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SUMMARY
- Janssen does not recommend any practices, procedures, or usage that deviate from approved labeling.
- TALisman (MMY2006) is a randomized, multicenter, open-label, phase 2 study that aims to study oral toxicities and identify measuring instruments and investigate prophylactic measures that can minimize or prevent oral toxicities associated with the use of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM)1. 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 that aims to better understand oral toxicities and identify new tools for measurement and investigate prophylactic measures that can prevent and/or limit the severity of oral toxicities associated with the use of TALVEY in patients with RRMM.1
Study Design/Methods
- The study design is presented in the Figure: TALisman Study Design.
- The study will be conducted in 3 phases: screening (up to 28 days), treatment phase, and follow-up phase.1
- Dosing1:
- Patients will receive prophylaxis 1 week prior to starting TALVEY (0.8 mg/kg every other week after 3 step-up doses).
- Dose frequency reduction to every 4 weeks is permitted if very good partial response or better is achieved at cycle 5 or partial response or better is achieved at cycle 7.
- Patients will receive TALVEY until progressive disease, death, intolerable toxicity, withdrawal of consent, discontinuation, or end of study, whichever occurs first.
TALisman Study Design1
Abbreviations: AE, adverse event; BID, twice daily; BMI, body mass index; CD, cluster of differentiation; CR, complete response; CRS, cytokine release syndrome; 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; GPRC5D, G protein-coupled receptor family C group 5 member D; ICANS, immune effector cell-associated neurotoxicity syndrome; LOT, lines of therapy; ORR, overall response rate; PR, partial response; PRO, Patients reported outcome; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; Q2W, every other week; R, randomization; RRMM, relapsed or refractory multiple myeloma; STTA, Scale of Subjective Total Taste Acuity; VGPR, very good partial response; WETT, Waterless Empirical Taste Test.
aAs per the International Myeloma Working Group criteria and have measurable and progressive disease at screening.
bECOG PS of 2 or 3 permitted once physical limitations are stable.
cIncluding proteasome inhibitor, immunomodulatory drug, and an anti-CD38 monoclonal antibody.
dTarget enrollment across 6 countries.
eWith 3 step-up doses.
fSmell is evaluated by a smell assessment using the University of Pennsylvania Smell Identification Test and threshold testing.
gCommon Terminology Criteria for Adverse Events v5.0 will be utilized to grade AE.
hThe American Society for Transplantation and Cellular Therapy criteria will be utilized to grade CRS and ICANS.
iEvaluated with the following key procedures: taste assessment using WETT strips, PROs, optional tongue and/or salivary gland biopsies (only at selected sites), microbiome analysis via tongue swab (control cohort only), salivary flow and specific protein content assessments.
jQualitative patient interviews in the United States will be conducted to better understand patient experience.
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 23 October 2024.
| 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 open-label, phase 2, randomized study (TALisman). Poster presented at: International Myeloma Society; September 25-28, 2024; Rio de Janeiro, Brazil. |
