg QW
Tec 3.0 mg/kg Q2W
Tec 3.0 mg/kg Q4Wb
Tec 1.5 mg/kg on D8, D15,
+ Len
+ Len
+ Len
+ Len
and D22
Tec Q4W
Tec SUDᵃ +
Tec 3.0 mg/kg Q4Wb
+ Len
Tec 1.5 mg/kg on D8 and D15
+ Len
Tec SUDᵃ +
Tec Q4W
Tec 3.0 mg/kg Q4W
Tec 1.5 mg/kg on D8 and D15
Len was initiated at 10 mg/day from Cycles 2 to 4, followed by 15 mg/day in Cycles 5 to 26, if tolerated
All cohorts are 2-year fixed-duration maintenance regimens
D, Day; Q2W, every 2 weeks; SUD, step-up dosing.
"Patients received SUD of 0.06 and 0.3 mg/kg on D1 and D3, respectively. Patients who achieved >CR on Tec-Len after Cycle 13 discontinued Tec. Patients on Tec-Len could continue Len after Cycle 26.
4
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
|| EMN30/MajesTEC-4 SRI: Demographic and Disease
Characteristics
Tec QW + Q4W + Len
Tec Q4W + Len
Tec Q4W
Characteristic
(n=32)
(n=32)
(n=30)
Median(range) age, y
58.5 (31-73)
58.0 (38-73)
58.5 (34-72)
265, n (%)
12 (37.5)
5 (15.6)
9 (30.0)
Male, n n (%)
21 (65.6)
21 (65.6)
22 (73.3)
White, race, n (%)
32 (100)
32 (100)
30 (100)
ISS disease stage at diagnosis, n/N (%)
I
18/32 (56.3)
7/32 (21.9)
9/28 (32.1)
II
7/32 (21.9)
10/32 (31.3)
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 (%)
PP IMID
28 (87.5)
28 (87.5)
30 (100)
PP . IMID . anti-CD384
11 (34.4)
19 (59.4)
20 (66.7)
Prior consolidation, n (%)
6(18.8)
12 (37.5)
10 (33.3)
Median (range) time from ASCT to maintenance, mo
4.3 (2.0-6.2)
5.1 (1.8-7.4)
4.5 (2.1-6.9)
iss, International Staging System
High cytogenetic - presence of at of del(17p). (4.14) or (14,16) 9394 received borlezomb and 5/94 (3.2%) received carliformb. 5394 (56.4%) received Len, 36/94 5%) received haldomide, and 1/94 (%)
received pomaldomide 5094 (53.2%) received and 154 "%)received saturnab.
Presented by NWCJ - Donk - The 21st European Hematology Association (EHA) Annual Meeting June 11-54, 2020 Stockholm Seeden
CONGRESS | #EHA2026 | PRESENTATION
Niels van de Donk presents updated safety run-in results from the MajesTEC-4 study evaluating teclistamab ± lenalidomide versus lenalidomide alone as post-transplant maintenance for NDMM.
