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TALVEY® (talquetamab-tgvs)

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TALVEY - Dose Modifications

Last Updated: 06/06/2025

SUMMARY

  • MonumenTAL-1 (MMY1001) is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).1-3
    • Chari et al (2025)3,4 published a post hoc analysis with a longer-term follow-up that evaluated the efficacy and safety of TALVEY at the recommended phase 2 dose (RP2D) at a median follow-up of 25.6 months (interquartile range [IQR], 8.5-25.9) for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort, 19.4 months (IQR, 9.2-20.7) for the 0.8 mg/kg SC every other week (Q2W) cohort, and 16.8 months (IQR, 7.6-18.7) for the prior T-cell redirection therapy (TCR)-exposed cohort from phases 1 and 2 of the MonumenTAL-1 study. Dose modifications were reported for the 0.4 mg/kg SC QW (n=143), 0.8 mg/kg SC Q2W (n=145), and prior-TCR exposed TCR (n=51) cohorts.
    • Chari et al (2024)5 published clinical management for adverse events (AEs) associated with TALVEY in patients with RRMM from the MonumenTAL-1 study. Dose modification strategies, including dose reductions, delays, or skips, were reported for the 0.4 mg/kg QW (n=143), 0.8 mg/kg Q2W (n=145), and TCR (n=51) cohorts.
    • Chari et al (2023)6 presented efficacy and safety results in patients from MonumenTAL-1 who switched to reduced or less-frequent dosing with TALVEY at a data cutoff of October 11, 2023, in the responsive dose intensity reduction cohort (n=50) and October 2, 2023, in the prospective dose intensity reduction cohort (n=19).
    • Dose modifications based on efficacy and safety in the MonumenTAL-1 study protocol are summarized below.7
  • Banerjee et al (2024)8 presented a real-world, retrospective, observational, and descriptive cohort study describing TALVEY utilization patterns and dose schedules in patients with RRMM who were identified in the Multiple Myeloma Komodo Commercial Encounters (KCE) claims-based database and treated with TALVEY. The median follow-up time was 2.8 months (IQR, 2.0, 3.6). At the end of follow-up, among patients with ≥3 treatment doses after step-up dosing (SUD), 5/11 patients (45%) on QW dosing switched to Q2W or less-frequent dosing (LFD); 9/33 patients (27%) on Q2W dosing switched to once every 3 weeks (Q3W) or LFD.

Clinical Data - monumental-1 study

MonumenTAL-1 (MMY1001; NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.9,10

The study was conducted in 3 parts; the primary objectives are listed below11:

  • Part 1 (phase 1; dose escalation): to characterize the safety of TALVEY and determine the 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 cohorts1,12:

