The efficacy of TALVEY® as a single agent was evaluated in 219 patients with RRMM in the single-arm, open-label, multicenter, phase 1/2 MonumenTAL-1 trial1,2

Patients naïve to T-cell redirection therapy* were randomized to receive TALVEY® Q2W or QW1

(n=87)

(n=100)

Patients exposed to T-cell redirection therapy* received TALVEY® QW1

Patients exposed to T-cell redirection therapy* received TALVEY® QW1

(n=32)

*T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.

MonumenTAL-1 is the only clinical trial that included patients with ADC exposure and a specific cohort of patients with prior T-cell redirection exposure (bispecific antibody and/or CAR-T therapy).1,3

  • Received ≥3 prior systemic therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
  • ECOG PS of 0–2 included
  • No T-cell redirection therapy* within 3 months
  • No prior Grade 3 or higher CRS related to any T-cell redirection therapy*
  • No autologous stem cell transplant within the past 12 weeks
  • No stroke, seizure, or allogeneic stem cell transplant within the past 6 months
  • No CNS involvement or clinical signs of meningeal involvement of MM or plasma cell leukemia
  • No active or documented history of autoimmune disease, with the exception of vitiligo, resolved childhood atopic dermatitis, or resolved Graves' disease that is euthyroid based on clinical and laboratory testing

Primary endpoint4: ORR

Key secondary endpoints4: DOR and TTR

Clinical trial dosing4

Following the step-up dosing schedule, patients received TALVEY® Q2W (0.8 mg/kg) or QW (0.4 mg/kg) as a subcutaneous injection until disease progression or unacceptable toxicity.

*T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.

Patients with a range of characteristics, including those with high-risk features, were studied in MonumenTAL-11

In patients naïve to T-cell redirection therapy,* 22% had ISS stage 3 disease, 29% had high-risk cytogenetics, 22% had extramedullary disease, and 73% were triple-class refractory. In patients exposed to T-cell redirection therapy,* 81% had prior CAR-T and 25% had prior bispecific antibody therapy.

Naïve to T-cell redirection therapy*
Patient characteristicsSC Q2W/QW (n=187)
Gender
Male57%
Female43%
Race
White90%
Hispanic8%
Black or African American5%
Asian3%
ISS stage
144%
234%
322%
High-risk cytogenetics (presence of t[4;14], t[14;16], and/or del[17p])†29%
Extramedullary disease22%
Prior lines of therapy, median5 lines
(range:
4–13)		5 lines (range: 4–13)
Prior autologous stem cell transplantation78%
Triple-class exposed (proteasome inhibitor, immunomodulatory
agent, and anti-CD38 monoclonal antibody)		100%
Triple-class refractory (proteasome inhibitor, immunomodulatory
agent, and anti-CD38 monoclonal antibody)		73%
Refractory to last therapy94%

*T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.

†Baseline cytogenetic data were not available in 11% of patients.

Characteristics of patients naïve to T-cell redirection therapy* in the longer-term follow-up analyses5
Patient characteristicsSC Q2W/QW (n=187)
Age, median (n=190)†67 years
(range:
38–86)		67 years (range: 38–86)
<65 years39%
65 to >75 years38%
≥75 years22%
Weight (n=190)†
≤65 kg34%
65–85 kg42%
≥85 kg24%
BMI (n=188)
<18.51%
18.5–24.940%
25–29.940%
≥3019%

*T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.

†These demographic data were reported in the longer-term follow-up analysis of MonumenTAL-1. Due to rounding, calculations may not be exact.

Exposed to T-cell redirection therapy1*
Patient characteristicsSC QW (n=32)
Prior lines of therapy, median6 lines (range: 4–15)
Triple-class exposed (proteasome inhibitor, immunomodulatory
agent, and anti-CD38 monoclonal antibody)		100%
Prior CAR-T therapy81%
Prior bispecific antibody therapy25%
Prior BCMA-directed therapy94%

*T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.

ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; BMI, body mass index; CAR-T, chimeric antigen receptor T-cell; CD, cluster of differentiation; CNS, central nervous system; CRS, cytokine release syndrome; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; mDOR, median duration of response; MM, multiple myeloma; ORR, overall response rate; QW, once weekly; Q2W, every 2 weeks; RRMM, relapsed or refractory multiple myeloma; SC, subcutaneous; TTR, time to response.

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Explore the types of patients who could benefit from TALVEY®

    1. TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
    2. A study of talquetamab in participants with relapsed or refractory multiple myeloma (MonumenTAL-1). ClinicalTrials.gov identifier: NCT04634552. Updated May 23, 2024. Accessed October 1, 2025. https://clinicaltrials.gov/study/NCT04634552
    3. Chari A, Touzeau C, Schinke C, et al. Talquetamab, a G protein-coupled receptor family C group 5 member D x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma: phase 1/2 results from MonumenTAL-1. Poster presented at: 2022 American Society of Hematology Annual Meeting; December 10–13, 2022; New Orleans, LA.
    4. 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.
    5. Data on file. Janssen Biotech, Inc.