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(talquetamab-tgvs)

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TALVEY® (talquetamab-tgvs)
Medical Information

TALVEY - REALiTAL Study

Last Updated: 04/28/2026

SUMMARY  

  • REALiTAL is a retrospective, international, noninterventional study describing the management and outcomes of patients with relapsed or refractory multiple myeloma (RRMM) treated with TALVEY outside of clinical trials.1 
    • Uttervall et al (2025)1 presented efficacy and safety results from the REALiTAL study evaluating TALVEY in 93 patients with RRMM. At a median follow-up of 14.95 months (range, 0.36-25.26), overall response rate (ORR) was 66.7%. The most common adverse events (AEs; any grade) were skin/nail (67.7%), oral toxicity (66.7%), cytokine release syndrome (CRS; 55.9%), and infections (47.3%).
    • Kortüm et al (2025)2  presented a subgroup analysis of the REALiTAL study (N=93). At a median follow-up of 14.95 months (range, 0.36-25.26), patients previously exposed to B-cell maturation antigen (BCMA)-targeted therapies had an ORR of 61.2%. In patients previously treated with chimeric antigen receptor T-cell therapy (CAR-T) or bispecific antibodies (BsAbs), ORRs were 66.7% and 56.5%, respectively.
    • Popat et al (2025)3 presented the safety results from 93 patients treated with TALVEY in the REALiTAL study at a median follow-up of 14.95 months (range, 0.36-25.26).

CLINICAL DATA - RealitAL study

REALiTAL is a retrospective, observational study of TALVEY in patients with RRMM across 26 sites in 7 countries (United Kingdom, Ireland, Denmark, Germany, Sweden, Italy, Israel).1 

Study Design/Methods

  • Patient medical records, including demographics, disease characteristics, prior therapies, effectiveness, and safety, were used for data extraction.
  • Treatment outcomes assessed included response rates, time to first and best response, duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
  • Responses were assessed as per International Myeloma Working Group (IMWG) criteria.

Uttervall et al (2025)1 presented efficacy and safety results evaluating TALVEY in patients with RRMM at a median follow-up of 14.95 months (range, 0.36-25.26).

Results 

Treatment Disposition, Baseline Demographics, and Disease Characteristics 

  • A total of 93 patients received TALVEY on or before 31 December 2023, with most patients receiving TALVEY through preapproval access programs. See Table: REALiTAL Study: Baseline and Disease Characteristics for additional details.
  • Of 93 patients, 88.2% of patients (n=82) initiated TALVEY every 2 weeks (Q2W), and 11.8% of patients (n=11) initiated weekly (QW) dosing.
    • Among patients who initiated TALVEY Q2W, 22% of patients (n=18/82) switched to monthly (Q4W) dosing after a median of 6 months.
    • Among patients who switched from TALVEY Q2W to Q4W dosing, 66.7% of patients (n=12/18) switched due to disease response.

REALiTAL Study: Baseline and Disease Characteristics1,3 
Characteristic
N=93a
Median age, years (range)
65 (24-86)
   <65 years, n (%)
42 (45.2)
   ≥65 to <75 years, n (%)
37 (39.8)
   ≥75 years, n (%)
14 (15.1)
Male, n (%)
55 (59.1)
ECOG PS ≥1, n (%)
21b (60.0)
ISS stage II or III, n (%)
42c (60.9)
High-risk cytogeneticsd, n (%)
35e (72.9)
Extramedullary plasmacytoma, n (%)
11f (21.6)
LDH >245 U/L, n (%)
43g (53.8)
Median time since diagnosis, years (range)
6.03 (1.5-23.1)
Prior lines of therapy, median (range)
5 (2-16)
   Triple-class exposed, n (%)
91 (97.8)
   Penta-class exposed, n (%)
80 (86.0)
   Triple-refractory, n (%)
65 (69.9)
   Penta-refractory, n (%)
37 (39.8)
Refractory to last line of therapy, n (%)
71 (76.3)
Autologous SCT, n (%)
70 (75.3)
Patients receiving prior BCMA, n (%)
     CAR-T
11 (11.8)
     ADC
24 (25.8)
     BsAbs
22 (23.7)
Creatinine clearance mL/min/1.73m2
86
   <30 mL/min/1.73m2
7 (8.1)
   ≥30 to <40 mL/min/1.73m2
7 (8.1)
   ≥40 mL/min/1.73m2
72 (83.7)
History of severe infections, n (%)
10 (10.8)
Cardiac conditions, n (%)h
9 (9.7)
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.
bEvaluated in 35 patients.
cEvaluated in 69 patients.
dHigh-risk defined as having presence of t(4;14), t(14;16), del17p13, and amp1q21.
eEvaluated in 48 patients.
fEvaluated in 51 patients.
gEvaluated in 80 patients.
hCardiac conditions include myocardial infarction or coronary artery bypass graft.