  • TCR naive: 0.4 mg/kg SC QW, not previously exposed to TCR such as chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibodies (BsAbs; prior B-cell maturation antigen [BCMA] antibody-drug conjugate [ADC] allowed).
  • TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).
  • Prior TCR-exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.
    • Among the prior TCR-exposed cohort, patients were divided based on type of TCR (CAR-T, BsAb, or CAR-T and BsAb).
  • Key eligibility criteria3:
    • ≥18 years of age, measurable MM per International Myeloma Working Group (IMWG) criteria.
    • ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.
    • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.
  • Primary endpoint: overall response rate (ORR).3
  • Key secondary endpoints: duration of response (DOR), progression-free survival (PFS), overall survival, safety, pharmacokinetics, patient reported outcomes, and minimal residual disease.3
  • Dosing
    • SUDs of TALVEY were administered as follows3:
      • 0.4 mg/kg SC QW: 0.01 mg/kg, and 0.06 mg/kg.
      • 0.8 mg/kg SC Q2W: 0.01 mg/kg, 0.06 mg/kg, and 0.3 mg/kg. 
    • Subsequent treatment doses: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W until disease progression, unacceptable toxic effects, withdrawal of consent, or end of study.3
  • Premedications: glucocorticoid (dexamethasone 16 mg or equivalent), antihistamine, and antipyretic were required to be administered for each SUD, and for the first full treatment dose of TALVEY.3
  • Patients were required to be hospitalized for at least 48 hours from the start of each SUD and the first full treatment dose of TALVEY.3
Dose Modification Based on Efficacy
  • Per MonumenTAL-1 protocol (part 3), a switch from the 0.4 mg/kg SC QW dosing to a 0.8 mg/kg SC Q2W dosing schedule may occur at the start of the next cycle when a patient has had a complete response or better (≥CR) for a minimum of 6 months, after the decision has been made and if approved by the sponsor.7
    • At data cutoff (January 17, 2023), 20 patients switched from 0.4 mg/kg SC QW to 0.8 mg/kg SC Q2W after a prolonged response to TALVEY. Hospitalization
      (≥48 hours) was required after each step-up dose and cycle 1 day 1 dosing, but there was no requirement for hospitalization for switching from QW to Q2W after achieving a prolonged response.13,14
Dose Modification Based on Safety
  • Per MonumenTAL-1 protocol (part 3), dose delays are the primary method for managing AEs and toxicities.7
  • Dose reductions or frequency changes could be considered after consultation with the sponsor.15

Chari et al (2025)3,4 published a post hoc analysis with a longer-term follow-up to evaluate the efficacy and safety of TALVEY at RP2D at a median follow-up of 25.6 months (IQR, 8.5-25.9) for the 0.4 mg/kg SC QW cohort, 19.4 months (IQR, 9.2-20.7) for the 0.8 mg/kg SC Q2W cohort, and 16.8 months (IQR, 7.6-18.7) for the prior TCR-exposed cohort from phases 1 and 2 of the MonumenTAL-1 study.

Results

Safety


MonumenTAL-1 Study: Skin-, Nail-, Rash-, and Taste-Related AEs Leading to Dose Modification4
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)
Nail-related AEsc
   Total, n (%)
79 (55)
82 (53)
45 (58)
   Leading to dose modification,
   n (%)
1 (1)
1 (1)
2 (3)
Rash-related AEsd
   Total, n (%)
57 (40)
45 (29)
25 (32)
   Leading to dose modification,
   n (%)
9 (6)
6 (4)
2 (3)
Taste-related AEse
   Total, n (%)
103 (72)
110 (71)
59 (76)
   Leading to dose modification,
   n (%)
12 (8)
9 (6)
6 (8)
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.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.
dIncludes rash, maculopapular rash, erythematous rash, and erythema.
eIncludes dysgeusia, ageusia, hypogeusia, and taste disorder.

