J&J Medical Connect
TALVEY®

(talquetamab-tgvs)

J&J Medical Connect

Connect with us

  • Products

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 - Occurrence and Management of Skin Toxicities

Last Updated: 02/05/2026

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 skin- and rash-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 skin- and rash-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 skin- and rash-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. Rash-related AEs and non-rash-related skin AEs were reported in the QW, Q2W, and TCR cohorts.
    • Chari et al (2023)5 presented the incidence of skin-related toxicities 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 in combination with 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 skin- and rash-related TEAEs from 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 skin- and rash-related AEs from the TALVEY + pomalidomide cohort of the MonumenTAL-2 study at a longer median follow-up of 20.7 months.
  • RedirecTT-1 is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of TALVEY and TECVAYLI® (teclistamab-cqyv) in patients with RRMM, including those with extramedullary disease (EMD).9-12
    • Usmani et al (2025)10 presented the incidence of nonrash-skin and rash-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 nonrash skin- and rash-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.
    • Mateos et al (2025)12 presented the incidence of nonrash skin- and rash-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.
    • Cohen et al (2025)9 published the incidence of skin-related and rash 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 skin- and rash-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)14 presented the incidence of skin-related AEs from 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 skin- and nonrash-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:
    • Retrospective descriptive study reported skin toxicities.18
    • Cases series and case reports reported skin toxicities.19-22
    • Nursing and advance practice practitioner’s considerations for management of skin 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. GPRC5D is variable in the skin and highest in keratin-expressing hair follicles.32-34
  • Phase 1 dose-escalation studies of GPRC5D-targeting bispecific antibodies (BsAbs) or chimeric antigen receptor T-cell (CAR-T) therapy have reported AEs related to skin toxicities and rash. Clinical symptoms indicative of skin toxicities that may be attributed to GPRC5D-targeting BsAbs may include but are not limited to maculopapular rash, dry skin, palmar-plantar erythrodysesthesia syndrome, pruritus, and alopecia.32,34,35 Skin-related AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).36

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 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).37,38
  • TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).37,38
  • TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.37,38
  • 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 skin- and rash-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


MonumenTAL-1 Study: Summary of Skin- and Rash-Related AEs2
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
Skin relateda
85 (59.4)
0
113 (73.4)
1 (0.6)
53 (67.9)
0
Rash relatedb
57 (39.9)
2 (1.4)
48 (31.2)
8 (5.2)
25 (32.1)
2 (2.6)
Abbreviations: AE, adverse event; Q2W, every other week; QW, weekly, SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of September 2024.
aIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
bIncludes rash, maculopapular rash, erythematous rash, and erythema.

Chari et al (2025)1,39 published the incidence of skin-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


MonumenTAL-1 Study: Summary of Skin- and Rash-Related AEs1,39
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
Non-rash skin-related AEsd
81 (57)
0
0
113 73)
1 (1)
0
49 (63)
0
0
0
Rash-related AEse
57 (40)
2 (1)
0
45 (29)
8 (5)
0
23 (29)
2 (3)
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 included are grade 1/2 events occurring in ≥10% of patients or grade ≥3 AEs occurring in ≥5%. AEs are listed by frequency on an any-grade basis.
dIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
eIncludes rash, maculopapular rash, erythematous rash, and erythema.

MonumenTAL-1 Study: Duration and Outcomes of Skin- and Rash-Related AEs1,39
Event
0.4 mg/kg SC QWa (N=143)
0.8 mg/kg SC Q2Wa (N=154)
Prior TCRa
(N=78)
Non-rash skin-related AEsb
   Total, n (%)
81 (57)
113 (73)
49 (63)
   Leading to dose modification,
   n (%)
12 (8)
2 (1)
4 (5)
   Median duration, days (IQR)
37.5 (20.5-74.5)
40.0 (16.0-98.0)
31.0 (20.0-57.0)
   Outcome, n (%)
      Number of events
157 (-)
195 (-)
99 (-)
         Recovered or resolved
95 (61)
112 (57)
66 (67)
         Not recovered or not
         resolved
58 (37)
76 (39)
33 (33)
         Recovered or resolved
         with sequelae
1 (1)
0
0
         Recovering or resolving
1 (1)
1 (1)
0
         Unknown
0
0
0
      Missing
2 (1)
6 (3)
0
Rash-related AEsc
   Total, n (%)
57 (40)
45 (29)
25 (32)
   Leading to dose modification,
   n (%)
9 (6)
6 (4)
2 (3)
   Median duration, days (IQR)
27.5 (11.5-50.5)
28.5 (13.0-57.0)
14.0 (7.0-28.0)
   Outcome, n (%)
      Number of events
75
68
42
         Recovered or resolved
67 (89)
52 (76)
31 (74)
         Not recovered or not
         resolved
7 (9)
15 (22)
11 (26)
         Recovered or resolved
         with sequelae
0
0
0
         Recovering or resolving
1 (1)
1 (1)
0
         Unknown
0
0
0
         Missing
0
0
0
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.
aReceived 2-3 SUDs.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes rash, maculopapular rash, erythematous rash, and erythema.

