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TALVEY® (talquetamab-tgvs)

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TALVEY - TRIMM-3 (MMY1005) Study

Last Updated: 06/25/2025

SUMMARY

Janssen does not recommend the use of TALVEY in a manner inconsistent with the approved labeling.
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 teclistamab in patients with relapsed or refractory multiple myeloma (RRMM).¹^,²
- Perrot et al (2025)¹ presented the initial safety and efficacy results of TALVEY in combination with cetrelimab from the phase 1b of the TRIMM-3 study at a median follow-up of 11.5 months (range, 1.5-32.3).

CLINICAL DATA - TRIMM-3 Study

TRIMM-3 (MMY1005; clinicaltrials.gov identifier NCT05338775) is a phase 1b, nonrandomized, open-label study evaluating the dosing, safety, and tolerability of a PD-1 inhibitor in combination with TALVEY or teclistamab in patients with RRMM.¹^,²

Study Design/Methods

The study design is presented in Figure: TRIMM-3 Study Design.

TRIMM-3 Study Design¹^,²

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Abbreviations: BsAb, bispecific antibody; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; IMWG, International Myeloma Working Group; IV, intravenous; MM, multiple myeloma; ORR, overall response rate; PK, pharmacokinetics; Q2W, every other week; RP2D, recommended phase 2 dose; RRMM, relapsed or refractory multiple myeloma; SC, subcutaneous.
Note: Talquetamab and cetrelimab dosing regimens were escalated to their respective RP2Ds (talquetamab 0.8 mg/kg Q2W; cetrelimab 240 mg Q2W).
^aPatients received 2 to 3 step-up doses before the first full dose. Premedication included glucocorticoids, antihistamines, and antipyretics at the step-up and first full doses.
^bStarting in cycle 2 day 2.
^cAll patients in the dose expansion cohort had prior exposure to BsAb therapy, including CD3 redirecting antibody therapy.
^dAssessed using IMWG criteria.

Perrot et al (2025)¹ presented the initial safety and efficacy results of TALVEY in combination with cetrelimab from the phase 1b of the TRIMM-3 study at a median follow-up of 11.5 months (range, 1.5-32.3).

Results

Patient Characteristics

Baseline characteristics of patients from the TRIMM-3 study are outlined in Table: TRIMM-3 Study: Baseline Characteristics.

TRIMM-3 Study: Baseline Characteristics¹

Characteristic	All Patients (N=44)
Median age, years (range)	64 (45-87)
Male, n (%)	24 (54.5)
Race, n (%)
White	22 (50.0)
Black/African American	2 (4.5)
Asian	1 (2.3)
Not reported	15 (34.1)
High-risk cytogenetics^a, n (%)	17 (43.6)
ISS stage, n (%)
I	27 (61.4)
II	11 (25.0)
III	6 (13.6)
Median time since diagnosis, years (range)	6.8 (1.0-16.8)
Median prior lines of therapy, n (range)	5 (2-11)
Previous stem cell transplantation, n (%)	34 (77.3)
Prior therapies, n (%)
Triple-class^b	44 (100.0)
Penta-drug^c	29 (65.9)
BCMA-targeted therapy	31 (70.5)
CAR-T	9 (20.5)
BsAb	22 (50.0)
ADC	4 (9.1)
Refractory status, n (%)
Triple-class^b	37 (84.1)
Penta-drug^c	15 (34.1)
Any prior BCMA	24 (54.5)
To last line of therapy	35 (79.5)
Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; ISS, International Staging System; mAb, monoclonal antibody; PI, proteasome inhibitor. Clinical data cutoff date of April 2, 2025. ^adel(17p), t(4;14), and/or t(14;16); percentages calculated from 39 patients. ^b≥1 PI, ≥1 immunomodulatory drug, and ≥1 anti-CD38 mAb. ^c≥2 PIs, ≥2 immunomodulatory drugs, and ≥1 anti-CD38 mAb.

Safety

The incidence of hematologic adverse events (AEs) is outlined in Table: TRIMM-3 Study: Hematologic AEs (≥10% Overall).
The incidence of nonhematologic AEs is outlined in Table: TRIMM-3 Study: Nonhematologic AEs (≥25% Overall).

Infections and Hypogammaglobulinemia

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 immunoglobulin G [IgG] <400 mg/dL) occurred in 56.8% of patients; 34.1% of these patients received ≥1 dose of intravenous immunoglobulin (IVIG).

Cytokine Release Syndrome

Cytokine release syndrome (CRS) primarily occurred during step-up dosing and cycle 1 (prior to the cetrelimab administration) without any treatment discontinuation; all events resolved. No grade ≥3 CRS events were reported. A summary of CRS events is presented in Table: TRIMM-3 Study: CRS Events.

Neurotoxicity

Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 2 patients.

Treatment Discontinuation

No treatment discontinuation was reported due to G protein-coupled receptor class C group 5 member D (GPRC5D)-related AEs.
Treatment discontinuation due to AEs was reported in 14% of patients (n=6). Of these, 2 patients discontinued both TALVEY and cetrelimab due to ataxia and pneumonia, and 4 patients discontinued cetrelimab only due to pemphigoid, immune thrombocytopenia, diarrhea, or diarrhea with eosinophilia.
Dose reduction of TALVEY due to AEs was reported in 20% of patients (n=9).

TRIMM-3 Study: Hematologic AEs (≥10% Overall)¹

AE^a, n (%)	All Patients (N=44)
AE^a, n (%)	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; ASTCT, American Society for Transplantation and Cellular Therapy; 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.

