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(teclistamab-cqyv)

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TECVAYLI® (teclistamab-cqyv)

Medical Information

TECVAYLI - REALiTEC Study

Last Updated: 09/12/2025

SUMMARY  

  • REALiTEC (NCT06285318) is a multi-country, non-interventional, retrospective study of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM) outside of clinical trials.1,2 
    • Kortüm et al (2025)2 and Perrot et al (2025)3 presented efficacy and safety results from the REALiTEC study evaluating TECVAYLI in 113 patients with RRMM. At a median follow-up of 20.7 months (range, 0.7-35.8), overall response rate (ORR) was 80.2%. The most common adverse events (AEs; any grade) were infections (70.8%), cytokine release syndrome (CRS; 55.7%), and neutropenia (35.4%).
    • Popat et al (2025)4 presented the subgroup analysis of the REALiTEC study. At a median follow-up of 20.7 months, patients previously exposed to BCMA-targeted therapies had an ORR of 52.6%. In patients previously treated with ADC or CAR-T, ORRs were 53.2% and 50.0%, respectively.

CLINICAL DATA - Realitec study

REALiTEC (NCT06285318) is an ongoing retrospective, observational study of TECVAYLI in patients with RRMM.1 Kortüm et al (2025)2 and Perrot et al (2025)3 presented efficacy and safety results in 113 patients at a median follow-up of 20.7 months (range, 0.7-35.8).

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

  • A total of 113 patients were included, 100 from preapproval access programs, and 13 treated with commercial TECVAYLI. See Table: REALiTEC Study: Baseline Characteristics.2
  • All patients were admitted to the hospital for step-up dosing. The median inpatient length of stay during the step-up phase (including the first maintenance dose) was 8 days (range, 2-41).
  • After a median of 7 months (range, 0-18), 45 patients (39.8%) switched from weekly (QW) to every other week (Q2W) dosing; disease response was the most common reason for switching in 62.2% of patients.

REALiTEC Study: Baseline Characteristics2,3
Characteristic
N=113a
Age (years), median (range)
66 (43-86)
   <65 years, n (%)
47 (41.6)
   ≥65 to <75 years, n (%)
49 (43.4)
   ≥75 years, n (%)
17 (15.0)
Male, n (%)
57 (50.4)
ECOG PS ≥1, n (%)
27/49 (55.1)
ISS stage
   I
32/94 (34.0)
   II
41/94 (43.6)
   III
21/94 (22.3)
High-risk cytogeneticsb, n (%)
32/62 (51.6)
Extramedullary plasmacytoma, n (%)
9/59 (15.3)
Patients ineligible for MajesTEC-1, n (%)
78 (69.0)
LDH >245 U/L, n (%)
28/86 (32.6)
Time since diagnosis (years), median (range)
6.88 (0.7-24.2)
Prior lines of therapy, median (range)
6 (2-12)
   Triple-class exposed, n (%)
113 (100)
   Penta-class exposed, n (%)
100 (88.5)
   Triple-refractory, n (%)
89 (78.8)
   Penta-refractory, n (%)
50 (44.2)
Refractory to last line of therapy, n (%)
86 (76.1)
Autologous SCT, n (%)
86 (76.1)
Patients receiving prior BCMAc, n (%)
38 (33.6)
   Number of therapies
43
     CAR-T
10
     ADC
32
     BsAbs
1
Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; LDH, lactate dehydrogenase; SCT, stem cell transplant.
aData available added as denominators if some were missing and not available in the clinical chart for the whole cohort.
bHigh risk defined as having presence of t(4;14), t(14;16), del17p13, and amp1q21.
c38 patients received 43 prior BCMA-directed therapies.

Efficacy


REALiTEC Study: Summary of Efficacy Outcomes2
Parametera
N=113
ORR (%)
60.2
   VGPR (%)
25.7
   PR (%)
8
≥CR (%)
26.4
≥VGPR (%)
52.2
Time to first response, months (95% CI)
1.6 (1.2-1.9)
Time to best response, months (95% CI)
3.8 (2.8-5.0)
Median DOR, months (95% CI)
20.3 (14.8-NE)
Median PFSb, months (95% CI)
9.7 (5.5-18.8)
Median OSc, months (95% CI)
26.3 (16.5-NE)
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; ORR, overall response rate; NE, not estimated; PFS, progression-free survival; PR, partial response; OS, overall survival; sCR, stringent complete response; VGPR, very good partial response.
aResponses were evaluated via IMWG criteria.
bMedian PFS in patients achieving ≥VGPR was not reached (NR), with 12-month estimate of 72.1% (57.8-81).
cMedian OS in patients achieving ≥VGPR was NR, with 12-month estimate of 83.1% (70.8-90.5).