MonumenTAL-1 Study: Treatment Discontinuation and Dose Reductions due to Skin- and Rash-Related AEs1,39
Event
0.4 mg/kg SC QWa (N=143)
0.8 mg/kg SC Q2Wa (N=154)
Prior TCRa
(N=78)
Treatment discontinuation
   Skin-related disordersb
2 (1)
2 (1)
0
   Rash-related AEs
0
0
0
Dose reduction due to skin and rash disordersc
7 (5)
3 (2)
4 (5)
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.
aReceived 2-3 SUDs.
bIncludes skin exfoliation, dry skin, and generalized exfoliative dermatitis.
cIncludes dry skin, palmar-plantar erythrodysesthesia syndrome, maculopapular rash, hyperkeratosis, mucocutaneous toxicity, pruritus, rash, skin exfoliation, skin ulcer, and skin fissures.

Rasche et al (2024)3 presented the incidence of skin- and rash-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 Skin- and Rash-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)
Skin relateda
   Total
81 (56.6)
113 (73.4)b
50 (64.1)
   Leading to dose reduction
5 (3.5)
1 (0.6)
2 (2.6)
   Leading to discontinuation
2 (1.4)
1 (0.6)
0 (0)
Rash relatedc
   Total
57 (39.9)d
46 (29.9)e
25 (32.1)f
   Leading to dose reduction
1 (0.7)
1 (0.6)
0 (0)
   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 therapy.
Clinical data cutoff date of January 29, 2024.
aIncluding skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
bIncluding 1 (0.6%) grade 3/4 event.
cIncluding rash, maculo-papular rash, erythematous rash, and erythema.
dIncluding 2 (1.4%) grade 3/4 events.
eIncluding 8 (5.2%) grade 3/4 events.
fIncluding 2 (2.6%) grade 3/4 events.

Chari et al (2024)4 published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study.

Safety Results

  • In the MonumenTAL-1 study, rash-related AEs included rash, maculopapular rash, erythematous rash, and erythema. Non-rash-related AEs included rash, maculopapular rash, erythematous rash, and erythema.
  • A summary of dermatologic AEs associated with TALVEY in MonumenTAL-1 is presented in Table: MonumenTAL-1 Study: Dermatologic AEs Associated With TALVEY.
  • Across all events, patients experienced rash-related toxicity for a median total duration of 73 days (range, 6-610), and non-rash-related toxicity for a median of 196.5 days (range, 3-688).
  • Most rash-related and non-rash-related AEs never reached grade 2, and a majority of them partially or completely resolved. Most skin toxicities were grade 1/2 in severity (grade 3 rash-related AEs, n=12 [3.5%]; grade 3 non-rash-related AE, n=1 [0.3%]) across the 3 cohorts.
  • Few dose modifications occurred due to rash- and non-rash-related AEs.
  • No patients discontinued treatment due to rash-related AEs. Three patients discontinued treatment due to non-rash-related AEs (2 patients due to skin exfoliation in the 0.4 mg/kg QW cohort and 1 patient due to dry skin in the 0.8 mg/kg Q2W cohort).

