(talquetamab-tgvs)
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TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - MonumenTAL-3 (MMY3002) Study
Last Updated: 07/26/2024
SUMMARY
- Janssen does not recommend any practices, procedures or usage that deviate from approved labeling.
- DARZALEX FASPRO®
(daratumumab and hyaluronidase) for subcutaneous (SC) use in combination with TALVEY is not approved by the regulatory agencies. - MonumenTAL-3 (MMY3002) is a phase 3 study comparing the efficacy of TALVEY in combination with DARZALEX FASPRO (Tal-D) or TALVEY in combination with DARZALEX FASPRO and pomalidomide (Tal-DP) vs DARZALEX FASPRO in combination with pomalidomide and dexamethasone (DPd) in patients with relapsed or refractory multiple myeloma (RRMM).1
, 2 Enrollment of this study is currently ongoing, and results are not published at this time.
PRODUCT LABELING
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.
- TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.
CLINICAL DATA - monumental-3 study
Study Design/Methods
- The target enrollment was approximately 810 patients.
- The study design is presented in the Figure: MonumenTAL-3 Study Design.
Abbreviations: C, cycle; CD38, cluster of differentiation 38; CR, complete response; CRS, cytokine release syndrome; DARA SC, DARZALEX FASPRO; Dex, dexamethasone; 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; EQ-5D-5L, EuroQoL Five Dimension Questionnaire; GPRC5D, G protein-coupled receptor, family C, group 5, member D; HRQoL, health-related quality of life; ICANS, immune effector cell-associated neurotoxicity syndrome; IMWG, International Myeloma Working Group; ISS, International Staging System; IV, intravenously; LOT, lines of therapy; mAb, monoclonal antibody; MM, multiple myeloma; MRD, minimal residual disease; MySlm-Q, Multiple Myeloma Symptom and Impact Questionnaire; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; ORR, overall response rate; OS, overall survival; PD, pharmacodynamic; PFS, progression-free survival; PFS2, progression free survival on next-line of therapy; PK, pharmacokinetic; PO, orally; Pom, pomalidomide; PR, partial response; PRO, patient-reported outcome; PRO-CTCAE, PRO version of the Common Terminology Criteria for Adverse Events; PROMIS PF, PRO Measurement Information System Physical Function; Q2W, once every 2 weeks; Q4W, once every 4 weeks; QD, once a day; QW, once a week; R, randomization; Tal, TALVEY; TTNT, time to next treatment; VGPR, very good partial response.
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Per Protocol Recommendations for Restarting TALVEY after Dose Delays
- Per protocol, the following recommendations were to be followed for restarting TALVEY after dose delays. See table: Per Protocol Recommendations for Restarting TALVEY after Dose Delays.3
| Dosing Schedule | Last Dose Administered | Time from Last Dose Administered | TALVEY Recommendationa |
|---|---|---|---|
| Biweekly (Q2W) Dosing Schedule | 0.01 mg/kg | More than 7 days | Restart at 0.01 mg/kg |
| 0.06 mg/kg | 8 to 28 days | Repeat 0.06 mg/kg | |
| More than 28 days | Restart at 0.01 mg/kg | ||
| 0.4 mg/kg | 8 to 28 days | Repeat 0.4 mg/kg | |
| 29 to 56 days | Restart at 0.06 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg | ||
| 0.8 mg/kg | 15 to 28 days | Continue at 0.8 mg/kg | |
| 29 to 56 days | Restart at 0.4 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg | ||
| Monthly (Q4W) Dosing Schedule | 0.8 mg/kg | 29 to 35 days | Continue at 0.8 mg/kg |
| 36 to 56 days | Restart at 0.4 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg | ||
| Abbreviations: Q2W, once every 2 weeks; Q4W, once every 4 weeks.aPretreatment medications must be administered prior to TALVEY dose. | |||
Literature Search
A literature search of Ovid MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 02 July 2024.
References
| 1 | Cohen YC, Moreau P, Tolbert J, et al. Phase 3 trial of talquetamab + daratumumab ± pomalidomide versus daratumumab + pomalidomide + dexamethasone in relapsed/refractory multiple myeloma following ≥1 prior line of therapy. Poster presented at: 64th American Society of Hematology (ASH) Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA/Virtual meeting. |
| 2 | |
| 3 |