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TALVEY® (talquetamab-tgvs)

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TALVEY - Occurrence and Management of Hematologic Adverse Events

Last Updated: 11/20/2025

SUMMARY

  • Janssen does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
  • Hematologic adverse events (AEs) have been reported in the MonumenTAL-1, MonumenTAL-2, TRIMM-2, and RedirecTT-1 studies.1-6
  • 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).1,4,7
    • Rasche et al (2025)7 presented the incidence of hematologic AEs from the MonumenTAL-1 study at an extended median follow-up of 38.2 months for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort, 31.2 months for the 0.8 mg/kg SC every other week (Q2W) cohort, and 30.3 months for the prior T-cell redirection therapy (TCR)-exposed (QW and Q2W) cohorts.
    • Chari et al (2025)4,8 published the incidence of hematologic AEs from a post hoc analysis of phases 1 and 2 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.
    • Schinke et al (2024)9 presented the incidence of hematologic AEs from a subgroup analysis in Black and White patients at a median follow-up of 26 months for the Black subgroup and 31 months for the White subgroup. The subgroup of patients received TALVEY at the recommended phase 2 doses (RP2Ds) of 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W.
    • Schinke et al (2023)1 presented the incidence of hematologic AEs from the phase 2 portion of 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.
    • The prophylactic tocilizumab cohort is evaluating the administration of tocilizumab (8 mg/kg intravenous [IV]) prior to TALVEY to mitigate cytokine release syndrome (CRS) in 27 patients with RRMM.10
      • Dytfeld et al (2025)10 presented the incidence of hematologic AEs in the prophylactic tocilizumab cohort at a median follow-up of 4.4 months.
  • 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).5,11,12
    • Cohort D is evaluating the efficacy and safety of TALVEY + DARZALEX FASPRO® (daratumumab hyaluronidase) and lenalidomide in 34 patients with newly diagnosed multiple myeloma (NDMM).11
      • Nooka et al (2024)11 presented the incidence of hematologic AEs of 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.12
      • Searle et al (2024)12 presented the incidence of hematologic AEs in the TALVEY + pomalidomide cohort from the MonumenTAL-2 study at a median follow-up of 16.8 months.
  • RedirecTT-1 is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of the TALVEY and TECVAYLI® (teclistamab-cqyv) combination in patients with RRMM, including those with extramedullary disease (EMD).3,13-15
    • Kumar et al (2025)15 presented the incidence of hematologic AEs from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 12.6 months.
    • Cohen et al (2025)3 published the incidence of hematologic AEs from the phase 1 dose-escalation segment of the RedirecTT-1 study at a median follow-up of 20.3 months across dose levels (dose levels 1-5).
  • TRIMM-2 is an ongoing, phase 1b, multicohort open-label study evaluating the efficacy and safety of DARZALEX FASPRO + TECVAYLI or TALVEY with or without pomalidomide in patients with RRMM.6,16,17
    • Chari et al (2025)17,18 published the incidence of hematologic AEs 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)6 presented the incidence of hematologic AEs in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 15.8 months and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 17.5 months.
    • Dholaria et al (2023)16 presented the incidence of hematologic AEs from the TALVEY + DARZALEX FASPRO cohorts at a median follow-up of 16.8 months for the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO cohort and 15.0 months for the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO cohort.
  • 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.19,20 
    • Perrot et al (2025)19 presented the incidence of hematologic AEs of the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months.

PRODUCT LABELING

CLINICAL DATA - Monumental-1 Study

MonumenTAL-1 (MMY1001; NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.21,22

The study was conducted in 3 parts; the primary objectives are listed below23:

  • Part 1 (phase 1; dose escalation): to characterize the safety of TALVEY and determine the RP2Ds and schedule.
  • Part 2 (phase 1; dose expansion): to further characterize the safety of TALVEY at the RP2Ds.
  • Part 3 (phase 2): to evaluate the efficacy of TALVEY at the RP2Ds.

Study Design/Methods (Phase 2)

Patients were enrolled into 1 of the following 4 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).1,24
  • TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).1,24
  • TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.1,24
    • Among the prior TCR-exposed cohort, patients were divided based on type of TCR (CAR-T, BsAb, or CAR-T and BsAb).
  • Prophylactic tocilizumab: 0.8 mg/kg SC Q2W; tocilizumab 8 mg/kg IV prior to the first step-up dose (SUD) of TALVEY to mitigate CRS.10
  • Key eligibility criteria4:
    • ≥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.