Teclistamab-based maintenance was associated with grade https://t.co/ahupBsfwhC
Click to expand
Click to expand
Click to expand
Click to expand
EMN30/MajesTEC-4 SRI: Hematologic TEAEs
Cohort 1:
Cohort 2:
Cohort 3:
Median relative dose intensityᵇ:
Tec QW Q4W + Len
Tec Q4W + Len
Tec Q4W
- Tec: 96-99%c; Len: 55-56%
(n=32)
(n=32)
(n=30)
Discontinuation due to TEAEsd
Median follow-up, mo
32.7
21.2
21.2
Any
Grade
Any
Grade
Any
Grade
- Cohort 1: 4 (12.5%)
TEAEs,ᵃ n (%)
grade
3/4
grade
3/4
grade
3/4
- Cohort 2: 4 (12.5%)
Any TEAE
32 (100)
32 (100)
32 (100)
31 (96.9)
30 (100)
20 (66.7)
- Cohort 3: 1 (3.3%)
Hematologic TEAEs
Two Grade 5 TEAEs
Neutropenia
30 (93.8)
30 (93.8)
25 (78.1)
25 (78.1)
22 (73.3)
19 (63.3)
Leukopenia
8 (25.0)
3 (9.4)
0
0
2 (6.7)
1 (3.3)
- COVID-19 (Cohort 2)
Lymphopenia
2 (6.3)
1 (3.1)
4 (12.5)
4 (12.5)
6 (20.0)
4 (13.3)
- Radiculopathy (Cohort 2)
Thrombocytopenia
6 (18.8)
2 (6.3)
1 (3.1)
1 (3.1)
2 (6.7)
0
Two non-TEAE deaths
Anemia
3 (9.4)
0
2 (6.3)
1 (3.1)
3 (10.0)
0
- Complications after allo-SCT (Cohort 1)e
Febrile neutropenia
3 (9.4)
3 (9.4)
3 (9.4)
3 (9.4)
0
0
- Progressive disease (Cohort 3)
Eosinophilia
1 (3.1)
1 (3.1)
1 (3.1)
1 (3.1)
0
0
High median RDI maintained with Tec and low rates of discontinuation due to TEAEs
allo-SCT, allogenic stem cell transplant; MDS, myelodysplastic syndrome; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; RDI, relative dose intensity; TEAE, treatment-emergent adverse event.
"AEs (graded per NCI-CTCAE Version 5.0): any grade in >25% of patients or grade 3/4 in >1 patient. Ratio of total dose actually received/total planned dose per protocol. Planned doses not received due to study drug discontinuation
are excluded Includes SUD as well as repeat SUD if applicable. Discontinuation of all study treatment "Patient developed MDS and had a fatal event due to severe immunosuppression after allo-SCT unrelated to study treatment
7
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
|| EMN30/MajesTEC-4 SRI: Nonhematologic TEAEs
Tec QW
Q4W
+
Len
Tec Q4W + Len
Tec Q4W
All CRS was grade 1/2 (38.3%/6.4%)
(n=32)
(n=32)
(n=30)
- Most occurred after SUD 1/SUD 2
Median follow-up, mo
32.7
21.2
21.2
(37.2%/8.5%)
TEAEs,ᵃ n (%)
Any grade
Grade 3/4
Any grade
Grade 3/4
Any grade
Grade 3/4
- All resolved and no
Nonhematologic TEAEsᵇ
discontinuations
URTI
22 (68.8)
1 (3.1)
13 (40.6)
0
12 (40.0)
0
- 11.7% received tocilizumab for
Diarrhea
17 (53.1)
3 (9.4)
12 (37.5)
1 (3.1)
8 (26.7)
0
CRS treatment
CRS
16 (50.0)
0
13 (40.6)
0
13 (43.3)
0
No ICANS
Cough
14 (43.8)
0
8 (25.0)
0
10 (33.3)
0
COVID-19
13 (40.6)
1 (3.1)
7 (21.9)
0
9 (30.0)
1 (3.3)
Injection-site erythema
7 (21.9)
0
12 (37.5)
0
9 (30.0)
0
Fatigue
10 (31.3)
1 (3.1)
9 (28.1)
1 (3.1)
6 (20.0)
0
PSN
5 (15.6)
0
9 (28.1)
0
2 (6.7)
0
Pneumonia
8 (25.0)
4 (12.5)
3 (9.4)
0
2 (6.7)
1 (3.3)
CRS was mostly grade 1 and occurred during SUD, with no Tec discontinuations
CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; PSN, peripheral sensory neuropathy; URTI, upper respiratory tract infection.
"AEs (graded per NCI-CTCAE Version 5.0); any grade 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.
