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(teclistamab-cqyv)

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TECVAYLI® (teclistamab-cqyv)
Medical Information

TECVAYLI - Use as Monotherapy in Patients With Extramedullary Disease

Last Updated: 08/26/2026

SUMMARY

  • Data included in this response is limited to evaluations of TECVAYLI administered as monotherapy in patients with relapsed or refractory multiple myeloma (RRMM) with extramedullary disease (EMD).
  • Johnson & Johnson does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
  • MajesTEC-1 is a phase 1/2, multicohort study evaluating the efficacy and safety of TECVAYLI in patients with RRMM.1-4
    • Cohort A (triple-class exposed) included 165 patients who were previously treated with a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody (mAb).3
      • At a median follow-up of 14.1 months, lower response rates were observed in the 28 patients (17.0%) with EMD. A response was reported in 10/28 patients with EMD (overall response rate [ORR], 35.7% [95% confidence interval (CI), 18.6-55.9]) vs 94/137 patients without EMD (ORR, 68.6% [95% CI, 60.1-76.3]).3,5
      • Costa et al (2024)6 presented a subgroup analysis of the MajesTEC-1 study, evaluating efficacy and safety in patients with high-risk (HR) features, including patients with EMD (n=28). As of the data cutoff on August 22, 2023, the ORR was 63.0% for all patients and 35.7% in patients with EMD. Any grade treatment-emergent adverse events (TEAEs) were reported in 100% of patients with EMD; 92.9% were grade 3/4.
    • Cohort C included 40 patients previously treated with a PI, an immunomodulatory agent, an anti-CD38 mAb and anti-B-cell maturation antigen (BCMA)-targeted therapies.4
      • Touzeau et al (2024)4 published efficacy and safety results from Cohort C of the MajesTEC-1 study. At a median follow-up of 28.0 months, ORR was 52.5% for all patients and 58.3% in patients with EMD.
  • Torpe et al (2026)7 presented updated results from a nationwide multicenter retrospective ABCD study evaluating the effectiveness of TECVAYLI in heavily pretreated patients with RRMM and true non-osseous EMD vs those without EMD. The ORR was 29% vs 69% in patients with EMD and without EMD, respectively.
  • Afrough et al (2025)8 published results from a multicenter retrospective study conducted across 13 United States (US) centers evaluating the treatment outcomes according to soft tissue plasmacytoma (STP) type in patients with RRMM treated with TECVAYLI. The ORR was 38.0%, 54.1%, and 62.4% in patients with true-EMD, paraskeletal (PSK), and no-STP, respectively.
  • Dima et al (2024)9 presented the results from a multicenter, retrospective study evaluating the efficacy and safety of TECVAYLI vs chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with RRMM and EMD. ORR was 47% vs 77% in the TECVAYLI vs CAR-T cell groups.
  • Riedhammer et al (2024)10 conducted an investigator-initiated, multicenter, retrospective study evaluating the efficacy and tolerability of TECVAYLI in patients with RRMM. Significantly lower ORR and median progression-free survival (PFS) were observed in patients with EMD than in those with no EMD (P<0.01).
  • Joiner et al (2023)11 reported a preliminary experience evaluating the efficacy and safety of TECVAYLI in patients with RRMM and severely impaired renal function. Among the 7 patients included in their analysis, 2 patients presented with extramedullary plasmacytomas and showed disease progression leading to treatment discontinuation before the second cycle.
  • Venkatesh et al (2023)12 presented the results of a retrospective, real-world study evaluating the safety and efficacy of TECVAYLI in patients with RRMM. Among the 14 patients with EMD included in the study, ORR was 28%.
  • Other relevant literature has been identified in addition to the data summarized above.13-16

CLINICAL DATA - MAJESTEC-1 STUDY

MajesTEC-1 (NCT03145181; NCT04557098) is evaluating the safety and efficacy of TECVAYLI in patients with RRMM.1-4

Study Design/Methods

The main objectives are as follows: part 1 (dose escalation), to determine the recommended phase 2 dose (RP2D) for TECVAYLI; part 2 (dose expansion), to distinguish safety and tolerability at the RP2D; and part 3 (phase 2 component), to evaluate the efficacy of TECVAYLI at the RP2D.3,17

