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(teclistamab-cqyv)

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TECVAYLI - REALiTEC Study

Last Updated: 04/27/2026

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
    • Uttervall et al (2026)1 published the 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 60.2%. The most common adverse events (AEs; any grade) were infections (70.8%), cytokine release syndrome (CRS; 55.8%), and neutropenia (35.4%).

CLINICAL DATA - Realitec study

REALiTEC (NCT06285318) is an ongoing retrospective, observational study of TECVAYLI in patients with RRMM.1

Uttervall et al (2026)1 published the efficacy and safety results from the REALiTEC study evaluating TECVAYLI in patients with RRMM outside of clinical trials.

Results

Treatment Disposition, Baseline Characteristics, and Disease Characteristics

  • Out of 113 patients, 100 patients (88.5%) received TECVAYLI as part of preapproval access programs. See Table: REALiTEC Study: Baseline Characteristics.
  • 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).
  • The median time since diagnosis in B-cell maturation antigen (BCMA)-exposed patients (n=40) was 9.3 years (range, 2.1-18.5) vs 6.1 years (range, 0.7-24.2) in non-BCMA-exposed patients.
  • The median number of prior lines of therapy (LOTs) was 6 (range, 3-12) in BCMA-exposed patients vs 5 (range, 2-12) in non-BCMA-exposed patients; most had ≥5 prior LOTs (90.0% vs 58.9%).
  • Of the 40 BCMA-exposed patients, 20 patients received ≥1 LOTs (median 2; range, 1-4) between prior BCMA and TECVAYLI.

REALiTEC Study: Baseline Characteristics1
Characteristic
N=113a
Median age, years (range)
66 (43-83)
   <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)
Median weight, kg (range)
71.9 (42.0-118.1)
Race, n (%)
   White
83 (73.5)
   Black
3 (2.7)
   Multiple
1 (0.9)
   Unknown/not reported
26 (23.0)
ECOG PS ≥1, n/N (%)
27/49 (55.1)
ISS stage, n/N (%)
   I
32/94 (34.0)
   II
41/94 (43.6)
   III
21/94 (22.3)
High-risk cytogeneticsb, n/N (%)
32/62 (51.6)
   t (4;14)
12/62 (19.4)
   t (14;16)
1/62 (1.6)
   del17p13
18/62 (29.0)
   amp1q21
13/62 (21.0)
Extramedullary plasmacytoma, n (%)
9/59 (15.3)
LDH >245 U/Lc, n (%)
28/86 (32.6)
Median time since diagnosis, years (range)
7.4 (0.7-24.2)
Median prior lines of therapy, n (range)
6 (2-12)
   Triple-refractory, n (%)
89 (78.8)
   Penta-refractory, n (%)
50 (44.2)
   Refractory to last line of therapy, n (%)
86 (76.1)
Prior autologous SCT, n (%)
86 (76.1)
Prior allogeneic SCT, n (%)
8 (7.1)
Prior BCMA therapy, n (%)
40 (35.4)
Prior BCMA therapies, n
45
   CAR-T
10
   ADC
32
   BsAbs
3
Patients ineligible for MajesTEC-1, n (%)
80 (70.8)
Creatinine clearance/GFR, mL/min or mL/min/1.73 m2, n/N (%)
   <30
3/104 (2.9)
   ≥30 to <40
11/104 (10.6)
   ≥40
90/104 (86.5)
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; GFR, glomerular filtration rate; ISS, International Staging System; LDH, lactate dehydrogenase; SCT, stem cell transplant; ULN, upper limit of normal.
aData available added as denominators if some were missing and not available in the clinical chart for the whole cohort.
bHigh-risk cytogenetics defined as having presence of t(4;14), t(14;16), del17p13, and amp1q21 by fluorescent in situ hybridization.
cBaseline LDH stratification value of 245 U/L represents the institutional ULN.

Efficacy

Dosing Schedule Changes
  • Efficacy outcomes for patients who switched dosing frequency are presented in Table: REALiTEC Study: Efficacy Data in Patients Who Switched From Weekly Dosing to Either Biweekly or Monthly Dosing.
  • A total of 39.8% of patients (n=45) transitioned to biweekly dosing; achievement of very good partial response or better (≥VGPR) was reported as the primary reason for switching in 62.2% of patients.
  • A total of 23% of patients (n=26) transitioned to monthly dosing; achievement of ≥VGPR was reported as the primary reason for switching in 80.8% of patients.

