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TALVEY - TALisman Study
Last Updated: 07/07/2026
SUMMARY
- Johnson & Johnson does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
- TALisman is a randomized, multicenter, open-label, phase 2 study that aims to investigate prophylactic interventions for oral toxicities associated with the use of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM).1
- 4 - van de Donk et al (2026)4 presented updated results on dysgeusia and patient-reported outcomes at median follow-up durations of 5.8 months in the TALVEY-only group (group A), 5.4 months in the prophylactic dexamethasone group (group B), and 4 months in the prophylactic pregabalin group (group C).
- Popat et al (2025)3
presented preliminary results on the utility and sensitivity of the water extract taste test (WETT)-SA53 for detecting dysgeusia in patients treated with TALVEY. WETT detected early onset of taste changes and improvement and resolution starting after 3 months; 46% of patients showed resolution or improvement after 3 months and 60% after 7 months.
Study Design/Methods
- The study design is presented in the Figure: TALisman Study Design.
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Results
Patient Characteristics
- Patient characteristics are presented in Table: TALisman Study: Patient Characteristics.
- The median age was 62-69 years, median time from multiple myeloma diagnosis to randomization was 5.9-6.2 years, and the median number of prior lines of therapy was 4.
| Characteristic, % | Cohort A (n=19) | Cohort B (n=15) | Cohort C (n=16) |
|---|---|---|---|
| Male | 63.2 | 46.7 | 75 |
| Race | |||
| American Indian or Alaska Native | 5.3 | 0 | 0 |
| Asian | 15.8 | 20 | 12.5 |
| Black or African American | 5.3 | 13.3 | 12.5 |
| White | 73.7 | 66.7 | 75 |
| ISS stage | |||
| I | 36.8 | 53.3 | 25 |
| II | 31.6 | 26.7 | 25 |
| III | 31.6 | 20 | 50 |
| Abbreviation: ISS, International Staging System. | |||
Safety
- Dysgeusia incidence per WETT and Scale of Subjective Total Taste Acuity (STTA) analyses are presented in Tables: TALisman Study: Dysgeusia Incidence per WETT and TALisman Study: STTA Analyses Over Time.
- Data for dysgeusia and dry mouth severity per the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Table: TALisman Study: PRO-CTCAE Dysgeusia Severity and Dry Mouth Over Time.
- Mucin 5B (MUC5B)/amylase levels are presented in Table: TALisman Study: Changes in Salivary MUC5B and Amylase Levels Between C1D1 and C3D1.
- No patients discontinued TALVEY due to AEs.
- Overall, 63.2% of patients had dose modification of TALVEY.
- Hematologic and nonhematologic AEs are presented in Table: TALisman Study: Hematologic and Nonhematologic AEs.
| Parameter | Cohort A (n=19) | Cohort B (n=15) | Cohort C (n=16) |
|---|---|---|---|
| Patients with dysgeusia, n (%) | 16 (84.2) | 13 (86.7) | 16 (100) |
| Patients with severe dysgeusia, n (%) | 12 (63.2) | 13 (86.7) | 16 (100) |
| Median time to dysgeusia, days (95% CI) | 11.9 (6.1-28) | 7.9 (3-24) | 10 (4-21.9) |
| Median time to severe dysgeusia, days (95% CI) | 67.9a (7.9-NR) | 9.1 (4.9-28.9) | 16.4 (7.9-32.9) |
| Patients with improvement/resolutionb of dysgeusia, % | |||
| Month 3 | 66.7 (10/15) | 33.3 (4/12) | 57.1 (8/14) |
| Month 7 | 75 (3/4) | 60 (3/5) | NA |
| Month 9 | 100 (1/1) | - | - |
| Month 11 | 100 (2/2) | - | - |
| Abbreviations: CI, confidence interval; NA, not applicable; WETT, waterless empirical taste test. aThree patients in the TALVEY-only cohort had onset of severe dysgeusia during cycle 3 (median time to severe dysgeusia, 75 days (range, 68-99); 1 of 3 patients received repeat step-up dosing. bResolution/improvement is defined as either dysgeusia downgraded to no dysgeusia, or severe dysgeusia downgraded to dysgeusia or no dysgeusia. | |||
| STTA, % | Cohort A | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| C1D15 (n=16) | C2D1 (n=16) | C3D1 (n=14) | C4D1 (n=14) | C5D1 (n=10) | C6D1 (n=7) | C8D1 (n=5) | C10D1 (n=2) | C12D1 (n=1) | |
| Same taste | 31 | 13 | 14 | 7 | 10 | 14 | 40 | 50 | 100 |