  • Key eligibility criteria:
    • Cohort A: ≥3 prior lines of therapy, including a PI, an immunomodulatory drug, and an anti-CD38 mAb, and no prior BCMA-targeted therapy use.3
    • Cohort C: ≥3 prior lines of therapy, a prior PI, an immunomodulatory drug, and an anti-CD38 mAb, enrolled patients who had prior exposure to BCMA-targeted treatment (CAR-T cell and/or antibody drug conjugate [ADC]).4
  • Primary endpoint for Cohort A and Cohort C: ORR.3,4
  • Key secondary endpoint for Cohort A and Cohort C: safety.3,4

Cohort A Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

  • At a median follow-up of 14.1 months (range, 0.3-24.4), 165 patients received TECVAYLI at recommended phase 2 dose (RP2D): 40 patients in phase 1 and 125 patients in phase 2.3
  • EMD, defined as the presence of ≥1 extramedullary soft tissue lesions not associated with bone, was present in 28 patients (17.0%): 8 patients (20%) in phase 1 and 20 patients (16.0%) in phase 2.3

Efficacy

  • At a median follow-up of 14.1 months (range, 0.3-24.4), ORR in the total population was 63.0% (95% CI, 55.2-70.4).3
  • Lower response rates were observed in patients with EMD.3
  • Responses were reported in 10/28 patients with EMD (ORR, 35.7% [95% CI, 18.6-55.9]) vs 94/137 patients without EMD (ORR, 68.6% [95% CI, 60.1-76.3]).5

Safety

  • These publications did not report on the safety profile of TECVAYLI in the subpopulation of patients with EMD.

Costa et al (2024)6 presented a subgroup analysis from the MajesTEC-1 study evaluating efficacy and safety in patients with HR features. Results specific to the EMD sub-group are summarized below.

Treatment Disposition, Baseline Demographics, and Disease Characteristics

  • At a data cutoff of Aug 22, 2023, a total of 165 patients had received TECVAYLI at the RP2D.
  • EMD, defined as the presence of ≥1 soft tissue plasmacytoma with no contact with bony structures, was present in 28 patients (17.0%).

Efficacy


MajesTEC-1 (Cohort A) Study: Summary of ORR6
Overall RP2D
EMD
ORRa, n/N (%)
104/165 (63.0)
10/28 (35.7)
   sCR, %
38.8
17.9
   CR, %
7.3
-
   VGPR, %
13.3
10.7
   PR, %
3.6
7.1
≥CR, %
46.1
17.9
Abbreviations: CR, complete response; EMD, extramedullary disease; ORR, overall response rate; PR, partial response; RP2D, recommended phase 2 dose; sCR, stringent complete response; VGPR, very good partial response.
Note: Clinical data cutoff date of August 22, 2023.
aResponse assessed by independent review committee.

MajesTEC-1 (Cohort A) Study: DOR to TECVAYLI6
Overall RP2D
EMD
Responders, n
104
10
mFU, months (range)
30.4 (0.3-41.5)
30.9 (0.3-37.9)
24-month DOR rate, % (95% CI)
50.1 (40.1-59.4)
50.0 (18.4-75.3)
Abbreviations: CI, confidence of interval; DOR, duration of response; EMD, extramedullary disease; mFU, median follow-up; RP2D, recommended phase 2 dose.
Note: Clinical data cutoff date of August 22, 2023. Results should be interpreted with caution due to small patient numbers.

Safety


MajesTEC-1 (Cohort A) Study: Summary of Safety Outcomes6
Overall RP2D
(N=165)
EMD
(N=28)
Any grade TEAE, n (%)
165 (100)
28 (100)
   Grade 3/4 TEAE
156 (94.5)
26 (92.9)
Discontinuation due to TEAE, n (%)
8 (4.8)
1 (3.6)
Deaths, n (%)
94 (57.0)
20 (71.4)
   Due to AE
26 (15.8)
2 (7.1)
   Due to disease progression
56 (33.9)
15 (53.6)
Abbreviations: AE, adverse event; EMD, extramedullary disease; RP2D, recommended phase 2 dose; TEAE, treatment-emergent adverse event.
Note: Clinical data cutoff date of August 22, 2023. Results should be interpreted with caution due to small patient numbers.

Cohort C Results

Touzeau et al (2024)4 published efficacy and safety results from Cohort C of the MajesTEC-1 study at a median follow-up of 28.0 months (range, 0.7-31.1).