REALiTEC Study: Summary of Overall Best Confirmed Response in the Overall Study Population1
Responsea
N=113
Overall responseb, % (95% CI)
60.2 (50.5-69.3)
   sCR
5.3 (2.0-11.2)
   CR
21.2 (14.1-29.9)
   VGPR
25.7 (17.9-34.7)
   PR
8.0 (3.7-14.6)
≥VGPRc, % (95% CI)
52.2 (42.6-61.7)
≥CRd, % (95% CI)
26.5 (18.7-35.7)
   Near CRe, % (95% CI)
17.7 (11.2-26.0)
Minimal response, % (95% CI)
0.9 (0.0-4.8)
Stable disease, % (95% CI)
9.7 (5.0-16.8)
Progressive disease, % (95% CI)
15.9 (9.7-24.0)
Not available/not reported, % (95% CI)
13.3 (7.6-20.9)
Median time to first response, months (95% CI)
1.6 (1.2-1.9)
Median time to best response, months (95% CI)
3.8 (2.8-5.0)
Median TTNT, % (95% CI)
NR (24.4-NE)
   12-month TTNT, % (95% CI)
74.3 (65.2-81.4)
Median DOR, months (95% CI)
20.3 (14.8-NE)
Median PFS, months (95% CI)
9.7 (5.6-18.8)
   Estimated 12-month PFS, % (95% CI)
47.4 (38.0-56.3)
Median PFS2f, months (95% CI)
NR (NE–NE)
   Estimated 12-month PFS2, % (95% CI)
80.5 (72-86.7)
Median OS, months (95% CI)
26.3 (16.5-NE)
   Estimated 12-month OS, % (95% CI)
61.9 (52.3-70.2)
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; NE, not estimated; OS; overall survival; PFS, progression-free survival; PFS2, progression‑free survival 2; PR, partial response; sCR, stringent complete response; VGPR, very good partial response; TTNT, time to next treatment.
aResponses were as assessed by the investigator as per IMWG response criteria.
bDefined as sCR+CR+VGPR+PR.
cDefined as sCR+CR+VGPR.
dDefined as sCR+CR.
eDefined as a patient meeting all criteria for CR except for confirmatory bone marrow assessment.
fDefined as the time interval from the date of first dose of TECVAYLI to the date of disease progression occurring after initiation of subsequent antimyeloma therapy, as assessed by the investigator based on available data, or death from any cause, whichever occurred first.


REALiTEC Study: DOR, PFS, and OS Analyses in Response Categories1
Parameter
≥VGPR
<VGPR
Median DOR, months (95% CI)
26.1 (16.7-NE)
3.8 (0.8-NE)
Median PFS, months (95% CI)
NR (17.3-NE)
2.6 (1.6-3.3)
   Estimated 12-month PFS, % (95% CI)
71.2 (57.8-81.0)
-
Median OS, months (95% CI)
NR (26.3-NE)
6.2 (3.6-16.5)
   Estimated 12-month PFS, % (95% CI)
83.1 (70.8-90.5)
-
Abbreviations: CI, confidence interval; DOR, duration of response; NE, not estimated; NR, not reached; OS, overall survival; PFS, progression-free survival; VGPR, very good partial response.

REALiTEC Study: Response Rates in Subgroups1
Response Rates
PCR
(n=50)

HR
(n=32)

≥75 Years
(n=17)

ISS III
(n=21)

MajesTEC-1 Ineligible
(n=80)

ORR,
% (95% CI)

58.0
(43.2-71.8)

68.8
(50.0-83.9)

64.7
(38.3-85.8)

52.4
(29.8-74.3)

57.5
(45.9-68.5)

   CR/sCR, %
22.0
28.1
29.4
23.8
25.0
   VGPR, %
28.0
37.5
35.3
23.8
26.3
   PR, %
8.0
3.1
0
4.8
6.3
≥VGPR,
% (95% CI)

50.0
(35.5-64.5)

65.6
(46.8-81.4)

64.7
(38.3-85.8)

47.6
(25.7-70.2)

51.3
(39.8-62.6)

Abbreviations: CR, complete response; HR, high-risk cytogenetics; ISS, International Staging System; ORR, overall response rate; PCR, penta-class refractory; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.

REALiTEC Study: Response Rates in Patients With Prior Exposure to Anti-BCMA Therapy1
Response Rates
BCMA-naïve
(n=73)

Prior BCMA
(n=40)

Prior ADC
(n=32)

Prior CAR-T
(n=10)

ORR, % (95% CI)
63.0 (50.9-74.0)
55.0 (38.5-70.7)
53.1 (34.7-70.9)
50.0 (18.7-81.3)
   CR/sCR, %
28.8
22.5
25.0
10.0
   VGPR, %
24.7
27.5
21.9
40.0
   PR, %
9.6
5.3
6.3
0
≥VGPR, % (95% CI)
53.1 (41.4-65.2)
50.0 (33.8-66.2)
46.9 (29.1-65.3)
50.0 (18.7-81.3)
Median DOR, months (95% CI)
20.3 (12.4-NE)
17.4 (6.6-NE)
-
-
Median PFS, months (95% CI)
13.8 (7.5-NE)
3.4 (2.6-18.8)
-
-
Median OS, months (95% CI)
NR (26.3-NE)
15.2 (4.7-NE)
-
-
   Estimated 12-month
   OS, % (95% CI)

65.8 (53.7-75.4)
-
-
-
Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell therapy; CI, confidence interval; CR, complete response; NE, not estimated; NR, not reached; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.

