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TALVEY®

(talquetamab-tgvs)

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TALVEY® (talquetamab-tgvs)

Medical Information

TALVEY - Occurrence and Management of Infections and Hypogammaglobulinemia

Last Updated: 03/06/2026

SUMMARY

  • Johnson & Johnson does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
  • This response provides relevant data from company-sponsored clinical trials, and the content is limited to the studies included below.
  • MonumenTAL-1 is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).1
    • Schinke et al (2025)2 published the infection profile and parameters of humoral immune function from the MonumenTAL-1 study at a median follow-up of 18.8 months for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort, 12.7 months for the 0.8 mg/kg SC every other week (Q2W) cohort, and 14.8 months for the prior T-cell redirection therapy (TCR)-exposed cohort.
    • Rasche et al (2025)3 presented the incidence of infections from the MonumenTAL-1 study at an extended median follow-up of 38.2 months for the 0.4 mg/kg SC QW cohort, 31.2 months for the 0.8 mg/kg SC Q2W cohort, and 30.3 months for the prior TCR-exposed (QW and Q2W) cohorts.
    • Chari et al (2025)1 published the incidence of infections from a post hoc analysis of the MonumenTAL-1 study at a median follow-up of 25.6 months for the 0.4 mg/kg SC QW cohort, 19.4 months for the 0.8 mg/kg SC Q2W cohort, and 16.8 months for the prior TCR-exposed cohort.
    • Rasche et al (2024)4 presented the incidence of infections from the MonumenTAL-1 study at a median follow-up of 29.8 months for the 0.4 mg/kg SC QW cohort, 23.4 months for the 0.8 mg/kg SC Q2W cohort, and 20.5 months for prior TCR-exposed cohort.
    • Chari et al (2024)5 published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Infections were reported in the QW, Q2W, and prior TCR-exposed cohort.
  • MonumenTAL-2 is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with multiple myeloma (MM).6-8
    • Cohort D is evaluating the efficacy and safety of TALVEY + DARZALEX FASPRO® (daratumumab and hyaluronidase) + lenalidomide in 34 patients with newly diagnosed multiple myeloma (NDMM).8
      • Nooka et al (2024)8 presented the incidence of infections in the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 13.2 months and the TALVEY 0.8 mg/kg every 4 weeks (Q4W) + DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 5.8 months.
    • Cohort E is evaluating the safety and efficacy of TALVEY + pomalidomide in 35 patients with RRMM.6
      • Quach et al (2025)6 presented the incidence of infections from the TALVEY + pomalidomide cohort of the MonumenTAL-2 study at a longer median follow-up of 20.7 months.
  • RedirecTT-1 is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of TALVEY and TECVAYLI® (teclistamab-cqyv) in patients with RRMM, including those with extramedullary disease (EMD).9-12
    • Usmani et al (2025)10 presented the incidence of infections from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 16.8 months.
    • Kumar et al (2025)11 published the incidence of infections from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 12.6 months.
    • Mateos et al (2025)12 presented the incidence of infections from phase 1b of the RedirecTT-1 study across all dose levels (dose levels 1-5) at a median follow up of 38 months, in patients with RRMM, including those with EMD.
    • Cohen et al (2025)9 published the incidence of infections from the phase 1 dose-escalation segment of the RedirecTT-1 study at a median follow-up of 20.3 months across all dose levels (dose levels 1-5) cohort.
  • TRIMM-2 is an ongoing, phase 1b, multicohort open-label study evaluating the efficacy and safety of DARZALEX FASPRO in combination with TECVAYLI or TALVEY with or without pomalidomide in patients with RRMM.13-15
    • Chari et al (2025)15 published the incidence of infections in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO cohorts at a median follow-up of 18.6 months (range, 1.2-39.1).
    • Bahlis et al (2024)14 presented the incidence of infections in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 15.8 months and TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 17.5 months.
  • TRIMM-3 is a phase 1b, nonrandomized, open-label study evaluating the dosing, safety, and tolerability of a programmed cell death receptor-1 (PD-1) inhibitor in combination with TALVEY or TECVAYLI in patients with RRMM.16,17 
    • Perrot et al (2025)16 presented the incidence of infections of the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months.
  • Other relevant literature has been identified in addition to the data summarized above:
    • Nursing and advance practice practitioner’s considerations for management of infections.18

PRODUCT LABELING

CLINICAL DATA - Monumental-1 Study

MonumenTAL-1 (NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.1 

Study Design/Methods (Phase 2)

Patients were enrolled into 1 of the following 3 cohorts:

  • TCR naive: 0.4 mg/kg SC QW, not previously exposed to TCR such as chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibodies (BsAbs; prior B-cell maturation antigen (BCMA) antibody-drug conjugate [ADC] allowed).19,20
  • TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).19,20
  • TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.19,20
  • Key eligibility criteria1:
    • ≥18 years of age, measurable MM per International Myeloma Working Group (IMWG) criteria.
    • ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.
    • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.

Schinke et al (2025)2,21published the infection profile and parameters of humoral immune function from a post hoc analysis of the MonumenTAL-1 study at a median follow-up of 18.8 months for the 0.4 mg/kg SC QW cohort, 12.7 months for the 0.8 mg/kg SC Q2W cohort, and 14.8 months for the prior TCR-exposed cohort.

Safety

  • Median duration of TALVEY treatment was 6.9 months for the 0.4 mg/kg SC QW cohort, 8.8 months for the 0.8 mg/kg SC Q2W cohort, and 5.7 months for the prior TCR-exposed cohort.
  • Infections were reported concurrently with grade 3/4 neutropenia in 7.7% of patients in the 0.4 mg/kg QW cohort, 2.1% of patients in the 0.8 mg/kg Q2W cohort, and 17.6% of patients in the prior TCR-exposed cohort.
  • Febrile neutropenia (grade 3/4) was reported in 2.8% of patients in the 0.4 mg/kg QW cohort, 0.7% of patients in the 0.8 mg/kg Q2W cohort, and 3.9% of patients in the prior TCR-exposed cohort.
  • Summary of infections across the cohorts is shown in Table: MonumenTAL-1 Study: Summary of Infections and MonumenTAL-1 Study: Incidence of Infections.
  • Any-grade infections were reported in cycles 1-2 (30.2% in the 0.4 mg/kg SC QW cohort; 23.0% in the 0.8 mg/kg SC Q2W cohort; 45.1% in the prior TCR-exposed cohort), with bacterial and fungal infections occurring early. See Table: MonumenTAL-1 Study: Summary of Infections by Treatment Cycle.
  • Any-grade infection risk peaked early in treatment, decreased by month 3, and cumulative incidence stabilized at ~8 months (any grade). New-onset grade 3/4 infections peaked within the first 100 days and leveled off at ~4 months. Grade 3/4 infections occurred more frequently in nonresponders than in responders.
  • Opportunistic infections across cohorts are shown in Table: MonumenTAL-1 Study: Any-Grade and Grade 3/4 Opportunistic Infections Across Cohorts. No cases of Pneumocystis pneumonia were reported.
  • Infection prophylaxis and management across cohorts is presented in Table: MonumenTAL-1 Study: Infection Prophylaxis and Management.
  • Gastrointestinal infections were reported in 3.5% of patients in the 0.4 mg/kg QW cohort, 2.1% in the 0.8 mg/kg Q2W cohort, and 3.9% in the prior TCR-exposed cohort.
  • Viral infections (adenovirus, herpes zoster, and oral herpes) were reported in 2.1% of patients in the 0.4 mg/kg QW cohort, 2.8% in the 0.8 mg/kg Q2W cohort, and 7.8% in the prior TCR-exposed cohort.
  • Fungal infections were reported in 11.2% of patients (n=16) in the 0.4 mg/kg QW cohort, 7.1% of patients (n=11) in the 0.8 mg/kg Q2W cohort, and 7.7% of patients (n=6) in the prior TCR-exposed cohort.
  • A total of 5 patients (1.5%) died from infections across cohorts.
    • Death due to infections was reported in 2.1% of patients in the 0.4 mg/kg QW cohort and 1.4% of patients in the 0.8 mg/kg Q2W cohort.
    • COVID-19 pneumonia was the reported cause of death in 1 patient each in the 0.4 mg/kg QW and 0.8 mg/kg Q2W cohorts, respectively.