Treatment Disposition, Baseline Demographics, and Disease Characteristics

  • A total of 40 patients received TECVAYLI with a median duration of treatment of 6.0 months (range, 0.2-29.8).
  • EMD, defined as the presence of ≥1 extramedullary soft tissue plasmacytomas not associated with bone, was present in 12 patients (30%).

Efficacy

  • ORR was 52.5% for all patients and 58.3% in patients with EMD.

Safety

  • These data did not report on the safety profile of TECVAYLI in the subpopulation of patients with EMD.

ADDITIONAL INFORMATION

TECVAYLI Effectiveness by EMD Status in the Danish ABCD Study

Torpe et al (2026)7 presented updated results from a nationwide multicenter retrospective ABCD study evaluating the effectiveness of TECVAYLI in heavily pretreated patients with RRMM and true non-osseous EMD vs those without EMD.

Study Design/Methods

  • This study included consecutive Danish patients with RRMM treated with TECVAYLI between reimbursement approval in February 2024 and the May 2026 data cutoff.

Results

Baseline Demographics and Disease Characteristics
  • At a median follow-up of 14 months (interquartile range [IQR], 4-19), 145 patients had received TECVAYLI.
  • Patients were stratified based on EMD status as follows:
    • Patients with true EMD (n=41): defined as having ≥1 soft-tissue plasmacytoma not contiguous with bone and confirmed by positron emission tomography-computed tomography (PET-CT), magnetic resonance imaging (MRI), or computed tomography (CT). Patients with true EMD and co-existing PSK plasmacytomas were included.
    • Patients without EMD (n=85): had no evidence of EMD on PET-CT, MRI, or CT. Patients with sole PSK plasmacytomas were included.
    • Patients with unknown imaging status (n=19): did not have PET-CT, MRI, or CT performed before TECVAYLI initiation and were excluded from comparative analyses.
  • Baseline patient characteristics are presented in Table: Baseline Characteristics.

Baseline Characteristics7
EMD
(n=41)
No EMD
(n=85)
Median age at start of treatment, years, (IQR)
71 (67-78)
72 (65-78)
Median age at diagnosis, years, (IQR)
66 (60-71)
65 (57-71)
Male, n (%)
23 (56)
45 (52)
Performance status 0-1, n (%)
35 (85)
80 (93)
EMD at start of treatment, n (%)
41 (100)
-
   EMD diagnosed by PET-CT scan
28 (68)
-
   EMD diagnosed by CT scan
9 (22)
-
   EMD diagnosed by MRI
4 (10)
-
FISH performed, n (%)a
36 (88)
75 (88)
FISH high risk, n (%)a,b
18 (44)
27 (31)
   del(17p)
13 (32)
14 (16)
   t(4;14)
6 (15)
11 (13)
   t(14;16)
2 (5)
5 (6)
Measurable disease at start of treatment, n (%)c
28 (68)
68 (79)
Median prior lines of therapy, IQR
4 (3-5)
4 (3-5)
Previous HDT-ASCT, n (%)
29 (71)
58 (67)
Triple-class exposed, n (%)
40 (98)
84 (98)
Triple-class refractory, n (%)
32 (78)
57 (66)
Refractory immunomodulatory drugs, n (%)
37 (90)
77 (90)
Refractory PI, n (%)
35 (85)
66 (77)
Refractory CD38 mAb, n (%)
38 (93)
78 (91)
Refractory GPRC5D BsAbs, n (%)
2 (5)
7 (8)
Abbreviations: BsAbs, bispecific antibodies; CT, computed tomography; EMD, extramedullary disease; FISH, fluorescence in situ hybridization; FLC, free light chain; GPRC5D, G protein-coupled receptor class C group 5 member D; HDT-ASCT, high-dose melphalan with autologous stem cell transplantation; IQR, interquartile range; mAb, monoclonal antibody; MRI, magnetic resonance imaging; PET-CT, positron emission tomography-computed tomography; PI, proteasome inhibitor.
aIn patients with multiple FISH analyses, the most recent evaluation was reported.
bOf total population; high-risk FISH was defined as t(4;14), t(14;20), or del(17p).
cMeasurable disease was defined as M-protein ≥10 g/L, urine M-protein ≥200 mg/24 h, or involved FLC ≥100 mg/L.
Efficacy

Response Rates7
Responsea
EMD
(n=41)
No EMD
(n=85)
ORR, %
29
69
   ≥VGPR
24
67
   PR
5
2
MR, %
5
4
PD, %
34
12
SD, %
12
5
Unmeasurable disease,b %
20
11
Abbreviations: CR, complete response; EMD, extramedullary disease; IMWG, International Myeloma Working Group; MR, marginal response; ORR, overall response rate; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.
aResponse was assessed according to IMWG criteria. Since bone marrow biopsies were not routinely performed outside clinical trials in Denmark, sCR, CR, and VGPR were grouped as ≥VGPR. Response categories (except sCR) were applied only to patients with measurable disease at baseline per IMWG criteria.
bPatients without measurable disease who did not achieve sCR were classified as “unmeasurable disease”.