MonumenTAL-1 Study: AEs Leading to Treatment Discontinuation and Dose Modification3,4
Event, n (%)
0.4 mg/kg SC QWa (n=143)
0.8 mg/kg SC Q2Wa (n=154)
Prior TCRa
(n=78)
Treatment discontinuation
7 (5)
14 (9)
4 (5)
   Dysgeusia
0
2 (1)
0
   ICANS
2 (2)b
1 (1)b
0
   Ataxia
0
1 (1)
0
   Skin-related disordersc
2 (1)
2 (1)
0
   Nail-related AEs
0
0
0
   Rash-related AEs
0
0
0
   Taste change
0
2 (-)
0
   Administration site conditionsd
2 (1)
2 (1)
0
   Infectionse
2 (1)
0
1 (1)
   Cardiac disordersf
0
2 (1)
0
   Weight decreased
1 (1)
2 (1)
1 (1)
   GI disordersg
2 (1)
0
0
   CRS
0
1 (1)
0
   Graft vs host disease
0
0
1 (1)
   Hypercalcemia
0
1 (1)
0
   AML
0
1 (1)
0
   Myelodysplastic syndrome
0
0
1 (1)
   Renal failure
0
1 (1)
0
Dose reduction
22 (15)
13 (8)
9 (12)
   Taste disorderh
10 (7)
5 (3)
4 (5)
   Weight decreased
7 (5)
4 (3)
2 (3)
   Decreased appetite
2 (1)
1 (1)
1 (1)
   Dry mouth/dysphagia
1 (1)
4 (3)
4 (5)
   Other GI disorderi
2 (1)
1 (1)
0
   Parosmia
1 (1)
0
0
   Skin and rash disordersj
7 (5)
3 (2)
4 (5)
   Nail disorderk
2 (1)
1 (1)
1 (1)
   General disorders and
   administration site conditionsl
4 (3)
0
2 (3)
   CRS
1 (1)
1 (1)
0
   ICANS
1 (1)b
0
0
   Malnutrition
1 (1)
0
0
   CMV infection
0
1 (1)
0
   Myalgia
0
0
1 (1)
   Sinusitis
0
0
1 (1)
   Multisystem inflammatory
   syndrome
0
0
1 (1)
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CMV, cytomegalovirus; CRS, cytokine release syndrome; GI, gastrointestinal; ICANS, immune effector cell-associated neurotoxicity syndrome; 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.
bAssessed only in phase 2, with percentage calculated based on n=122 for the 0.4 mg/kg SC QW cohort and n=118 for the 0.8 mg/kg SC Q2W cohort.
cIncludes skin exfoliation, dry skin, and generalized exfoliative dermatitis.
dIncludes asthenia, general physical health deterioration, and mucosal inflammation.
eIncludes fungal sepsis, pneumonia, and rash pustular.
fIncludes cardiac arrest and sinus bradycardia.
gIncludes colitis and oral AEs.
hIncludes dysgeusia, ageusia, and taste disorder.
iIncludes glossitis, nausea, and oral AEs.
jIncludes dry skin, palmar-plantar erythrodysesthesia syndrome, maculopapular rash, hyperkeratosis, mucocutaneous toxicity, pruritus, rash, skin exfoliation, skin ulcer, and skin fissures.
kIncludes nail disorder, nail hypertrophy, nail onycholysis, and nail onychomadesis.
lIncludes asthenia, chills, fatigue, and malaise.

Chari et al (2024)5 published clinical management for AEs associated with TALVEY in patients with RRMM from the MonumenTAL-1 study.

Results

Safety

  • AEs resulted in treatment discontinuation in 4.9%, 8.3%, and 7.8% of patients and dose reductions in 14.7%, 8.3%, and 9.8% of patients in the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR cohorts, respectively.
  • See Tables: Treatment Discontinuation due to Select TEAEs and Dose Modifications for Select TEAEs for additional details.
  • Dose modification strategies, including reductions, delays, or skips, were advised as per investigator’s experience and were considered as effective management strategies for TEAEs.

Treatment Discontinuation due to Select TEAEs5
AE, n
TALVEY 0.4 mg/kg QW
(n=143)
TALVEY 0.8 mg/kg Q2W
(n=145)
Prior TCR
(n=51)
Dysgeusia
-
2
-
Dysphagia
0
0
0
Dry mouth
0
0
0
Skin (rash-related) toxicity
0
0
0
Skin (nonrash-related) toxicity
2a
1b
0
Nail-related toxicity
0
0
0
Infections
2
0
1
CRS
-
1
0
ICANSc
2
1
-
Rare AEs
   Alopecia
0
0
0
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; Q2W, once every other week; QW, once every week; TCR, T-cell redirection therapy; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of January 17, 2023.
aDue to skin exfoliation.
bDue to dry skin.
cAs ICANS was only assessed in phase 2 of the trial, the number of patients included in the analysis was 122, 109, and 34 in the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR cohorts, respectively.