8
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
|| EMN30/MajesTEC-4 SRI: Response Rates Post-ASCT and
During Maintenance
Efficacy data cutoff: December 8, 2025
≥CR rate
46.9%
100%
40.6%
96.9%
60.0%
96.7%
100
12.5
10.0
sCR
31.3
80
CR
28.1
VGPR
75.0
50.0
60
15.6
76.7
Patients (%)
PR
93.8
40
34.4
43.8
23.3
20
21.9
20.0
18.8
15.6
3.1
16.7
3.3
0
6.3
Response
Best response
Response
Best response
Response
Best response
post-ASCT
on maintenance
post-ASCT
on maintenance
post-ASCT
on maintenance
Tec QW
Q4W + Len (n=32)
Tec Q4W + Len (n=32)
Tec Q4W (n=30)
Median follow-up, 35.3 mo
Median follow-up, 23.7 mo
Median follow-up, 23.7 mo
≥CR was reached in nearly 100% of patients during maintenance across cohorts
sCR, stringent complete response; VGPR, very good partial response.
Response based on investigator assessment "Post-ASCT * consolidation
11
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
|| EMN30/MajesTEC-4 SRI: Progression-Free Survival
Estimated 18-mo Estimated 24-mo
96.4%
100
96.6%
90
Cohort 3:
Tec Q4W
Cohort 2:
80
93.8%
Tec Q4W +Len
Cohort 1:
Median PFS was not
Tec QW -> Q4W +
% of patients progression
70
reached in any cohort
Len
free and alive
60
Only 3 patients progressed
50
- 2 in Cohort 1
40
30
- 1 in Cohort 3
20
10
0
0
3
6
9
12
15
18
21
24
27
30
33
Number at risk
PFS (months)
Tec QW -> Q4W + Len
32
32
32
32
31
29
28
28
28
25
2
0
Tec Q4W + Len
32
31
31
31
31
26
5
0
0
0
0
0
Tec Q4W
30
29
28
27
26
26
6
0
0
0
0
0
Estimated 18- and 24-month PFS rates were 94%-97%, with only 3 progression events
Clinical cutoff date: May 7. 2025.
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Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
MAJESTEC-4 (EMN30; NCT05243797) is the first Phase 3 trial to test a BCMA-directed bispecific antibody as maintenance therapy after autologous stem-cell transplant (ASCT) in newly-diagnosed multiple myeloma. It randomizes transplant-eligible patients to teclistamab + lenalidomide, teclistamab alone, or lenalidomide alone, asking whether adding a T-cell-engaging bispecific to (or in place of) standard lenalidomide maintenance can deepen and sustain MRD-negative remissions. A safety run-in (SRI) was presented at ASH 2024 (Zamagni et al.) and updated at EHA 2026 (van de Donk). Teclistamab is FDA-approved only for relapsed/refractory myeloma; its use as frontline maintenance here is investigational.
Responses deepened on maintenance across all three cohorts. ≥CR reached 100% in Cohort 1 (Tec-Len QW→Q4W), 90.6% in Cohort 2 (Tec-Len Q4W) and 93.3% in Cohort 3 (Tec alone) — driven largely by sCR (90.6% / 65.6% / 70.0%). MRD-negativity (10⁻⁵, NGF) reached 100% of evaluable patients during maintenance in every cohort, up from 63.0% / 83.3% / 73.3% after ASCT. Median PFS was not reached in any cohort. These remain safety-run-in cohorts (≈30 patients each; median follow-up 21.1 months in Cohort 1, ~9.2 months in Cohorts 2–3), not randomized efficacy outcomes.
≥CR 100% / 90.6% / 93.3% · 100% MRD-negativity (10⁻⁵) on maintenance · PFS not reached
Grade 3–4 TEAEs occurred in 100% (Cohort 1), 84.4% (Cohort 2) and 56.7% (Cohort 3) — the gradient tracking teclistamab intensity. There were no cases of ICANS and no grade ≥3 CRS; grade 1–2 CRS occurred in 50.0% / 40.6% / 43.3%, and one COVID-19 death occurred in Cohort 2. Median teclistamab relative dose intensity was 95.5–99.7% (lenalidomide 58.4–61.5%), supporting feasibility of schedule-adjusted, teclistamab-based maintenance.