Safety

  • Any grade treatment related adverse events (TEAEs) were reported in 108 (95.6%) patients and grade 3/4 TEAEs were reported in 85 (75.2%) patients. See Table: Summary of TEAEs for additional details.3
  • Treatment discontinuation due to AEs was reported in 18 patients (15.9%; dose delays, n=53 [46.9%]; dose omissions, n=34 [30.1%]; and dose reductions, n=1 [0.9%] due to AEs).3
  • Thirteen patients died due to AEs, with five deaths considered related to TECVAYLI (febrile neutropenia, septic shock, hyponatremia, pneumonia, and toxic encephalopathy).3
Infection
  • A total of 80 patients experienced 261 infection events (bacterial, n=66; viral, n=70; fungal, n=5), of which 261 (90.1%) infection events resolved or were resolving at data cutoff. Incidence of infection events is presented in Table: Incidence of Infection Events.3
  • Death due to infections were reported in 6 (5.3%) patients (septic shock, n=3; pneumonia, n=3).3
  • Infection rates declined over time. Incidence of infections over time is summarized in Table: Incidence of Infections Over Time.3
  • Intravenous immunoglobulin (IVIG) was administered to 60.2% of patients (68/113), with 70.6% of patients (48/68) receiving it as primary prophylaxis.3
CRS and ICANS
  • CRS and ICANS events were mostly low grade. Grade 3 CRS was reported in 2 patients (1.8%), with no grade 4 events reported.3
  • All events resolved, and no patients discontinued treatment due to CRS or ICANS.3
  • Tocilizumab was administered to 15% of patients for CRS management; no prophylactic use was reported. Incidence of CRS and management is presented in Table: CRS Events and Management.3
  • ICANS was observed in 4 (3.5%) patients, with no grade ≥3 events.3

Summary of TEAEs3 
TEAE, n (%)
N=113
Any Grade, n (%)
Grade 3/4, n (%)
Infections
80 (70.8)
44 (38.9)
   Pneumonia
24 (21.2)
16 (14.2)
   COVID-19
17 (15.0)
8 (7.1)
   Unknown
12 (10.6)
2 (1.8)
   CMV reactivation
3 (2.7)
1 (0.9)
Hematologic TEAEs
   Neutropenia
40 (35.4)
37 (32.7)
   Anemia
29 (25.7)
19 (16.8)
   Thrombocytopenia
21 (18.6)
17 (15.0)
Nonhematologic TEAEs
   CRS
63 (55.8)
2 (1.8)
   Diarrhea
17 (15.0)
0
Neurologic TEAEs of interest
   Peripheral sensory neuropathy
5 (4.4)
0
   ICANS
4 (3.5)
0
   Motor dysfunction
1 (0.9)
0
   Encephalopathya
3 (2.7)
1 (0.9)
Abbreviations: AE, adverse event; CMV, cytomegalovirus; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; TEAE, treatment-emergent adverse event; URTI, upper respiratory tract infection.
aIncludes toxic encephalopathy and encephalopathy.

Incidence of Infection Events3
Parameter
Total
Bacteriala
Virala
Patients with any event, n (%)
80 (70.8)
36 (31.9)
36 (31.9)
   Patients with multiple events
60 (53.1)
18 (15.9)
17 (15.0)
   Patients with grade 3/4 events
44 (38.9)
25 (22.1)
14 (12.4)
   Patients with grade 5
6 (5.3)
2 (1.8)
1 (0.9)
Number of infection events
261
70
66
   Time to onset,
   median days to event (range)
128.0 (1-1062)
101.0 (2-1062)
126.0 (1-859)
   Grade 3/4 infection onset,
   median days to event (range)
99.0 (2-820)
63.5 (2-734)
148.0 (4-820)
   Duration, median event days
   (range)
15.0 (1-300)
14.0 (1-181)
15.5 (1-273)
Patients with AE leading to dose interruption, n (%)
52 (46.0)
19 (16.8)
25 (22.1)
Patients with AE leading to discontinuation, n (%)
10 (8.8)
2 (1.8)
4 (3.5)
Events recovering, recovered, or resolvedb, n/N (%)
236/261 (90.4)
62/66 (90.4)
64/70 (91.4)
Abbreviation: AE, adverse event.
aClassification of some infections were not recorded due to unavailability of medical records.
bIncludes recovered/resolved, recovered/resolved with sequelae, recovering/resolving.