Survival Outcomes7
EMD
(n=41)
No EMD
(n=85)
Median PFS,a months
2.7
19.7
12-month PFS, % (95% CI)
32 (20-51)
62 (52-74)
Median DOR,b months
22.1
20.4
12-month DOR, % (95% CI)
70 (47-100)
75 (64-88)
Median OS, months
11.5
NR
12-month OS,c % (95% CI)
50 (36-68)
75 (66-86)
Abbreviations: CI, confidence interval; DOR, duration of response; EMD, extramedullary disease; NR, not reached; OS, overall survival; PFS, progression-free survival.
aP value for the comparison of PFS between patients with EMD and without EMD=<0.001.bP value for the comparison of DOR between patients with EMD and without EMD=0.7.cP value for the comparison of OS between patients with EMD and without EMD=0.002.

US Myeloma Immunotherapy Consortium TECVAYLI Outcomes by Soft Tissue Plasmacytoma Status

Afrough et al (2025)8 published results from a multicenter retrospective study conducted across 13 US centers evaluating the treatment outcomes according to STP type in patients with RRMM treated with TECVAYLI.

Study Design/Methods

  • This multicenter retrospective study included patients with RRMM who received TECVAYLI across 13 US centers participating in the US Myeloma Immunotherapy Consortium through September 2023, with follow-up through April 2024.
  • Responses were assessed by treating investigators using the International Myeloma Working Group (IMWG) criteria.

Results

Baseline Demographics and Disease Characteristics
  • Patients were stratified by STP status at TECVAYLI initiation into true EMD, PSK, and No-STP cohorts.
    • True EMD (n=109): soft tissue (visceral or non-visceral) plasmacytomas non-contiguous with bone.
      • A total of 59 (54%) patients had visceral disease involvement and 79 patients (72%) presented with more than one EMD lesion at TECVAYLI initiation.
      • A total of 33 (30%) patients with true-EMD had known concurrent PSK disease; the presence of PSK along with EMD was unknown for 41 (38%) patients.
    • PSK (n=33): characterized by soft tissue extension from bone-based lesions.
      • A total of 15 (45%) patients had multiple disease sites.
    • No STP (n=243): patients without soft tissue plasmacytomas.
  • Baseline patient characteristics are presented in Table: Baseline Characteristics Based on STP Type.

