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TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - Use of Prophylactic Tocilizumab
Last Updated: 07/18/2025
- Janssen 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 safety and efficacy 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).
The prophylactic tocilizumab cohort is an ongoing prospective, phase 2, exploratory cohort evaluating the administration of intravenous (IV) tocilizumab (8 mg/kg IV) prior to TALVEY to mitigate cytokine release syndrome (CRS) in 27 patients with RRMM.1 , 2 - Dytfeld et al (2025)1 presented the impact of prophylactic tocilizumab on CRS with TALVEY to enable safe and effective outpatient dosing of step-up doses (SUDs) and the first-full dose of TALVEY. At a median follow-up of 4.4 months, CRS occurred at a rate of 18.5% (5/27).
CLINICAL DATA - Monumental-1 study - prophylactic tocilizumab cohort
The prophylactic tocilizumab cohort is an ongoing prospective, phase 2, exploratory cohort of the MonumenTAL-1 study evaluating the administration of IV tocilizumab (8 mg/kg IV) prior to TALVEY dosing to mitigate CRS in patients with RRMM.1,2
Study Design/Methods
The main objectives are as follows: part 1 (dose escalation) to determine the RP2D for TALVEY; part 2 (dose expansion) to characterize safety at RP2D; and part 3 (phase 2 component) to evaluate the efficacy and safety of TALVEY at RP2D.3,4
- Key eligibility criteria: documented RRMM per International Myeloma Working Group (IMWG) criteria; ≥3 prior lines of treatment, including a PI, an immunomodulatory drug, and an anti-CD38 mAb.1
- Prophylactic tocilizumab cohort dosing:
- Tocilizumab: single-dose 8 mg/kg IV, along with required pretreatments (glucocorticoid, antihistamine, and antipyretic), approximately 3 hours before administering TALVEY SUD 1.1
- TALVEY: SUDs (0.01 mg/kg, 0.06 mg/kg and 0.3 mg/kg or 0.4 mg/kg subcutaneous [SC]) followed by first treatment dose and subsequent treatment doses of TALVEY (0.8 mg/kg) SC Q2W. The SUDs were administered 2-4 days apart and completed 2-4 days prior to the first full treatment dose of TALVEY.1
- Posttreatments: 8 mg dexamethasone by mouth (PO)/IV administered daily for 2 days after each SUD and first full treatment dose of TALVEY.1
- CRS was graded as per American Society for Transplantation and Cellular Therapy (ASTCT) criteria.1
- Patients could be treated on an inpatient or outpatient basis.1
Study Design/Methods
- The study design for prophylactic tocilizumab cohort is presented in Figure: MonumenTAL-1 Prophylactic Tocilizumab Cohort Study Design.
MonumenTAL-1 Prophylactic Tocilizumab Cohort Study Design1
Abbreviations: dex, dexamethasone; IV, intravenous; PO, oral; Q2W, every other week; SC, subcutaneous; SUD, step-up dose; tal, talquetamab; toci, tocilizumab.
a
b
Results
Patient Characteristics
- The baseline characteristics are presented in Table: MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): Baseline Characteristics. A total of 10 patients received inpatient treatment and 17 patients received outpatient treatment.
| Parameter | Prophylactic Tocilizumab (N=27) |
|---|---|
| Median age, years (range) | 69.0 (51.0-79.0) |
| Male, n (%) | 16 (59.3) |
| ECOG PS, n (%) | |
| 0 | 8 (29.6) |
| 1 | 18 (66.7) |
| 2 | 1 (3.7) |
| Extramedullary plasmacytomas, n (%) | |
| 0 | 22 (81.5) |
| ≥1 | 5 (18.5) |
| High-risk cytogeneticsa, n (%) | 7 (31.8) |
| ISS stageb, n (%) | |
| I | 15 (60.0) |
| II | 7 (28.0) |
| III | 3 (12.0) |
| Prior LOT, median (range) | 4.0 (3.0-11.0) |
| Refractory status, n (%) | |
| Triple-classc | 19 (70.4) |
| Penta-drugd | 6 (22.2) |
| To last LOT | 24 (88.9) |
| Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; LOT, line of therapy; mAb, monoclonal antibody; PI, proteasome inhibitor. aDefined as del(17p), t(4;14), and/or t(14;16); calculated from n=22. bISS staging is derived based on serum β2-microglobulin and albumin; calculated from n=25; n=2 patients had missing assessments. c≥1 PI, ≥1 immunomodulatory drug, and ≥1 anti-CD38 mAb. d≥2 PIs, ≥2 immunomodulatory drugs, and ≥1 anti-CD38 mAb. | |
Safety
- Summary of CRS events across the cohorts is presented in Table: MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): CRS Events.
- CRS incidence and severity in patients treated in an inpatient vs outpatient setting are presented in Table: MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): CRS Events in Inpatient and Outpatient Settings.