MonumenTAL-1 Study: Dermatologic AEs Associated With TALVEY4
AE
0.4 mg/kg SC QW
(n=143)
0.8 mg/kg SC Q2W (n=145)
Prior TCR
(n=51)
Skin (rash-related), n (%)
57 (39.9)
43 (29.7)
18 (35.3)
   Median time to onseta, days
20.0
22.0
27.0
   Median durationb, days
28.0
26.0
15.0
   Resolvedc, n (%)
66 (88.0)
47 (72.3)
22 (71.0)
Skin (non-rash-related), n (%)
80 (55.9)
106 (73.1)
35 (68.6)
   Median time to onseta, days
29.5
27.0
26.0
   Median durationb, days
36.0
39.0
32.0
   Resolvedc, n (%)
90 (60.0)
99 (57.2)
45 (63.4)
Abbreviations: AE, adverse event; Q2W, every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.
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

  • According to the MonumenTAL-1 protocol, rashes should be managed following institutional guidelines, with topical corticosteroids used for rashes in the first treatment cycle.
    • Early use of oral corticosteroids is advised to minimize the risk of rash progression.
    • Investigators used low-potency topical corticosteroids for skin toxicities, varying the potency based on the location and severity of the condition, per protocol recommendations.
    • Short pulses of oral corticosteroids should be considered for generalized rashes not controlled by topical corticosteroids and/or those affecting a large surface area.
  • Management of skin toxicities should involve early intervention with liberal use of emollients (applied several times daily and especially after bathing) and adequate systemic hydration at the start of treatment (on and before development of symptoms) is crucial.
  • Concomitant medications were also used to manage skin toxicities in all 3 cohorts. See Table: MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Skin Toxicities.
  • Investigator experience indicates that exfoliation mainly occurs on the palms and soles.
  • Dermatological consultation may be considered for persistent or high-grade skin toxicities, particularly after cycle 2 or if rashes remain unresponsive to emollients or low-potency corticosteroids. This is essential if the treatment center, including its dermatology consultants, has limited experience with TALVEY.
  • Photographic records may help in assessing skin toxicities over time.

MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Skin Toxicities4
AE, n (%)
0.4 mg/kg SC QW (n=143)
0.8 mg/kg SC Q2W (n=145)
Prior TCR
(n=51)
Skin (rash-related)
   Concomitant medications (≥5 patients in
   any cohort)a
42 (29.4)
32 (22.1)
15 (29.4)
      Topical medications
32 (22.4)
23 (15.9)
11 (21.6)
         Corticosteroids
28 (19.6)
22 (15.2)
9 (17.6)
         White soft paraffin
11 (7.7)
4 (2.8)
1 (2.0)
         Liquid paraffin
8 (5.6)
2 (1.4)
1 (2.0)
         Glycerol
7 (4.9)
1 (0.7)
0
         Ammonium lactate
1 (0.7)
5 (3.4)
1 (2.0)
      Oral medications
21 (14.7)
17 (11.7)
8 (15.7)
         Cetirizine
8 (5.6)
3 (2.1)
1 (2.0)
         Corticosteroids
5 (3.5)
7 (4.8)
4 (7.8)
         Desloratadine
5 (3.5)
1 (0.7)
0
Skin (non-rash-related)
   Concomitant medications (≥5 patients
   in any cohort)a
50 (35.0)
57 (39.3)
22 (43.1)
      Topical medications
37 (25.9)
46 (31.7)
20 (39.2)
         Triamcinolone
9 (6.3)
18 (12.4)
7 (13.7)
         Ammonium lactate
4 (2.8)
12 (8.3)
2 (3.9)
         White soft paraffin
7 (4.9)
10 (6.9)
1 (2.0)
         Clobetasol
8 (5.6)
9 (6.2)
1 (2.0)
         Propylene glycol
2 (1.4)
9 (6.2)
1 (2.0)
         Liquid paraffin
8 (5.6)
5 (3.4)
3 (5.9)
         Macrogol
1 (0.7)
8 (5.5)
1 (2.0)
         Simethicone
1 (0.7)
8 (5.5)
1 (2.0)
         Sorbic acid
1 (0.7)
8 (5.5)
1 (2.0)
         Sorbitol
1 (0.7)
8 (5.5)
1 (2.0)
         Betamethasone
7 (4.9)
0
0
      Oral medication
23 (16.1)
10 (6.9)
9 (17.6)
         Cetirizine
5 (3.5)
2 (1.4)
0
Abbreviations: AE, adverse event; Q2W, every other week; QW, weekly; 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 skin toxicities of patients in MonumenTAL-1 who switched to reduced or less frequent dosing with TALVEY at a median follow-up of 13.2 months (range, 4.0±16.1).