Baseline Characteristics Based on STP Type8
Characteristic
True-EMD
(n=109)
PSK
(n=33)
No-STP
(n=243)
Age in years, median, (range)
65.7 (31.2-88.7)
65.3 (39-84)
69.2 (37.1-92)
Female, n (%)
49 (45)
15 (45)
118 (49)
Race, n (%)
   White
74 (68)
19 (58)
162 (67)
   Black
20 (18)
10 (30)
57 (23)
   Other
15 (14)
4 (12)
24 (10)
Myeloma type, n (%)
   IgA
24 (22)
9 (28)
44 (18)
   IgG
57 (53)
17 (53)
135 (56)
   Light chain only
24 (22)
6 (16)
61 (25)
   Others
3 (3)
0
3 (1.2)
ECOG PS ≥2, n (%)
24 (23)
11 (33)
61 (26)
ISS, n (%)
   Stage I
3 (2.7)
0
4 (1.6)
   Stage II
14 (13)
2 (6)
35 (14.4)
   Stage III
12 (11)
3 (9)
22 (9)
   Unknown/not reported
80 (73)
28 (85)
182 (75)
R2-ISS, n (%)
   Stage II
6 (5.5)
1 (3)
7 (3)
   Stage III
20 (18)
4 (12)
34 (14)
   Stage IV
3 (3)
0
17 (7)
   Unknown/not reported
80 (73)
28 (85)
185 (76)
Cytogenetic risk,a n (%)
   Standard risk
65 (64)
22 (69)
156 (68)
   Confirmed High-risk
24 (23.5)
7 (22)
34 (15)
   Isolated 17p
13 (13)
3 (9)
38 (17)
Plasma cell leukemia (any time), n (%)
5 (5.0)
1 (3)
6 (2.5)
Triple-class refractory,b n (%)
95 (87)
27 (82)
200 (82)
Penta-refractory,c n (%)
44 (40)
11 (33)
89 (37)
Median prior LOTs, range
6.5 (3-16)
6 (2-18)
6 (2-17)
Prior BCMA-directed therapy, n (%)
68 (62)
17 (51.5)
108 (44)
Abbreviations: BCMA, B-cell maturation antigen; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD; extramedullary disease; Ig, immunoglobulin; IMS, International Myeloma Society; IMWG, International Myeloma Working Group; ISS, International Staging System; LOTs, lines of therapy; PSK, paraskeletal; R2-ISS, Revised Second International Staging System; STP; soft tissue plasmacytoma.
aPatients were classified based on a modified version of the 2025 IMS/IMWG consensus criteria: standard risk, confirmed high-risk, defined as t(4;14), t(14;16), or t(14;20) in combination with either gain/amp(1q) or del(1p), or concomitant gain/amp(1q) and del(1p) (including cases with concurrent del[17p]), and isolated del(17p), categorized separately if not meeting criteria for confirmed high-risk, regardless of variant allele frequency or clonal fraction, given the absence of TP53 mutation data and incomplete FISH threshold information.
bRefractory to ≥1 immunomodulatory drug, ≥1 proteasome inhibitor, and ≥1 anti-CD38 monoclonal antibody.
cRefractory to ≥2 immunomodulatory drugs, ≥2 proteasome inhibitors, and ≥1 anti-CD38 monoclonal antibody.

Efficacy


Response Rates8
Response
True-EMD
PSK
No-STP
Best hematologic response
   ORR, %
38
54.1
62.4
      ≥CRa
12
21
28
      VGPR
13
24
27
      PR
13
9.1
7.4
Best radiographic responseb
   ORR, %
44
66.5
-
      CR
34
29
-
      PR
10
37.5
-
Abbreviations: CR, complete response; EMD, extramedullary disease; ORR, overall response rate; PR, partial response; PSK, paraskeletal; STP, soft tissue plasmacytoma; VGPR, very good partial response.
aP value=0.006.
bRadiographic response was evaluable in 62% of the patients (n=68) in true-EMD group and 73% (n=24) in PSK group.

Survival Outcomes8
Survival Outcomes
True EMD
(n=109)
PSK
(n=33)
No-STP
(n=243)
Median PFS,a months (95% CI)
1.41 (0.98-3.9)
6.50 (3.5-NR)
8.95 (6.7-12.1)
Median OS,b months (95% CI)
9.5 (4.54-NR)
NR (13.1-NR)
NR (16.1-NR)
Abbreviations: CI, confidence interval; EMD, extramedullary disease; NR, not reached; OS, overall survival; PFS, progression-free survival; PSK, paraskeletal disease; STP, soft tissue plasmacytoma.aP value for PFS among groups=<0.0001.bP value for OS among groups=0.00012.

Safety


Summary of Safety Data8
Adverse event
True-EMD
(n=109)
PSK
(n=33)
No-STP
(n=243)
P Value
CRS
   Any grade CRS, n (%)
57 (52)
18 (54.5)
144 (59)
0.3
   ≥Grade 2 CRS, n (%)
9 (8)
2 (6)
30 (12)
0.4
   Median time to start of CRS, days
3 (1–8)
3 (1–8)
2 (0–15)
0.079
   Median duration of CRS, daysᵃ
0 (0–11)
0 (0–3)
0 (0–11)
0.2
ICANS
   Any grade ICANS, n (%)
17 (16)
5 (15)
31 (13)
0.7
   ≥Grade 2 ICANS, n (%)
10 (9)
5 (15)
13 (5)
0.045
   Median time to start of ICANS, days
5 (0–25)
4 (1–21)
3 (0–14)
0.2
Cause of TECVAYLI discontinuation, n (%)
0.003
   MM or PD related
76 (82)
15 (65)
97 (60)
   Infection
9 (10)
1 (4)
26 (16)
   Others
8 (10%)
7 (30)
39 (24)
Cause of death, n (%)
   PD related
45 (41)
8 (24)
48 (20)
0.14
   NRM related
10 (9)
2 (6)
24 (10)
-
Abbreviations: CRS, cytokine release syndrome; EMD, extramedullary disease; ICANS, immune effector cell-associated neurotoxicity syndrome; MM, multiple myeloma; NRM, nonrelapse mortality; PD, progressive disease; PSK, paraskeletal; STP, soft tissue plasmacytoma.
aIn CRS, a median time of 0 indicates that it lasted less than 1 day.

