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TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - Use in The Treatment of Multiple Myeloma With Central Nervous System Involvement
Last Updated: 04/28/2026
SUMMARY
- Johnson & Johnson does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
- MonumenTAL-1 is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).1
- 3 - Per protocol, patients with central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma (MM), were excluded from enrollment.4
- Per protocol, patients with central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma (MM), were excluded from enrollment.4
- Noveihed et al (2025)5
published a multicenter retrospective analysis of 9 patients with CNS-MM treated with bispecific antibodies at 3 academic medical centers in the United States. - A search of the scientific literature retrieved limited information from 2 congress posters, describing the use of TALVEY in the included patients with MM and CNS involvement:
- Mersi J, Eisele F, Zhou X, et al. The role of bispecific antibodies and CAR T cells in the treatment of multiple myeloma with central nervous system involvement. Poster presented at: European Hematology Association (EHA) 2024 Hybrid Congress; June 13-16, 2024; Madrid, Spain.
- Gill SK, Fleming E, Gebre H, et al. Real world outcomes with talquetamab, a T-cell-redirecting GPRC5D bispecific antibody: A single center experience for relapsed/ refractory multiple myeloma (RRMM). Presented at the 66th American Society for Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, California.
REAL-WORLD DATA
Study Design/Methods
- CNS-MM was defined by the presence of plasmacytomas (brain parenchymal or optic nerve lesions), leptomeningeal enhancement on imaging or plasma cell meningitis confirmed by cerebrospinal fluid (CSF) cytology.
- Of the 9 patients, 8 were treated with TALVEY and 1 with teclistamab.
- CNS response, defined as stability or reduction in the size of intracranial or optic plasmacytoma on radiographic evaluation or reduction in the number of plasma cells in the CSF, was evaluated.
- Systemic responses were evaluated based on the International Myeloma Working Group (IMWG) Uniform Response Criteria.
Patient Characteristics
- Individual baseline characteristics for patients who received TALVEY are presented in Table: Baseline Characteristics of Patients Treated With TALVEY.
- Across all 9 patients:
- The median age at CNS-MM diagnosis was 66 years (range, 48-73); 66.7% were male.
- High-risk cytogenetics (t[4;14], t[14;16], t[14;20], gain/amp[1q21], del[1p] and/or del [17p]) were present in 77.8% of patients.
- Most patients (77.8%) were penta-refractory, defined as resistance to 5 major anti-myeloma therapies: lenalidomide, pomalidomide, bortezomib, carfilzomib, and either daratumumab or isatuximab.
- All patients had received prior autologous stem cell transplant (autoHSCT), and 44.4% of patients had received prior B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy.
| Case | Age at MM Diagnosis, Years | Sex | MM Isotype | Cytogeneticsa | Induction Therapy | Prior AutoSCT | Prior CAR-T | Prior Lines of Therapy Before TALVEY | Time From MM Diagnosis to CNS Diagnosis, Months | Treatment Prior to CNS Diagnosis | Type of CNS Disease | Additional CNS Treatment Modality Utilized |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 67 | F | IgA Kappa | 1q21 | VRd | Yes | Ide-Cel | 6 | 37 | Ide-cel | Plasmacytoma | RT |
| 2 | 73 | M | IgA Kappa | 1q21 | D-VRd | Yes | No | 5 | 13 | Carfilzomib/Dara/ Dex | Plasmacytoma | RT |
| 3 | 62 | M | IgG Lambda | 1q21, del(17p) | KCyd | Yes | No | 4 | 29 | Dara and Revlimid maintenance | Plasmacytoma and meningitis | RT and IT triple therapyb |
| 4 | 52 | M | IgG Lambda | 1q21, del(17p), del(1p) | VRD | Yes | Ide-Cel | 7 | 132 | Elotuzumab/ Bortezomib/Dex | Meningitis | RT and IT with chemotherapy with MTX/Cytarabine alternating |
| 5 | 67 | M | Kappa Light Chain | NA | VRD | Yes | No | 6 | 64 | Teclistamab | Meningitis | RT and IT chemotherapy with MTX/Cytarabine alternating |
| 6 | 66 | F | IgA Lambda | t(4;14) 1q21 | D-KRd | Yes | Cilta-Cel | 6 | 141 | Cilta-cel | Plasmacytoma and meningitis | RT and IT triple therapy |
| 7 | 48 | F | IgG Kappa | 1q21 | CyBorD | Yes | Ide-Cel | 8 | 73 | PACMED with Selinexor | Plasmacytoma and meningitis | RT and IT triple therapy |
| 8 | 65 | M | IgG Kappa | del(17p) | VTD-PACE | Yes | No | 9 | 94 | Belantamab-mafodotin | Plasmacytoma | RT |
| Abbreviations: CAR-T, chimeric antigen receptor T-cell; Cilta-cel, ciltacabtagene autoleucel; CNS, central nervous system; CyBorD, cyclophosphamide, bortezomib and dexamethasone; Dara, daratumumab; Dex, dexamethasone; D-KRd, daratumumab, carfilzomib, lenalidomide, and dexamethasone; D-VRd, daratumumab, bortezomib, lenalidomide, and dexamethasone; F, female; FISH, fluorescent in situ hybridization; Ide-cel, idecabtagene vicleucel; Ig, immunoglobulin; IT, intrathecal; KCyd, carfilzomib, cyclophosphamide, and dexamethasone; M, male; MM, multiple myeloma; MTX, methotrexate; PACMED, cisplatin, cytarabine, cyclophosphamide, mesna, etoposide, and dexamethasone; RT, radiation therapy; VRd, bortezomib, lenalidomide, and dexamethasone; VTD-PACE, bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide. aCytogenetic abnormalities evaluated: FISH for t(11;14), t(4;14), t(14;16), t(14;20), del(17p), 1q21, del(1p), hyperdiploidy. Presence of t(4;14), t(14;16), t(14;20), gain/amp(1q21), del(1p) and/or del(17p) indicates high risk. bIT triple therapy: a combination of MTX, cytarabine, and hydrocortisone injection. | ||||||||||||
Results
- Key aspects of clinical courses of patients are summarized in Table: Clinical Courses of Patients Who Received TALVEY.