Incidence of Infections Over Time3
Time Interval, months
Patients at Risk, N
Any Grade
Grade ≥3
Infections Rate, n (%)
Infections Events, n
Infections Rate, n (%)
Infections Events, n
0 to <3
113
61 (54.0)
100
27 (23.9)
38
3 to <6
99
40 (40.4)
57
20 (20.2)
25
6 to <9
79
19 (24.1)
26
5 (6.3)
6
9 to <12
76
17 (22.4)
24
6 (7.9)
7
12 to <15
70
10 (14.3)
14
2 (2.9)
2
15 to <18
66
10 (15.2)
15
2 (3.0)
3
18 to <21
54
10 (18.5)
10
0 (0.0)
0
21 to <24
26
3 (11.5)
3
1 (3.8)
1

CRS Events and Management3
Patients, n (%)
CRS AEs
N=113
Patients with any event, n (%)
63 (55.8)
   No of events, n
90
   Grade 3 events, n (%)
2 (1.8)
Duration, days, median (range)
2.0 (1-23)
Resolved, n (%)
90 (100)
Management
   Antipyretics
33 (29.2)
   Tocilizumab
17 (15.0)
   Corticosteroids
11 (9.7)
   Intravenous fluids
6 (5.3)
   Vasopressor
1 (0.9)
   Oxygen
0
   Other
18 (15.9)
Abbreviations: AE, adverse event; CRS, cytokine release syndrome.

Popat et al (2025)4 presented results from the subgroup analysis of the REALiTEC study at a median follow-up of 20.7 months.

Results

Treatment Disposition, Baseline Characteristics, and Disease Characteristics

  • The median time since diagnosis in BCMA-exposed patients (n=38) was 9.3 years (range, 0.7-24.2) vs 6.4 years (range, 2.1-18.5) in non-BCMA-exposed patients.
  • The median number of prior lines of therapy was 6 (range, 3-12) in BCMA-exposed patients vs 5 (range, 2-12) in non-BCMA-exposed patients; most had ≥5 prior lines of therapy (89.5% vs 60%).

Efficacy


Response Rates in Subgroups4
Response Rates
Overall
(N=113)
PCR
(n=50)
HR
(n=32)
≥75 Years
(n=17)
≤3 PL
(n=17)
ISS (II-III)
(n=62)
ORR, %
60.2
58
68.8
64.7
58.8
64.5
   ≥VGPR, n (%)
52.2
50.0
56.8
64.7
47.1
56.5
   PR, n (%)
8.0
8.0
12.0
0
11.8
8.1
Abbreviations: HR, high-risk cytogenetics; ISS, International Staging System; ORR, overall response rate; PCR, penta-class refractory; PL, prior lines of therapy; PR, partial response; VGPR, very good partial response.

Response Rates in Patients With Prior Exposure to BCMA-Targeted Therapy4
Response rates
No Prior BCMA
(n=75)
Prior BCMA
(n=38)
Prior ADCa
(n=32)
Prior CAR-Ta
(n=10)
ORR, %
64.0
52.6
53.2
50.0
   ≥VGPR, n (%)
54.7
47.4
46.9
50.0
   PR, n (%)
9.3
5.2
6.3
0
Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell therapy; PR, partial response; ORR, overall response rate; VGPR, very good partial response.
aFive patients are included in both the ADC and CAR-T groups, having received both before.