Effectiveness of TECVAYLI and CAR-T Therapy in RRMM With EMD Across USMIRC Centers

Dima et al (2024)9 presented the results from a multicenter, retrospective study evaluating the efficacy and safety of TECVAYLI vs CAR-T cell therapy for the treatment of patients with RRMM and EMD (EMD was not defined).

Study Design/Methods

  • Patients with RRMM who had a known history of EMD or currently had EMD, including those who had undergone apheresis up until August 15, 2023, received either TECVAYLI or CAR-T cell therapy.

Results

  • A total of 110 patients from 3 US academic centers (part of the US Myeloma Innovations Research Collaborative [USMIRC]) who received TECVAYLI (n=45), or CAR-T cell therapy (n=65) were included.
  • The median follow-up for the entire group was 5 months (range, 0.5-22).
  • In the TECVAYLI vs CAR-T cell group, patients received a median of 6 (range, 4-14) vs 6 (range, 4-15) prior lines of therapy, 93% vs 88% of patients had triple-class refractory disease, and 55.5% vs 15% of patients had received prior BCMA-directed therapy.
Efficacy

Summary of Efficacy Data9
Efficacy Parameters
TECVAYLI Group
(n=45)
CAR-T cell Group
(n=65)
P Value
Median follow-up, months (range)
3.7 (0.5-10.4)
6.5 (0.5-22)
-
Median PFS, months (95% CI)
2 (1.1-NR)
6.5 (5.1-9.6)
0.039
Median OS, months (95% CI)
NR (3.9-NR)
12.9 (9.5-NR)
0.057
ORR, n (%)
21 (47)
50 (77)
0.002
   ≥CR
9 (20)
27 (42)
0.02
Abbreviations: CAR, chimeric antigen receptor; CI, confidence interval; CR, complete response; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.
Safety

Summary of Safety Data9
Safety Parameters, n (%)
TECVAYLI Group
(n=45)
CAR-T cell Group
(n=65)
P Value
Incidence of CRS
27 (60)
47 (72)
0.21
   Grade ≥3
0 (0)
3 (4.5)
Incidence of ICANS
7 (15.5)
18 (27.5)
0.16
   Grade ≥3
2 (4.5)
3 (4.5)
Infections ≤8 weeks after TECVAYLI initiation or CAR-T cell infusion
13 (29)
25 (38)
0.31
Abbreviations: CAR, chimeric antigen receptor; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome.

TECVAYLI Outcomes by EMD Status Across German Centers

Riedhammer et al (2024)10 conducted an investigator-initiated, multicenter, retrospective study evaluating the efficacy and tolerability of TECVAYLI in patients with RRMM. Patients either received TECVAYLI through the pre-approval access program or received commercial TECVAYLI.18 

Study Design/Methods

  • Patients who had received ≥1 full treatment dose of TECVAYLI between July 2022 and October 2023 at 18 German centers were included.
  • Patients received TECVAYLI 1.5 mg/kg QW as per the label, after step-up doses (SUDs) of 0.06 mg/kg and 0.3 mg/kg.
  • Patients were retrospectively assessed for the fulfillment of select key inclusion criteria of the MAJESTEC-1 study at screening.
  • Outcomes were assessed per the IMWG response criteria.

Results

  • A total of 123 patients (median age, 67 years [range, 35.0-87.0]) were included in the study; 43 of 119 patients (36.1%) had EMD (EMD was not defined).
Efficacy

Median PFS in the EMD Subgroup Assessed via Univariable and Multivariable Models10
Characteristic
n (event n)
Median PFS, Months
Univariable
Multivariable
HR (95% CI)
P Value
HR (95% CI)
P Value
EMD
-
-
-
<0.01
-
<0.01
   No
73 (26)
NR
1.00 (referent)
-
1.00 (referent)
-
   Yes
43 (24)
2.07
2.31 (1.29-4.14)
-
3.00 (1.63-5.51)
-
Abbreviations: CI, confidence interval; EMD, extramedullary disease; HR, hazard ratio; NR, not reached; PFS, progression-free survival.