TRIMM-3 Study: Nonhematologic AEs (≥25% Overall)¹

AE^a, n (%)	All Patients (N=44)
AE^a, n (%)	Any Grade	Grade 3/4
Taste events^b	36 (81.8)	0 (0)
Infections	36 (81.8)	13 (29.5)
Nail events^c	33 (75.0)	0 (0)
Nonrash skin events^d	31 (70.5)	0 (0)
CRS	27 (61.4)	0 (0)
Dry mouth	21 (47.7)	0 (0)
Weight decreased	15 (34.1)	1 (2.3)
Diarrhea	14 (31.8)	1 (2.3)
Rash events^e	14 (31.8)	1 (2.3)
PD-1 immune-mediated events^f	13 (29.5)^f	3 (6.8)
Pyrexia	13 (29.5)	0 (0)
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; PD-1, programmed cell death receptor-1. Clinical data cutoff date of April 2, 2025. ^aAEs were graded per CTCAE v5.0, except for CRS, which was graded per ASTCT criteria. AEs reported were treatment emergent. ^bInclude dysgeusia, ageusia, taste disorder, and hypogeusia. Per CTCAE, the maximum grade for dysgeusia is 2. ^cInclude nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. ^dInclude skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. ^eInclude rash, maculopapular rash, erythematous rash, and erythema. ^fImmune-mediated class effects of PD-1 inhibitors include (but are not limited to) pruritus, diarrhea, hypothyroidism, hyperthyroidism, pneumonitis, amylase/lipase increased, and rash. Immune-mediated AEs due to cetrelimab were investigator attributed and included skin-related (18.2%), hematologic (4.5%), gastrointestinal (4.5%), and pyrexia (2.3%).

TRIMM-3 Study: Summary of Infections (≥10% Overall)¹

AE^a, n (%)	All Patients (N=44)
AE^a, n (%)	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; ASTCT, American Society for Transplantation and Cellular Therapy; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events. Clinical data cutoff date of April 2, 2025. ^aPatients with prior TCR, including CAR-T and BsAbs in the MonumenTAL-1 study. AEs were graded per CTCAE v5.0. AEs reported were treatment emergent.

TRIMM-3 Study: CRS Events¹

Parameter	All Patients (N=44)
Patients with CRS^a, n (%)	27 (61.4)
Grade 1	20 (45.5)
Grade 2	7 (15.9)
Time to onset (days)^b, median (range)	2 (1-11)
Duration (days), median (range)	2 (1-7)
Received supportive measures^c, n (%)	24 (54.5)
Tocilizumab	15 (34.1)
Corticosteroids	1 (2.3)
Other	19 (43.2)
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome. Clinical data cutoff date of April 2, 2025. ^aCRS and ICANS were graded per ASTCT criteria. ^bRelative to the most recent dose (day of the most recent dose=day 1). ^cA patient could receive >1 supportive therapy.

Efficacy

At the data cutoff date of April 2, 2025, the overall response rate (ORR) was 70.5% in the overall population. See Table: TRIMM-3 Study: Efficacy Outcomes in the Overall Population.
Efficacy outcomes in patients who received prior bispecific antibody (BsAb) therapy are shown in Table: TRIMM-3 Study: Efficacy Outcomes in Patients With Prior BsAb Therapy.
A total of 18 patients received B-cell maturation antigen (BCMA)-targeted BsAb therapy, of which 1 patient received cevostamab.
BsAb therapy was the immediate prior line of therapy (LOT) for 95% of patients.
The median time since prior BsAb exposure was 39 days.

TRIMM-3 Study: Efficacy Outcomes in the Overall Population¹

Parameter	All Patients (N=44)
Median follow-up, months (range)	11.5 (1.5-32.3)
ORR^a, % (n)	70.5 (31)
sCR, %	34.1
CR, %	6.8
VGPR, %	25.0
PR, %	4.5
≥VGPR, %	65.9
Median time to first response, months (range)	1.9 (0.8-17.5)
Median time to best response, months (range)	4.0 (1.1-22.8)
Median DOR, months (range)	16.8 (10.6-NE)
9-month DOR, %	72.6
6-month PFS, %	69.9
Abbreviations: CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; NE, not evaluable; ORR, overall response rate; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. Clinical data cutoff date of April 2, 2025. ^aResponse was assessed using IMWG criteria. Percentages are calculated with the number of patients in each group as the denominator.

TRIMM-3 Study: Efficacy Outcomes in Patients With Prior BsAb Therapy¹

Parameter	Patients With Prior BsAb Therapy (n=19)
Median follow-up, months (range)	10.9 (1.5-17.5)
ORR^a, % (n)	68.4 (13)
sCR, %	31.6
VGPR, %	31.6
PR, %	5.3
≥VGPR, %	63.2
Median time to first response, months (range)	1.9 (0.8-3.7)
Median time to best response, months (range)	3.7 (1.8-7.4)
Median DOR, months (range)	12.0 (8.9-NE)
9-month DOR, %	65.9
6-month PFS, %	61.5
Abbreviations: BsAb, bispecific antibody; DOR, duration of response; IMWG, International Myeloma Working Group; NE, not evaluable; ORR, overall response rate; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. Clinical data cutoff date of April 2, 2025. ^aResponse was assessed using IMWG criteria. Percentages are calculated with the number of patients in each group as the denominator.

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 23 June 2025.

References

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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.

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 2025 June 23]. Available from: https://clinicaltrials.gov/study/NCT05338775 NLM Identifier: NCT05338775.

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