Study Design/Methods

  • Patients were divided into the Responsive Dose Intensity Reduction Cohorts and the 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 (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 Skin Toxicities Status After Switch vs Matched Cohort Without Dose Reductiona,5

Abbreviations: AE, adverse event; 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 a respective AE on day 100. Color signifies how that respective AE 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 + 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.6

Cohort D

Nooka et al (2024)8 presented the incidence of skin- and rash-related TEAEs 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

Cohort E

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

Safety Results

AE, %
Any Grade (%)
Grade 3/4 (%)
Skin relateda
74.3
5.7
Rash relatedb
31.4
2.9
Abbreviation: AE, adverse event.Clinical data cutoff date of March 2025.
aIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
bIncludes rash, maculopapular rash, erythematous rash, erythema, pruritic rash, urticaria, dermatitis, eczema, and erythema multiforme.

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 nonrash-skin and rash-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): Nonrash Skin and Rash-Related AEs10
AEa, %
TALVEY + TECVAYLI
(N=90)
Any Grade
Maximum Grade 3/4
Nonrash skin AEb
68.9
0
Rash-related AEc
31.1
1.1
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 skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes rash, maculopapular rash, erythematous rash, and erythema.

Kumar et al (2025)11,40 published the incidence of nonrash skin- and rash-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, nonrash skin- and rash-related AEs were evaluated in patients with RRMM and EMD (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.
  • Nonrash skin AEs included skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. Rash-related AEs included rash, maculopapular rash, erythematous rash, and erythema.
  • Rash-related skin AEs included rash, maculopapular rash, erythematous rash, and erythema.
  • Outcomes for non‑rash skin AEs (n=89 events) included recovery/resolution in 51.7% of patients, not recovered/resolved in 46.1% of patients, recovery/resolution with sequelae in 1.1% of patient, and recovering or resolving in 1.1% of patient.
  • Outcomes for rashrelated AEs (n=36 events) included recovery/resolution in 86.1% of patients and not recovered/resolved in 13.9% of patients.

Occurrence and Management of Nonrash Skin and Rash-related AEs

  • Any-grade nonrash skin AEs were reported in 68.9% of patients (n=62); no grade 3/4 events were reported.
    • Dose modifications due to nonrash skin AEs were reported in 1.1% of patients (n=1).
    • Median time to onset was 4 days (range, 1-30) relative to the most recent dose where day 1 is the day the most recent dose was received, based on 89 nonrash skin AEs.
    • Median duration was 87 days (range, 14-484) among events with both start and end dates available, based on 48 nonrash skin AEs.
    • A total of 37.8% of patients (n=34) received ≥1 supportive therapy for nonrash skin AEs.
  • Any-grade rash-related AEs were reported in 28.9% of patients (n=26); grade 3/4 events were reported in 1.1% (n=1).
    • Dose modifications due to rash-related AEs were reported in 2.2% of patients (n=2).
    • Median time to onset was 6.5 days (range, 1-41) relative to the most recent dose where day 1 is the day the most recent dose was received, based on 36 rash-related AEs.
    • Median duration was 21 days (range, 1-190) among events with both start and end dates available, based on 31 rash-related AEs.
    • A total of 18.9% of patients (n=17) received ≥1 supportive therapy for rash-related AEs.

Mateos et al (2025)12 presented the incidence of nonrash skin- and rash-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: Nonrash Skin and Rash-Related AEs12 
AEa, %
All Dose Levels
(N=94)
Any Grade
Grade 3/4
Nonrash skinb
62.8
1.1
Rash relatedc
43.6
1.1
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 skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes rash, maculopapular rash, erythematous rash, and erythema.

Cohen et al (2025)9,41 published the incidence of skin-related and rash 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, skin-related and rash AEs were reported 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.
  • Skin-related AEs included skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. Rash AEs included rash, maculopapular rash, erythematous rash, and erythema.