ORR in the EMD Subgroup Assessed via Univariable Model10
Characteristic
n (event n)
Response Rate (%) 
OR (95% CI)
P Value
EMD
-
-
-
<0.01
   No
75 (53)
72.6
1.00 (referent)
-
   Yes
43 (16)
37.2
4.47 (2.00-9.99)
-
Abbreviations: CI, confidence interval; EMD, extramedullary disease; OR, odds ratio; ORR, overall response rate.
Safety
  • These data did not report on the safety profile of TECVAYLI in the subpopulation of patients with EMD.

TECVAYLI in RRMM With Severe Renal Impairment and Extramedullary Plasmacytomas

Joiner et al (2023)11 reported a preliminary experience evaluating the efficacy and safety of TECVAYLI in patients with RRMM and severely impaired renal function.

Study Design/Methods

  • The Food and Drug Administration (FDA)-approved TECVAYLI prescribing information dosing schedule was followed for dosing cycles 1 and 2. At dosing cycle 3, the frequency was modified to every 2 weeks (Q2W) for 8 doses followed by every 4 weeks (Q4W) starting cycle 7 onward.
  • Mitigation for infection included oral levofloxacin; prophylaxis for Herpes simplex virus/varicella zoster virus and Pneumocystis jirovecii, started at the onset of TECVAYLI therapy.

Results


Characteristics of 2 Patients With RRMM, Severe Renal Impairment, and Extramedullary Plasmacytomas Treated With TECVAYLI11
Characteristic
Patient 5
Patient 7
Age, years
67
48
Sex
F
M
ECOG PS
2
3
Time since diagnosis, months
81
15
MM isotype
IgGλ
IgAκ
Cytogenetic abnormalities
N/A
+1q, del(13), hyperdiploid
Extramedullary plasmacytoma
Yes
Yes
Number of prior lines of therapy
7
4
Triple-class refractory
Yes
Yes
Penta-drug refractory
Yes
Yes
Prior AHCT
Yes
No
Prior BCMA-directed CAR-T
No
No
eGFR at time of TECVAYLI initiation (mL/min)
22
HD
Abbreviations: AHCT, autologous hematopoietic cell transplantation; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T cell; CRS, cytokine release syndrome; ECOG PS, Eastern Cooperative Oncology Group performance status; eGFR, estimated glomerular filtration rate; F, female; HD, hemodialysis; ICANS, immune effector cell-associated neurotoxicity syndrome; Ig, immunoglobulin; M, male; MM, multiple myeloma; N/A, not available; PD, progressive disease; RRMM, relapsed or refractory multiple myeloma; VGPR, very good partial response.
Efficacy
  • Two patients with extramedullary plasmacytomas showed disease progression leading to treatment discontinuation before the second cycle. See Table: Summary of Efficacy Outcomes.

Summary of Efficacy Outcomes11
Efficacy Parameters
Patient 5
Patient 7
Duration of follow-up, months
1.5
1
Best response
PD
PD
Abbreviation: PD, progressive disease.
Safety
  • One patient (patient number 5), who had extramedullary plasmacytoma, experienced grade 3 cytokine release syndrome (CRS) with TECVAYLI.
  • No immune effector cell-associated neurotoxicity syndrome (ICANS) or infections were reported.

TECVAYLI Outcomes in Patients With EMD at the University of Kansas

Venkatesh et al (2023)12 presented the results of a retrospective, real-world study evaluating the safety and efficacy of TECVAYLI in patients with RRMM, including those who were ineligible for enrollment in the MajesTEC-1 study.

Study Design/Methods

  • Electronic medical records of patients with RRMM who had received TECVAYLI at the University of Kansas Health System as of February 10, 2023, was retrospectively reviewed in collaboration with USMIRC.
  • Responses were evaluated using the IMWG criteria.

Results

  • A total of 22 patients were included in the study; 14 patients (64%) had EMD (EMD was not defined).
Efficacy
  • At the median follow-up of 3.1 months (range, 1.7-4.1), ORR was 50% for the evaluated population, and was 28% in patients with EMD.
Safety
  • These data did not report on the safety profile of TECVAYLI in the subpopulation of patients with EMD.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 19 August 2026.

