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Powerful efficacy1

In patients who have been triple-class exposed, TALVEY® provided

Treatment versatility: TALVEY® was evaluated in patients naïve and exposed to T-cell redirection therapy* in the MonumenTAL-1 trial1

The efficacy of TALVEY® as a single agent was evaluated in 219 patients with relapsed or refractory multiple myeloma in the single-arm, open-label, multicenter, phase 1/2 MonumenTAL-1 trial.1-3

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

Q2W

(N=87)

QW

(N=100)

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

QW

(N=32)

Key eligibility criteria

  • 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 multiple myeloma, or plasma cell leukemia
  • No active or documented history of autoimmune disease, with the exception of vitiligo, resolved childhood atopic dermatitis, resolved Graves' Disease that is euthyroid based on clinical and laboratory testing

Primary endpoint:

 ORR3

Key secondary endpoints: DOR and TTR3

Clinical trial dosing

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

Inclusion of patients who were naïve and exposed to T-cell redirection therapy* demonstrated the versatile use of TALVEY®

*

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

CAR-T, chimeric antigen receptor-T cell; CD, cluster of differentiation; CNS, central nervous system; CRS, cytokine release syndrome; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ORR, overall response rate; QW, once weekly; Q2W, every 2 weeks; TTR, time to response.

  1. TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Data on file. Janssen Biotech, Inc.
  3. A study of talquetamab in participants with relapsed or refractory multiple myeloma. ClinicalTrials.gov identifier: NCT04634552. Updated May 23, 2024. Accessed June 11, 2024. https:// www.clinicaltrials.gov/ study/NCT04634552
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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 III, 29% had high-risk cytogenetics, 22% had extramedullary disease, and 73% were triple-class refractory

Naïve to T-Cell Redirection Therapy*
Patient CharacteristicsSC Q2W/QW (N=187)
Age, median67 years (range: 38-86)
Gender
Male		57%
Race
White
Hispanic
Black or African American
Asian		90%
8%
5%
3%
ISS Stage
I
II
III		44%
34%
22%
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)
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%

In patients exposed to T-cell redirection therapy,* 81% had prior CAR-T and 25% had prior bispecific antibody therapy

Exposed to T-Cell Redirection Therapy*
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.

†

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

BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor-T cell; CD, cluster of differentiation; del(17p), deletion 17p; ISS, International Staging System; QW, once weekly; Q2W, every 2 weeks; SC, subcutaneous; t, translocation.

  1. TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
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Powerful responses with TALVEY®1,2

Efficacy was based on ORR and DOR as assessed by an IRC using IMWG criteria.*

Naïve to T-Cell Redirection Therapy Efficacy data Over 72% of patients responded to TALVEY monotherapy, with nearly 60% achieving ≥VGPR. Median prior lines of therapy: 5 (range 4-13) Deep responses with Q2W dosing (N=87) ORR 73.6% (n=55/87) PR 16% (n=14/87) VGPR 25% (n=22/87) sCR 20% (n=17/87) ≥CR ~32% (n=28/28) 95% CI, 63.0%-82.4%) Median follow-up of 5.9 months (range:0-9.5) from first response Deep responses with QW dosing (n=100) PR 16% (n=16/100) VGPR 22% (n=22/100) sCR 26% (n=26/100) CR 9% (n=9/100) ≥CR 35% (n=35/100) 95% CI, 63.2%-81.4%) Median follow-up of 13.8 months (range: 0.8-15.4) from first responsePatients who received TALVEY achieved durable responses Responses with Q2W dosing (N=87) mDOR: NE mTTR: 1.3 months (range 0.2-9.2 months) Median duration of follow-up from first response among responders was 5.9 months; an estimated 85% of patients continued to respond for at least 9 months. Responses with QW dosing (N=100) mDOR: 9.5 months (95% CI, 6.5-NE months) mTTR: 1.2 months (range: 0.2-10.9 months)
Naïve to T-Cell Redirection Therapy Efficacy data Over 72% of patients responded to TALVEY monotherapy, with nearly 60% achieving ≥VGPR. Median prior lines of therapy: 5 (range 4-13) Deep responses with Q2W dosing (N=87) ORR 73.6% (n=55/87) PR 16% (n=14/87) VGPR 25% (n=22/87) sCR 20% (n=17/87) ≥CR ~32% (n=28/28) 95% CI, 63.0%-82.4%) Median follow-up of 5.9 months (range:0-9.5) from first response Deep responses with QW dosing (n=100) PR 16% (n=16/100) VGPR 22% (n=22/100) sCR 26% (n=26/100) CR 9% (n=9/100) ≥CR 35% (n=35/100) 95% CI, 63.2%-81.4%) Median follow-up of 13.8 months (range: 0.8-15.4) from first response

Patients who received TALVEY® achieved durable responses

Patients who received TALVEY achieved durable responses Responses with Q2W dosing (N=87) mDOR: NE mTTR: 1.3 months (range 0.2-9.2 months) Median duration of follow-up from first response among responders was 5.9 months; an estimated 85% of patients continued to respond for at least 9 months. Responses with QW dosing (N=100) mDOR: 9.5 months (95% CI, 6.5-NE months) mTTR: 1.2 months (range: 0.2-10.9 months)

Durable responses in patients exposed to T-cell redirection therapy1,2†

Exposed to T-Cell Redirection Therapy data Responses with QW dosing (N=32) Median prior therapies: 6 (range 4-15) ORR 72% (n=23/32) (95% CI, 53%-86%) Median follow up of 10.4 months With a median duration of follow-up of 10.4 months, an estimated 59% of patients continued to respond for at least 9 months
Exposed to T-Cell Redirection Therapy data Responses with QW dosing (N=32) Median prior therapies: 6 (range 4-15) ORR 72% (n=23/32) (95% CI, 53%-86%) Median follow up of 10.4 months With a median duration of follow-up of 10.4 months, an estimated 59% of patients continued to respond for at least 9 months
*

Efficacy results reflect patients who received ≥4 prior lines of therapy.

†

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

‡

≥VGPR: sCR+CR+VGPR.

§

Deep responses: sCR+CR+VGPR.

||

Reflects the median prior lines of therapy for the entire naïve to T-cell redirection therapy population (Q2W and QW dosing).

¶

ORR: sCR+CR+VGPR+PR.

#

Due to rounding, calculation may not be exact.

CAR-T, chimeric antigen receptor-T cell; CI, confidence interval; CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; IRC, Independent Review Committee; mDOR, median duration of response; mTTR, median time to response; NE, not estimable; ORR, overall response rate; PR, partial response; QW, once weekly; Q2W, every 2 weeks; sCR, stringent complete response; VGPR, very good partial response.

  1. TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Data on file. Janssen Biotech, Inc.
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