Occurrence and Management of Skin-related and Rash AEs

  • Any-grade skin-related AEs were reported in 60.6% of patients (n=57) and rash AEs were reported in 39.4% of patients (n=37) across all dose levels.
  • Any-grade skin-related AEs were reported in 56.8% of patients (n=25) and rash AEs were reported in 31.8% of patients (n=14) in the RP2R cohort.
  • No grade 3/4 skin-related AEs were reported; grade 3 rash AEs were reported in 1.1% of patients (n=1) across all dose levels and in 2.3% of patients (n=1) in the RP2R cohort.
  • Dose modifications due to rash AEs were reported in 2.1% of patients (n=2) across all dose levels.
  • No dose discontinuations were reported for skin-related or rash AEs.
  • The median time to onset was 5 days (range, 1-491) for skin-related AEs and 4 days (range, 1-23) for rash AEs across all dose levels.
  • The median duration was 55 days (range, 1-880) for skin-related AEs and 14 days (range, 1-142) for rash AEs across all dose levels.
  • A total of 60.6% of patients (n=57) with skin-related AEs and 39.4% of patients (n=37) with rash AEs across all dose levels received supportive measures for the management of skin-related AEs and rash AEs.

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 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.

Chari et al (2025)15,42 published the incidence of skin- and rash-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): Skin- and Rash-Related AEs15
Parameter
TALVEY 0.4 mg/kg QW + DARZALEX FASPRO
(n=14)
TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO
(n=51)
Skin AEsa, n (%)
10 (71)
42 (82)
   Grade 3 or 4, n (%)
0
3 (6)
   Leading to dose modificationsb, n (%)
0
3 (6)
   Median time to onsetc, days (range)
1.0 (1-15)
1.0 (1-31)
   Median duration, days (range)
57.0 (12-420)
33.0 (1-388)
   Concomitant medications d, n (%)
7 (50)
22 (43)
   Outcome, n (%)
      Recovered or resolved
17 (68)
43 (57)
      Not recovered or resolved
7 (28)
31 (41)
      Recovering or resolving
1 (4)
1 (1)
Rash AEse, n (%)
6 (43)
24 (47)
   Grade 3/4, n (%)
2 (14)
1 (2)
   Leading to dose modificationsf, n (%)
1 (7)
4 (8)
   Median time to onsetg, days (range)
1.5 (1-17)
2.0 (1-29)
   Median duration, days (range)
31.0 (8-421)
19.5 (1-267)
   Concomitant medicationsh, n (%)
4 (29)
18 (35)
   Outcome, n (%)
      Recovered or resolved
5 (50)
36 (84)
      Not recovered or resolved
3 (30)
7 (16)
      Recovering or resolving
2 (20)
0 (0)
Abbreviations: AE, adverse events; Q2W, every other week; QW, once a week.
aSkin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
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).
dMost common concomitant medications (≥3 patients in the combined cohort) included triamcinolone acetonide, other dermatologicals, ammonium lactate, clobetasol, hydrocortisone, and menthol.
eRash, maculopapular rash, erythematous rash, and erythema.
fDose modification includes cycle delays, delays within cycle, dose reductions, dose skips, and schedule changes.
gRelative to most recent dose (day of most recent dose=day 1).
hMost common concomitant medications (≥2 patients in the combined cohort) included methylprednisolone aceponate, triamcinolone, ammonium lactate, hydrocortisone, and triamcinolone acetonide.
Data cutoff date: November 17, 2023.

TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Treatment Discontinuation and Dose Modification due to Skin- and Rash-Related AEs42
AE, n (%)
All patients (N=65)
Discontinuation
   Discontinuation of TALVEY due to toxic skin eruption
1 (2)
Dose skip
   Dose skips of TALVEY
      Rash AEsa
3 (5)
      Skin AEsb
2 (3)
   Dose skips of DARZALEX FASPRO
      Rash AEsa
2 (3)
Dose reduction
   Rash-related AEsc
1 (2)
   Skin-related AEsd
1 (2)
Abbreviation: AE, adverse event.
aIncludes rash, maculopapular rash, erythematous rash, and erythema. The events that led to TALVEY dose skips were rash and maculopapular rash. The event that led to DARZALEX FASPRO dose skips was maculopapular rash.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. The events that led to TALVEY dose skips were skin exfoliation and palmar-plantar erythrodysesthesia syndrome.
cRash, maculopapular rash, erythematous rash, and erythema. The events that led to dose reduction were rash and maculopapular rash.
dSkin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. The event that led to dose reduction was palmar-plantar erythrodysesthesia syndrome.
Data cutoff date: November 17, 2023.