 

References

Show
1 Janssen Research & Development, LLC. A phase 1, first-in-human, open-label, dose escalation study of teclistamab, a humanized BCMA x CD3 bispecific antibody in subjects with relapsed or refractory multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 August 19]. Available from: https://clinicaltrials.gov/study/NCT03145181 NLM Identifier: NCT03145181.  
2 Janssen Research & Development, LLC. A phase 1/2, first-in-human, open-label, dose escalation study of teclistamab, a humanized BCMA x CD3 bispecific antibody, in subjects with relapsed or refractory multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 August 19]. Available from: https://clinicaltrials.gov/study/NCT04557098 NLM Identifier: NCT04557098.  
3 Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505.  
4 Touzeau C, Krishnan AY, Moreau P, et al. Efficacy and safety of teclistamab in patients with relapsed/refractory multiple myeloma after BCMA-targeting therapies. Blood. 2024;144(23):2375-2388.  
5 Miao X, Wu LS, Lin SXW, et al. Population pharmacokinetics and exposure-response with teclistamab in patients with relapsed/refractory multiple myeloma: results from MajesTEC-1. Target Oncol. 2023;18(5):667-684.  
6 Costa LJ, Bahlis NJ, Usmani SZ, et al. Efficacy and safety of teclistamab in patients with relapsed/refractory multiple myeloma with high-risk features: a subgroup analysis from the phase 1/2 MajesTEC-1 study. Poster presented at: European Hematology Association (EHA) 2024 Hybrid Congress; June 13-16, 2024; Madrid, Spain.  
7 Torpe AH, Thorsen J, Iversen KF, et al. Real-world outcomes of teclistamab in heavily pretreated RRMM patients with true extramedullary disease: results from the ABCD study. Poster presented at: the European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden.  
8 Afrough A, Dima D, Razzo B, et al. The impact of extramedullary and paraskeletal plasmacytomas on treatment outcomes in multiple myeloma treated with teclistamab: U.S. Myeloma Immunotherapy Consortium real-world experience. Blood Cancer J. 2025;16(1):12.  
9 Dima D, Davis JA, Ahmed N, et al. Outcomes of BCMA-directed chimeric antigen receptor T-cell (CAR T) therapy and teclistamab in patients with relapsed-refractory multiple myeloma with extramedullary disease: a real-world experience. Poster presented at: The Transplantation & Cellular Therapy Meetings of American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR); February 21-24, 2024; San Antonio, TX.  
10 Riedhammer C, Bassermann F, Besemer B, et al. Real-world analysis of teclistamab in 123 RRMM patients from Germany. Leukemia. 2024;38:365-371.  
11 Joiner L, Bal S, Godby KN, et al. Teclistamab in patients with multiple myeloma and impaired renal function. Am J Hematol. 2023;98(11):E322-E324.  
12 Venkatesh P, Atrash S, Paul B, et al. Efficacy of teclistamab in patients (pts) with heavily pretreated, relapsed/refractory multiple myeloma (RRMM), including those refractory to penta RRMM and BCMA (B-cell maturation antigen) directed therapy (BDT). J Clin Oncol. 2023;41(16_suppl):e20044-e20044.  
13 Salah IB, Mordier L, Leleux C, et al. Impressive extramedullary plasmacytoma response in refractory multiple myeloma treated with teclistamab. eJHaem. 2024;5(1):262-263.  
14 Mudawi D, Al-Mashdali AF, Tawalbeh A, et al. Sequential myelomatous pleural and pericardial effusions in multiple myeloma: a case report demonstrating extended survival with teclistamab. Case Rep Oncol. 2025;18:620-629.  
15 Ishida T, Yi JH, Nagarajan C, et al. Teclistamab in a large cohort of ~100 Asian patients with triple-class exposed multiple myeloma: experience from trial and non-trial settings. Poster presented at: the 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.  
16 Takakuwa T, Ohta K, Tanada Y, et al. Teclistamab for multiple pulmonary lesions in extramedullary myeloma: first successful case and review of the literature. Ann Hematol. 2026;105(5):265.  
17 Moreau P, Garfall AL, van de Donk NWCJ, et al. Protocol to: Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505.  
18 Data on File. Janssen Scientific Affairs, LLC. Correspondence from Medical Affairs (Communication dated 17 September 2025); 2026.  

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