Rasche et al (2025)7 presented the incidence of hematologic AEs 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: Hematologic AEs (≥30% in Any Cohort)7
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
Anemia
65 (45.5)
46 (32.2)
67 (43.5)
39 (25.3)
38 (48.7)
22 (28.2)
Neutropenia
50 (35.0)
44 (30.8)
44 (28.6)
33 (21.4)
40 (51.3)
37 (47.4)
Thrombocytopenia
39 (27.3)
29 (20.3)
46 (29.9)
28 (18.2)
30 (38.5)
22 (28.2)
Abbreviations: AE, adverse event; Q2W, every other week; QW, weekly, SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of September 2024.

Chari et al (2025)4,8 published the incidence of hematologic AEs from the post hoc analysis of phases 1 and 2 of the MonumenTAL-1 study at a median follow-up of 25.6 months (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


MonumenTAL-1 Study: Hematologic AEs4,8
Event, n (%)
0.4 mg/kg SC QWa,b
(N=143)
0.8 mg/kg SC Q2Wa,b
(N=154)
Prior TCRa,c
(N=78)
Grade 1/2
Grade 3
Grade 4
Grade 1/2
Grade 3
Grade 4
Grade 1/2
Grade 3
Grade 4
Grade 5
Neutropenia
6 (4)
29 (20)
15 (10)
11 (7)
24 (16)
9 (6)
3 (4)
18 (23)
19 (24)
0
Anemia
19 (13)
45 (31)
0
26 (17)
40 (26)
0
17 (22)
21 (27)
0
0
Thrombocytopenia
10 (7)
15 (10)
14 (10)
17 (11)
14 (9)
14 (9)
9 (12)
11 (14)
10 (13)
0
Leukopenia
12 (8)
6 (4)
5 (3)
11 (7)
14 (9)
4 (3)
3 (4)
8 (10)
6 (8)
0
Lymphopenia
3 (2)
17 (12)
20 (14)
6 (4)
14 (9)
26 (17)
2 (3)
4 (5)
9 (12)
0
Febrile neutropenia
-
-
-
-
-
-
0
4 (5)
0
0
Abbreviations: AE, adverse event; 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.
bAEs are listed by frequency on an any-grade basis. AEs listed are grade 1-2 events occurring in at least 20% of patients in either group or grade 3 or worse occurring in at least 10% of patients in either group.
cAEs are listed by frequency on an any-grade basis and include those occurring in ≥10% of patients or grade ≥3 AEs occurring in ≥5%.

Schinke et al (2024)9 presented the incidence of hematologic AEs from a subgroup analysis in Black patients who received TALVEY at the RP2Ds of 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W in phase 1/2 of the MonumenTAL-1 study at a median follow-up of 26 months for the Black subgroup and 31 months for the White subgroup.

Safety Results


MonumenTAL-1 Study: Summary of Hematologic AEs in Black vs White Patients (≥30% in Either Group)9
AE, n (%)
White
(N=254)
Black
(N=29)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Anemia
119 (46.9)
75 (29.5)
9 (31.0)
7 (24.1)
Lymphopenia
67 (26.4)
59 (23.2)
11 (37.9)
11 (37.9)
Neutropenia
77 (30.3)
62 (24.4)
9 (31.0)
8 (27.6)
Thrombocytopenia
77 (30.3)
53 (20.9)
5 (17.2)
3 (10.3)
Abbreviations: AE, adverse event.
Clinical data cutoff date of June 20, 2024.

Schinke et al (2023)1 presented the incidence of hematologic AEs from 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 Results


MonumenTAL-1 (Phase 2) Study: Hematologic AEs1
AE, n (%)
0.4 mg/kg SC QW
(n=143)
0.8 mg/kg SC Q2W
(n=145)
Prior TCR
(n=51)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Anemia
64 (44.8)
45 (31.5)
66 (45.5)
40 (27.6)
25 (49.0)
14 (27.5)
Neutropenia
50 (35.0)
44 (30.8)
41 (28.3)
32 (22.1)
28 (54.9)
27 (52.9)
Thrombocytopenia
39 (27.3)
29 (20.3)
43 (29.7)
27 (18.6)
19 (37.3)
15 (29.4)
Abbreviations: AE, adverse event; CTCAE, common terminology criteria for adverse events; QW, weekly; Q2W, every other week; SC, subcutaneous; TCR, T cell redirection therapy.
Clinical data cutoff date of 17 January 2023. These AEs were assessed per CTCAE v4.03.

