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TALVEY® (talquetamab-tgvs)

Medical Information

TALVEY - Use in Patients With Extramedullary Disease

Last Updated: 09/03/2025

SUMMARY

  • Janssen does not recommend the use of TALVEY in a manner inconsistent with the approved labeling.
  • 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).1-3
    • Chari et al (2025)3,4 published a post hoc analysis with a longer-term follow-up that evaluated the efficacy and safety of TALVEY at the recommended phase 2 dose (RP2D) at a median follow-up of 25.6 months (interquartile range [IQR], 8.5-25.9) for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort, 19.4 months (IQR, 9.2-20.7) for the 0.8 mg/kg SC every other week (Q2W) cohort, and 16.8 months (IQR, 7.6-18.7) for the prior T-cell redirection therapy (TCR)-exposed cohort from phases 1 and 2 of the MonumenTAL-1 study. The overall response rate (ORR) in the extramedullary plasmacytoma (≥1) subgroup was 48% for the 0.4 mg/kg SC QW cohort and 41% for the 0.8mg/kg SC Q2W cohort.
    • Rasche et al (2024)5 presented long-term follow-up efficacy and safety results from the MonumenTAL-1 study at a median follow-up of 29.8 months for the 0.4 mg/kg SC weekly QW cohort, 23.4 months for the 0.8 mg/kg SC Q2W cohort, and 20.5 months for the prior TCR therapy-exposed cohort. The ORR in the extramedullary plasmacytoma (≥1) subgroup was 48.5%, 41.5%, and 44.0% for the 0.4 mg/kg SC QW, 0.8 mg/kg SC Q2W, and prior TCR therapy-exposed cohorts, respectively.
    • Krishnan et al (2023)6 presented subgroup analyses of the efficacy and safety results from the MonumenTAL-1 study phases 1/2 in patients who received TALVEY at the recommended phase 2 doses (RP2Ds) of 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W, including those who were naïve or exposed to TCR therapy. At a median follow-up of 18.4 months for the 0.4 mg/kg SC QW extramedullary disease (EMD) subgroup, the ORR was 48.5%. At a median follow-up of 12.1 months for the 0.8 mg/kg SC Q2W EMD subgroup, the ORR was 43.2%.
  • Other relevant literature has been identified in addition to the data summarized above.7 

PRODUCT LABELING

CLINICAL DATA - mONUMENTAL-1 STUDY

MonumenTAL-1 (MMY1001; NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.8,9

Study Design/Methods (Phase 2)

Patients were enrolled into 1 of the following 3 cohorts2,10:

  • 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).
  • TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).
  • Prior TCR-exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.
    • Among the prior TCR-exposed cohort, patients were divided based on type of TCR (CAR-T, BsAb, or CAR-T and BsAb).
  • Key eligibility criteria3:
    • ≥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.

Chari et al (2025)3,4 published a post hoc analysis with a longer-term follow-up to evaluate the efficacy and safety results in patients receiving TALVEY in phases 1 and 2 of the MonumenTAL-1 study. The efficacy results for the subgroup of patients with baseline extramedullary disease are summarized below.

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics

  • A total of 143 patients were included in the 0.4 mg/kg SC QW cohort, 154 patients in the 0.8 mg/kg SC Q2W cohort, and 78 patients in the prior TCR-exposed cohort.
  • The median duration of follow-up was 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.

Efficacy


MonumenTAL-1 Study: ORR in Patients With Baseline Extramedullary Disease4 
Extramedullary Plasmacytomas
0.4 mg/kg QW
0.8 mg/kg Q2W
ORR, n/N (%)
95% CI
ORR, n/N (%)
95% CI
0
90/110 (82)
73.3-88.5
90/113 (80)
71.0-86.6
≥1
16/33 (48)
30.8-66.5
17/41 (41)
26.3-57.9
Abbreviations: CI, confidence interval; ORR, overall response rate; Q2W, every other week; QW, weekly; TCR, T-cell redirection therapy.
Clinical data cutoff date of October 11, 2023.

MonumenTAL-1 Study: Median PFS in Patients With Baseline Extramedullary Disease3,4 
Plasmacytomas
0.4 mg/kg QW
(N=143)
0.8 mg/kg Q2W
(N=154)
Median PFS, Months
95% CI
Median PFS, Months
95% CI
0
9.2
7.0-11.8
16.9
11.3-NE
≥1
4.6
2.8-5.6
3.4
2.1-5.4
Abbreviations: CI, confidence interval; NE, not estimable; PFS, progression-free survival; Q2W, every other week; QW, weekly; TCR, T-cell redirection therapy.
Clinical data cutoff date of October 11, 2023.

Rasche et al (2024)5 presented longer term follow-up efficacy and safety results in patients receiving TALVEY in the MonumenTAL-1 study. The efficacy results of the latest follow-up are summarized below.

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics

  • A total of 143 patients were included in the 0.4 mg/kg SC QW cohort, 154 patients in the 0.8 mg/kg SC Q2W cohort, and 78 patients in the prior TCR-exposed cohort.
  • The median duration of follow-up was 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 cohort.

Efficacy


MonumenTAL-1 Study: ORR in the EMD Plasmacytomas Subgroup5
ORR, % (95% CI)
0.4 mg/kg SC QW (n=143)
0.8 mg/kg SC Q2W (n=154)
Prior TCR
(n=78)
Extramedullary plasmacytomas, ≥1a
48.5 (30.8-66.5)
41.5 (26.3-57.9)
44.0 (24.4-65.1)
Abbreviations: CI, confidence interval; ORR, overall response rate; Q2W, once every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 29, 2024. Data are reported from phase 2 only.
aSoft tissue plasmacytomas not associated with the bone were included.