| Mild loss | 25 | 31 | 14 | 21 | - | 43 | 40 | 50 | - |
| Moderate loss | 13 | 31 | 29 | 21 | 70 | 14 | 20 | - | - |
| Severe loss | 19 | 13 | 43 | 21 | - | 29 | - | - | - |
| Complete loss | 13 | 13 | - | 29 | 20 | - | - | - | - |
| Abbreviations: C, cycle; D, day; STTA, scale of subjective total taste acuity. | |||||||||
| Cohort A | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | C2D1 | C3D1 | C4D1 | C5D1 | C6D1 | C8D1 | C10D1 | C12D1 | |
| Dysgeusia severityb | |||||||||
| Number of patients, n | 16 | 16 | 14 | 14 | 10 | 7 | 5 | 2 | 2 |
| None, % | 87.5 | 12.5 | 7.1 | 14.3 | 10 | 28.6 | 40 | 50 | 100 |
| Mild, % | 6.3 | 25 | 28.6 | 21.4 | 30 | 14.3 | 40 | 50 | - |
| Moderate, % | - | 18.8 | 21.4 | 21.4 | 30 | 28.6 | - | - | - |
| Severe, % | 6.3 | 31.3 | 21.4 | 35.7 | 30 | 28.6 | 20 | - | - |
| Very severe, % | - | 12.5 | 21.4 | 7.1 | - | - | - | - | - |
| Dry mouth severity | |||||||||
| Number of patients, n | 16 | 16 | 14 | 14 | 9 | 6 | 5 | 2 | 2 |
| None, % | 50 | 25 | 14.3 | 14.3 | 22.2 | 50 | 80 | 50 | 100 |
| Mild, % | 31.1 | 12.5 | 35.7 | 21.4 | 22.2 | 33.3 | - | - | - |
| Moderate, % | 12.5 | 31.3 | 42.9 | 50 | 55.6 | - | 20 | 50 | - |
| Severe, % | 6.3 | 31.3 | 7.1 | - | - | 16.7 | - | - | - |
| Very severe, % | - | - | - | 14.3 | - | - | - | - | - |
| Abbreviations: C, cycle; D, day; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; STTA, scale of subjective total taste acuity. aIncludes all patients from the concurrent control group of cohorts B and C. bPatients responded to the prompt “In the last 7 days, what was the severity of your problems with tasting food or drink at their worst?” | |||||||||
| Group | n (C1D1) | n (C3D1) | C1D1 Median | C3D1 Median | % Change | P Value | |
|---|---|---|---|---|---|---|---|
| MUC5Ba | Stimulated salivaᵇ | 25 | 7 | 0.7 | 0.06 | 92% decreaseᶜ | <0.001 |
| Unstimulated salivaᵇ | 25 | 7 | 0.43 | 0.05 | 88% decreaseᶜ | <0.001 | |
| Amylasea | Stimulated salivaᵇ (Excellent/normal taste) | 20 | 3 | 63.9 | 92.7 | 45% increaseᶜ | ns |
| Stimulated salivaᵇ (Dysgeusia/severe dysgeusia) | 5 | 4 | 72.5 | 39.9 | 45% decreaseᶜ | ns | |
| Unstimulated salivaᵇ (Excellent/normal taste) | 20 | 3 | 63.9 | 103.9 | 63% increaseᶜ | ns | |
| Unstimulated salivaᵇ (Dysgeusia/severe dysgeusia) | 5 | 4 | 70.7 | 22.9 | 68% decreaseᶜ | ns | |
| Abbreviations: C, cycle, D, day; MUC5B, mucin 5B; ns, not significant; NR, not reported; PRO, patient-reported outcome. ᵃIncludes patients from cohorts A and B for whom data were available. ᵇUnstimulated saliva represents baseline salivary secretion at rest; stimulated saliva is salivary secretion collected in response to stimulus (chewing a standardized absorptive sponge). ᶜPercent change calculated between C1D1 and C3D1. | |||||||
| TEAE, n (%)b | Total (N=19) | |
|---|---|---|
| Any grade | Grade 3/4 | |
| Hematologic AEsc | ||
| Neutropenia | 11 (57.9) | 10 (52.6) |
| Thrombocytopenia | 10 (52.6) | 6 (31.6) |
| Anemia | 7 (36.8) | 3 (15.8) |
| Nonhematologic AEs | ||
| Skin and subcutaneous tissue disordersd | 18 (94.7) | 0 |
| Infectionse | 12 (63.2) | 6 (31.6) |
| Dysgeusiaf | 12 (63.2) | - |
| CRS | 8 (42.1) | 0 |
| Xerostomia | 8 (42.1) | 0 |
| Abbreviations: AE, adverse event; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events. aPer CTCAE v5.0. bIncludes all patients from the concurrent control group of cohorts B and C. cMaximum toxicity grade. dIncludes dry skin, skin exfoliation, pruritus, onychomadesis, palmar-plantar erythrodysesthesia syndrome, nail dystrophy, erythema, nail disorder, onychoclasis, onycholysis, rash, dermatitis, eczema, exfoliative rash, madarosis, night sweats, palmar erythema, petechiae, photosensitivity reaction, plantar erythema, rash erythematosus, rash maculopapular, rash pruritic, skin fissures. eMaximum toxicity grade by System Organ Class. Most common infections were pneumonia (15.8%) and gastroenteritis (10.5%). fMaximum grade of dysgeusia is 2 per CTCAE. | ||
Results
Patient Characteristics
- Patient characteristics are presented in Table: TALisman Study: Patient Characteristics.