Bahlis et al (2024)14 presented the incidence of skin-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

  • Skin-related AEs are summarized in Table: TRIMM-2 Study (TALVEY + DARZALEX FASPRO + Pomalidomide Cohort): Non-Rash Skin AEs.
  • Rash (rash, maculopapular rash, erythematous rash, and erythema) was reported in 27.8% and 25.4% of patients in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide and TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + pomalidomide cohorts, respectively.
  • No treatment discontinuation was observed due to skin AEs.

TRIMM-2 Study (TALVEY + DARZALEX FASPRO + Pomalidomide Cohort): Non-Rash Skin AEs14
AEa, 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
Non-rash skin AEsb
16 (88.9)
0 (0)
40 (67.8)
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 29 July 2024.
aGraded by CTCAE v5.0
bSkin AEs include skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.

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

Safety Results


TRIMM-3 Study: Nonrash and Rash-Related AEs (≥25% Overall)16 
AEa, n (%)
All Patients
(N=44)
Any Grade
Grade 3/4
Nonrash skin eventsb
31 (70.5)
0 (0)
Rash eventsc
14 (31.8)
1 (2.3)
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.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes rash, maculopapular rash, erythematous rash, and erythema.

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

Show
1 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.  
2 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.  
3 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.  
4 Chari A, Krishnan A, Rasche L, et al. Clinical management of patients with relapsed/refractory multiple myeloma treated with talquetamab. Clin Lymphoma Myeloma Leuk. 2024;24(10):665-693.e14.  
5 Chari A, Oriol A, Krishnan A, et al. Efficacy and safety of less frequent/lower intensity dosing of talquetamab in patients with relapsed/refractory multiple myeloma: results from the phase 1/2 MonumenTAL-1 study. Oral Presentation presented at: The 65th American Society of Hematology (ASH) Annual Meeting; December 9-12, 2023; San Diego, CA.  
6 Quach H, Perrot A, Matous JV, et al. Talquetamab, a GPRC5D×CD3 bispecific antibody, in combination with pomalidomide in patients with relapsed/refractory multiple myeloma: updated safety and efficacy results from the phase 1b MonumenTAL-2 study. Poster presented at: The 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.  
7 Janssen Research & Development, LLC. A multi-arm phase 1b study of talquetamab with other anticancer therapies in participants with multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 February 3]. Available from: https://clinicaltrials.gov/ct2/show/NCT05050097 NLM Identifier NCT05050097.  
8 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.  
9 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.  
10 Usmani SZ, Kumar S, Mateos MV, et al. Efficacy and safety of talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma and extramedullary disease: updated phase 2 results from the RedirecTT-1 study with extended follow-up. Oral Presentation presented at: the 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.  
11 Kumar S, Mateos MV, Ye JC, et al. Dual targeting of extramedullary myeloma with Talquetamab and Teclistamab. N Engl J Med. 2026;394(1):51-61.  
12 Mateos MV, Magen H, Gatt M, et al. Safety and efficacy of talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma from phase 1b of RedirecTT-1: results with an extended median follow-up of 3 years. Oral presentation presented at: the 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.  
13 Janssen Research & Development, LLC. A phase 1b study of subcutaneous daratumumab regimens in combination with bispecific T cell redirection antibodies for the treatment of subjects with multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 February 3]. Available from: https://clinicaltrials.gov/ct2/show/NCT04108195 NLM Identifier: NCT04108195.  
14 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.  
15 Chari A, van de Donk NWCJ, Dholaria B, et al. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025;146(24):2902-2913.  
16 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.  
17 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 2026 February 3]. Available from: https://clinicaltrials.gov/study/NCT05338775 NLM Identifier: NCT05338775.  