Humoral Immunity

  • At baseline, median CD19⁺ B-cell counts were 5.3 ×10⁶/L in the 0.4 mg/kg SC QW cohort, 10.1 ×10⁶/L in the 0.8 mg/kg SC Q2W cohort, and 22.8 ×10⁶/L in the prior TCR-exposed cohort. CD19⁺ B-cell levels remained consistent through early cycles, with an upward shift noted by cycle 7.
  • Hypogammaglobulinemia (immunoglobulin G [IgG] values <400 mg/dL) reported across cohorts is presented in Table: MonumenTAL-1 Study: Summary of Hypogammaglobulinemia.
  • From baseline to cycle 3 (3 months), polyclonal IgG levels declined in the combined cohorts. Polyclonal IgG levels in the 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W cohorts remained relatively stable and consistently below the lower limit of normal (7.0 g/L) during this period.
  • In the overall population, polyclonal IgG levels began to rise after cycle 3 (month 3) and continued to increase, surpassing baseline levels through cycle 17 (month 17).
  • Polyclonal IgA and IgM levels remained stable across all cohorts from baseline through cycle 7, with no decline observed and values stayed below the lower limits of normal (0.7 g/L for IgA and 0.4 g/L for IgM).

MonumenTAL-1 Study: Summary of Infections2
Infectiona
0.4 mg/kg QW
(n=143)
0.8 mg/kg Q2W
(n=145)
Prior TCR
(n=51)
Median duration, days (range)
11.5 (2-148)
12.0 (1-201)
12.0 (2-51)
Any grade, n (%)
84 (58.7)
96 (66.2)
37 (72.5)
Grade 3/4, n (%)
31 (21.7)
23 (15.9)
14 (27.5)
Resolved infections, %
94
93.8
100
Led to deathb, n (%)
3 (2.1)
2 (1.4)
0
Led to discontinuationc, n (%)
2 (1.4)
0
1 (2.0)
Led to dose interruption, n (%)
45 (31.5)
49 (33.8)
19 (37.3)
Serious infections (overnight hospitalizations), %
15.4
9.7
7.8
   Median hospital stays, days (range)
8.0 (2-21)
5.5 (3-24)
10.0 (4-25)
Multiple medical encounters, n (%)
14 (9.8)
8 (5.5%)
2 (3.9)
Abbreviations: COVID-19, coronavirus disease 2019; Q2W, every 2 weeks; QW, once weekly; TCR, T cell receptor.
Clinical data cutoff date of January 17, 2023.
aPercentages are calculated with the number of patients in the all-treated analysis set in each cohort as the denominator.
bIncludes COVID-19 pneumonia (n=1, 0.4 mg/kg QW; n=1, 0.8 mg/kg Q2W; neither patient vaccinated), septic shock (n=1, 0.4 mg/kg QW), Candida sepsis (n=1, 0.4 mg/kg QW), and infection of unknown etiology (n=1, 0.8 mg/kg Q2W).
cIncludes grade 3 pneumonia and grade 4 fungal sepsis (Candida) in the 0.4 mg/kg QW cohort; 1 case of grade 3 pustular rash was reported in a patient from the prior TCR-exposed cohort.

MonumenTAL-1: Incidence of Infections2,21
0.4 mg/kg QW
(n=143)
0.8 mg/kg Q2W
(n=145)
Prior TCR
(n=51)
Most common infectionsa, n (%)
   Upper respiratory tract infection
18 (12.6)
13 (9.0)
9 (17.6)
   COVID-19
15 (10.5)
34 (23.4)
6 (11.8)
   Nasopharyngitis
14 (9.8)
10 (6.9)
2 (3.9)
   Urinary tract infection
14 (9.8)
6 (4.1)
6 (11.8)
   Bronchitis
12 (8.4)
6 (4.1)
0
   Pneumonia
11 (7.7)
9 (6.2)
3 (5.9)
Most common grade 3/4 infectionsb, n (%)
   Pneumonia
5 (3.5)
3 (2.1)
3 (5.9)
   Urinary tract infection
3 (2.1)
0
2 (3.9)
   COVID-19
2 (1.4)
3 (2.1)
1 (2.0)
   Sepsis
2 (1.4)
1 (0.7)
0
   COVID-19 pneumonia
1 (0.7)
2 (1.4)
1 (2.0)
   Cellulitis
0
2 (1.4)
0
   Infection (unknown etiology)
0
2 (1.4)
0
Viral infections, %
2.1
2.8
7.8
Fungal infections, n (%)
16 (11.2)
11 (7.1)
6 (7.7)
Abbreviations: COVID-19, coronavirus disease 2019; Q2W, every 2 weeks; QW, weekly; TCR, T cell receptor.
Clinical data cutoff date of January 17, 2023.
aIncludes events reported in ≥10 patients in any treatment cohort.
bIncludes events reported in ≥2 patients in any treatment cohort.

MonumenTAL-1 Study: Summary of Infections by Treatment Cycle21

Total
SUD
Cycles
1-2
Cycles
3-4
Cycles
5-6
Cycles
7-8
Cycles
9-10
Cycles
11-12
Cycles
13-14
0.4 mg/kg QW (n=143)
Treated, n
143
143
139
122
100
81
67
54
49
Infections, n (%)
84 (58.7)
9 (6.3)
42 (30.2)
21 (17.2)
24 (24.0)
13 (16.0)
11 (16.4)
14 (25.9)
8
(16.3)
0.8 mg/kg Q2W (n=145)
Treated, n
145
145
139
119
99
84
77
62
38
Infections, n (%)
96 (66.2)
26 (17.9)
32 (23.0)
20 (16.8)
14 (14.1)
14 (16.7)
10 (13.0)
8
(12.9)
10 (26.3)
Prior TCR-Exposed Cohort (n=51)
Treated, n
51
51
51
41
31
25
22
19
15
Infections, n (%)
37 (72.5)
4
(7.8)
23 (45.1)
11 (26.8)
7
(22.6)
6
(24.0)
2
(9.1)
4
(21.1)
2
(13.3)
Abbreviations: Q2W, every other week; QW, weekly; SUD, step-up dose; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.

MonumenTAL-1 Study: Any-Grade and Grade 3/4 Opportunistic Infections Across Cohorts21

Opportunistic Infectiona, n (%)
0.4 mg/kg QW
(n=143)
0.8 mg/kg Q2W
(n=145)
Prior TCR
(n=51)
Any grade
5 (3.5)
8 (5.5)
3 (5.9)
   Esophageal candidiasis
2 (1.4)
3 (2.1)
1 (2.0)
   Adenovirus infection
1 (0.7)
1 (0.7)
1 (2.0)
   Fungal sepsis
1 (0.7)
0
0
   Retinitis viral
1 (0.7)
0
0
   Cytomegalovirus infection
0
1 (0.7)
0
   Cytomegalovirus viremia
0
1 (0.7)
0
   Herpes ophthalmic
0
1 (0.7)
0
   Human herpesvirus 6 infection
0
1 (0.7)
0
   Disseminated varicella-zoster virus infection
0
0
1 (2.0)
Grade 3/4
2 (1.4)
0
1 (2.0)
   Disseminated varicella-zoster virus infection
0
0
1 (2.0)
   Esophageal candidiasis
1 (0.7)
0
0
   Candida sepsis
1 (0.7)
0
0
Abbreviations: QW, once weekly; Q2W, every 2 weeks; TCR, T cell receptor.
Clinical data cutoff date of January 17, 2023.
aPercentages are calculated with the number of patients in the all-treated analysis set in each cohort as the denominator.