Prophylactic Tocilizumab Cohort Safety Results

Dytfeld et al (2025)10 presented the incidence of hematologic AEs in the prophylactic tocilizumab cohort at a median follow-up of 4.4 months (range, 0.5-18.4).

Safety Results


MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): Hematologic AEs (≥20% of Total Population)10
AEa, n (%)
Prophylactic tocilizumab
(N=27)
Any Grade
Grade 3/4
Neutropenia
9 (33.3)
6 (22.2)
Anemia
7 (25.9)
3 (11.1)
Lymphopenia
6 (22.2)
5 (18.5)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events.
aAEs were graded by CTCAE v4.03.

CLINICAL DATA - MONUMENTAL-2 STUDY

MonumenTAL-2 (MMY1004; NCT05050097) is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with MM.5,11,12,25

Study Design/Methods

  • Key eligibility criteria:
    • Cohort D: measurable MM, NDMM, ECOG PS of 0-1, and transplant ineligible or not intended for transplant.11,25
    • 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.12,25
  • Primary endpoint for Cohort D and Cohort E: safety; AEs assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, except for CRS and immune effector cell-associated neurotoxicity syndrome, which were graded per American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.11,12,25 

Cohort D

Nooka et al (2024)11 presented the incidence of hematologic AEs 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


MonumenTAL-2 Study (Cohort D): Summary of Hematologic TEAEs (≥30%)11
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
Neutropenia
6 (75.0)
6 (75.0)
12 (46.2)
11 (42.3)
Anemia
5 (62.5)
3 (37.5)
8 (30.8)
3 (11.5)
Thrombocytopenia
4 (50.0)
1 (12.5)
8 (30.8)
2 (7.7)
Abbreviations: Q2W, every other week; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of September 23, 2024.

Cohort E

Searle et al (2024)12 presented the incidence of hematologic AEs in the TALVEY + pomalidomide cohort from the MonumenTAL-2 study at a median follow-up of 16.8 months (range, 1.2-25.1).

Safety Results


MonumenTAL-2 (Cohort E) Study: Hematologic AEs12
AEs, n (%)
TALVEY + Pomalidomide (N=35)
Any Grade
Grade 3/4
Neutropenia
22 (62.9)
20 (57.1)
Anemia
13 (37.1)
9 (25.7)
Thrombocytopenia
10 (28.6)
7 (20.0)
Abbreviation: AE, adverse event.
Clinical data cutoff date of April 22, 2024.

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

RedirecTT-1 (MMY1003; NCT04586426) is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of the combination of TALVEY and TECVAYLI in patients with RRMM.3,13-15,26

Study Design/Methods

  • Key inclusion 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.3,14
  • Primary endpoints: dose limiting toxicity and ORR.3,14

Kumar et al (2025)15 presented the incidence of hematologic AEs from phase 2 of the RedirecTT-1 study in patients with RMM and EMD at a median follow-up of 12.6 months (range, 0.5-19.5).

Safety Results


RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Hematologic AEs (≥30% Overall)15
AEa, n (%)
TALVEY + TECVAYLI
(N=90)
Any Grade
Grade 3/4
Neutropenia
65 (72.2)
56 (62.2)
Anemia
46 (51.1)
28 (31.1)
Thrombocytopenia
34 (37.8)
23 (25.6)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; EMD, extramedullary disease.
Clinical data cutoff date of March 18, 2025. Median follow-up of 12.6 months.
aAEs graded by CTCAE v5.0.

Cohen et al (2025)3 published the incidence of hematologic AEs from the phase 1 dose-escalation segment of the RedirecTT-1 study 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

  • At the data cutoff date of March 15, 2024, hematologic AEs were reported across all dose levels (N=94) and in the RP2R cohort (n=44).
  • AEs were graded per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and reported as TEAEs up to 30 days after the last dose of study treatment.

