TALVEY®

(talquetamab-tgvs)

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TALVEY® (talquetamab-tgvs)

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TALVEY - TALisman Study

Last Updated: 12/17/2025

SUMMARY

Janssen 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^-³
- Popat et al (2025)³ presented preliminary TALisman study data 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.

CLINICAL DATA - TALisman study

TALisman (NCT06500884) is a multicenter, randomized, open-label, phase 2 study to investigate prophylactic interventions for oral toxicities associated with TALVEY treatment using objective and patient-derived assessment tools.¹^-⁴

Study Design/Methods

The study design is presented in the Figure: TALisman Study Design.

TALisman Study Design³

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; GPRC5D, G protein-coupled receptor class C group 5 member D; mAb, monoclonal antibody; PROs, patient-reported outcomes; Q2W, every other week; RRMM, relapsed or refractory multiple myeloma; STTA, scale of subjective total taste acuity; SUD, step-up dose; WETT, waterless empirical taste test.
^aMaximum target enrolment.
^bIncluding a proteasome inhibitor, immunomodulatory drug, and anti-CD38 mAb.
^cECOG PS of 2 or 3 permitted once physical limitations are stable.
^dTo accommodate prophylaxes being available at different times.
^eTal dose of 0.8 mg/kg Q2W.
^fPatients receive prophylaxis starting 7 days before Tal step-up doses followed by Tal 0.8 mg/kg Q2W.

Popat et al (2025)³ presented data on the utility and sensitivity of the WETT-SA53, as demonstrated by the initial results from the TALisman study. This analysis pooled data from patients (N=28) from groups A (control, n=14) and B (dexamethasone mouthwash, n=14).

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.

TALisman Study: Patient Characteristics³

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 randomization^a, years (range)	6.4 (0.9-13.0)
ISS stage^b, 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%).

TALisman Study: WETT and STTA Analyses Over Time³

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	40.0	8.3	-	16.7
Severe/ complete loss	11.1	-	22.2	13.3	13.3	13.3	25.0	16.7	33.3
Abbreviation: WETT, waterless empirical taste test; STTA, scale of subjective total taste acuity.

TALisman Study: WETT Scores (Dysgeusia)³

Time Point	Number of Patients Evaluated	Number of Patients With Improvement or Resolution^a	Improvement Rate (%)
After 3 months	13^b	6	46
After 7 months	5^c	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.

TALisman Study: Efficacy Outcomes³

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.

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 15 December 2025.

References

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1	Popat R, Laheij A, van de Donk NWCJ, 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	Popat R, Laheij A, van de Donk NWCJ, et al. Prophylactic interventions for oral toxicities with the GPRC5D×CD3 bispecific antibody talquetamab in relapsed/refractory multiple myeloma: an open-label, phase 2, randomized study (TALisman). Poster presented at: International Myeloma Society (IMS); September 25-28, 2024; Rio de Janeiro, Brazil.
3	Popat R, van de Donk NWCJ, Faiman B, et al. Utility and sensitivity of WETT-SA53 to measure dysgeusia associated with talquetamab, a GPRC5D×CD3 bispecific antibody, in relapsed/refractory multiple myeloma: preliminary data from the TALisman study. Poster presented at: the 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL.
4	Janssen Research & Development, LLC. A phase 2, open-label, randomized study to evaluate prophylactic interventions on talquetamab-related oral toxicity. In: ClinicalTrials.Gov [Internet]. Bethesda (MD): National Library of Medicine (US). [cited 2025 December 15]. Available from: https://clinicaltrials.gov/study/NCT06500884 NLM Identifier NCT06500884.