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(talquetamab-tgvs)

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TALVEY® (talquetamab-tgvs)

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TALVEY - Occurrence and Management of Nail Toxicity

Last Updated: 03/03/2026

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
    • Rasche et al (2025)2 presented the incidence of nail-related 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)1 published the incidence of nail-related AEs 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)3 presented the incidence of nail-related AEs 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 therapy exposed cohort.
    • Chari et al (2024)4 published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Nail-related AEs were reported in the QW, Q2W, and TCR cohorts.
    • Chari et al (2023)5 presented the incidence of nail-related AEs in patients from the Prospective Dose Intensity Reduction Cohorts of the MonumenTAL-1 study at a median follow-up of 13.2 months.
  • MonumenTAL-2 is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY + other anticancer therapies in patients with multiple myeloma (MM).6-8
    • 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).8
      • Nooka et al (2024)8 presented the incidence of nail-related 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.6
      • Quach et al (2025)6 presented the incidence of nail-related AEs from the TALVEY + pomalidomide cohort of the MonumenTAL-2 study at a longer median follow-up of 20.7 months (range, 1.2-38.7).
  • RedirecTT-1 is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of TALVEY and TECVAYLI® (teclistamab-cqyv) combination in patients with RRMM, including those with extramedullary disease (EMD).9-12
    • Usmani et al (2025)10 presented the incidence of nail-related AEs 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 nail-related AEs from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 12.6 months (range, 0.5-19.5).
    • Mateos et al (2025)12 presented the incidence of nail-related AEs 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.
    • Cohen et al (2025)9 published the incidence of nail-related AEs 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).
  • 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.13-15
    • Chari et al (2025)15 published the incidence of nail-related 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)14presented the incidence of nail-related 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.
  • 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 nail-related AEs in 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.18-27
    • Retrospective descriptive studies reported nail toxicities.18
    • Case reports and case series reported nail toxicities.19-22
    • Nursing and advance practice practitioner’s considerations for management of nail toxicities.23-26
    • Real-world evidence describing and managing skin toxicities.27

PRODUCT LABELING

BACKGROUND

  • G protein-coupled receptor, class C, group 5, member D (GPRC5D) is a 7-segment transmembrane orphan receptor protein that belongs to the family of G-protein-coupled receptors.28 It is predominantly expressed in cells with a plasma-cell phenotype, with higher expression levels on the surface of malignant plasma cells in patients with MM, thereby making it a potential immunotherapeutic target.29-31 It is also found to be expressed in plasma cells and hard, keratinized tissues, such as skin and nails.32-34
  • TALVEY may cause nail toxicity by targeting highly proliferating cells, such as those in the nail matrix, with GPRC5D receptors present on them.20

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).35,36
  • TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).35,36
  • TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.35,36
  • 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.

Rasche et al (2025)2 presented the incidence of nail-related 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

  • Any-grade nail-related AEs (includes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging) were reported in 55.9% of patients (n=80) in 0.4 mg/kg SC QW cohort, 54.5% of patients (n=84) in the 0.8 mg/kg SC Q2W cohort, and 60.3% of patients (n=47) in the prior TCR-exposed cohort. No grade 3/4 nail-related AEs were reported.

Chari et al (2025)1,37 published the incidence of nail-related 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 (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

  • Grade 1/2 nail-related AEs were reported in 55% of patients (n=79) in the 0.4 mg/kg SC QW cohort, 53% of patients (n=82) in the 0.8 mg/kg SC Q2W cohort, and 58% of patients (n=45) in the prior TCR-exposed cohort. No grade 3/4 nail-related AEs were reported.
  • No treatment discontinuation was reported in any cohort due to nail-related AEs.
  • Dose reduction due to nail disorder (includes nail disorder, nail hypertrophy, nail onycholysis and nail onychomadesis) was reported in 1% of patients (n=2) in the 0.4 mg/kg SC QW cohort, 1% of patients (n=1) in the 0.8 mg/kg SC Q2W cohort, and 1% of patients (n=1) in the prior TCR-exposed cohort.
  • The median duration and outcomes of nail-related AEs are presented in Table: MonumenTAL-1 Study: Duration and Outcomes of Nail-Related AEs.