MonumenTAL-1 Study: Infection Prophylaxis and Management2
Parameter, %
0.4 mg/kg QW
(n=143)
0.8 mg/kg Q2W
(n=145)
Prior TCR
(n=51)
IVIG (any use)
14.7
13.1
15.7
   Prior to TALVEY
4.9
6.2
9.8
   Initiated during TALVEY
9.8
6.9
5.9
Serious infection while on TALVEY treatment
18.9
15.9
19.6
   Received IVIG after serious infection
40.7
13.0
10
Growth factors use
   Prior to TALVEY (7-day washout period)
3.5
1.4
3.9
   During TALVEY treatment
23.1
15.2
37.3
Antiviral prophylaxisa
90.9
82.8
92.2
   Acyclovir use
52.4
71.7
74.5
   Valacyclovir
37.1
11.0
17.6
Pneumocystis jirovecii pneumonia prophylaxis
   At baselineb
22.4
24.1
31.4
   During treatmentc (includes baseline
   continuation)
34.3
31.5
43.1
COVID-19 supportive measures
   Anti-infectives
4.9
15.9
3.9
   Glucocorticoids
-
1.4
-
   Tocilizumab
-
0.7
-
COVID-19 prophylaxis
   COVID-19 vaccination
59.4
62.8
41.2
   mAbs for prophylaxis
0
0
0
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; IVIG, intravenous immunoglobulin; mAbs, monoclonal antibodies; Q2W, every other week; QW, weekly; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.
aHerpes prevention was the most common reason for antiviral prophylaxis (88.8% in the 0.4 mg/kg QW cohort, 82.8% in the 0.8 mg/kg Q2W cohort, and 90.2% in the prior TCR-exposed cohort.
bThe most common regimen for Pneumocystis jirovecii pneumonia prophylaxis was the combination of sulfamethoxazole and trimethoprim.
cIncluding those who continued prophylaxis from baseline.

MonumenTAL-1 Study: Summary of Hypogammaglobulinemia2

Hypogammaglobulinemia, %
0.4 mg/kg QW
(n=143)
0.8 mg/kg Q2W
(n=145)
Prior TCR
(n=51)
Baseline
36.4
31.7
49.0
Post-treatment initiation
57.3
60.7
66.7
Treatment emergent
23.1
28.3
19.6
Abbreviations: Q2W, every other week; QW, weekly; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.

Rasche et al (2025)3 presented the incidence of infections from the MonumenTAL-1 study at an extended median follow-up of 38.2 months for the 0.4 mg/kg SC QW cohort, 31.2 months for the 0.8 mg/kg SC Q2W cohort, and 30.3 months for the prior TCR-exposed (QW and Q2W) cohorts.

Safety Results


MonumenTAL-1 Study: Summary of Infections3
AE, n (%)
0.4 mg/kg SC QW (n=143)
0.8 mg/kg SC Q2W (n=154)
Prior TCR
QW and Q2W
(n=78)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Infectionsa
87 (60.8)
33 (23.1)
109 (70.8)
33 (21.4)
61 (78.2)
20 (25.6)
Abbreviations: AE, adverse event; Q2W, every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of September 2024.
aInfections were reported as a system organ class.

MonumenTAL-1 Study: New-Onset Grade ≥3 Infections3

A graph with red lines AI-generated content may be incorrect.

Note: Shaded areas represent the 95% confidence intervals. Data were plotted if ≥25 patients remained on treatment.

Chari et al (2025)1,22 published the incidence of infections from the post hoc analysis of phases 1 and 2 of the MonumenTAL-1 study at a median follow-up of 25.6 months (interquartile range [IQR], 8.5-25.9) for the 0.4 mg/kg SC QW cohort, 19.4 months (IQR, 9.2-20.7) for the 0.8 mg/kg SC Q2W cohort, and 16.8 months (IQR, 7.6-18.7) for the prior TCR-exposed cohort.

Safety Results

  • Details on infections are presented in the Table: MonumenTAL-1 Study: Infections.
  • Grade 1/2 upper respiratory tract infections were reported in 17% of patients (n=13) in the prior TCR-exposed cohort.
  • The polyclonal immunoglobulin G (IgG) level/titer transiently dropped for the first 2 to 3 months of therapy but gradually increased above the baseline value as patients continued TALVEY therapy. IgG patterns were similar between responders and nonresponders.
  • In the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR-exposed cohorts, intravenous immunoglobulin (IVIG; before TALVEY or for post-treatment hypogammaglobulinemia) was administered to 8% (n=12), 9% (n=14), and 19% (n=15) of patients, respectively.
  • A total of 5 patients died due to infections (0.4 mg/kg SC QW cohort, n=3; 0.8 mg/kg SC Q2W cohort, n=2). Coronavirus disease 2019 (COVID-19) pneumonia led to death in 2 patients (0.4 mg/kg SC QW, n=1; 0.8 mg/kg SC Q2W cohort, n=1).
  • Treatment discontinuation due to infections was reported in 1% of patients (n=2) in the 0.4 mg/kg SC QW cohort and 1% of patient (n=1) in the prior-TCR cohort.
  • Dose reduction due to cytomegalovirus (CMV) infection was reported in 1% of patients (n=2) in the 0.8 mg/kg SC QW cohort.

MonumenTAL-1 Study: Infections1,22
Event, n (%)
0.4 mg/kg SC QWa (N=143)
0.8 mg/kg SC Q2Wa
(N=154)
Prior TCRa (N=78)
Any infection
85 (59)
105 (68)
59 (76)
Grade 3-4 infections
29 (20)
28 (18)
20 (26)
Opportunistic infectionsb
5 (3)
9 (6)
3 (4)
COVID-19
16 (11)
39 (25)
11 (14)
Abbreviations: COVID-19, coronavirus disease 2019; IVIG, intravenous immunoglobulin; Q2W, every other week; QW, weekly; SC, subcutaneous; SUD, step-up dose; TCR, T-cell redirection therapy.
Clinical data cutoff date of October 11, 2023.
aReceived 2-3 SUDs.
bIncludes esophageal candidiasis, adenovirus infection, herpesvirus 6 infection, ophthalmic herpes, varicella zoster virus infection, cytomegalovirus infection, fungal sepsis, and viral retinitis.

Rasche et al (2024)4 presented the incidence of infections from the MonumenTAL-1 study at a median follow-up of 29.8 months for the 0.4 mg/kg SC QW cohort, 23.4 months for the 0.8 mg/kg SC Q2W cohort, and 20.5 months for the prior TCR-exposed cohort.

Safety Results

  • At a longer follow-up, no increase in grade 3/4 infections was observed. Incidence of infections in Q2W cohort is detailed in Figure: New-Onset Grade ≥3 Infections Over Time in the Q2W Cohort.
  • IVIG was required in 16%, 14%, and 24% of patients in the QW, Q2W, and prior TCR cohorts, respectively.

New-Onset Grade ≥3 Infections Over Time in the Q2W Cohort4

Abbreviations: CI, confidence interval; pts, patients; mo, months.

Chari et al (2024)5 published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Results specific to infections are summarized below.