Efficacy
- Median time from MM diagnosis to CNS relapse was 65.5 months (range, 15-131) among the CNS responders versus 73 months (range, 64-141) among the non-responders.
- Median time to best CNS response was 10 weeks (range, 1-20), occurring after a median of 6.5 doses (range, 4-10) of BsAb.
- Two patients demonstrated CNS responses prior to the initiation of adjunctive CNS-directed therapies.
- Myelomatous meningitis was diagnosed in one patient after CSF cytology identified 498 clonal plasma cells. Upon initiation of TALVEY using a step‑up dosing approach, the CSF plasma cell count fell to 74 cells within 1 week. This occurred before the administration of intrathecal (IT) chemotherapy or radiation therapy. The patient then received IT chemotherapy in combination with TALVEY, which resulted in complete resolution of CNS involvement.
Safety
- A total of 44.4% of patients experienced cytokine release syndrome (CRS). All CRS events were grade 1 (n=3) or grade 2 (n=1).
- Grade ≥3 CRS or any immune effector cell-associated neurotoxicity syndrome (ICANS) was not reported in any patients.
| Case | Type of CNS Disease | Responder Status | Best Systemic Responsea | CRS Grade | ICANS Grade | Time to Best CNS Response, Weeksb | Additional CNS Treatment Modality Utilized | Time on TALVEY by Data Cutoff Date, Months | Relapse or Progression After TALVEYd |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Plasmacytoma | R | VGPR | 2 | 0 | 20 | RT | 11 | No |
| 2 | Plasmacytoma | R | CR | 1 | 0 | 8 | RT | 4 | No |
| 3 | Plasmacytoma and meningitis | R | CR | 0 | 0 | 1 | RT and IT triple therapyc | 6 | Yes |
| 4 | Meningitis | R | NE | 0 | 0 | 5 | RT and IT with chemotherapy with MTX/cytarabine alternating | 2 | No |
| 5 | Meningitis | NR | NE | 0 | 0 | NA | RT and IT chemotherapy with MTX/cytarabine alternating | 3 | Deceased |
| 6 | Plasmacytoma and meningitis | NR | NE | 0 | 0 | NA | RT and IT triple therapyc | 1 | No |
| 7 | Plasmacytoma and meningitis | NR | CR | 1 | 0 | NA | RT and IT triple therapy | 6 | Deceased |
| 8 | Plasmacytoma | R | CR | 0 | 0 | 12 | RT | 12 | No |
| Abbreviations: BsAb, bispecific antibody; CNS, central nervous system; CR, complete response based on IMWG response criteria; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; IMWG, International Myeloma Working Group; IT, intrathecal; MM, multiple myeloma; MTX, methotrexate; NA, not applicable; NE, not evaluable; NR, non-responder; R, responder; RT, radiation therapy; VGPR, very good partial response based on IMWG response criteria. aBest systemic response: based on IMWG uniform response criteria of 2016. No other systemic therapies (immunomodulatory drugs, chemotherapy, proteasome inhibitors, anti-CD38 monoclonal antibodies) were administered. bTime to best CNS response: defined as number of weeks from first BsAb administration to CNS response. cIT triple therapy: a combination of MTX, cytarabine, and hydrocortisone injection. dData cutoff date is 31 December 2024 apart from patient 6 who was added with data cutoff date of 31 March 2025. Additional follow-up data were unavailable for review. | |||||||||
literature search
A literature search of MEDLINE®
References
| 1 | Chari A, Touzeau C, Schinke C, et al. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025;12(4):e269-e281. |
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