DOR, PFS, and OS Subgroup Analyses4
Subgroup
DOR
PFS
OS
HR
(95% CI)
P Value
HR
(95% CI)
P Value
HR
(95% CI)
P Value
Age
(<75 vs ≥75 years)
1.03
(0.40-2.69)
0.950
1.17
(0.58-2.36)
0.663
1.05
(0.47-2.33)
0.904
MM diagnosis
(≤6 vs >6 years ago)
1.29
(0.63-2.64)
0.485
1.07
(0.66-1.75)
0.771
1.23
(0.71-2.13)
0.454
ISS stage
(I vs II/III)
0.84
(0.33-2.12)
0.712
1.05
(0.60-1.86)
0.858
0.88
(0.45-1.71)
0.712
EMD
(with vs without)
0.51
(0.12-2.15)
0.360
0.53
(0.24-1.17)
0.118
0.51
(0.22-1.20)
0.123
Prior lines of therapy
(≤3 vs >3)
0.80
(0.24-2.66)
0.720
0.85
(0.42-1.72)
0.651
0.94
(0.42-2.10)
0.887
Prior BCMA therapy
(with vs without)
0.64
(0.31-1.34)
0.240
0.65
(0.40-1.07)
0.090
0.49
(0.29-0.85)
0.011
Prior BCMA (ADC)
(with vs without)
0.51
(0.24-1.09)
0.083
0.51
(0.31-0.85)
0.009
0.42
(0.24-0.73)
0.002
Prior BCMA (CAR-T)
(with vs without)
0.98
(0.23-4.10)
0.973
0.98
(0.39-2.44)
0.966
0.61
(0.26-1.44)
0.263
Triple-class refractory
(with vs without)
1.12
(0.48-2.61)
0.791
0.89
(0.49-1.60)
0.686
0.62
(0.29-1.31)
0.207
Triple-class exposed
(with vs without)
NE
NE
NE
NE
NE
NE
Penta-drug refractory
(with vs without)
1.27
(0.62-2.60)
0.517
0.79
(0.49-1.28)
0.347
0.89
(0.51-1.53)
0.661
Penta-drug exposed
(with vs without)
0.48
(0.11-2.03)
0.320
0.93
(0.43-2.04)
0.861
1.35
(0.61-3.01)
0.457
Cytogenetic risk
(standard vs high)
0.84
(0.35-1.99)
0.687
1.37
(0.72-2.61)
0.341
0.89
(0.40-2.02)
0.789
Risk-minus amp1q21
(standard vs high)
0.53
(0.22-1.26)
0.149
1.02
(0.53-1.94)
0.963
0.59
(0.26-1.34)
0.206
ECOG PS
(0 vs ≥1)
0.44
(0.15-1.29)
0.134
0.44
(0.19-1.01)
0.053
0.74
(0.30-1.82)
0.516
Baseline thrombocytopenia
(with vs without)
0.56
(0.24-1.28)
0.168
0.60
(0.35-1.03)
0.062
0.61
(0.33-1.12)
0.109
LDH level
(≤245 U/L vs >245 U/L)
0.46
(0.21-1.01)
0.054
0.59
(0.33-1.04)
0.070
0.43
(0.22-0.84)
0.013
≥VGPR vs <VGPR
0.42
(0.17-1.04)
0.061
0.23
(0.14-0.39)
<0.001
0.21
(0.11-0.40)
<0.001
MajesTEC-1
(eligible vs ineligible)
0.38
(0.16-0.88)
0.024
0.42
(0.23-0.75)
0.004
0.42
(0.21-0.085)
0.015
Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell herapy; CI, confidence interval; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; HR, hazard ratio; ISS, International Staging System; LDH, lactate dehydrogenase; MM, multiple myeloma; NE, not estimated; OS, overall survival; PFS, progression-free survival; VGPR, very good partial response.

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 09 September 2025.  

 

References

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1 Janssen Research & Development, LLC. A study of clinical outcomes in patients with relapsed/refractory multiple myeloma (RRMM) treated with T-cell redirectors outside of clinical trials (REALiTEC/TAL). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/NCT006285318 NLM Identifier: NCT006285318.  
2 Kortüm K, Uttervall K, Popat R, et al. First results from REALiTEC: a multi-country non-interventional retrospective study of teclistamab outside of clinical trials in RRMM. Poster presented at: 6th European Myeloma Network (EMN) Annual Meeting; April 10-12, 2025; Athens, Greece.  
3 Perrot A, Uttervall K, Kortüm M, et al. Safety results from REALiTEC: A multi-country observational retrospective study of teclistamab in relapsed/refractory multiple myeloma outside of clinical trials. Poster presented at: 11th World Congress on Controversies in Multiple Myeloma (COMy); May 15-18, 2025; Paris, France and online.  
4 Popat R, Kortüm K, Uttervall K, et al. REALiTEC subgroup Analysis: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials. presented at: European Hematology Association (EHA) Hybrid Congress; June 12-15, 2025; Milan, Italy.