Efficacy 


REALiTAL Study: Efficacy Outcomes1 
Parametera
N=93
ORR (%)
66.7
   VGPR (%)
38.7
   PR (%)
9.7
≥CR (%)
18.3
≥VGPR (%)
57
Median time to first response, months (95% CI)
1.2 (0.9-1.3)
Median time to best response, months (95% CI)
3.6 (2.7-4.9)
Median DORb, months (95% CI)
12.3 (7.9-NE)
Median PFSc, months (95% CI)
8.2 (6.1-10.7)
Median OSd, months (95% CI)
25.3 (17.3-NE)
Median treatment duration, months (95% CI)
7.9 (5.7-9.9)
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; NE, not estimated; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.
aResponses were evaluated via IMWG criteria.
bMedian DOR in patients achieving ≥VGPR was 13.4 months.
cMedian PFS in patients achieving ≥VGPR was 18.2 months.
dMedian OS in patients achieving ≥VGPR was 25.3 months.

Safety 

  • Summary of safety events is shown in Table: REALiTAL Study: Summary of TEAEs.
  • A total of 28% (n=26) treatment-emergent adverse events (TEAEs) were grade 3/4.
  • Overall, 8.6% (n=8) of fatalities were due to general health deterioration (n=3), disease progression, pneumonia, spontaneous bacterial peritonitis, gastrointestinal hemorrhage, and hypercalcemia (n=1 each).
Treatment Discontinuation
  • A total of 73.1% of patients (n=68) discontinued treatment, 61.3% of patients (n=57) discontinued due to disease progression, 5.4% of patients (n=5) discontinued due to adverse events, and 3.2% of patients (n=3) discontinued due to physician decision.
Skin, Nail, and Oral Toxicity
  • A total of 2.2% of patients (n=2) had treatment interruptions and 1.1% of patients (n=1) reduced dose due to oral toxicity; 1.1% of patients (n=1) discontinued due to dysgeusia.
  • A total of 4.3% of patients (n=4) had treatment interruptions due to skin and nail toxicity, none discontinued treatment.
  • At the time of data collection, 75% of skin and nail toxicity events and 58% of oral toxicity events had resolved or were resolving.
CRS and Neurotoxicity
  • CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly grade 1/2; 1.1% of patients (n=1) had grade 3 CRS. All but 1 CRS events resolved/were resolving at time of data collection.
Infections
  • A total of 9.7% of patients (n=9) had grade 3/4 infections of which 1.1% of patients (n=1) discontinued treatment and 2.2% of patients (n=2) died due to infection.

REALiTAL Study: Summary of TEAEs1 
TEAE, n (%)
N=93
Any Grade
Grade 3/4
Any TEAE
92 (98.9)
28 (30.1)
Infections
44 (47.3)
9 (9.7)
   COVID-19
7 (7.5)
1 (1.1)
   Pneumonia
6 (6.5)
3 (3.2)
   Upper respiratory tract infection
5 (5.4)
0 (0)
   Urinary tract infection
5 (5.4)
1 (1.1)
Hematologic TEAEs
   Anemia
13 (14.0)
8 (8.6)
   Neutropenia
9 (9.7)
6 (6.5)
   Thrombocytopenia
7 (7.5)
6 (6.5)
Nonhematologic TEAEs
   Skin/nail toxicity
63 (67.7)
1 (1.1)
   Oral toxicity
62 (66.7)
1 (1.1)
      Dysgeusiaa
53 (57.0)
NA
   CRS
52 (55.9)
1 (1.1)
   Neurologic TEAEs of interest
      ICANS
2 (2.2)
0 (0)
Abbreviations: COVID‑19, coronavirus disease 2019; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; NA, not applicable; TEAE, treatment-emergent adverse event.
aIncludes dysgeusia, ageusia and taste disturbance. Maximum grade is 2.

Kortüm et al (2025)2presented results from a subgroup analysis of patients in the REALiTAL study based on prior therapy and depth of response at a median follow-up of 14.95 months (range, 0.36-25.26).