Dose Modifications for Select TEAEs5
AE, n (%)
TALVEY 0.4 mg/kg QW
(n=143)
TALVEY 0.8 mg/kg Q2W
(n=145)
Prior TCR
(n=51)
Dysgeusia
   Dose modification
12 (8.4)
8 (5.5)
6 (11.8)
      Delayed
0 (0)
0 (0)
0 (0)
      Skippeda
7 (4.9)
4 (2.8)
5 (9.8)
      Reducedb
10 (7.0)
5 (3.4)
4 (7.8)
Dysphagia
   Dose modification
2 (1.4)
2 (1.4)
3 (5.9)
      Delayed
0 (0)
0 (0)
0 (0)
      Skippeda
2 (1.4)
1 (0.7)
1 (2.0)
      Reducedb
0 (0)
1 (0.7)
2 (3.9)
Dry mouth
   Dose modification
2 (1.4)
4 (2.8)
3 (5.9)
      Delayed
0 (0)
0 (0)
0 (0)
      Skippeda
2 (1.4)
2 (1.4)
2 (3.9)
      Reducedb
1 (0.7)
3 (2.1)
2 (3.9)
Skin (rash-related) toxicity
   Dose modification
9 (6.3)
6 (4.1)
2 (3.9)
      Delayed
1 (0.7)
1 (0.7)
0 (0)
      Skippeda
7 (4.9)
5 (3.4)
2 (3.9)
      Reducedb
1 (0.7)
1 (0.7)
0 (0)
Skin (nonrash-related) toxicity
   Dose modification
12 (8.4)
1 (0.7)
3 (5.9)
      Delayed
1 (0.7)
0 (0)
0 (0)
      Skippeda
9 (6.3)
1 (0.7)
3 (5.9)
      Reducedb
5 (3.5)
0 (0)
1 (2.0)
Nail-related toxicity
   Dose modification
1 (0.7)
0 (0)
1 (2.0)
      Delayed
0 (0)
0 (0)
0 (0)
      Skippeda
1 (0.7)
0 (0)
1 (2.0)
      Reducedb
1 (0.7)
0 (0)
0 (0)
Infections
   Dose modification
32 (22.4)
29 (20.0)
10 (19.6)
      Delayed
1 (0.7)
9 (6.2)
0 (0)
      Skippeda
31 (21.7)
20 (13.8)
9 (17.6)
      Reducedb
0 (0)
1 (0.7)
1 (2.0)
CRSc
   Dose modification
18 (12.6)
21 (14.5)
3 (5.9)
      Delayed
17 (11.9)
21 (14.5)
3 (5.9)
      Skippeda
2 (1.4)
2 (1.4)
0 (0)
      Reducedb
1 (0.7)
1 (0.7)
0 (0)
ICANSc,d
   Dose modification
2 (1.6)
2 (1.8)
0 (0)
      Delayed
0 (0)
2 (1.8)
0 (0)
      Skippeda
2 (1.6)
0 (0)
0 (0)
      Reducedb
1 (0.8)
0(0)
0 (0)
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; LFD, less-frequent dosing; Q2W, once every other week; QW, once every week; TCR, T-cell redirection therapy; TCR, T-cell redirection, TEAE, treatment-emergent adverse event.
Clinical data cutoff date of January 17, 2023.
aDefined as patients who had at least 1 dose skip before resuming on the same dosing level and schedule thereafter.
bDefined as changes to either a reduced dose or an LFD schedule.
c≥1 treatment-emergent symptoms of CRS/ICANS leading to dose modification.
dAs ICANS was only assessed in phase 2 of the trial, the number of patients included in the analysis was 122, 109, and 34 in the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR cohorts, respectively.

Chari et al (2023)6 presented efficacy and safety results in patients in MonumenTAL-1 who switched to reduced or LFD with TALVEY.

