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(talquetamab-tgvs)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TALVEY® (talquetamab-tgvs)

Medical Information

TALVEY - Patient Outcomes and Experiences

Last Updated: 09/15/2025

SUMMARY

  • 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
    • Schinke et al (2025)4,5 published patient-reported outcomes (PROs) for T-cell redirection therapy (TCR) naïve patients receiving TALVEY 0.8 mg/kg every other week (Q2W) from the MonumenTAL-1 study. Improvements from baseline were observed in physical, emotional, social functioning, and overall health-related quality of life, as well as in multiple myeloma (MM) symptoms including pain and fatigue.
  • Faiman et al (2024)6 presented the real-world experience of patients receiving TALVEY as well as physician perspectives regarding TALVEY treatment. Patients reported a high overall satisfaction. Symptoms did not limit treatment or cause missed doses. Patients found the symptoms bearable and noted that the treatment was effective at controlling the disease.

ClinIcal data

MonumenTAL-1 (MMY1001; NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.7,8

The study was conducted in 3 parts; the primary objectives are listed below9:

  • Part 1 (phase 1; dose escalation): to characterize the safety of TALVEY and determine the recommended phase 2 doses (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 3 cohorts1,10:

  • TCR naïve: 0.4 mg/kg subcutaneous (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 criteria11:
    • ≥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)4,5 published PROs for TCR-naïve patients receiving TALVEY 0.8 mg/kg Q2W from the MonumenTAL-1 study.

Study Design/Methods

  • PROs were evaluated at screening (designated as baseline and evaluated prior to step-up doses [SUD]), on day 1 of cycle 1 (first-full dose), and on day 1 of every alternate treatment cycle.
  • This study included patients with triple-class-exposed RRMM who received RP2D of TALVEY 0.8 mg/kg Q2W.
  • PRO assessments included the following instruments for scoring:
    • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) with a score range of 0-100:
      • Global health status (GHS) scale: 30 items across one GHS scale.
      • Five functional scales: physical, emotional, role, social, and cognitive.
      • Single items: fatigue, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, nausea and vomiting.
      • Higher scores indicate better GHS and functioning. For symptom-oriented scales, higher scores indicate worse severity, and ≥10 points change from baseline indicates meaningful change.
    • EuroQol 5-Dimension 5-Level (EQ-5D-5L):
      • Visual analogue scale (VAS): patient health rated from 0 (worst) to 100 (best). Assesses generic health status on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
    • Patient Global Impression of Severity (PGIS): severity of MM symptoms rated from "none" to "very severe."

Results

Patient Characteristics and Compliance With PRO assessment

  • As of the data cutoff date of January 29, 2024, a total of 154 patients received TALVEY 0.8 mg/kg Q2W. Out of 154 patients, PRO data from phase 2 were available for 118 who received ≥1 TALVEY dose at a median follow-up of 23.4 months.
  • Baseline characteristics of patients in the PRO population are detailed in Table: Baseline Characteristics in the PRO Population.
  • Compliance in completing EORTC QLQ-C30, EQ-5D-5L-VAS, and PGIS assessments was >95% at screening and >80% at most posttreatment visits.

Baseline Characteristics in the PRO Population5 
Characteristic
N=118
Median (range) age, years
67.5 (38-82)
Male, n (%)
74 (62.7)
Race, n (%)
   White
96 (81.4)
   Black or African American
15 (12.7)
   Asian
4 (3.4)
   Native Hawaiian or other Pacific Islander
1 (0.8)
   Unknown
1 (0.8)
Ethnicity, n (%)
   Not Hispanic or Latino
105 (89.0)
   Hispanic or Latino
13 (11.0)
ECOG PS, n (%)
   0
39 (33.1)
   1
67 (56.8)
   2
12 (10.2)
Time from MM diagnosis (years), median (range)
6.4 (1.1-25.4)
Number of prior lines of therapy, median (range)
5 (3-12)
Refractory status, %
   Triple-class
72
   Penta-drug
27
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; MM, multiple myeloma; PRO, patient-reported outcome.

Change from Baseline in EORTC QLQ-C30

LS Mean Changes From Baseline in EORTC QLQ-C30 (A) Functional Scores and (B) Symptom Scores4 

Abbreviations: BL, baseline; C, cycle; CF, cognitive functioning; EF, emotional functioning; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Core 30-item; GHS, global health status; LS, least square; PF, physical functioning; RF, role functioning; SF, social functioning.
Schinke C, et al. Cancer. 2025 Jul 15;131(14):e35927. Figure reproduced from Schinke C, et al. Cancer. 2025, covered by a CC-BY-4.0 license: http://creativecommons.org/licenses/by/4.0/.