- Summary of AEs in the prophylactic tocilizumab cohort is detailed in the Table: MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): Hematologic and Nonhematologic AEs (≥20% of Total Population).
| Parameter | Prophylactic Tocilizumab (N=27) |
|---|---|
| CRSa, n (%) | |
| Grade 1 | 5 (18.5) |
| Grade 2 | 0 (0) |
| Grade 3 | 0 (0) |
| Onset of CRSb, days, median (range) | 2.5 (2.0-12.0) |
| Duration of CRS, days, median (range) | 1.0 (1.0-6.0) |
| Supportive measures for CRSc, n (%) | 4 (14.8) |
| Tocilizumab | 3 (11.1) |
| Oxygen | 0 (0) |
| Corticosteroids | 0 (0) |
| Paracetamol | 3 (11.1) |
| Other | 1 (3.7) |
| CRS recovered or resolvedd, n (%) | 6 (100.0) |
| Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome. aCRS was graded by ASTCT criteria. bRelative to the most recent dose. cPatients could receive ≥1 supportive therapy. dPatients could have ≥1 event. | |
MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): CRS Events in Inpatient and Outpatient Settings1
| Parameter | Inpatient (n=10) | Outpatient (n=17) |
|---|---|---|
| CRSa, n (%) | 3 (30.0) | 2 (11.8)b |
| Grade 1 | 3 (30.0) | 2 (11.8)b |
| Grade 2 | 0 (0) | 0 (0) |
| Grade 3 | 0 (0) | 0 (0) |
| Onset of CRSc, days, median (range) | 2.0 (2.0-12.0) | 5.5 (3.0-8.0) |
| Duration of CRS, days, median (range) | 1.0 (1.0-6.0) | 2.0 (1.0-3.0) |
| During SUD periodd, n (%) | 3 (30.0) | 0 (0) |
| During 1st | 0 (0) | 2 (11.8) |
| During 2nd | 1 (10.0) | 0 (0) |
| CRS recovered or resolvedd, n (%) | 4 (100.0) | 2 (100.0) |
| Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; SUD, step-up dose. aCRS was graded by ASTCT criteria. bOne patient treated on an outpatient basis had CRS while hospitalized for bone pain. cRelative to the most recent dose. dPatients could have ≥1 event. | ||
MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): Hematologic and Nonhematologic AEs1
| Most Common AEs (≥20% of Total Population) and AEs of Interesta, n (%) | Prophylactic Tocilizumab (N=27) | |
|---|---|---|
| Any Grade | Grade 3/4 | |
| Hematologic AEs | ||
| Neutropenia | 9 (33.3) | 6 (22.2) |
| Anemia | 7 (25.9) | 3 (11.1) |
| Lymphopenia | 6 (22.2) | 5 (18.5) |
| Nonhematologic AEs | ||
| Taste changesb | 18 (66.7) | NA |
| Skin AEsc | 13 (48.1) | 0 (0) |
| Dry mouth | 12 (44.4) | 0 (0) |
| Weight decrease | 8 (29.6) | 0 (0) |
| Nail AEsd | 7 (25.9) | 0 (0) |
| Cough | 6 (22.2) | 0 (0) |
| Fatigue | 6 (22.2) | 0 (0) |
| Other AEs of interest | ||
| Infectionse | 15 (55.6) | 5 (18.5) |
| ICANS | 2 (7.4) | 0 (0) |
| Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CTCAE, Common Terminology Criteria for Adverse Events; ICANS, immune effector cell-associated neurotoxicity syndrome; NA, not available. aICANS was graded by ASTCT criteria; other AEs were graded by CTCAE v4.03. bIncludes dysgeusia, ageusia, hypogeusia, and taste disorder; maximum grade for taste changes is 2 per CTCAE. cIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. dIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. eInfections described on a System Organ Class basis, and thus not grouped with Preferred Term data in terms of incidence. | ||
- At a median follow-up of 4.4 months (range, 0.5-18.4), ORR was 81.8% in the prophylactic tocilizumab cohort. See Table: MonumenTAL-1 Study (Prophylactic Tocilizumab Cohort): Efficacy Outcomes for additional details.
| Response, % | Prophylactic Tocilizumab (N=11) |
|---|---|
| ORRa | 81.8 (9) |
| sCR | 54.5 |
| CR | 9.1 |
| VGPR | 18.2 |
| PR | - |
| ≥CR | 63.6 |
| ≥VGPR | 81.8 |
| Abbreviations: CR, complete response; IMWG, International Myeloma Working Group; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. aResults presented based on the latest available data assessed by independent committee review per IMWG criteria. | |
literature search
A literature search of MEDLINE®
References
| 1 | Dytfeld D, Vij R, Jagannath S, et al. Prophylactic tocilizumab to mitigate cytokine release syndrome and outpatient dosing of talquetamab in relapsed/refractory multiple myeloma: updated phase 1/2 MonumenTAL-1 results. Poster presented at: The European Hematology Association (EHA) Hybrid Congress; June 12-15, 2025; Milan, Italy. |
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