Results

Baseline Characteristics

  • Patient baseline characteristics are summarized in Table: REALiTAL Study: Select Baseline Characteristics.
    • A total of 52.7% of patients (n=49) had previously received anti-BCMA treatments.
      • Of these, 35.5% of patients (n=33) received prior anti-BCMA T-cell redirection (TCR) therapy; 12 received prior CAR-T, and 23 received prior BsAb therapy.
    • Antibody-drug conjugate (ADC) therapy was administered to 25.8% of patients (n=24).

REALiTAL Study: Select Baseline Characteristics2
Characteristic
Overall
(N=93)a
Prior CAR-Tb Subgroup (n=12)
Prior BsAbb
Subgroup (n=23)
Age (years), median (range)
65 (24-86)
56.5 (50-70)
66.1 (46-85)
   <65 years, n (%)
42 (45.2)
8 (66.7)
10 (43.5)
   ≥65 to <75 years, n (%)
37 (39.8)
4 (33.3)
7 (30.4)
   ≥75 years, n (%)
14 (15.1)
0
6 (26.1)
Male, n (%)
55 (59.1)
8 (66.7)
13 (56.5)
ECOG PS ≥1, n (%)
21/35 (60.0)
3/6 (50.0)
5/9 (55.6)
ISS stage II or IIIc, n (%)
42/69 (60.9)
3/8 (37.5)
12/20 (60.0)
High-risk cytogeneticsd, n (%)
35/48 (72.9)
3/5 (60.0)
12/17 (70.6)
Extramedullary plasmacytoma, n (%)
8/51 (15.7)
0/5 (0)
2/14 (14.3)
LDH >245 U/L, n (%)
43/80 (53.8)
4/11 (36.4)
11/18 (61.1)
Time since diagnosis (years), median (range)
6.0 (1.5-23.1)
6.4 (2.4-14.5)
6.6 (1.5-18.8)
Abbreviations: BMCA, 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.
aData available added as denominators if some were missing and not available in the clinical chart for the whole cohort.
bTwelve patients were categorized as having received prior CART therapy; of these, 11 had received antiBCMA CART therapy; 22 of 23 with prior BsAb had anti-BCMA BsAb. Patients may have received >1 CAR-T or BsAb treatment.
cAt baseline or at diagnosis, if missing.
dHigh risk defined as having presence of t(4;14), t(14;16), del17p13, and amp1q21.

Efficacy 


REALiTAL Study: Response Rates by Subgroups2 
Response Rates
Overall
(N=93)
Triple-Class Refractory
(n=65)
PCR
(n=37)
HR
(n=35)
≥75 Years
(n=14)
≤3 PL
(n=19)
ISS
(II-III)
(n=52)
Prior anti-BCMAa
(n=49)
ORR, %
66.7
67.7
75.7
71.4
64.3
84.2
61.5
61.2
≥VGPR, n (%)
57.0
60.0
62.2
65.7
42.9
78.9
53.8
51
PR, n (%)
9.7
7.7
13.5
5.7
21.4
5.3
7.7
10.2
Abbreviations: ADC, antibody-drug conjugate; BCMA, B‑cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; 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.
aPrior anti-BCMA therapy cohort includes prior ADC, CAR-T and BsAbs.

REALiTAL Study: Response Rates in Patients With Prior Exposure to CAR-T or BsAb2 
Response Rates
Prior CAR-Ta
(n=12)
Prior BsAba
(n=23)
ORR, % (95% CI)
66.7 (34.9-90.1)
56.5 (34.5-76.8)
   VGPR, %
16.7
43.5
   PR, %
16.7
4.3
   ≥CR, %
33.3
8.7
Median time to first response, months
1.6b
1c
Abbreviations: BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; CI, confidence interval; CR, complete response; ORR, overall response rate; PR, partial response; VGPR, very good partial response.
a11 of the 12 patients with prior CAR-T had anti-BCMA CAR-T and 22 of the 23 with prior BsAb had anti-BCMA BsAb. Patients may have received ›1 CAR-T or BsAb treatment.
bAfter a median duration of TALVEY treatment of 11.7 months.
cAfter a median duration of TALVEY treatment of 6.3 months.