18 Lery M, Perrot A, Ortiz-Brugués A, et al. Dermatological toxicities induced by T-cell-redirecting G protein-coupled receptor family C class 5 member D bispecific antibody talquetamab [abstract]. J Am Acad Dermatol. 2024;90(2):376-377.  
19 Heini AD, Bacher VU, Akhoundova D, et al. Peeling back the layers: recurrent talquetamab skin toxicity after supportive stem cell boost in multiple myeloma. Acta Haematol. 2024;:1-6.  
20 Narayan N, Williams B, Lipe B, et al. Onychomadesis and palmoplantar keratoderma associated with talquetamab therapy for relapsed and refractory multiple myeloma. JAAD Case Rep. 2022;31:66-68.  
21 Kresch M, Guenin S, Mubasher A, et al. Talquetamab-Induced Grover’s Disease. J Drugs Dermatol. 2023;22(8):828-829.  
22 Mansilla‐Polo M, Martín‐Torregrosa D, Martínez‐Cozar V, et al. Dermatological toxicities of talquetamab, a new bispecific antibody: case series and literature review. JDDG: J Dtsch Dermatol Ges. 2024.  
23 Esler E, Ray C, Hefner K, et al. Management considerations for dermatologic toxicities associated with talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma: experience in monumenTAL-1. Poster presented at: The 49th Annual Oncology Nursing Society (ONS) Congress; April 24-28, 2024; Washington, DC.  
24 Purcell K, Catamero D, Dai V, et al. Management considerations for dermatologic toxicities associated with talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. Oral Presentation presented at: The 20th International Myeloma Society (IMS) Annual Meeting Nursing Symposium; September 27-30, 2023; Athens, Greece.  
25 Catamero D, Purcell K, Ray C, et al. Practical management of patients with relapsed/refractory multiple myeloma receiving talquetamab, a GPRC5D×CD3 bispecific antibody: Experience in MonumenTAL-1. Poster presented at: The 20th International Myeloma Society (IMS) Annual Meeting Nurse Symposium; September 27-30, 2023; Athens, Greece.  
26 Catamero D, Ray C, Purcell K, et al. Nursing considerations for the clinical management of adverse events associated with talquetamab in patients with relapsed or refractory multiple myeloma. Semin Oncol Nurs. 2024;40(5):151712.  
27 Schinke C, Dhakal B, Mazzoni S, et al. Real-world experience with clinical management of talquetamab in relapsed/refractory multiple myeloma: a qualitative study of US healthcare providers. Curr Méd Res Opin. 2024;40(10):1705-1711.  
28 Bräuner-Osborne H, Jensen A, Sheppard P, et al. Cloning and characterization of a human orphan family C G-protein coupled receptor GPRC5D. Biochim Biophys Acta. 2001;1518(3):237-248.  
29 Verkleij C, Broekmans M, Duin M. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. Blood Adv. 2021;5(8):2196-2215.  
30 Kodama T, Kochi Y, Nakai W, et al. Anti-GPRC5D/CD3 bispecific T-cell-redirecting antibody for the treatment of multiple myeloma. Mol Cancer Ther. 2019;18(9):1555-1564.  
31 Atamaniuk J, Gleiss A, Porpaczy E, et al. Overexpression of G protein-coupled receptor 5D in the bone marrow is associated with poor prognosis in patients with multiple myeloma. Eur J Clin Invest. 2012;42(9):953-960.  
32 Mailankody S, Devlin S, Landa J, et al. GPRC5D-targeted CAR T Cells for myeloma. N Eng J Med. 2022;387(13):1196-1206.  
33 Smith E, Harrington K, Staehr M, et al. GPRC5D is a target for the immunotherapy of multiple myeloma with rationally designed CAR T cells. Sci Transl Med. 2019;11(485):eaau7746.  
34 Zhang M, Wei G, Zhou L, et al. GPRC5D CAR T cells (OriCAR-017) in patients with relapsed or refractory multiple myeloma (POLARIS): a first-in-human, single-centre, single-arm, phase 1 trial. Lancet Haematol. 2023;10(2):e107-e116.  
35 Riley C, Hutchings M, Yoon SS, et al. RG6234, A novel GPRC5D T-CELL engaging bispecific antibody, induces rapid responses in patients with relapsed/refractory multiple myeloma: preliminary results from a first-in-human trial. Oral presentation presented at: European Hematology Association (EHA) Annual Meeting; June 9-12, 2022; Vienna, Austria/Virtual.  
36 National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.03. National Institute of Health. 2010;(44174).  
37 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.  
38 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.  
39 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.  
40 Kumar S, Mateos MV, Ye JC, et al. Supplement: Dual targeting of extramedullary myeloma with Talquetamab and Teclistamab. N Engl J Med. 2026;394(1):51-61.  
41 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.  
42 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.