Krishnan et al (2023)6 evaluated the efficacy and safety of TALVEY in key high-risk and BCMA-exposed subgroups of patients from phases 1/2 of the MonumenTAL-1 study.

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics


MonumenTAL-1 Study: Baseline Demographic Characteristics in EMD Subgroup6
Parameter
0.4 mg/kg SC QW
(n=33)
0.8 mg/kg SC Q2W
(n=37)
Median age, years
60.0
63.0
Male, n (%)
20 (60.6)
23 (62.2)
Race, n (%)
   White
31 (93.9)
32 (86.5)
   Black/AA
2 (6.1)
3 (8.1)
   Asian
0
1 (2.7)
   Native Hawaiian/OPI
0
0
   Not reported/unknown
0
1 (2.7)
Ethnicity, n (%)
Non-Hispanic/non-Latino
28 (84.8)
31 (83.8)
Hispanic/Latino
5 (15.2)
6 (16.2)
ECOG PS, n (%)
   0
10 (30.3)
16 (43.2)
   1
21 (63.6)
18 (48.6)
   2
2 (6.1)
3 (8.1)
Abbreviations: AA, African American; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; OPI, other Pacific Islander; Q2W, once every other week; QW, weekly; SC, subcutaneous.
Clinical data cutoff date of January 17, 2023.

Efficacy

EMD Subgroup

MonumenTAL-1 Study: ORR in EMD Subgroup6
Parameter
0.4 mg/kg SC QW
(n=33)
0.8 mg/kg SC Q2W
(n=37)
Median follow-up, months
18.4
12.1
ORR, n (%)
16 (48.5)
16 (43.2)
Abbreviations: EMD, extramedullary disease; ORR, overall response rate; Q2W, once every other week; QW, weekly; SC, subcutaneous.
Clinical data cutoff date of January 17, 2023.

MonumenTAL-1 Study: Efficacy Outcomes in the EMD Subgroup in the 0.8 mg/kg SC Q2W Cohort6
Parameter
Median DORa,Months (95% CI)
Median PRs, Months (95% CI)
EMD
   0
NE (NE-NE)
NE (14.2-NE)
   ≥1
9.3 (2.3-NE)
3.9 (2.1-5.7)
Abbreviations: CI, confidence interval; DOR, duration of response; EMD, extramedullary disease; NE, not estimable; PFS, progression-free survival; Q2W, once every other week.
Clinical data cutoff date of January 17, 2023.
adore: for ≥1 EMD, n=16; for 0 EMD, n=88.
biffs: for ≥1 EMD, n=37; for 0 EMD, n=108

Safety

  • Adverse events (AEs) observed in the RP2Ds of the 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W EMD subgroup are summarized in Table: MonumenTAL-1 Study: Summary of AEs in the EMD Subgroup.
    • Rates of AEs (dysgeusia, nail AEs, and skin AEs) were lower in EMD subgroup in the 0.4 mg/kg SC QW cohort.
    • Rates of infection were lower in the EMD subgroup in both cohorts.

MonumenTAL-1 Study: Summary of AEs in the EMD Subgroup6
AE, n (%)
0.4 mg/kg SC QW
(n=33)
0.8 mg/kg SC Q2W
(n=37)
Any grade
33 (100.0)
37 (100.0)
Grade 3/4
24 (72.7)
 29 (78.4)
Discontinuations
0
1 (2.7)
CRS
 27 (81.8)
 29 (78.4)
Dysgeusiaa
 17 (51.5)
25 (67.6)
Infections
 15 (45.5)
 17 (45.9)
Skin relatedb
 14 (42.4)
 26 (70.3)
Nail relatedc
 12 (36.4)
 22 (59.5)
Rash relatedd
11 (33.3)
 11 (29.7)
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; EMD, extramedullary disease; Q2W, once every other week; QW, weekly; SC, subcutaneous.
Clinical data cutoff date of January 17, 2023.
aIncludes ageusia, dysgeusia, hypogeusia, and taste disorder. Per CTCAE, the maximum possible grade of dysgeusia is 2.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.
dIncludes rash, maculopapular rash, erythematous rash, and erythema.

Literature Search

A literature search of Ovid MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 29 August 2025.

 

References

Show
1 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.  
2 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.  
3 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.  
4 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.  
5 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.  
6 Krishnan A, Costa L, Schinke C, et al. Talquetamab, a GPRC5D×CD3 bispecific antibody, in relapsed/refractory multiple myeloma: efficacy and safety of patient subgroups from MonumenTAL-1. Poster presented at: The 20th International Myeloma Society (IMS) Annual Meeting and Exposition; September 27-30, 2023; Athens, Greece.  
7 Forsberg M, Beltran S, Goldfinger M, et al. Phenomenon of tumor flare with talquetamab in a patient with extramedullary myeloma. Haematologica. 2024;109(7):2368-2371.  
8 Janssen Research & Development, LLC. A phase 1, first-in-human, open-label, dose escalation study of talquetamab, a humanized GPRC5D x CD3 bispecific antibody, in subjects with relapsed or refractory multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 August 29]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03399799 NLM Identifier: NCT03399799.  
9 Janssen Research & Development, LLC. A phase 1/2, first-in-human, open-label, dose escalation study of talquetamab, a humanized GPRC5D x CD3 bispecific antibody, in subjects with relapsed or refractory multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 August 29]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04634552 NLM Identifier: NCT04634552.  
10 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.