TALVEY® (talquetamab-tgvs)

SUMMARY

• Johnson & Johnson does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• OPTec/OPTal is an ongoing, phase 2, two-arm, non-randomized, multicenter, prospective clinical study. The study is evaluating the use of prophylactic tocilizumab in reducing the incidence and severity of cytokine release syndrome (CRS) associated with TECVAYLI and TALVEY, to allow safe outpatient administration of step-up dosing in patients with relapsed/refractory multiple myeloma (RRMM).^1-6
  • Forsberg et al (2026)⁶ evaluated outpatient step-up administration of TECVAYLI and TALVEY in patients with RRMM in the phase 2 OPTec/OPTal study. A total of 4 patients (8.9%) experienced 6 grade 1 CRS events in the TECVAYLI arm, while 4 CRS events were reported in 2 patients (28.5%) in the TALVEY arm. No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS) or grade 3 or 4 CRS events in either arm.
  • Prior analyses of the data were presented by Forsberg et al (2025)⁵, Rifkin et al (2024)³ and Rifkin et al (2024)².

PRODUCT LABELING

• TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.
• TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf

CLINICAL DATA – optec/OPTAL study

OPTec/OPTal (NCT05972135) is an ongoing, phase 2, two-arm, non-randomized, multicenter, prospective clinical study. The study is evaluating the use of prophylactic tocilizumab in reducing the incidence and severity of CRS associated with TECVAYLI and TALVEY, to allow safe outpatient administration of step-up dosing in patients with RRMM.^1-6

Study Design/Methods

• The study design for the outpatient administration of TECVAYLI and TALVEY is presented in the Figure: OPTec/OPTal Study Design.⁶
• A single dose of intravenous tocilizumab 8 mg/kg was administered 2-4 hours prior to the first step-up dosing (SUD) of TECVAYLI and TALVEY.^5,6
• Protocol-defined patient safety measures^5,6:
  • Premedication: administer corticosteroids, H₁ receptor antagonists, or antipyretics 1-3 hours prior to each SUD.
  • Investigator observation: monitor patients for 2 days after each SUD and first full treatment dose; remote follow-up (eg, phone) permitted on weekends.
  • Home monitoring: instruct patients to record temperature and oxygen saturation twice daily (≥8 hours apart); report fever ≥38°C (≥100.4°F) immediately and hospitalization for CRS as determined by investigator.
  • Intravenous immunoglobulin (IVIG) support: recommend IVIG if immunoglobulin G (IgG) <400 mg/dL.
  • Companion requirement: ensure the presence of a trained adult for 48 hours after each SUD and first full treatment dose.
  • Travel restriction: limit patient travel within 60 minutes of study site.

Forsberg et al (2026)⁶ evaluated outpatient step-up administration of TECVAYLI and TALVEY in patients with RRMM in the phase 2 OPTec/OPTal study.

Results

Treatment Disposition, Baseline Characteristics, and Disease Characteristics

• At the data cutoff of March 6, 2026, 45 patients were included in the TECVAYLI arm, and 7 patients were included in the TALVEY arm.
  • A total of 17 patients discontinued therapy (withdrawal, n=4; death, n=1; progressive disease, n=11; adverse events, n=1) in the TECVAYLI arm and 1 patient in the TALVEY arm (withdrawal, n=1).
  • In the TECVAYLI arm, 12 patients remain on active therapy; in the TALVEY arm, 2 patients remain on active therapy.
  • Overall, 16 patients completed 12 treatment cycles in the TECVAYLI arm, and 4 patients completed 6 cycles in the TALVEY arm.
• Patient demographics are presented in Table: OPTec/OPTal Study: Patient Demographics (Treated Population).

Safety

• Data for common adverse events (AEs) across both arms are presented in Table: OPTec/OPTal Study: Safety.
• Neutropenia (n=13), sepsis (n=4), and anemia (n=4) were the most common grade ≥3 AEs across both arms.

Treatment Discontinuation

• Six patients were discontinued from the study for the following reasons before eventual death due to PD:
  • Two patients discontinued TECVAYLI due to AEs.
  • Three patients discontinued TECVAYLI due to physician decision, followed by subsequent therapy and death.
  • One withdrew consent, followed by subsequent death during follow-up.

CRS and Neurotoxicity

• In the TECVAYLI arm, 4 patients (8.9%) experienced 6 grade 1 CRS events (occurring on days 2-3, n=2; days 5-7, n=2; and days 9-56, n=2; no patients were admitted; all were treated with dexamethasone, range: 8-20 mg).
• In the TALVEY arm, 2 patients (28.5%) experienced 4 CRS events (occurring on days 5-7, n=1 and days 16-56, n=3). Grade 1 CRS events were reported in 3 patients and grade 2 CRS event was reported in 1 patient.
  • Grade 1: one patient had 3 CRS events, day 34, day 41, day 53; admitted for all events (serious adverse events [SAEs]); treated with dexamethasone, 8 mg, ± antibiotics.
  • Grade 2: one patient hospitalized (SAEs); treated with dexamethasone, 10 mg, fluids, and tocilizumab; resolved in 3 days; TALVEY held 1 week; SUD-2 repeated after 7 days; no further CRS during treatment.
• No grade 3 or 4 CRS events were reported in either arm.
• No patients developed ICANS on treatment in either arm.

Infections

• In the TECVAYLI arm, any grade infections were reported in 51.1% (23/45) of patients while grade ≥3 infections were reported in 17.8% (8/45) of patients.
• In the TALVEY arm, any grade infections were reported in 71.4% (5/7) of patients while grade ≥3 infections were reported in 28.6% (2/7) of patients.
• A fatal sepsis event (grade 5) was reported in 1 patient in the TECVAYLI arm.
  • Sepsis was defined based on positive blood culture results.
  • Hypogammaglobinemia or IVIG replacement were not reported.

Efficacy

• At a median follow-up of 11.8 months, 75.6% of patients did not experience progression in the TECVAYLI arm. No progression events were reported to date in the TALVEY arm.
• Overall, 11 patients (24.4%) experienced clinical or objective progression because of end of treatment in the TECVAYLI arm. See Table: OPTec/OPTal Study: Response Rate.

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 17 June 2026.