Safety Results

  • A summary of infections associated with TALVEY in MonumenTAL-1 is presented in Table: MonumenTAL-1 Study: Infections Associated With TALVEY.
  • The most frequently reported any-grade infections were Coronavirus Disease 2019 (COVID-19), upper respiratory tract infections, nasopharyngitis, urinary tract infections, bronchitis, and pneumonia.
    • The most common grade 3/4 infections (requiring invasive or urgent intervention per Common Terminology Criteria for Adverse Events [CTCAE] classification) were pneumonia, urinary tract infections, COVID-19, sepsis, and cellulitis.
    • Most high-grade infections occurred during the first 100 days of treatment.
  • No cases of Pneumocystis pneumonia were reported.
  • Treatment discontinuation due to infections was reported in 2 patients in the 0.4 mg/kg SC QW cohort and 1 patient in the prior TCR-exposed cohort.
  • A total of 5 (1.5%) patients died from infections (COVID-19 pneumonia, n=2; 1 patient each due to septic shock, fungal sepsis, and infection).

MonumenTAL-1 Study: Infections Associated With TALVEY5
AE
0.4 mg/kg SC QW
(n=143)
0.8 mg/kg SC Q2W (n=145)
Prior TCR
(n=51)
Infectionsa
   Any grade, n (%)
84 (58.7)
96 (66.2)
37 (72.5)
   Grade 3/4, %
19.6
14.5
27.5
   Median time to onsetb, days
148.0
108.0
96.0
   Median durationc, days
11.5
12.0
12.0
   Resolvedd, n (%)
207 (90.4)
166 (87.4)
82 (89.1)
   Opportunistic infections, n (%)
5 (3.5)e
8 (5.5)f
3 (5.9)g
   Infections (concurrently with
   grade 3/4 neutropenia), %
13.1
3.1
24.3
Hypogammaglobulinemia by IgG, %
64.3
67.6
72.5
   IVIG administration, %
14.7
13.1
15.7
Abbreviations: AE, adverse event; Ig, immunoglobulin; IVIG, intravenous immunoglobulin; Q2W, every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.
aNo additional decrease in IgG levels was reported during TALVEY treatment.
bMedian time to onset calculated relative to the most recent dose received.
cMedian duration is based on events with both start and end time/dates available.
dPatients could have more than 1 event. Percentages are calculated with the number of events as the denominator
eEsophageal candidiasis, n=2; 1 patient each had adenovirus infection, fungal sepsis, and viral retinitis.
fEsophageal candidiasis, n=3; 1 patient each had adenovirus infection, herpes ophthalmic, cytomegalovirus infection, cytomegalovirus viremia, and human herpesvirus 6 infection.
gOne patient each had esophageal candidiasis, adenovirus infection, and disseminated varicella zoster virus infection.

Supportive Measures/Management

  • In MonumenTAL-1, medications given most commonly for infections were antibiotics, with some use of antifungals, anticholinergics, and glucocorticoids. See Table: MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Infections.
  • Infection prophylaxis was used in patients receiving TALVEY.
    • Acyclovir was the most common prophylactic medication used in the MonumenTAL-1 study for infections and given to 52.4%, 71.7%, and 74.5% of patients in the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR cohorts, respectively.
    • Valaciclovir was the second most common form of prophylaxis and given to 37.1%, 11.0%, and 17.6% of patients in the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR cohorts, respectively.
    • Antibacterial prophylaxis may be beneficial in patients with an elevated risk of developing infections. Antifungal prophylaxis should be considered if patients have undergone treatment with high-dose or prolonged use of corticosteroids.
    • Filgrastim should be considered to manage neutropenia.
  • New infections often occurred in early treatment cycles, suggesting the need for more aggressive infection prevention until cytopenia recovers.
  • Vaccinations are still expected to be effective as patients treated with TALVEY showed preservation of humoral immune function and no decreases in B cells or polyclonal IgG levels.
    • Vaccines should be given before starting treatment, though this may not always be possible, such as for annual influenza and COVID-19 vaccinations.
  • Testing for cytomegalovirus and Epstein-Barr virus is recommended for patients with unexplained fever or unexplained symptoms, such as weight loss, extreme fatigue, and diarrhea.
  • Monitoring for hypogammaglobulinemia and administration of IVIG are crucial for preventing and managing infections during novel antibody treatment, including TALVEY.
    • IVIG use should be considered for patients with hypogammaglobulinemia and recurrent infections. Based on investigator experience, it can also be administered on the same day as TALVEY after the cytokine release syndrome (CRS) risk period has elapsed.
  • During SUD and early treatment cycles, fever should be evaluated to distinguish between CRS and infection, as symptoms may overlap.
  • Temporarily interrupting dosing to allow infections to resolve before resuming TALVEY is also a key part of infection management.

MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Infections5
Treatment
0.4 mg/kg SC QW (n=143)
0.8 mg/kg SC Q2W (n=145)
Prior TCR
(n=51)
Concomitant medications (≥ 5 patients in any cohort)a
76 (53.1)
86 (59.3)
35 (68.6)
   Amoxicillin
34 (23.8)
22 (15.2)
6 (11.8)
   Clavulanate
26 (18.2)
14 (9.7)
5 (9.8)
   Azithromycin
9 (6.3)
14 (9.7)
8 (15.7)
   Nirmatrelvir/ritonavir
1 (0.7)
14 (9.7)
1 (2.0)
   Fluconazole
6 (4.2)
13 (9.0)
2 (3.9)
   Levofloxacin
12 (8.4)
11 (7.6)
5 (9.8)
   Paracetamol
11 (7.7)
10 (6.9)
6 (11.8)
   Vancomycin
8 (5.6)
9 (6.2)
1 (2.0)
   Ciprofloxacin
9 (6.3)
1 (0.7)
7 (13.7)
   Salbutamol
4 (2.8)
8 (5.5)
2 (3.9)
   Piperacillin/tazobactam
7 (4.9)
7 (4.8)
2 (3.9)
   Nystatin
7 (4.9)
4 (2.8)
1 (2.0)
   Meropenem
4 (2.8)
6 (4.1)
2 (3.9)
   Dexamethasone
3 (2.1)
6 (4.1)
1 (2.0)
   Ipratropium bromide
5 (3.5)
5 (3.4)
1 (2.0)
   Moxifloxacin
2 (1.4)
5 (3.4)
3 (5.9)
   Cefepime
1 (0.7)
5 (3.4)
3 (5.9)
   Metronidazole
3 (2.1)
5 (3.4)
0
Abbreviations: Q2W, every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.
aPatients could receive ≥1 concomitant medication.

CLINICAL DATA - Monumental-2 study

MonumenTAL-2 (NCT05050097) is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with MM.6-8

Study Design/Methods

  • Key eligibility criteria:
    • Cohort D: measurable MM, NDMM, ECOG PS of 0-1, and transplant ineligible or not intended for transplant.8
    • Cohort E: measurable MM, ≥2 prior LOTs, including a PI and an immunomodulatory drug, ECOG PS of 0-1, prior pomalidomide and prior TCR (CAR-T and BsAb) permitted, and no prior GPRC5D-targeted therapy.6

Cohort D

Nooka et al (2024)8 presented the incidence of infections in the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 13.2 months (range, 10.0–14.6) and the TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 5.8 months (range, 1.7 [denotes patients who died]-12.0).

Safety Results

  • Details on infections are summarized in Table: MonumenTAL-2 Study (Cohort D): Summary of Infections.
  • Hypogammaglobulinemia was reported in 63% and 54% of patients in the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide and TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohorts, respectively; 50% and 19% of these patients received ≥1 IVIG during treatment, respectively.
  • The most commonly reported infections were COVID-19, rhinovirus, and other upper respiratory tract infections.