Study Design/Methods

  • Patients were treated at the RP2Ds and reduced dose once they achieved a response.
  • Patients were divided into the Responsive Dose Intensity Reduction Cohorts and the Prospective Dose Intensity Reduction Cohorts:
    • Responsive Dose Intensity Reduction Cohorts (n=50); after treatment at the RP2Ds, patients received reduced dose or less-frequent dose. Patients had partial response or better (≥PR), TEAE mitigation or both:
      • In TCR-naïve TALVEY 0.4 mg/kg QW cohort: 25 patients received a reduced dose or a less-frequent dose.
      • In TCR-naïve TALVEY 0.8 mg/kg Q2W cohort: 15 patients received a reduced dose or a less-frequent dose.
      • In the prior TCR TALVEY 0.4 mg/kg QW or 0.8 mg/kg Q2W cohort: 10 patients received a reduced dose or less-frequent dose.
    • 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 ≥PR.
      • TALVEY 0.8 mg/kg Q2W was reduced to 0.8 mg/kg once every 4 weeks in 10 patients who had ≥PR.

Results

Efficacy

  • Responsive Dose Intensity Reduction Cohorts: At a data cutoff date of October 11, 2023, most patients with dose reductions were in response. Relative to treatment start, dose reduction occurred at a median of 3.2 months (range, 1.8-27.0) in the QW cohort, 4.5 months (range, 1.2-28.9) in the Q2W cohort and 4.7 months (range, 2.3-9.7) in the prior TCR cohort. Full details are provided in Table: Duration of Response (Responsive Dose Intensity Reduction Cohorts).
  • Prospective Dose Intensity Reduction Cohorts: At a data cutoff of October 2, 2023, patients with dose reductions had to be in response (n=19). Relative to treatment start, dose reduction occurred at a median of 3.1 months (range, 2.3-4.2). Full details are provided in Table: Response and Duration of Response (Prospective Dose Intensity Reduction Cohorts).

Duration of Response (Responsive Dose Intensity Reduction Cohorts)6
Responders With Dose Reductions
QWa (n=24)
Q2Wb (n=13)
Prior TCRc (n=10)
Median follow-up, months (range)
27.6 (2.7-41.2)
20.8 (12.3±33.6)
21.3 (9.2-29.4)
Median DOR, months (95% CI)
19.8 (12.7-NE)
NE (12.5-NE)
24.2 (20.4-NE)
12-month DOR rate, % (95% CI)
78.3 (55.4-90.3)
84.6 (51.2-95.9)
100.0 (100.0-100.0)
Abbreviations: AE, adverse event; CI, confidence interval; DOR, duration of response; NE, not estimable; Q2W, once every other week; QW, once every week; TCR, T-cell redirection therapy.
Clinical data cutoff date of October 11, 2023.
aPatients who dose reduced due to AE (n=21); patients who dose reduced due to response only (n=3).
bPatients who dose reduced due to AE (n=11); patients who dose reduced due to response only (n=2).
cPatients who dose reduced due to AE (n=9); patients who dose reduced due to response only (n=1).

Response and Duration of Response (Prospective Dose Intensity Reduction Cohorts)6
Prospective Cohorts
(n=19)
Median follow-up, months (range)a
13.2 (4.0±16.1)
Median PFS, months (95% CI)a
13.2 (8.8-NE)
   12-month PFS rate, % (95% CI)a
50.1 (27.9-68.7)
Median DOR, months (95% CI)
NE (8.3-NE)
ORR, n (%)
19 (79.2)a
   sCR, %
25.0a
   CR, %
29.2a
   VGPR, %
20.8a
   PR, %
4.2a
≥VGPR, %
75.0a
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; NE, not estimable; 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 October 2, 2023.
aBased on all patients included in the cohorts (N=24).

Safety

Prospective Cohorts With Change in AE Status After Switch vs Matched Cohort Without Dose Reductiona,6

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).

Immune Fitness in Dose-Reduced Cohorts

  • As of October 2, 2023, maintenance of CD3+ T-cell recovery was comparable between dose-reduced and non-dose-reduced cohorts between Cycle 3 Day 1 and Cycle 7 Day 1 of TALVEY (12/68 patients from the RP2D group included in the analysis had dose reductions outside the Cycle 3 Day 1 and Cycle 7 Day 1 timeframe).
  • Reduction in coinhibitory receptor expression in dose-reduced vs sustained expression in non-dose-reduced cohorts between Cycle 3 and Cycle 7 of TALVEY was observed.