Time to Meaningful Change

  • In most EORTC QLQC-30 domains, median time to first improvement from baseline was 2-3 months; cognitive functioning had median time to improvement of <1 month.
  • Median time to first improvement in GHS vs EQ-5D-5L VAS scores was 2.6 vs 3.4 months.
  • Median time to first worsening from baseline in EORTC QLQC-30 domains was 2-18 months. The shortest time to first worsening was reported for role and social functioning.
  • Median time to first worsening in GHS vs EQ-5D-5L VAS scores was 3.1 vs 5.8 months.
  • Median time to first worsening was 8.3 months for physical functioning, 17.9 months for emotional functioning, and 11.3 months for fatigue.

Impression of MM Severity


PGIS Severity Scores4 
PGIS Scores
BL
N=116
C1
N=96
C3
N=80
C5
N=71
C7
N=63
C9
N=62
C11
N=46
C13
N=40
C15
N=37
C17
N=35
C19
N=30
C21
N=33
C23
N=22
C25
N=12
C27
N=9
Very Severe
12
6
4
1
0
3
2
5
3
3
3
3
5
0
0
Severe
34
37
13
11
18
10
17
10
8
11
10
3
9
17
0
Moderate
35
38
45
38
32
31
30
33
19
17
30
33
18
33
33
Mild
16
17
30
39
43
39
35
35
54
43
47
36
41
42
56
None
3
3
9
10
8
18
15
18
16
26
10
24
27
8
11
Abbreviations: BL, baseline; C, cycle; PGIS, Patient Global Impression of Severity.

real-world study

Faiman et al (2024)6 reported the real-world experience of patients receiving TALVEY as well as physician perspectives regarding TALVEY treatment.

Study Design/Methods

  • This qualitative study involved adults with MM from the United States (US) and physicians who had experience with TALVEY. These patients received TALVEY for at least 4 months.
  • The overall study design was approved by both Johnson & Johnson’s Methods Review Board and the Sterling institutional review board (IRB).

Phase 1

  • Patients were recruited through the HealthTree Cure Hub Registry, a platform sponsored by HealthTree that enables patients to voluntarily share their health information.
  • A 2-hour virtual interview was conducted to discuss patients' experiences 1 to 2 months before and 4 to 5 months after starting TALVEY, focusing on GPRC5D-related symptoms, overall treatment impact, and satisfaction. The interviews took place from February 2024 to April 2024.

Phase 2

  • In May 2024, patients and physicians met at a 2.5-hour, facilitated roundtable in Chicago, IL, to review phase 1 findings and generate ideas for symptom management.

Results


Patient Characteristics6
Characteristic, %
Phase 1
(N=12)
Phase 2
(N=3)
Sex
   Male
67
67
   Female
33
33
Median age, years
   50-59
8
-
   60-69
8
33
   70-79
84
67
Race
   White
84
100
   Hispanic
8
-
   Black/African American
8
-
Education
   Some college
17
-
   College
42
67
   Graduate degree
42
33

Overall Satisfaction With TALVEY


Patient Satisfaction With TALVEY Treatment on a 10-Point Scale6
Extremely Satisfied
(9-10), %
Very Satisfied
(7-8), %
Somewhat Satisfied
(5-6), %
Not Satisfied
(1-4), %
Declined to
Rate, %
42
33
0
17
8

Patient Experience

  • Symptoms did not limit treatment or cause missed doses. Patients found the symptoms bearable and noted that the treatment was effective at controlling the disease. See Table: Patient Experience With Oral Symptoms.
  • Oral symptoms, such as distorted taste/loss of taste and dry mouth, were common with varying severity.
  • Ten patients reported weight loss; 92% of patients maintained adequate nutrition.
  • Skin and nail symptoms were common; 83% of patients reported them having a mild impact on their quality of life.

Patient Experience With Oral Symptoms6
Still Experiencing Symptoms, %
Partial Recovery, %
Full Recovery, %
25
33
42
Abbreviation: GPRC5D, G protein-coupled receptor class C group 5 member D.
Note: A total of 12 patients reported current taste-related symptoms at the time of interview.