MonumenTAL-2 Study (Cohort D): Summary of Infections8
TEAE, n (%)
TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO +
Lenalidomide
(n=8)
TALVEY 0.8 mg/kg Q4W +
DARZALEX FASPRO +
Lenalidomide
(n=26)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Infectionsa
8 (100.0)
3 (37.5)
13 (50.0)
1 (3.8)
Abbreviations: COVID-19, coronavirus disease 2019; Q2W, every other week; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of September 23, 2024.
aGrade 3/4 infections included gastroenteritis, influenza, pneumonia, and COVID-19 pneumonia in the Q2W cohort and esophageal candidiasis in the Q4W cohort.

Cohort E

Quach et al (2025)6 presented the incidence of infections from cohort E of the MonumenTAL-2 study at a median follow-up of 20.7 months (range, 1.2-38.7).

Safety Results

  • At a data cutoff date of March 2025, any-grade infections/infestations were reported in 85.7% of patients and grade 3/4 infections were reported in 31.4% of patients.

CLINICAL DATA - redirectt-1 STUDY - TALVEY + tecvayli COHORT

RedirecTT-1 (NCT04586426) is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of TALVEY and TECVAYLI in patients with RRMM, including those with EMD.9-12

Study Design/Methods

  • Key eligibility criteria: relapsed or refractory or intolerant to established therapies including the last LOT, prior exposure to a PI, an immunomodulatory drug, and an anti-CD38 mAb.10

Usmani et al (2025)10 presented the incidence of infections from the RedirecTT-1 phase 2 study in patients with RRMM and EMD at a median follow-up of 16.8 months.

Safety Results

  • Details on infections are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Infections (≥10% Overall).
  • Grade 3/4 infections were reported in 33.3% of patients (n=30); mostly limited to first six months and then declined.
  • The median duration of infection was 13.0 days.
  • A total of 6.7% of patients had opportunistic infections (patients could experience ≥1 opportunistic infection; CMV infection reactivation, n=4; CMV infection, n=2; cytomegalovirus oesophagitis, n=1; esophageal candidiasis, n=1; polyomavirus viraemia, n=1), of which 3.3% were grade 3/4 infections.
  • At baseline, 22.2% of patients had Ig values <400 mg/dL.
  • A total of 71.1% of patients had post-treatment hypogammaglobulinemia with post-treatment immunoglobulin G (IgG) <400 mg/dL or hypogammaglobulinemia treatment-emergent AE.
    • Of these patients, 75.6% of patients received ≥1 dose of Ig replacement.
  • Discontinuation of both TALVEY and TECVAYLI due to infections was reported in 2 patients and deemed related to TALVEY or TECVAYLI by the investigator:
    • Not resolved: pseudomonal pneumonia and pseudomonal sepsis (n=1).
    • Resolved: CMV infection (n=1).
  • Incidence of infections after switching to Q4W dosing is presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Infections Following Adjustment to Q4W dosing.
  • Grade 5 infections were reported in 6.7% of patients (n=6). See Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Grade 5 Infection AEs for additional details.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Infections (≥10% Overall)10
AEa, n (%)
TALVEY + TECVAYLI
(N=90)
Any Grade
Maximum Grade 3/4
Infections
72 (80.0)
30 (33.3)
   Upper respiratory tract infection
27 (30.0)
4 (4.4)
   COVID-19
20 (22.2)
5 (5.6)
   Pneumonia
19 (21.1)
8 (8.9)
   Urinary tract infection
12 (13.3)
4 (4.4)
   Viral upper respiratory tract infection
9 (10.0)
2 (2.2)
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; CTCAE, Common Terminology Criteria for Adverse Events.
Clinical data cutoff date of July 18, 2025. Median follow-up 16.8 months.
aAEs were graded by CTCAE v5.0; patients could experience ≥1 infection.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Infections Following Adjustment to Q4W Dosing10
Outcomea, n (%)
Initial Q2W Dosing
(N=90)
After Adjustment to Q4W Dosing
(n=56)b
Any-grade infections
65 (72.2)
34 (60.7)
   Grade ≥3 infections
29 (32.2)
14 (25.0)
Abbreviations: AE, adverse event; Q2W, every other week; Q4W, once every 4 weeks.
Clinical data cutoff date of July 18, 2025. Median follow-up 16.8 months.
aNew onset AEs only; AEs are only counted once either before or after switch.
bA total of 34 patients did not switch to Q4W dosing.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Grade 5 Infection AEs10
AE
Study Day of Death
IgG Level Prior to Death (mg/dL)
Received
≥1 Dose Ig Replacement
Response
at Time
of Death
Klebsiella sepsis
38
70
No
PR
COVID-19 pneumoniaa,b
63
2455
No
SD
Klebsiella pneumoniaa
86
892
Yes
PR
Pseudomonal sepsisa
190
246
No
PR
Escherichia sepsisa
240
449
Yes
VGPR
Pneumoniaa
254
346
Yes
PD
Abbreviations: AE, adverse event; PD, progressive disease; PR, partial response; SD, stable disease; VGPR, very good partial response.
Clinical data cutoff date of July 18, 2025. Median follow-up 16.8 months.
aDeemed related to TALVEY or TECVAYLI by investigators.
bPatient declined COVID-19 vaccine prior to study entry.

Kumar et al (2025)11,23 presented the incidence of infections from phase 2 of the RedirecTT-1 study at a median follow-up of 12.6 months (range, 0.5-19.5) in patients with RRMM and EMD.

Safety Results

  • Any-grade infections were reported in 79% of patients (n/N=71/90) and grade 3/4 infections were reported in 31% of patients (n=28). Patients could have multiple infections.
  • Any-grade infections (>5%) that emerged during treatment up to 30 days after the last treatment dose:
    • Any-grade upper respiratory tract infection was reported in 24% of patients (n=22) and grade 3/4 in 3% (n=3).
    • Any-grade COVID-19 infection was reported in 22% of patients (n=20), grade 3/4 in 6% (n=5), and grade 5 in 1% (n=1).
    • Any-grade pneumonia was reported in 18% of patients (n=16), grade 3/4 in 4% (n=4), and grade 5 in 1% (n=1).
    • Any-grade urinary tract infection was reported in 13% of patients (n=12) and grade 3/4 in 3% (n=3).
    • Any-grade viral upper respiratory tract infection was reported in 10% of patients (n=9) and 3/4 in 2% (n=2).
    • Any-grade oral candidiasis was reported in 7% of patients (n=6).
    • Any-grade sinusitis was reported in 6% of patients (n=5) and grade 3/4 in 2% (n=2).
  • Across 242 infections, the median interval from the last treatment dose to onset was 12 days (range, 1-87), and 86% (n=209) had resolved or the patient had recovered by the data cutoff date.
  • For 218 infections with both start and end dates available, the median duration was 13 days (range, 2-140).
  • Grade 3/4 infections occurred within the first 6 months of treatment; incidence declined thereafter.
  • A total of 97% of patients (n=87) received anti-herpes prophylaxis, 6% of patients (n=5) received antiviral hepatitis B prophylaxis and 82% of patients (n=74) received COVID-19 vaccination.
  • A total of 87% patients (n=78) received any IVIG during the study.
  • At baseline, 22% of patients (n=20) had IgG <400 mg/dL; post-treatment, 70% of patients (n=63) had hypogammaglobulinemia or IgG <400 mg/dL.
  • Of the 63 patients, 86% of patients (n=54) received ≥1 dose of IVIG; median time from first study dose to first immune globulin dose was 50 days.
  • Opportunistic infections were reported in 7% of patients (n=6; reactivation of cytomegalovirus infection, n=4; CMV infection, n=2; CMV esophagitis, n=1; esophageal candidiasis, n=1; polyomavirus viremia, n=1) and were generally confined to the first 6 months of treatment; none were fatal.
  • Treatment discontinuation of TALVEY or TECVAYLI due to grade 4 pseudomonal pneumonia and grade 4 pseudomonal sepsis was reported in 1 patient.