Real-world study - TALVEY UTILIZATION PATTERNS AND DOSE SCHEDULES

Banerjee et al (2024)8 presented a real-world, retrospective, observational, and descriptive cohort study describing TALVEY utilization patterns and dose schedules in patients with MM identified in the MM KCE database and treated with TALVEY.

Study Design/Methods

  • The study included patients with MM treated with TALVEY, as identified in the MM KCE database, between August 9, 2023 (United States [US] approval date) and March 4, 2024.
  • Patients were identified using Komodo Healthcare Map™. See Figure: Study Design: Tal Utilization Patterns and Dose Schedules for additional details.
  • Eligibility criteria:
    • Adult patients with ≥1 MM diagnosis code, ≥1 pharmacy or medical claim for TALVEY (between August 9, 2023 [US approval date], and March 4, 2024 [latest data cut]), and triple-class exposure were included in this study.
    • Patients enrolled in clinical trials were excluded.
  • Primary objective:
    • To describe the demographic and clinical characteristics, treatment history, and TALVEY utilization patterns in patients treated with TALVEY from the MM KCE claims-based database.

Study Designa: Tal Utilization Patterns and Dose Schedules8

Abbreviations: BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell; MM, multiple myeloma; PI, protease inhibitor; SUD, step-up dosing; tal, talquetamab.
aData were collected from the Komodo Health payer-complete dataset.
bThe index date was the date of an inpatient TALVEY encounter that occurred within 28 days prior to the first TALVEY treatment dose (40 mg/mL) in the outpatient setting, or the date of the first outpatient TALVEY step-up dosing (SUD; 3 mg/1.5 mL) claim.
cDemographic characteristics included age, race, ethnicity, region, and payer channel.
dThe baseline period (used to describe patient demographic and clinical characteristics) was 6 months before the index date.
eTreatment history included, PI, BCMA, and CAR-T.

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics


Demographic and Clinical Characteristics of Patients Treated With TALVEY8
Characteristic
Patients With RRMM With an eligible
TALVEY Claim
(n=82)
Age at index
   Age (years), median (IQR)
65.0 (57.0-71.8)
   ≥ 75 years, n (%)
14 (17.1)
Sex, n (%)
   Male
48 (58.5)
   Female
34 (41.5)
Race, n (%)
   White
50 (65.8)
   Black
14 (18.4)
   Hispanic
3 (3.9)
   Other/Unknown
9 (11.8)
Comorbidities, n (%)
   Infections
38 (46.3)
   Peripheral neuropathy
35 (42.7)
   Hypogammaglobulinemia
34 (41.5)
   Extramedullary plasmacytoma
3 (3.7)
   Solitary plasmacytoma
6 (7.3)
   Plasma cell leukemia
1 (1.2)
Prior LOT, n, median (IQR)
5 (4-7)
Treatment history, n (%)
   Prior triple-class exposed
82 (100)
   Prior penta-drug exposed
35 (42.7)
Prior therapiesa, n (%)
   Prior commercial BCMA-targeted therapy
56 (68.3)
      Teclistamab
39.0
      Belantamab mafodotin-blmf
20.7
      Idecabtagene vicleucel
20.7
      Ciltacabtagene autoleucel
7.3
      Elranatamab
1.2
   Prior TCR therapies naïve
39
Abbreviations: IQR, interquartile range; LOT, line of therapy; RRMM, relapsed or refractory multiple myeloma; TCR, T-cell redirection.
aSome patients had prior treatment with >1 therapy.