REALiTEC Study: DOR, PFS, and OS Subgroup Analyses1
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)

0.61
(0.14-2.69)

0.511
0.48
(0.21-1.10)

0.084
0.48
(0.19-1.19)

0.112
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)

0.80
(0.38-1.67)

0.549
0.75
(0.46-1.23)

0.250
0.55
(0.32-0.96)

0.034
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
Response
(≥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)

0.46
(0.20-1.07)

0.070
0.47
(0.26-0.85)

0.013
0.47
(0.24-0.94)

0.033
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.

REALiTEC Study: Efficacy Data in Patients Who Switched from Weekly Dosing to Either Biweekly or Monthly Dosing1
Parameter
Switch to Biweekly (n=45)
Switch to Monthly (n=26)
Patients who switched of total cohort, %
39.8
23
Median time to switch, months (range)
7.0 (0-18)
10.5 (1-22)
Overall response, % (95% CI)
82.2 (67.9-92.0)
88.5 (69.8-97.6)
≥VGPR, % (95% CI)
80.0 (65.4-90.4)
84.6 (65.1-95.6)
≥CR, % (95% CI)
44.4 (29.6-60.0)
42.3 (23.4-63.1)
Near CR, % (95% CI)
31.1 (18.2-46.6)
34.6 (17.2-55.7)
Median duration of treatment, months (range)
18.9 (2.6-35.8)
18.1 (1.4-35.8)
Median DOR, months (range)
NE (20.3-NE)
NE (20.3-NE)
   Estimated 12month DOR, % (95% CI)
85.7 (68.9-93.8)
95.0 (69.5-99.3)
Median PFS, months (range)
NE (22.2-NE)
NE (22.2-NE)
   Estimated 12month PFS, % (95% CI)
86.7 (72.7-93.8)
92.3 (72.6-98.0)
Median OS, months (range)
NE (26.3-NE)
NE (NE-NE)
   Estimated 12month OS, % (95% CI)
97.8 (85.3-99.7)
96.2 (75.7-99.4)
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; NE, not estimated; OS, overall survival; PFS, progression‑free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.

Safety

Treatment Modifications and Discontinuation

  • Overall, 15.9% of patients (n=18) discontinued TECVAYLI therapy due to AEs.
  • A total of 46.9% of patients (n=53) experienced dose delays, 30.1% of patients (n=34) skipped ≥1 dose, and 0.9% of patients (n=1) required dose reduction due to AEs.
  • Infections led to TECVAYLI discontinuation in 8.8% of patients (n=10).
  • None of the patients discontinued TECVAYLI due to CRS and immune effector cell-associated neurotoxicity syndrome (ICANS).

Infections

  • Infection details are shown in Table: REALiTEC Study: Incidence of Infection Events.
  • A total of 53.1% of patients (n=60) had multiple infectious events.
  • Infection treatments were reported in 65.5% of patients (n=74), including antibiotics in 63.7% of patients (n=72), antivirals in 23% of patients (n=26), antifungals in 9.7% of patients (n=11), intravenous immunoglobulin (IVIG) used as treatment in 48.7% of patients (n=55), and intravenous fluids in 9.7% of patients (n=11).

CRS and ICANS

  • A total of 94.4% of CRS events were reported after a step‑up dose or the first maintenance dose. See Table: REALiTEC Study: CRS Events and Management.
  • ICANS was reported in 3.5% of patients (n=4), with 6 total ICANS events, all of which were grade 1-2.
  • Two ICANS events were reported concurrently with CRS.
  • All ICANS events were reported after a step‑up dose or the firstmaintenance dose and had a median duration of 1.5 days (range, 1-6).
  • No grade ≥3 ICANS events were reported.

Grade 5 Events

  • Grade 5 treatment‑emergent adverse events (TEAEs) were reported in 13 patients, of which 5 deaths were considered related to TECVAYLI as assessed by the investigator.
  • Grade 5 TEAEs related to TECVAYLI were:
    • Infectious: pneumonia/neurotoxicity encephalopathy and septic shock.
    • Non-infectious: febrile neutropenia and hyponatremia.
  • Grade 5 TEAEs not related to TECVAYLI were:
    • Infectious: bacteremia pneumonia due to Escherichia coli, lung infection, and septic shock.
    • Noninfectious: acute renal failure, poor general condition, febrile respiratory distress, mild hypovolemia, multiple fracture, and progressive multiple myeloma with impaired general condition.