MonumenTAL-1 Study: Duration and Outcomes of Nail-Related AEs37
Nail-Related AEsa
0.4 mg/kg SC QWb (N=143)
0.8 mg/kg SC Q2Wb (N=154)
Prior TCRb
(N=78)
Total, n (%)
79 (55)
82 (53)
45 (58)
Leading to dose modification,
n (%)
1 (1)
1 (1)
2 (3)
Median duration, days (IQR)
106.0 (61.0-190.0)
99.0 (59.0-203.0)
83.0 (18.5-151.5)
Outcome, n (%)
   Number of events
100
105
57
      Recovered or resolved
36 (36)
33 (31)
20 (35)
      Not recovered or not resolved
63 (63)
67 (64)
34 (60)
      Recovered or resolved with
      sequelae
0
0
0
      Recovering or resolving
0
0
0
      Unknown
1 (1)
0
1 (2)
      Missing
0
5 (5)
2 (4)
Abbreviations: AE, adverse event; IQR, interquartile range; 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.
aIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.
bReceived 2-3 SUDs.

Rasche et al (2024)3 presented the incidence of nail-related AEs from the MonumenTAL-1 study in patients receiving TALVEY 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 cohort.

Safety Results


MonumenTAL-1 Study: GPRC5D-Associated Nail-Related AEs3
AE (Any Grade), n (%)
0.4 mg/kg SC QW (n=143)
0.8 mg/kg SC Q2W (n=154)
Prior TCR
(n=78)
Nail relateda
   Total
79 (55.2)
82 (53.2)
46 (59.0)
   Leading to dose reduction
1 (0.7)
1 (0.6)
1 (1.3)
   Leading to discontinuation
0 (0)
0 (0)
0 (0)
Abbreviations: AE, adverse event; GPRC5D, G protein-coupled receptor class C group 5 member D; Q2W, every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection.Clinical data cutoff date of January 29, 2024.
aIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.

Chari et al (2024)4 published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Results specific to nail-related toxicities are summarized below.

Safety Results

  • In the MonumenTAL-1 study, nail toxicities (on fingers and toes) included nail discoloration, nail disorder, onycholysis [separation of the nail from its nail bed], onychomadesis [detachment of the nail from its nail bed], onychoclasis [nail breakage], nail dystrophy, nail toxicity, and nail ridging).
  • A summary of nail-related AEs associated with TALVEY in MonumenTAL-1 is presented in Table: MonumenTAL-1 Study: Nail-Related AEs Associated With TALVEY.
  • All nail-related AEs were grade 1/2, and many events persisted over the course of treatment.
  • The median total duration that patients experienced nail toxicities across all events was 220.5 days (range, 6-832) across the 0.4 mg/kg QW, 0.8 mg/kg Q2W and prior TCR cohorts.
  • Few dose modifications occurred for nail-related toxicities, and no treatment discontinuations were reported due to nail-related toxicities.

MonumenTAL-1 Study: Nail-Related AEs Associated With TALVEY4
AEs
0.4 mg/kg SC QW
(n=143)
0.8 mg/kg SC Q2W (n=145)
Prior TCR
(n=51)
Nail-related AEs, n (%)
78 (54.5)
78 (53.8)
32 (62.7)
   Median time to onseta, days
68.5
67.5
64.0
   Median durationb, days
88.5
74.0
122.0
   Resolvedc, n (%)
32 (32.7)
25 (25.5)
13 (31.7)
Abbreviations: AE, adverse event; Q2W, every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection.
aMedian time to onset calculated relative to the most recent dose received.
bMedian duration is based on events with both start and end time/dates available.
cPatients could have more than 1 event. Percentages are calculated with the number of events as the denominator.

Supportive Measures/Management

  • The MonumenTAL-1 protocol recommends managing nail toxicities with nail soaks, topical moisturizers, and topical corticosteroids.
    • Emollients were commonly used; investigators also considered the use of vitamin E oil, systemic hydration, biotin, triamcinolone 0.025% ointment, and protective coverings like socks and gloves at night for managing nail toxicities.
    • Occlusion may be used to concentrate the effect of topical corticosteroids and moisturizers.
    • Nail hardeners, acrylics, and gels should be avoided to prevent fungal infections.
  • Concomitant medications were also used to manage nail toxicities in all 3 cohorts. See Table: MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Nail Toxicities for additional details.
  • Nail assessments should be part of the physical examination during TALVEY therapy.

MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Nail Toxicities4
Treatment
0.4 mg/kg SC QW (n=143)
0.8 mg/kg SC Q2W (n=145)
Prior TCR
(n=51)
Topical concomitant medications (≥3 patients in any cohort)a
10 (7.0)
11 (7.6)
6 (11.8)
   Ammonium lactate
0 (0)
5 (3.4)
1 (2.0)
   Glycerol
3 (2.1)
1 (0.7)
0 (0)
   Liquid paraffin
3 (2.1)
1 (0.7)
0 (0)
   White soft paraffin
3 (2.1)
1 (0.7)
0 (0)
Abbreviations: AE, adverse event; Q2W, every other week; QW, once every week; SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.
aPatients could receive ≥1 concomitant medication.

Chari et al (2023)5 presented the incidence of nail-related AEs of patients in MonumenTAL-1 who switched to reduced or less frequent dosing with TALVEY at a median follow-up of 13.2 months.

Study Design/Methods

  • Patients were divided into Responsive Dose Intensity Reduction Cohorts and Prospective Dose Intensity Reduction Cohorts.
    • Prospective Dose Intensity Reduction Cohorts (n=19):
      • TALVEY 0.8 mg/kg Q2W was reduced to 0.4 mg/kg Q2W in 9 patients who had partial response or better (≥PR).
      • TALVEY 0.8 mg/kg Q2W was reduced to 0.8 mg/kg Q4W in 10 patients who had ≥PR.

Safety Results

MonumenTAL-1 Study: Prospective Cohorts With Change in Nail Toxicity After Switch vs Matched Cohort Without Dose Reductiona,5

Abbreviations: DR, dose reduction; PR, partial response.
Clinical data cutoff date of October 2, 2023.
aPatients included had ≥PR before day 200 from the prospective dose intensity reduction cohorts (n=18) and from the MonumenTAL-1 cohort who did not dose reduce (n=206). Each category shows only patients who had nail toxicity on day 100. Color signifies how that nail toxicity grade changed from day 100 to last day of follow-up (within 30 days of last treatment; capped at 500 days).

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.7

Cohort D

Nooka et al (2024)8 presented the incidence of nail-related AEs of 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 Nail-Related TEAEs8
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
Nail relateda
5 (62.5)
0
13 (50.0)
0
Abbreviations: Q2W, every other week; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of September 23, 2024.
aIncludes nail discoloration, nail disorder, nail toxicity, nail dystrophy, nail ridging, onychoclasis, onycholysis, and onychomadesis.

Cohort E

Quach et al (2025)6 presented the incidence of nail-related AEs from the TALVEY + pomalidomide cohort of the of the MonumenTAL-2 study at a median follow-up of 20.7 months (range, 1.2-38.7).

Safety Results


MonumenTAL-2 Study (Cohort E): Nail-Related AEs6
AE, %
Any Grade (%)
Grade 3/4 (%)
Nail relateda
68.6
0
Abbreviation: AE, adverse event.
Clinical data cutoff date of March 2025.
aIncludes nail discoloration, nail disorder, nail toxicity, nail dystrophy, nail ridging, onychoclasis, onycholysis, and onychomadesis.

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.9

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

Safety Results


RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Nail-Related AEs10
AEa, %
TALVEY + TECVAYLI
(N=90)
Any Grade
Maximum Grade 3/4
Nail-related AEb
55.6
0
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events.
Clinical data cutoff date of July 18, 2025. Median follow-up 16.8 months.
aAEs graded by CTCAE v5.0. AEs were reported as treatment-emergent AEs recorded up to 30 days after the patient received last study treatment dose or until start of subsequent therapy.
bIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.

Kumar et al (2025)11,38 published the incidence of nail-related AEs 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

  • At the data cutoff date of March 18, 2025, nail-related AEs were evaluated in patients with RRMM and EMD who received TALVEY and TECVAYLI (N=90).
  • AEs were reported up to 30 days after the patient received the last dose of study treatment or until the start of subsequent antimyeloma therapy, whichever occurred first.
  • Nail-related AEs included nail discoloration, nail disorder, nail dystrophy, nail ridging, nail toxicity, onychoclasis, onycholysis, and onychomadesis.

Occurrence and Management of Nail-Related AEs

  • Any-grade nail-related AEs were reported in 55.6% of patients (n=50); no grade 3/4 events were reported.
  • Dose modifications due to nail-related AEs were reported in 1.1% of patients (n=1).
  • Median time to onset was 3 days (range, 1-43) relative to the most recent dose where day 1 is the day the most recent dose was received, based on 57 nail-related AEs.
  • Median duration was 205 days (range, 46-494) among events with both start and end dates available, based on 9 nail-related AEs.
  • A total of 2.2% of patients (n=2) received ≥1 supportive therapy for nail-related AEs.
  • Nail-related AEs were recovered or resolved in 15.8% of patients (n=9) and were not recovered or resolved in 84.2% of patients (n=48).

