TALVEY - Use of Prophylactic Tocilizumab

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 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).
• Rodriguez et al (2026)³ presented a retrospective, single-center, real-world study in patients with RRMM treated with TALVEY or teclistamab at Icahn School of Medicine at Mount Sinai to evaluate the safety and healthcare resource utilization (HCRU) associated with SUD following treatment or prophylaxis with tocilizumab. CRS within 14 days post-index was reported in 100% of TALVEY-treated patients (n=17) in the hybrid setting (SUD-1 in the inpatient setting and the remaining SUDs in the outpatient setting, and treatment with tocilizumab for CRS). None of the 21 patients who received outpatient-tocilizumab (fully outpatient SUD with prophylactic tocilizumab) experienced CRS.

CLINICAL DATA - Monumental-1 study - prophylactic tocilizumab cohort

MonumenTAL-1 (NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.^4,5

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.^4,5 

• 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

Dytfeld et al (2025)¹ presented the impact of prophylactic tocilizumab on CRS with TALVEY administration in patients with RRMM from the MonumenTAL-1 study to enable safe and effective outpatient dosing of SUDs and the first full dose of TALVEY.

Study Design/Methods

• The study design for prophylactic tocilizumab cohort is presented in Figure: MonumenTAL-1 Prophylactic Tocilizumab Cohort Study Design.

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.

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).

Efficacy

• 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.

CLINICAL DATA - REAL-WORLD STUDIES

Rodriguez et al (2026)³ presented a retrospective, single-center, real-world study in patients with RRMM treated with TALVEY or teclistamab at a large United Staes (US) academic center to evaluate the safety and HCRU associated with SUD.

Study Design/Methods

• Adult patients ≥18 years old with RRMM who initiated TALVEY after August 9, 2023, or teclistamab after October 25, 2022, at Icahn School of Medicine at Mount Sinai were included and data were extracted until March 10, 2026.
• Patients who received care at Icahn School of Medicine at Mount Sinai within the first 14 days following SUD initiation were included in this analysis; 1 patient with grade 2 ICANS was excluded due to early discontinuation of care before completion of this period.
• Patient eligibility for outpatient SUD: absence of cytopenias requiring transfusion or growth factor; marrow involvement <60% (if available); presence of a caregiver; no significant comorbidities.
• TALVEY and teclistamab SUDs were implemented in hybrid and outpatient-tocilizumab treatment scenarios.
  • Hybrid setting (pre-January 2025; before National Comprehensive Cancer Network [NCCN] guidelines incorporated prophylactic tocilizumab):
    • Patients received the first SUD in the inpatient setting.
    • In the event of CRS, patients were treated with tocilizumab.
    • Following resolution of CRS and if outpatient eligibility criteria were met, patients were discharged to complete remaining SUDs in the outpatient setting.
  • Outpatient-tocilizumab setting (post-January 2025; after NCCN guidelines incorporated prophylactic tocilizumab):
    • Patients received SUD entirely in the outpatient setting.
    • Prophylactic tocilizumab (8 mg/kg) was administered within 10 hours of the
      1^st SUD.
    • Patients subsequently completed all SUDs in the outpatient setting.
• During follow-up, adverse events (AEs; 14-day CRS and immune effector cell-associated neurotoxicity syndrome [ICANS] rates) and HCRU outcomes, including 14- and 30-day all-cause hospitalizations or readmissions were reported.
  • CRS and ICANS were defined and graded according to the ASTCT definitions. Infections were not captured due to the limited follow-up time of the study.

Results

Patient and Clinical Characteristics

• A total of 54 patients were included in this analysis, and clinical characteristics are summarized in Tables: Treatment Setting Distribution and Baseline Characteristics and Treatment History.
• Prior exposure to B-cell maturation antigen (BCMA)-directed therapy (belantamab mafodotin, chimeric antigen receptor T-cell [CAR-T] therapy, and bispecific antibodies) was reported in 29.4% of patients in the hybrid cohort and 33.3% of patients in the outpatient-tocilizumab cohort.

Completion of SUD

• Hybrid cohort: All patients completed SUD, except for 1 teclistamab-treated patient who discontinued following disease progression and subsequent death.
• Outpatient-tocilizumab cohort: All patients completed SUD.

Safety

• For a safety summary, see Table: AEs During SUD in Patients Treated With TALVEY.
• Across all patients in the hybrid cohort, 14.3% of patients received steroids and 81% of patients received tocilizumab for the treatment of CRS; all events were resolved. All ICANS events resolved with 10 mg pocket dexamethasone.

HCRU During SUD

• HCRU in patients who received TALVEY or teclistamab SUD is summarized in Table: HCRU in Patients Treated with TALVEY.

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 03 July 2026.