Supportive Care and Prophylaxis

  • Immunoglobulin replacement therapy was prescribed in 60.2% of patients (n=68), with 70.6% of these patients receiving it as primary prophylaxis.
    • The median time to initiation of immunoglobulin replacement therapy was 78 days (range, 0-391).
    • Administration of immunoglobulin (Ig) replacement therapy included intravenous IgG in 59 patients and subcutaneous IgG in 13 patients.
  • Prior to initiation of TECVAYLI, 80.5% of patients received ≥1 prophylactic medication, including 16.8% of patients (n=19) for CRS management, 1.8% of patients (n=2) for ICANS management, and 40.7% of patients (n=46) for infection management.
  • During TECVAYLI treatment, 45.1% of patients received ≥1 growth factor, including 22.1% of patients who received growth factors as prophylaxis.
  • Overall, 9.7% of patients (n=11) received ≥1 cycle of radiotherapy during TECVAYLI treatment.

REALiTEC Study: Summary of TEAEs1
TEAE, n (%)
N=113
Any grade
Grade 3/4
Patients with any TEAE
108 (95.6)
83 (73.5)
Hematologic
   Neutropenia
40 (35.4)
37 (32.7)
   Anemia
29 (25.7)
19 (16.8)
   Thrombocytopenia
21 (18.6)
17 (15.0)
Nonhematologic
   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)
   Infections
80 (70.8)
49 (43.4)
      Pneumonia
24 (21.2)
16 (14.2)
      SARSCoV2 virus (COVID19)
17 (15.0)
8 (7.1)
      Infection (unknown)
12 (10.6)
2 (1.8)
      Upper respiratory tract infection
11 (9.7)
0
      CMV reactivation
3 (2.7)
1 (0.9)
Abbreviations: COVID-19, coronavirus disease 19; CMV, cytomegalovirus; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; TEAE, treatment-emergent adverse event.
aIncludes toxic encephalopathy and encephalopathy.


REALiTEC Study: Incidence of Infection Events1
Event
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 events
6 (5.3)
2 (1.8)
1 (0.9)
Number of infection events
261
66a
70a
   Median time to onset of events, days    
   (range)

128.0 (1-1062)
101.0 (2-1062)
126.0 (1-859)
   Median time to onset of grade 3/4
   infection event, days (range)

99.0 (2-820)
63.5 (2-734)
148.0 (4-820)
   Median duration, 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 (93.9)
64/70 (91.4)
Abbreviation: AE, adverse event.
aClassifications of some infections (n=120) were not recorded due to unavailability of medical records; 5 fungal infections were also reported.
bIncludes recovered/resolved, recovered/resolved with sequelae, recovering/resolving.


REALiTEC Study: CRS Events and Management1
Event
N=113
Patients with any event, n (%)
63 (55.8)
   Grade 1-2, %
98.2
   Grade 3 events, n
2
Multiple CRS events, n (%)
16.8 (19)
Median duration of CRS, days (range)
2.0 (1-23)
Management
   Antipyretics
33 (29.2)
   Tocilizumab
17 (15.0)
   Corticosteroids
11 (9.7)
   Intravenous fluids
6 (5.3)
   Vasopressor
1 (0.9)
   Other
18 (15.9)
Abbreviation: CRS, cytokine release syndrome.

Subsequent Treatments

  • Overall, 34.5% of patients (n=39) received ≥1 subsequent treatment after study therapy.
  • Talquetamab was administered to 15 patients, including 13 of 15 patients who received talquetamab as monotherapy; the ORR to talquetamab was 45.5% (5/11), with 100% of responders achieving very good partial response or better (≥VGPR).
  • Proteasome inhibitor (PI)based combinations were administered to 19.5% of patients (n=22); the ORR with PIbased combinations was 37.5% (6/16), with 12.5% of patients achieving ≥VGPR.
  • BCMA chimeric antigen receptor T-cell (CART) therapy was received by 5.3% of patients (n=6) as subsequent treatment; the ORR with BCMA CART therapy was 80.0% (4/5), with 20.0% of patients achieving ≥VGPR.
  • Other subsequent therapies included alkylating agents in 15.0% of patients (n=17; most commonly cyclophosphamide), immunomodulatory drugs in 11.5% of patients (n=13; most commonly pomalidomide), and antiCD38 therapies in 8.0% of patients (n=9).

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 23 April 2026.

 

References

1 Uttervall K, Kortum MK, Perrot A, et al. REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials. [published online ahead of print March 05, 2026]. Haematologica. doi:10.3324/haematol.2025.289281.