Patients (%)
ORR¶ 72%
(23/32)
(95% CI, 53%–86%)
Median follow-up of 10.4 months
With a median follow-up of 10.4 months, an estimated
59% of patients continued to respond for
at least 9 months
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:
(N=87)
(N=100)
Patients exposed to T-cell redirection therapy* received TALVEY® QW:
(N=32)
Key eligibility criteria1
- 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.
MonumenTAL-1 is the only clinical trial that included patients with ADC exposure and a specific cohort of patients with prior TCR exposure (bispecific antibody and/or CAR-T cell therapy)
*T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.
ADC, antibody-drug conjugates; 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; TCR, T-cell receptor; TTR, time to response.
- TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- Data on file. Janssen Biotech, Inc.
- A study of talquetamab in participants with relapsed or refractory multiple myeloma (MonumenTAL-1). ClinicalTrials.gov identifier: NCT04634552. Updated May 23, 2024. Accessed June 11, 2024. https://clinicaltrials.gov/study/NCT04634552
*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.
- TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- Data on file. Janssen Biotech, Inc.
Powerful responses with TALVEY®1,2
Efficacy was based on ORR and DOR as assessed by an IRC using IMWG criteria.1*
Patients who received TALVEY® achieved durable responses
Responses with Q2W dosing (N=87)
mTTR:
1.3 months
(range: 0.2–9.2 months)
mDOR:
NE
(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)
mTTR:
1.2 months
(range: 0.2–10.9 months)
mDOR:
9.5 months
(95% CI, 6.5–NE months)
Median duration of follow-up from first response among responders was 5.9 months;
an estimated 85% of patients continued to respondddd for at least 9 months.
Naïve to T-Cell Redirection Therapy1,2†
About 73% of patients responded to TALVEY®, with ≥32% achieving ≥CR‡
Median prior lines of therapy: 5 (range: 4–13)§
Deep responses with Q2W dosing (N=87)||
Deep responses with QW dosing (N=100)||
Patients who received TALVEY® achieved durable responses
Responses with Q2W dosing (N=87)
mTTR:
1.3 months
(range: 0.2–9.2 months)
mDOR:
NE
(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)
mTTR:
1.2 months
(range: 0.2–10.9 months)
mDOR:
9.5 months
(95% CI, 6.5–NE 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.
(range: 0.2–9.2 months)
†
T-cell redirection therapy refers to both CAR-T and bispecific antibody treatment.
‡
≥CR: sCR+CR
§
Reflects the median prior lines of therapy for the entire naïve to T-cell redirection therapy population (Q2W and QW dosing).
§Reflects the median prior lines of therapy for the entire naïve to T-cell redirection therapy population (Q2W and QW dosing).
||
Deep responses: sCR+CR+VGPR.
¶
ORR: sCR+CR+VGPR+PR.
#
Due to rounding, calculation may not be exact.
CR, complete response; mDOR, median duration of response; mTTR, median time to response; ORR, overall response rate; sCR, stringent complete response; TCR, T-cell redirection; VGPR, very good partial response; QW, once weekly; Q2W, every 2 weeks.
Durable responses were seen in patients exposed to T-cell redirection therapy1,2†
Efficacy was based on ORR and DOR as assessed by an IRC using IMWG criteria.1*
Exposed to T-Cell Redirection Therapy†
Responses with QW dosing (N=32)
Exposed to T-Cell Redirection Therapy†
Responses with QW dosing (N=32)
Patients (%)
ORR¶ 72%
(23/32)
(95% CI, 53%–86%)
Median follow-up of 10.4 months
With a median 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.
‡
≥CR: sCR+CR.
§Reflects the median prior lines of therapy for the entire naïve to T-cell redirection therapy population (Q2W and QW dosing).
‖Deep responses: sCR+CR+VGPR.
¶
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; TCR, T-cell redirection; VGPR, very good partial response.
- TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- Data on file. Janssen Biotech, Inc.