Incidence of AEs

  • Incidence of hematologic AEs in the RP2R cohort is presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Hematologic AEs in the RP2R Cohort.
  • Any-grade neutropenia was reported in 73% of patients (n=69), anemia in 56% of patients (n=53), and thrombocytopenia in 43% of patients (n=40) across all dose levels.
  • Grade 3/4 neutropenia was reported in 68% of patients (n=64), anemia in 38% of patients (n=36), and thrombocytopenia in 30% of patients (n=28) across all dose levels.
  • Febrile neutropenia was reported in 12.8% of patients.3,14

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Hematologic AEs in the RP2R Cohort3,14
AEa, n (%)
RP2R
(n=44)
Any Grade
Grade 3/4
Neutropenia
30 (68.2)
25 (56.8)
Anemia
18 (40.9)
11 (25.0)
Thrombocytopenia
12 (27.3)
9 (20.5)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; RP2R, recommended phase 2 regimen.
Clinical data cutoff date of March 15, 2024. Median follow-up time of 18.2 months.
aAEs were graded per CTCAE v5.0. AEs were reported up to 30 days after the patient received the last dose of study treatment. Patients could have had multiple AEs.

CLINICAL DATA - TRIMM-2 STUDY

TRIMM-2 (MMY1002; 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.6,16,27

Study Design/Methods

  • Key eligibility criteria16:
    • 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.
  • Key primary endpoints16:
    • Part 1: identify the RP2D for each treatment combination.
    • Part 2: safety and tolerability at the selected RP2D of each treatment combination.
    • Antitumor activity.

Chari et al (2025)17,18 published the incidence of hematologic AEs 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


TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Hematologic AEs (≥25% Patients)23,a
AEb, n (%)
Any grade
(N=65)
Grade 3/4
(N=65)
Anemia
33 (51)
17 (26)
Neutropenia
26 (40)
19 (29)
Thrombocytopenia
25 (38)
15 (23)
Lymphopenia
19 (29)
17 (26)
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CTCAE, Common Terminology Criteria for Adverse Events.
aData are presented for the combined TALVEY 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W cohorts.
bAEs were graded by CTCAE v5.0.
Clinical data cutoff date of November 17, 2023.

TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Dose Modification Due to Hematologic AEs24
AE (≥3%), n (%)
All patients (N = 65)
Dose skips of TALVEY
   Anemia
2 (3)
   Thrombocytopenia
2 (3)
   Neutropenia
2 (3)
Dose skips of DARZALEX FASPRO
   Neutropenia
3 (5)
   Thrombocytopenia
3 (5)
Dose reductiona
   Anemia
1 (2)
   Neutropenia
1 (2)
Abbreviation: AE, adverse event.
aPatients could have experienced multiple AEs leading to dose reduction.
Clinical data cutoff date of November 17, 2023.

Bahlis et al (2024)6 presented the incidence of hematologic AEs 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): Hematologic AEs6
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
Neutropenia
15 (83.3)
14 (77.8)
47 (79.7)
42 (71.2)
Anemia
9 (50.0)
6 (33.3)
30 (50.8)
22 (37.3)
Thrombocytopenia
6 (33.3)
4 (22.2)
31 (52.5)
20 (33.9)
Leukopenia
4 (22.2)
4 (22.2)
22 (37.3)
19 (32.2)
Lymphopenia
9 (50.0)
9 (50.0)
16 (27.1)
16 (27.1)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; Q2W, every other week; QW, weekly.
Clinical data cutoff date of July 29, 2024.
aAEs were graded by CTCAE v5.0.

Dholaria et al (2023)16 presented the incidence of hematologic AEs the TRIMM-2 study for the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO 1800 mg Q4W cohort at a median follow-up of 16.8 months (range, 1.9-31.0) and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO 1800 mg Q4W cohort at a median follow-up of 15.0 months (range, 1.0-23.3).