TALVEY Utilization

  • A total of 89.0% of the patients (n=73) received TALVEY as monotherapy. See Table: TALVEY Utilization Patterns in Patients With RRMM.
  • The first observed LFD schedule among patients who received ≥3 treatment doses after SUD is presented in Table: First Observed LFD Schedule.
    • A total of 7/11 patients (63.6%) on QW switched to Q2W or LFD (median time to switching: 43 days), and 12/33 patients (36.4%) on Q2W switched to Q3W or LFD (median time to switching: not reached).
    • At the end of the follow-up period, 5/11 patients (45%) on QW switched to Q2W or LFD, and 9/33 patients (27%) on Q2W dosing switched to Q3W or LFD. See Table: Dosing Frequency at the End of Follow-Up, by Initial Dosing Schedule.
    • At the data cutoff, among patients with ≥3 treatment doses after SUD (n=50), 8 (16.0%), 32 (64.0%), and 6 (12.0%) patients were on QW, Q2W, and once every 4 weeks (Q4W) schedules, respectively.

TALVEY Utilization Patterns in Patients With RRMM8
TALVEY Regimen, n (%)a
Patients With RRMM With an Eligible TALVEY Claim
(n=82)
TALVEY
73 (89.0)
TALVEY + Teclistamab
3 (3.7)
TALVEY + Pomalidomide
2 (2.4)
TALVEY + Bortezomib
1 (1.2)
TALVEY + Daratumumab + Carfilzomib + Ixazomib
1 (1.2)
TALVEY + Daratumumab
1 (1.2)
TALVEY + Isatuximab + Pomalidomide
1 (1.2)
Abbreviation: RRMM, relapsed or refractory multiple myeloma.
aCombination regimens were identified within 2 months following the initiation of TALVEY.

First Observed LFD Schedulea,8
Initial treatment frequency
First LFD, n (%)
Q2W
(12-17 days)
Q3W
(18-24 days)
Q4W
(25-31 days)
Other
(≥32 days)
QW (6-11 days; n=11)
6 (54.5)
0
0
1 (9.1)
Q2W (12-17 days; n=33)
NA
4 (12.1)
6 (18.2)
2 (6.1)
Abbreviations: LFD, less-frequent dosing; NA, not applicable; Q2W, every other week; Q3W; once every 3 weeks; Q4W; once every 4 weeks; QW, weekly.
aAmong patients who received ≥3 treatment doses after SUD, the first observed LFD was defined as having ≥2 consecutive doses administered at a lower frequency than the initial treatment schedule.

Dosing Frequency at the End of Follow-Up, by Initial Dosing Schedulea,8
Frequency of the First Treatment
Frequency at the End of Follow-Up, n (%)
QW
(6-11 days)
Q2W
(12-17 days)
Q3W
(18-24 days)
Q4W
(25-31 days)
Other
(≥32 days)
QW (6-11 days; n=11)
6 (54.5)
4 (36.4)
0
0
1 (9.1)
Q2W (12-17 days; n=33)
2 (6.1)
22 (66.7)
2 (6.1)
6 (18.2)
1 (3.0)
Abbreviations: Q2W, every other week; Q3W; once every 3 weeks; Q4W; once every 4 weeks; QW, weekly; SUD, step-up dosing.
aAmong patients with ≥3 treatment doses after SUD.

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 June 2025.

 

References

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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 Chari A, Touzeau C, Schinke C, et al. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025;12(4):e269-e281.  
4 Chari A, Touzeau C, Schinke C, et al. Supplement to: Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025;12(4):e269-e281.  
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6 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.  
7 Data on File. Talquetamab. Protocol 64407564MMY1001. Janssen Research & Development, LLC. EDMS-RIM- 856432; version 22.0; 2021.  
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9 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 June 6]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03399799 NLM Identifier: NCT03399799.  
10 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 June 6]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04634552 NLM Identifier: NCT04634552.  
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15 Data on File. Janssen Scientific Affairs, LLC. Correspondence from Medical Affairs (Communication dated 09 August 2023); 2023.  
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