Grade 5 Infection

  • Out of the 5 patients who died due to infections, 3 did not receive IVIG and 3 had immunoglobulin G levels <400 mg/dL at time of death.
  • Covid-19 pneumonia led to death in 1.1% of patients (n=1) on day 63; related to TALVEY or TECVAYLI by investigators, patient was unvaccinated, did not receive IVIG, and had stable or progressive disease.
  • Klebsiella pneumonia led to death in 1.1% of patients (n=1) on day 86; related to TALVEY or TECVAYLI by investigators.
  • Klebsiella sepsis led to death in 1.1% of patients (n=1) on day 38; patient did not receive IVIG and had IgG <400 mg/dL at the time of death.
  • Pneumonia of unspecified origin led to death in 1.1% of patients (n=1) on day 254; related to TALVEY or TECVAYLI by investigators, patient had IgG <400 mg/dL and stable or progressive disease at the time of death.
  • Pseudomonal sepsis led to death in 1.1% of patients (n=1) on day 190; related to TALVEY or TECVAYLI by investigators, patient did not receive IVIG, had IgG <400 mg/dL, and stable or progressive disease at the time of death.

Mateos et al (2025)12 presented the incidence of infections from phase 1b of the RedirecTT-1 study across all dose levels (dose levels 1-5) at a median follow up of 38 months, in RRMM patients, including those with EMD.

Safety Results

  • Details on infections are presented in Table: RedirecTT-1 Study: Infections (≥15% Overall) and RedirecTT-1 Study: Timing of New Onset Infections Across All Dose Levels.
  • Median duration of infection was 13.5 days; 87.2% of infection events resolved.
  • A total of 17% of patients (n=16) had opportunistic infections (CMV infection reactivation, n=5; progressive multifocal leukoencephalopathy (PML), n=4; adenovirus infection, n=2; esophageal candidiasis, n=2; other infections, n=10).
    • Other infections included CMV colitis (n=1), disseminated varicella–zoster virus infection (n=1), hepatitis B reactivation (n=1), human herpesvirus‑6 encephalitis (n=1), listeriosis (n=1), adenoviral pneumonia (n=1), CMV pneumonia (n=1), fungal pneumonia (n=1), pulmonary nocardiosis (n=1), and Kaposi’s sarcoma (n=1).
  • A total of 89.4% of patients (n=84) had hypogammaglobulinemia (post-treatment hypogammaglobulinemia AEs or IgG of <400 mg/dL).
  • A total of 69.1% of patients (n=65) received ≥1 dose of immunoglobulin replacement.
  • Treatment discontinuation of TALVEY + TECVAYLI due to progressive multifocal leukoencephalopathy was reported in 1 patient (PML event onset was 301 days after the most recent dose of TALVEY + TECVAYLI).

Grade 5 Infection

  • Details of grade 5 infections is presented in Table: RedirecTT-1 Study: Grade 5 Infections.
  • At RP2R, five grade 5 infections were reported.
    • Confounding factors for grade 5 infections at RP2R included absence of COVID-19 vaccination in 2 of 3 COVID-19 pneumonia cases and severe hypogammaglobulinemia in 3 of 5 cases.
  • Across all dose levels, 15 grade 5 infection-related AEs were reported.

RedirecTT-1 Study: Infections (≥15% Overall)12 
AE, n (%)
All Doses
(N=94)
RP2R
(n=44)
Any Grade
Grade 3/4
Any Grade
Grade ¾
Infections
88 (93.6)
50 (53.2)
41 (93.2)
19 (43.2)
   COVID-19a
38 (40.4)
15 (16.0)
20 (45.5)
7 (15.9)
   URTI
29 (30.9)
4 (4.3)
15 (34.1)
1 (2.3)
   Pneumonia
25 (26.6)
10 (10.6)
11 (25.0)
4 (9.1)
   Nasopharyngitis
16 (17.0)
0
4 (9.1)
0
   Rhinovirus infection
16 (17.0)
3 (3.2)
6 (13.6)
0
   UTI
12 (12.8)
2 (2.1)
8 (18.2)
1 (2.3)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; COVID-19, coronavirus disease 2019; RP2R, recommended phase 2 regimen; URTI, upper respiratory tract infection; UTI, urinary tract infection.
Clinical data cutoff date of July 2025. Median follow-up of 38.0 months for all doses levels and 34.5 months for the RP2R cohort.
aPatient recruitment began in December 2020, running concurrently with the COVID-19 pandemic and overlapping with peak infection and death rates worldwide, based on World Health Organization data.

RedirecTT-1 Study: Timing of New Onset Infections Across All Dose Levels12 
Parameter
New Onset Infection Within
Total
(N=94)
≤6
Months
(N=94)
>6 to ≤12 Months
(N=61)
>12 to ≤18 Months
(N=55)
>18 to ≤24 Months
(N=42)
> 24 to ≤36 Months
(N=38)
>36
Months
(N=23)
Any grade infectiona, n (%)
87 (92.6)
73 (77.7)
42 (68.9)
37 (67.3)
28 (66.7)
22 (57.9)
15 (65.2)
Grade ≥3
infectiona, n (%)
64 (68.1)
44 (46.8)
21 (34.4)
17 (30.9)
9 (21.4)
7 (18.4)
4 (17.4)
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; RP2R, recommended phase 2 regimen; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of July 2025. Median follow-up of 38.0 months for all doses levels and 34.5 months for the RP2R cohort.
aIncludes patients either treated or who experienced any TEAEs of infection within the specific window. Data shown are system organ class treatment-emergent infections and infestations and graded by CTCAE v5.0.

RedirecTT-1 Study: Grade 5 Infections12 
AE
Study Day
of Death
Calendar Year of Death
Received ≥1 Dose of Ig Replacement
IgG Level Prior to Death (mg/dL)
Response at Time
of Death
At RP2R
   COVID-19 pneumoniaa
96
2022
No
109
PR
   COVID-19 pneumoniab,c
144
2022
No
159
sCR
   COVID-19 pneumoniaa
51
2022
No
596
NA
   Fungal pneumonia
57
2022
No
217
NA
   PMLc,d
661
2023
Yes
514
sCR
At non-RP2R dose levels
   Adenovirus infectiond
395
2022
Yes
16
CR
   Aspiration pneumonia
70
2022
Yes
1325
SD → NE
   CMV pneumoniaec
117
2021
No
69
VGPR
   COVID-19a
264
2021
Yes
911
PR
   PMLc,d
217
2021
Yes
823
PD → NE
   PMLc,d
296
2022
No
16
VGPR
   Respiratory tract infectiond
217
2021
No
39
CR
   Sepsisd
110
2021
No
167
PR
   Septic shockd
1274
2024
Yes
399
NE
   Septic shock
91
2021
No
153
MR
Abbreviations: IgG, immunoglobulin G; NA, not available; PML, progressive multifocal leukoencephalopathy; PR, partial response; RP2R, recommended phase 2 regimen; sCR, stringent complete response.
Clinical data cutoff date of July 2025. Median follow-up of 38.0 months for all doses levels and 34.5 months for the RP2R cohort.
aPatient did not receive COVID-19 vaccination.
bPatient received COVID-19 vaccination.
cDeemed related to TALVEY + TECVAYLI by the investigator.
dPML onset occurred 62, 5, and 226 days, respectively, after the most recent dose of TALVEY + TECVAYLI.

Cohen et al (2025)9,24 published the incidence of infections from the phase 1 dose-escalation segment of the RedirecTT-1 study reported across all dose levels at a median follow-up of 20.3 months (range, 0.5-37.1) and in the RP2R cohort at 18.2 months.