- Of the 28 patients enrolled, 46.4% of patients (n=13) received ≥3 cycles of TALVEY, with 17.9% of patients (n=5) continuing through ≥6 and ≥10 cycles.
| Characteristic | Total (N=28) |
|---|---|
| Median age, years (range) | 62.5 (48-82) |
| Male, n (%) | 16 (57.1) |
| Race, n (%) | |
| Asian | 6 (21.4) |
| Black/African American | 3 (10.7) |
| White | 19 (67.9) |
| Median time from MM diagnosis to randomizationa, years (range) | 6.4 (0.9-13) |
| ISS stageb, n (%) | |
| I | 12 (44.4) |
| II | 9 (33.3) |
| III | 6 (22.2) |
| Median number of prior lines of therapies, n (range) | 3.5 (1-10) |
| Abbreviations: ISS, International Staging System; MM, multiple myeloma. aData available for 18 patients. bData available for 27 patients. | |
Safety
- TEAEs were reported in 92.9% of patients; however, none resulted in treatment discontinuation.
- Objective taste changes assessed by WETT were identified earlier than subjective taste changes reported by patients through STTA.
- WETT and STTA changes over time are presented in Table: TALisman Study: WETT and STTA Analyses Over Time.
- WETT scores to detect improvement or resolution of dysgeusia after 3 and 7 months are presented in Table: TALisman Study: WETT Scores (Dysgeusia).
- Apart from dysgeusia, the most frequently observed adverse events (AEs) included cytokine release syndrome (42.9%), neutropenia (35.7%), and thrombocytopenia (32.1%).
| STTA (Subjective), % | Cycle 1 Day 15 (n=18) | Cycle 2 Day 1 (n=15) | Cycle 3 Day 1 (n=12) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| WETT (Objective) | |||||||||
| Normal | Dysgeusia | Severe Dysgeusia | Normal | Dysgeusia | Severe Dysgeusia | Normal | Dysgeusia | Severe Dysgeusia | |
| Same taste | 5.6 | 5.6 | 16.7 | 6.7 | - | - | - | - | - |
| Mild/ moderate loss | 11.1 | 5.6 | 22.2 | 6.7 | 6.7 | 40 | 8.3 | - | 16.7 |
| Severe/ complete loss | 11.1 | - | 22.2 | 13.3 | 13.3 | 13.3 | 25 | 16.7 | 33.3 |
| Abbreviations: WETT, waterless empirical taste test; STTA, scale of subjective total taste acuity. | |||||||||
| Time Point | Number of Patients Evaluated | Number of Patients With Improvement or Resolutiona | Improvement Rate (%) |
|---|---|---|---|
| After 3 months | 13b | 6 | 46 |
| After 7 months | 5c | 3 | 60 |
| Abbreviation: WETT, waterless empirical taste test. aResolution/improvement is defined as either dysgeusia downgraded to no dysgeusia, or severe dysgeusia downgraded to nonsevere dysgeusia at each corresponding month. bThrough data cutoff, 13 patients completed ≥3 months on treatment. cThrough data cutoff, 5 patients completed ≥8 months on treatment. | |||
Efficacy
- Efficacy outcomes in patients receiving ≥3 treatment cycles is presented in Table: TALisman Study: Efficacy Outcomes.
- Among the initial 5 patients treated for ≥6 cycles, all attained very good partial response (VGPR) or complete response (CR) by cycle 5 and continued treatment through the data cutoff.
| Parameter, n | ≥3 Cycles (n=13) |
|---|---|
| sCR | 3 |
| VGPR | 4 |
| PR | 2 |
| ≥PR | 9 |
| Abbreviations: PR, partial response; sCR, stringent complete response; VGPR, very good partial response. | |
References
| 1 | Popat R, Laheij A, NWCJ van de Donk, et al. Prophylactic interventions for oral toxicities with the GPRC5D×CD3 bispecific antibody talquetamab in relapsed/refractory multiple myeloma: An update on the open-label, phase 2, randomized TALisman study. Poster presented at: The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL/Virtual. |
| 2 | |
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| 4 | |
| 5 |
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