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SUMMARY
- Janssen does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
- TALisman (MMY2006) 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).1,2 Enrollment in this study is currently ongoing, and results have not been published at this time.
CLINICAL DATA - TALisman study
TALisman (MMY2006; clinicaltrials.gov identifier 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.1-3
Study Design/Methods
- The study design is presented in the Figure: TALisman Study Design.
- The target enrollment for the study is 130 patients. The study will be conducted in 3 phases: screening, treatment phase, and follow-up phase.1
TALisman Study Design1
Abbreviations: AE, adverse event; BMI, body mass index; CR, complete response; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item; EORTC-QLQ-OH15, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oral Health; GPCRD5, G protein-coupled receptor class C group 5 member; RRMM, relapsed or refractory multiple myeloma; ORR, overall response rate; PFS, progression-free survival; PR, partial response; PROs, patient-reported outcomes; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; Q2W, every 2 weeks; Q4W, every 4 weeks; SUD; step-up dose; Tal, talquetamab; TTR, time to response; USA, the United States of America; VGPR, very good partial response; WETT, Waterless Empirical Taste Test.
aIncluding a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.
bECOG PS of 2 or 3 permitted once physical limitations are stable.
cTo accommodate prophylaxes being available at different times.
dTwo-part enrollment (part 1 and part 2 expansion) to allow for an independent futility analysis of each cohort.
eTo evaluate study cohorts after approximately 15 patients per cohort have been treated with Tal for ≥3 cycles (or discontinue prior to 3 cycles).
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.
| 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 | 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 June 6]. Available from: https://clinicaltrials.gov/study/NCT06500884 NLM Identifier: NCT06500884. |