Mateos et al (2025)12 presented the incidence of nail-related AEs 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.

Safety Results


RedirecTT-1 Study: Nail-Related AEs12
AEa, %
All Dose Levels (N=94)
Any Grade
Grade 3/4
Nail relatedb
52.1
0
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; RP2R, recommended phase 2 regimen.
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.
aAEs graded by CTCAE v5.0.
bIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.

Cohen et al (2025)9,39 published the incidence of nail-related 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, nail-related AEs were reported in patients who received TALVEY and TECVAYLI across all dose levels (N=94) and in the RP2R cohort (n=44).
  • AEs were reported as TEAEs and recorded up to 30 days after the last dose of study treatment.
  • Nail-related AEs included nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.

Occurrence and Management of Nail-Related AEs

  • Any-grade nail-related AEs were reported in 52.1% of patients (N=49) across all dose levels and in 47.7% of patients (n=21) in the RP2R cohort.
  • No grade 3/4 nail-related AEs were reported.
  • No dose modifications or discontinuations were reported for nail-related AEs across all dose levels.
  • The median time to onset of nail-related events was 1 day (range, 1-29) from the last administration of study treatment across all dose levels.
  • The median duration for nail-related AEs was 149.5 days (range, 11-536) across all dose levels.
  • A total of 52.1% of patients (n=49) received supportive measures for the management of nail-related AEs across all dose levels.
  • Nail-related AEs were recovered or resolved in 37.9% of patients (n=22), not recovered or resolved in 58.6% of patients (n=34), and recovering or resolved in 3.4% of patients (n=2).

Clinical Data - TRIMM-2 Study

TRIMM-2 (NCT04108195) is an ongoing, phase 1b, 2-part, multicohort, open-label study evaluating DARZALEX FASPRO 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 lines of treatment (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)15,40 published the incidence of nail-related 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): Nail-Related AEs15
Parameter
TALVEY 0.4 mg/kg QW + DARZALEX FASPRO
(n=14)
TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO
(n=51)
Nail-Related AEsa, n (%)
8 (57)
36 (71)
   Grade 3 or 4, n (%)
0 (0)
0 (0)
   Leading to dose modificationsb, n (%)
1 (7)
1 (2)
   Median time to onsetc, days (range)
4.0 (1-44)
1.0 (1-28)
   Median duration, days (range)
182.0 (15-486)
84.0 (15-646)
   Concomitant medicationsd, n (%)
1 (7)
1 (2)
Outcome, n (%)
      Recovered or resolved
6 (43)
13 (27)
      Not recovered or resolved
8 (57)
35 (73)
Abbreviations: AE, adverse events; Q2W, every other week; QW, once a week.
aNail disorder, nail toxicity, onychomadesis, nail dystrophy, nail discoloration, nail ridging, onycholysis, and onychoclasis.
bDose modification includes cycle delays, delays within cycle, dose reductions, dose skips, and schedule changes.
cRelative to most recent dose (day of most recent dose=day 1).
dConcomitant medications included clobetasol propionate, sodium chloride, tacrolimus monohydrate, urea, and vitamin E (all 1 patient [1.5%] each in the combined cohort).
Data cutoff date: November 17, 2023.

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

Safety Results


TRIMM-2 Study (TALVEY + DARZALEX FASPRO + Pomalidomide Cohort): Nail-Related Events14
AEsa, n (%)
Tal 0.4 mg/kg QW + Dara + Pom (n=18)
Tal 0.8 mg/kg Q2W + Dara+ Pom (n=59)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Nail eventsb
15 (83.3)
0 (0)
33 (55.9)
0 (0)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; Dara, DARZALEX FASPRO; Pom, pomalidomide; Q2W, every other week; QW, weekly; Tal, TALVEY.
Clinical data cutoff date of July 29, 2024.
aGraded by CTCAE v5.0.
bNail AEs include nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.

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 nail-related AEs in the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months (range, 1.5-32.3).

Safety Results

  • Any-grade nail events (nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging) were reported in 75% of patients (n=33); no grade 3/4 nail-related AEs were reported.

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 03 February 2026.

 

References

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37 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.  
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39 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.  
40 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.