Safety Results

Infections

  • Across all dose levels, any-grade infections were reported in 89% of patients (n=84) and grade 3/4 infections were reported in 64% of patients (n=60).9,24,25
    • Across all dose levels (N=94), infections occurring in ≥10% of patients included COVID-19 (any grade 40.4%; grade 3/4 18.1), pneumonia (any grade, 36.2%; grade 3/4 20.2%), upper respiratory tract infection (any grade, 24.5%), nasopharyngitis (any grade, 14.9%), sinusitis (any grade, 12.8%), and rhinovirus infection (any grade, 10.6%).
  • In the RP2R cohort, any-grade infections were reported in 86.4% of patients (n=38) and grade 3/4 infections were reported in 47.7% of patients (n=21).9,24,25
    • In the RP2R cohort (n=44), infections occurring in ≥10% of patients included COVID-19 (any grade, 47.7%; grade 3/4, 13.6%), pneumonia (any grade, 31.8%; grade 3/4, 15.9%), upper respiratory tract infection (any grade, 25%).
  • Across all dose levels, opportunistic infections were reported in 10.6% of patients (n=10), including 3.2% of patients (n=3) with grade 3/4 opportunistic infections.
  • The median time to onset from the last administration of study treatment was 9 days (range, 1-89) across all dose levels.
  • The median duration of infections was 13 days (range, 1-223) across all dose levels.
  • A total of 82.5% of events (n=113; calculated with number of events as the denominator [N=137]) were recovered or resolved across all dose levels.
  • Across all dose levels, the incidence of first-onset of grade ≥3 infections was higher in the first 6 months of study treatment and then plateaued.
  • Infection prophylaxis was administered as per institutional guidelines. A total of 82% of patients (n=77) across all dose levels received antiviral prophylaxis, and 49% of the patients (n=46) received prophylaxis against Pneumocystis jirovecii pneumonia.9,24
  • In total, 63% of patients (n=59) received a COVID-19 vaccine.9
  • Immunoglobulin replacement therapy (0.4 g/kg every 3-6 weeks) was recommended to maintain serum immunoglobulin G (IgG) levels above 400 mg/dL, regardless of current or past infections, with monitoring recommended at least every 3 months after reaching steady state.24
  • Immunoglobulin replacement was provided per institutional guidelines for managing serious, recurrent, or chronic infections.24
  • Dose delay or dose modification due to infections was reported in 68% of patients (n=64) across all dose levels.
  • Deaths due to infections were reported in 11.7% of patients (n=11) across all dose levels cohort and 6.8% of patients (n=3) in the RP2R cohort.9,24

Hypogammaglobulinemia

  • At baseline, 56% of patients across all dose levels (n=53) had non-IgG myeloma.9
    • Of these patients, 70% of patients (n=37) had hypogammaglobulinemia (defined as IgG <400 mg/dL) at baseline and 57% of patients (n=30) had post-treatment hypogammaglobulinemia.9
  • The assessments excluded patients with IgG myeloma and those who received IVIG replacement.9
  • A total of 57% of patients (n=30) with non-IgG myeloma received IVIG.9
  • A patient experienced grade 2 John Cunningham (JC) virus infection on day 163, PD on day 170 (when the patient discontinued TALVEY and TECVAYLI), and died on day 217 from grade 5 JC virus infection.24
    • This patient’s baseline IgG value was 248 g/dL; the patient had hypogammaglobulinemia with no IVIG administered and experienced intermittent neutropenia prior to the AE.24

CLINICAL DATA - TRIMM-2 STUDY

TRIMM-2 (NCT04108195) is an ongoing, phase 1b, 2-part, multicohort, open-label study evaluating DARZALEX FASPRO regimens in combination with bispecific TCR antibodies with or without pomalidomide in patients with RRMM.13-15

Study Design/Methods

  • Key eligibility criteria15:
    • Double refractory to a PI and an immunomodulatory drug or received ≥3 prior LOTs (including a PI and an immunomodulatory drug).
    • Treatment with an anti-CD38 mAb (>90 days prior allowed), including anti-CD38 refractory patients.
    • Prior BsAb and CAR-T were allowed.

Chari et al (2025)15,26 published the incidence of infections in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO cohorts at a median follow-up of 18.6 months (range, 1.2-39.1).

Safety Results

  • Infections were reported in 71% of patients (n=46); grade 3/4 infections were reported in 29% of patients (n=19), with no treatment discontinuations. A summary of infections is provided in Table: TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Infections (≥4%).
  • Grade 3 or higher opportunistic infections were reported in 1 patient (Pneumocystis jirovecii pneumonia within the first 6 months of treatment in a patient with no prophylaxis).
  • Polyclonal IgG levels declined during the initial 2-3 months of treatment, followed by a steady increase.
  • A total of 54% of patients (n=30) received at least 1 dose of IVIG.
  • Discontinuation of DARZALEX FASPRO was reported in 2% of patients (n=1) due to COVID-19 and in 2% of patients (n=1) due to parainfluenza virus infection.
  • Dose skips due to infections were reported in 38% of patients (n=25) receiving TALVEY and 20% of patients (n=13) receiving DARZALEX FASPRO.
  • Dose reductions due to infections were reported in 6% of patients (n=4).

TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Infections (≥4%)15 
Parameter
TALVEY 0.4 mg/kg QW + DARZALEX FASPRO
(n=14)
TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO
(n=51)
Patients with infections, n (%)
9 (64)
37 (73)
   COVID-19
5 (36)
14 (27)
   UTI
0 (0)
11 (22)
   Upper respiratory tract infection
4 (29)
6 (12)
   Pneumonia
2 (14)
7 (14)
   Respiratory tract infection
1 (7)
7 (14)
   Rhinovirus infection
1 (7)
4 (8)
   Gastroenteritis
0 (0)
4 (8)
   Parainfluenza virus infection
2 (14)
2 (4)
   Fungal skin infection
2 (14)
1 (2)
   Oral herpes
0 (0)
3 (6)
   Skin infection
2 (14)
1 (2)
   Viral upper respiratory tract infection
1 (7)
2 (4)
Grade 3 or 4 infections, n (%)
3 (21)
16 (31)
Median time to onseta, days (range)
8.0 (1-36)
9.5 (1-211)
Median duration, days (range)
17.0 (5-155)
15.0 (2-148)
Number of events, n
48
134
Outcome, n (%)
   Recovered or resolved
45 (94)
118 (88)
   Not recovered or not resolved
3 (6)
14 (10)
   Fatal
0 (0)
2 (1)
Abbreviations: COVID-19, coronavirus disease 2019; Q2W, every other week; QW, weekly; UTI, urinary tract infection.
aRelative to most recent dose.
Data cutoff date: November 17, 2023.

Bahlis et al (2024)14 presented the incidence of infections in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 15.8 months (range, 3.2-37.9) and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 17.5 months (range, 0.2-37.7).

Safety Results


TRIMM-2 Study (TALVEY + DARZALEX FASPRO + Pomalidomide Cohort): Infections (≥10% Overall)14
AEa, n (%)
TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + Pomalidomide
(n=18)
TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + Pomalidomide
(n=59)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Infections
13 (72.2)
3 (16.7)
46 (78.0)
22 (37.3)
   COVID-19
7 (38.9)
0 (0)
16 (27.1)
0 (0)
   Upper respiratory tract
   infection (undefined)
2 (11.1)
0 (0)
15 (25.4)
1 (1.7)
   Pneumonia
0 (0)
0 (0)
10 (16.9)
4 (6.8)
   Viral upper respiratory
   tract infection
3 (16.7)
0 (0)
6 (10.2)
0 (0)
   Sinusitis
4 (22.2)
0 (0)
4 (6.8)
3 (5.1)
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; CTCAE, Common Terminology Criteria for Adverse Events; Dara; DARZALEX FASPRO; Pom, pomalidomide; Q2W, every other week; QW, once a week; Tal, TALVEY.
aAEs were graded by CTCAE v5.0.
Clinical data cutoff of July 29, 2024.