REALiTAL Study: mDOR, mPFS, and mOS Rates2
Response
Overall Population
(N=93)
Prior CAR-Ta
(n=12)
Prior BsAba
(n=23)
mDOR, months (95% CI)
12.32 (7.85-NE)
NE (1.45-NE)
16.1 (5.95-NE)
mPFS, months (95% CI)
8.18 (6.05-10.71)
10.71 (2.23-NE)
7.36 (3.88-18.20)
   12-month PFS rate, % (95% CI)
38.3 (28.3-48.2)
48.6 (19.2-73.0)
32.8 (14.8-52.1)
mOS, months (95% CI)
25.26 (17.31-NE)
NE (4.47-NE)
NE (9.2-NE)
   12-month OS rate, % (95% CI)
68.3 (57.6-76.8)
75 (40.8-91.2)
55.3 (32.7-73.0)
Abbreviations: BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; CI, confidence interval; mDOR, median duration of response; mOS, median overall survival; mPFS, median progression free survival; NE, not estimated; OS, overall survival; PFS, progression‑free survival.
a11 of the 12 patients with prior CAR-T had anti-BCMA CAR-T and 22 of the 23 with prior BsAb had anti-BCMA BsAb. Patients may have received >1 CAR-T or BsAb treatment.

Safety  


REALiTAL Study: Summary of TEAEs2 
TEAE, n (%)
Overall Population
(N=93)
Prior anti-BCMAa
(n=49)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any TEAE
92 (98.9)
35 (37.6)
49 (100.0)
23 (46.9)
Infections
44 (47.3)
9 (9.7)
26 (53.1)
4 (8.2)
Hematologic TEAEs
   Anemia
13 (14.0)
8 (8.6)
8 (16.3)
4 (8.2)
   Neutropenia
9 (9.7)
6 (6.5)
9 (18.4)
6 (12.2)
   Thrombocytopenia
7 (7.5)
6 (6.5)
5 (10.2)
5 (10.2)
Nonhematologic TEAEs
   Skin/nail toxicity
63 (67.7)
1 (1.1)
32 (65.3)
0
   Oral toxicity
62 (66.7)
1 (1.1)
36 (73.5)
0
      Dysgeusiaa
53 (57.0)
NA
31 (63.3)
NA
   CRS
52 (55.9)
1 (1.1)
31 (63.3)
1 (2.0)
Neurologic TEAEs of interest
   ICANS
2 (2.2)
0
1 (2.0)
0
Abbreviations: ADC, antibody-drug conjugate; BCMA, B‑cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; NA, not applicable; TEAE, treatment-emergent adverse event; BCMA, B-cell maturation antigen; aPrior anti-BCMA therapy cohort includes prior ADC, CAR-T and BsAb.
bIncludes dysgeusia, ageusia and taste disturbance. Maximum grade is 2.

Popat et al (2025)3 presented the safety results from 93 patients treated with TALVEY in the REALiTAL study at a median follow-up of 14.95 months (range, 0.36-25.26).

Study Design/Methods 

  • Data, including baseline characteristics, prior therapies, and safety information, were collected from medical records.
  • Safety data included incidence and severity of CRS, ICANS, infections, and G protein-coupled receptor, class C, group 5, member D (GPRC5D)-related AEs.
  • AEs were graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CRS and ICANS were graded by American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

Results 

Baseline Characteristics

  • A total of 93 patients included in the study received TALVEY on or before 31 December 2023, with most patients receiving TALVEY through preapproval access programs. See Table: REALiTAL Study: Select Baseline Characteristics.1
  • A total of 88.2% (n=82) of patients started TALVEY Q2W administration, and 11.8% (n=11) started TALVEY QW administration.
    • Of the 25 patients who switched from QW to Q2W or from Q2W to Q4W, 24% of patients (n=6) switched due to AEs.