Improvements in Quality of Life

  • Ratings largely stayed consistent from 1 to 2 months before starting TALVEY to 4 to 5 months after starting TALVEY; however, improvement was noted more often than decline in several main areas. Physicians affirmed these findings as consistent with their observations. See Table: Improvements in Quality of Life.

Improvements in Quality of Lifea,6
Parameter, %
Improvement
No Change
Decline
Overall energy or strength
25
67
8
Overall emotional health
25
67
8
MM disease-related fatigue
42
50
8
Ability to work, volunteer, or do hobbies
42
50
8
Ability to do common physical activitiesb
25
58
17
Abbreviation: MM, multiple myeloma.
aData reflect patient ratings (n=12) that changed by 2 or more points on a 10-point scale from baseline (1-2 months prior to starting TALVEY) to after testing (4-5 months after starting TALVEY).
bTaking a short walk or climbing a few flights of stairs.

Symptom Management


Physician and Patient Suggestions for Symptom Management Strategies6
Symptom
Symptom Management Strategies to Consider
Taste-related issues
  • Add flavors to enhance taste, such as cinnamon, spice enhancers, or MSG.
  • Liberalize diet to find foods that are palatable and foods to avoid.
  • Center diet around foods that are palatable.
  • Monitor progress over time to note improvements.
Dry mouth
  • Use Biotene® mouthwash, oral dexamethasone rinses, or steroids combined with nystatin rinses.
  • Use lozenges or ice chips to keep the mouth moist.
  • Chew sugar-free gum.
  • Drink ice water with lemon juice.
  • Get regular dental checkups with fluoride application.
Issues swallowing
  • Focus diet on foods that are easier to swallow, and avoid foods that are dry.
  • Prior to eating, stimulate saliva production by chewing something bitter.
  • Use sauce, gravy, salsa, and so on, to maintain moisture in food.
  • Take small bites and small sips of water while eating.
  • Walk or lift the neck up while eating.
Weight loss
  • Monitor weight frequently, especially initially.
  • Maintain regular eating habits and portions.
  • Prioritize getting enough calories and protein.
  • Center diet around foods with a higher number of calories.
  • Work with a nutritional counsellor to address weight-loss issues.
Skin issues
  • Use moisturizers, including topical creams and lotions.
  • Use cortisone creams for itchiness or topical steroids for inflammation.
  • Use emollients to recover from skin peeling.
  • Use mittens or gloves to protect the skin as needed.
  • Proactively monitor for infection.
  • Create a stronger moisture barrier when there is an infection risk.
Nail issues
  • Use nail thickener, nail hardener, or clear nail polish preventatively throughout treatment to strengthen nails.
  • Use products such as tea tree oil or vitamin E to keep nails lubricated.
  • Practice nail hygiene and keep nails short to reduce the risk of snagging.
  • Use cloth or disposable gloves or finger cots to protect nails from snagging.
  • Use topical antibiotics or topical steroids if nails are inflamed or irritated.
  • Educate and reassure patients that while nail loss is annoying, it is not harmful or dangerous.
Abbreviation: MSG, monosodium glutamate.

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 06 September 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 Touzeau C, Chari A, Schinke C, et al. Health-related quality of life in patients with relapsed/refractory multiple myeloma treated with talquetamab, a G protein-coupled receptor family C group 5 member D x CD3 bispecific antibody: patient-reported outcomes from MonumenTAL-1. Poster presented at: 64th American Society of Hematology (ASH) Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA/Virtual.  
4 Schinke C, Touzeau C, Oriol A, et al. Talquetamab improves patient‐reported symptoms and health‐related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL‐1 study. Cancer. 2025;131(14):e35927.  
5 Schinke C, Touzeau C, Oriol A, et al. Supplement to: Talquetamab improves patient‐reported symptoms and health‐related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL‐1 study. Cancer. 2025;131(14):e35927.  
6 Faiman B, Rodriguez C, Giri S, et al. Satisfaction and experiences with talquetamab: results from qualitative patient and physician research. Poster presented at: The 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024; San Diego, CA.  
7 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 September 6]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03399799 NLM Identifier: NCT03399799.  
8 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 September 6]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04634552 NLM Identifier: NCT04634552.  
9 Data on File. Talquetamab. Protocol 64407564MMY1001. Janssen Research & Development, LLC. EDMS-RIM-856432; version 31.0; 2025.  
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.  
11 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.