CLINICAL DATA - TRIMM-3 Study - TALVEY + Cetrelimab COHORT

TRIMM-3 (NCT05338775) is a phase 1b, nonrandomized, open-label study evaluating the dosing, safety, and tolerability of TALVEY in combination with cetrelimab in patients with RRMM.16,17

Study Design/Methods

  • Key eligibility criteria16:
    • MM per IMWG criteria
    • RRMM who may not be eligible for or expected to benefit from available therapies
    • ECOG PS 0 or 1

Perrot et al (2025)16 presented the incidence of infections in the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months (range, 1.5-32.3).

Safety Results

  • A summary of infections is presented in Table: TRIMM-3 Study: Summary of Infections (≥10% Overall).
  • One death was reported due to pneumonia.
  • Hypogammaglobulinemia (or IgG <400 mg/dL) occurred in 56.8% of patients; 34.1% of these patients received ≥1 dose of IVIG.

TRIMM-3 Study: Summary of Infections (≥10% Overall)16 
AEa, n (%)
All Patients
(N=44)
Any Grade
Grade 3/4
Infections
36 (81.8)
13 (29.5)
   COVID-19
10 (22.7)
1 (2.3)
   Bronchitis
7 (15.9)
0 (0)
   Nasopharyngitis
6 (13.6)
1 (2.3)
   Pneumonia
6 (13.6)
2 (4.5)
   Upper respiratory tract infection
5 (11.4)
0 (0)
Abbreviations: AE, adverse event; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; COVID-19, coronavirus disease 2019; TCR, T-cell redirection therapy.
Clinical data cutoff date of April 2, 2025.
aPatients with prior TCR, including CAR-T and BsAbs in the MonumenTAL-1 study. AEs reported were treatment emergent.

literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) topic was conducted on 03 February 2026.

 

References

Show
1 Chari A, Touzeau C, Schinke C, et al. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025;12(4):e269-e281.  
2 Schinke C, Rodriguez-Otero P, Donk NWCJ van de, et al. Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1. Blood Adv. 2025.  
3 Rasche L, Schinke C, Touzeau C, et al. Efficacy and safety from the phase 1/2 MonumenTAL-1 study of talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma: analyses at an extended median follow-up. Poster presented at: The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL/Virtual.  
4 Rasche L, Schinke C, Touzeau C, et al. Long-term efficacy and safety results from the phase 1/2 MonumenTAL-1 study of talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. Poster presented at: The European Hematology Association (EHA) 2024 Hybrid Congress; June 13-16, 2024; Madrid, Spain.  
5 Chari A, Krishnan A, Rasche L, et al. Clinical management of patients with relapsed/refractory multiple myeloma treated with talquetamab. Clin Lymphoma Myeloma Leuk. 2024;24(10):665-693.e14.  
6 Quach H, Perrot A, Matous JV, et al. Talquetamab, a GPRC5D×CD3 bispecific antibody, in combination with pomalidomide in patients with relapsed/refractory multiple myeloma: updated safety and efficacy results from the phase 1b MonumenTAL-2 study. Poster presented at: The 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.  
7 Janssen Research & Development, LLC. A multi-arm phase 1b study of talquetamab with other anticancer therapies in participants with multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 February 3]. Available from: https://clinicaltrials.gov/ct2/show/NCT05050097 NLM Identifier NCT05050097.  
8 Nooka AK, Cochrane T, D’Souza A, et al. Talquetamab, a GPRC5D×CD3 bispecific antibody, in combination with daratumumab and lenalidomide in patients with newly diagnosed multiple myeloma: safety and efficacy results from the phase 1b MonumenTAL-2 study. Poster presented at: The 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024; San Diego, CA.  
9 Cohen YC, Magen H, Gatt M, et al. Talquetamab plus teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2025;392(2):138-149.  
10 Usmani SZ, Kumar S, Mateos MV, et al. Efficacy and safety of talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma and extramedullary disease: updated phase 2 results from the RedirecTT-1 study with extended follow-up. Oral Presentation presented at: the 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.  
11 Kumar S, Mateos MV, Ye JC, et al. Dual targeting of extramedullary myeloma with Talquetamab and Teclistamab. N Engl J Med. 2026;394(1):51-61.  
12 Mateos MV, Magen H, Gatt M, et al. Safety and efficacy of talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma from phase 1b of RedirecTT-1: results with an extended median follow-up of 3 years. Oral presentation presented at: the 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.  
13 Janssen Research & Development, LLC. A phase 1b study of subcutaneous daratumumab regimens in combination with bispecific T cell redirection antibodies for the treatment of subjects with multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 February 3]. Available from: https://clinicaltrials.gov/ct2/show/NCT04108195 NLM Identifier: NCT04108195.  
14 Bahlis N, van de Donk NWCJ, Reece D, et al. Talquetamab + daratumumab + pomalidomide in patients with relapsed/refractory multiple myeloma: results from the phase 1b TRIMM2 study. Oral Presentation presented at: 21st International Myeloma Society (IMS) Annual Meeting; September 25-28, 2024; Rio de Janeiro, Brazil.  
15 Chari A, van de Donk NWCJ, Dholaria B, et al. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025;146(24):2902-2913.  
16 Perrot A, Touzeau C, Rodríguez-Otero P, et al. Talquetamab + cetrelimab in patients with relapsed/refractory multiple myeloma: initial safety and efficacy results from the phase 1b TRIMM-3 study. Oral Presentation presented at: the European Hematology Association (EHA) Annual Meeting; June 12-15, 2025; Milan, Italy.  
17 Janssen Research & Development, LLC. A phase 1b study of bispecific T cell redirection antibodies in combination with checkpoint inhibition for the treatment of participants with relapsed or refractory multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 February 3]. Available from: https://clinicaltrials.gov/study/NCT05338775 NLM Identifier: NCT05338775.  
18 Catamero D, Ray C, Purcell K, et al. Nursing considerations for the clinical management of adverse events associated with talquetamab in patients with relapsed or refractory multiple myeloma. Semin Oncol Nurs. 2024;40(5):151712.  
19 Jakubowiak AJ, Anguille S, Karlin L, et al. Updated results of talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma with prior exposure to T-cell redirecting therapies: results of the phase 1/2 MonumenTAL-1 study. Poster presented at: The 65th American Society of Hematology (ASH) Annual Meeting; December 9-12, 2023; San Diego, CA/Virtual.  
20 Schinke CD, Touzeau C, Minnema MC, et al. Pivotal phase 2 MonumenTAL-1 results of talquetamab, a GPRC5DxCD3 bispecific antibody, for relapsed/refractory multiple myeloma. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL/Virtual.  
21 Schinke C, Rodriguez-Otero P, Donk NWCJ van de, et al. Supplement to: Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1. Blood Adv. 2025.  
22 Chari A, Touzeau C, Schinke C, et al. Supplement to: Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025;12(4):e269-e281.  
23 Kumar S, Mateos MV, Ye JC, et al. Supplement: Dual targeting of extramedullary myeloma with Talquetamab and Teclistamab. N Engl J Med. 2026;394(1):51-61.  
24 Cohen YC, Magen H, Gatt M, et al. Supplement to: Talquetamab plus teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2025;392(2):138-149.  
25 Cohen YC, Magen H, Gatt M, et al. Talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma: updated phase 1b results from RedirecTT-1 with >1 year of follow-up. Oral Presentation presented at: 21st International Myeloma Society (IMS) Annual Meeting; September 25-28, 2024; Rio de Janeiro, Brazil.  
26 Chari A, van de Donk NWCJ, Dholaria B, et al. Supplement to: Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025;146(24):2902-2913.