Safety Results


TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Hematologic AEs16
AE, n (%)
TALVEY 0.4 mg/kg SC QW + DARZALEX FASPRO 1800mg SC Q4W
(n=14)
TALVEY 0.8 mg/kg SC Q2W + DARZALEX FASPRO 1800 mg SC Q4W
(n=51)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Anemia
9 (64.3)
5 (35.7)
25 (49.0)
13 (25.5)
Lymphopenia
8 (57.1)
8 (57.1)
10 (19.6)
9 (17.6)
Neutropenia
6 (42.9)
4 (28.6)
20 (39.2)
14 (27.5)
Thrombocytopenia
6 (42.9)
4 (28.6)
19 (37.3)
10 (19.6)
Abbreviations: AE, adverse event; Q2W, every other week; QW, weekly.
Clinical data cutoff date of April 06, 2023.

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

TRIMM-3 (MMY1005; 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.19,20

Study Design/Methods

  • Key eligibility criteria19:
    • MM per IMWG criteria
    • RRMM who may not be eligible for or expected to benefit from available therapies
    • ECOG PS 0 or 1
  • Primary endpoint19: safety

Perrot et al (2025)19 presented the incidence of hematologic AEs of the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months (range, 1.5-32.3).

Safety Results


TRIMM-3 Study: Hematologic AEs (≥10% Overall)19 
AEa, n (%)
All Patients
(N=44)
Any Grade
Grade 3/4
Anemia
26 (59.1)
17 (38.6)
Neutropenia
24 (54.5)
19 (43.2)
Thrombocytopenia
16 (36.4)
7 (15.9)
Lymphopenia
12 (27.3)
12 (27.3)
Leukopenia
6 (13.6)
4 (9.1)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events.
Clinical data cutoff date of April 2, 2025.
aAEs were graded per CTCAE v5.0. 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) was conducted on 20 November 2025.

References

Show
1 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.  
2 Chari A, Minnema MC, Berdeja JG, et al. Talquetamab, a T-cell-redirecting GPRC5D bispecific antibody for multiple myeloma. N Engl J Med. 2022;387(24):2232-2244.  
3 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.  
4 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.  
5 Matous J, Biran N, Perrot A, et al. Talquetamab + pomalidomide in patients with relapsed/refractory multiple myeloma: safety and preliminary efficacy results from the phase 1b MonumenTAL-2 study. Oral Presentation presented at: The 65th American Society of Hematology (ASH) Annual Meeting; December 9-12, 2023; San Diego, CA.  
6 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.  
7 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.  
8 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.  
9 Schinke C, Morgan G, Costa LJ, et al. Clinical outcomes in Black patients with relapsed/refractory multiple myeloma following talquetamab treatment: analyses from the phase 1/2 MonumenTAL-1 study. Poster presented at: The 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024; San Diego, CA.  
10 Dytfeld D, Vij R, Jagannath S, et al. Prophylactic tocilizumab to mitigate cytokine release syndrome and outpatient dosing of talquetamab in relapsed/refractory multiple myeloma: updated phase 1/2 MonumenTAL-1 results. Poster presented at: The European Hematology Association (EHA) Hybrid Congress; June 12-15, 2025; Milan, Italy.  
11 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.  
12 Searle E, Quach H, Biran N, et al. Talquetamab, a GPRC5D×CD3 bispecific antibody, in combination with pomalidomide in patients with relapsed/refractory multiple myeloma: efficacy and safety results from the phase 1b monumenTAL-2 study. Poster presented at: the European Hematology Association (EHA) annual meeting; June 13-16, 2024; Madrid, Spain.  
13 Cohen Y, Morillo D, Gatt M, et al. First results from the RedirecTT-1 study with teclistamab + talquetamab simultaneously targeting BCMA and GPRC5D in patients with relapsed/refractory multiple myeloma. Oral presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL, USA/Virtual.  
14 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.  
15 Kumar S, Mateos MV, Ye JC, et al. Phase 2 study of talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma and extramedullary disease: RedirecTT-1. Oral Presentation presented at: the 2025 European Hematology Association (EHA) Annual Meeting; June 12-15, 2025; Milan, Italy.  
16 Dholaria B, Weisel K, Mateos M, et al. Talquetamab + daratumumab in patients with relapsed/refractory multiple myeloma: updated TRIMM-2 results. Oral presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL, USA/Virtual.  
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18 Chari A, Donk NWCJ van de, 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.  
19 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.  
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