Efficacy

Safety 

Skin and Nail Toxicity
  • Skin and nail AEs were reported in 67.7% of patients (n=63); all were grade 1/2 except 1 grade 3 AE.
    • A total of 4.3% of patients (n=4) had treatment interruption due to skin and nail AEs; however, none discontinued treatment.
    • Skin and nail toxicity events had resolved or were resolving in 75% of patients at the time of data collection.
    • Details regarding management of skin and nail toxicity are shown in Table: REALiTAL Study: Concomitant Medication for Skin/Nail Toxicity Management.
    • The median duration of skin and nail AEs was 63.5 days (range, 3-458 days).
Oral Toxicity
  • Oral toxicity was reported in 66.7% of patients (n=62); most were grade 1/2, with 1.1% of patients (n=1) experiencing grade 4 stomatitis that did not lead to discontinuation.
    • A total of 2.2% of patients (n=2) had treatment interruption, 1.1% of patients (n=1) required dose reduction, and 1.1% of patients (n=1) discontinued due to oral toxicities.
    • Oral toxicity had resolved or were resolving in 58% of patients at the time of data collection.
    • Details on management of oral toxicities are shown in Table: REALiTAL Study: Concomitant Medication for Oral Toxicity Management.
    • The median duration of oral toxicity was 125 days (range, 6-473 days).
Cytokine Release Syndrome
  • CRS was reported in 55.9% of patients (n=52); most events were grade 1/2, with 1.1% of patients (n=1) experiencing a grade 3 event.
    • A total of 91.2% of CRS events were reported during the step-up dosing phase and 8.8% of CRS events were reported at any subsequent dose.
    • A total of 53.8% of patients (n=50) received ≥1 medication for management of CRS events.
    • A total of 44.1% of patients (n=41) received AE treatment for management of CRS.
    • Tocilizumab for CRS management was administered to 23.7% of patients (n=22), 20.4% of patients (n=19) received prophylaxis for CRS.
    • The median duration of CRS was 2 days (range, 1-368 days).
Neurotoxicity
  • ICANS was reported in 2.2% of patients (n=2); both events were grade 1.
  • One patient experienced a grade 3/4 nervous system disorder; no ataxia or balance disorders were reported.
Infections
  • Infections were reported in 47.3% of patients (n=44); 8.6% of patients (n=8) experienced grade 3/4 infections, and 1.1% of patients (n=1) discontinued due to infection (grade 5; septic shock).
Grade 5 AEs
  • A total of 8.6% of patients (n=8) had grade 5 AEs, none of which were considered related to TALVEY (general disorders and administration site conditions, n=4; infections and infestations, n=2; gastrointestinal disorders, n=1; and metabolism and nutrition disorders, n=1).

REALiTAL Study: Concomitant Medication for Skin/Nail Toxicity Management3 
AE, n (%)
N=93
Patients receiving ≥1 medication
35 (37.6)
AE treatment
32 (34.4)
      Emollients and moisturizers
12 (12.9)
      Corticosteroids
19 (20.4)
      Antihistamines
5 (5.4)
Prophylaxis
3 (3.2)
Abbreviation: AE, Adverse event.

REALiTAL Study: Concomitant Medication for Oral Toxicity Management3 
AE, n (%)
N=93
Patients receiving ≥1 medication
28 (30.1)
AE treatment
25 (26.9)
   Corticosteroids
9 (9.7)
   Anti-infectives
10 (10.8)
Prophylaxis
3 (3.2)
Abbreviation: AE, Adverse event.

REALiTAL Study: Concomitant Medications for Infection Management3 
Concomitant Medication, n (%)
N=93
Patients receiving ≥1 medication
77 (82.8)
AE treatment
39 (41.9)
   Antibiotics
34 (36.6)
   Antiviral
6 (6.5)
   Antifungal
2 (2.2)
Prophylaxis
65 (69.9)
   Antibiotics
48 (51.6)
   Antiviral  
52 (55.9)
   Antifungal
5 (5.4)
Immunoglobulin replacement therapy use
42 (45.2)
   Primary prophylaxis
35 (37.6)
   Secondary prophylaxis
4 (4.3)
   Other
3 (3.2)
Abbreviation: AE, adverse event.

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 27 April 2026.  

 

References

Show
1 Uttervall K, Kortüm KM, Perrot A, et al. First Results From REALiTAL: A European Multi-Country Observational Retrospective Study of Talquetamab in Patients with Relapsed/Refractory Multiple Myeloma Outside of Clinical Trials. Poster presentation presented at: European Hematology Association; June 12-15, 2025; Milan, Italy.  
2 Kortüm KM, Magen H, Mykytiv V, et al. Analysis of Patients With Prior BCMA-Targeted Therapy and Those Achieving CR in REALiTAL: A Multi-Country Observational Study of Talquetamab in RRMM Outside of Clinical Trials. Poster presentation presented at: International Myeloma Society; September 17-20, 2025; Toronto, Canada.  
3 Popat R, Uttervall K, Perrot A, et al. Safety results from REALiTAL: A multi-country observational retrospective study of talquetamab in patients with relapsed/refractory multiple myeloma outside of clinical trials. Poster presented at: 67th American Society of Hematology Meeting & Exposition; December 6-9 2025; Orlando, Florida.