TALVEY® (talquetamab-tgvs)TALVEY - Prior and Subsequent Antimyeloma Therapy in the MonumenTAL-3 Study

SUMMARY  

• Johnson & Johnson does not recommend the use of TALVEY in a manner inconsistent with the approved labeling.
• MonumenTAL-3 is a phase 3 randomized, open-label, multicenter study comparing the efficacy of TALVEY in combination with DARZALEX FASPRO^® (daratumumab hyaluronidase; Tal-D) or TALVEY in combination with DARZALEX FASPRO and pomalidomide (Tal-DP) vs DARZALEX FASPRO in combination with pomalidomide and dexamethasone (DPd) in patients with relapsed/refractory multiple myeloma (RRMM).^1,2
  • Details pertaining to prior antimyeloma therapies, refractory status, and subsequent antimyeloma therapies from the MonumenTAL-3 study in the intentiontotreat (ITT) population is summarized below.^3,4

PRODUCT LABELING

• TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.
• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.  

CLINICAL DATA

MonumenTAL-3 (NCT05455320) is a phase 3 randomized, open-label, multicenter study comparing the efficacy of Tal-D or Tal-DP vs DPd in patients with RRMM who have received ≥1 prior line of therapy (LOT).^1,2

MonumenTAL-3 Study - Prior Antimyeloma Therapies

• In the ITT population, patients had received 1, 2-3, and >3 prior LOTs in 38.7% (n=111), 52.3% (n=150), and 9.1% (n=26) of the TalDP arm; 36.9% (n=106), 53.3% (n=153), and 9.8% (n=28) of the TalD arm; and 39.3% (n=114), 51% (n=148), and 9.7% (n=28) of the DPd arm, respectively.¹
• The median number of prior LOTs in the ITT population was 2 (range, 1-8) in the TalDP arm, 2 (range, 1-7) in the TalD arm, and 2 (range, 1-8) in the DPd arm.¹
• Details pertaining to prior antimyeloma therapy from the MonumenTAL-3 study are summarized in Table: MonumenTAL-3 Study - Summary of Prior Antimyeloma Therapies (ITT Population).³

MonumenTAL-3 Study - Refractory Status

• Details pertaining to refractory status from the MonumenTAL-3 Study are summarized in Table: MonumenTAL-3 Study - Refractory Status (ITT Population).³
• Overall, in the ITT population, 93.4% of patients were refractory to their last LOT.³

MonumenTAL-3 Study - Subsequent Antimyeloma Therapies

• Overall, ≥1 subsequent antimyeloma therapy was received by 18.1% of patients (n=52) in the Tal‑DP arm, 18.5% of patients (n=53) in the Tal‑D arm, and 40% of patients (n=116) in the DPd arm in the ITT population.^1,4
• Use of antineoplastic agents (proteasome inhibitors, chemotherapy agents/regimens, immunomodulatory drugs, chimeric antigen receptor T-cell (CAR-T) therapies, and selective inhibitor of nuclear export, and targeted small-molecule inhibitors) was reported in 17.4% of patients (n=50) in the Tal‑DP arm, 17.8% of patients (n=51) in the Tal‑D arm, and 39.7% of patients (n=115) in the DPd arm.⁴
• Among monoclonal antibodies and antibody-drug conjugates, use was reported in 8.4% of patients (n=24) in the Tal‑DP arm, 11.8% of patients (n=34) in the Tal‑D arm, and 17.9% of patients (n=52) in the DPd arm. The most common subsequent therapies (≥2% in any treatment arm) were⁴:
  • Teclistamab: Tal-DP (2.8%), Tal-D (1%), DPd (6.6%)
  • Daratumumab: Tal-DP (2.4%), Tal-D (5.2%), DPd (3.4%)
  • TALVEY: Tal-DP (0%), Tal-D (0.3%), DPd (3.4%)
  • Elranatamab: Tal-DP (1%), Tal-D (2.1%), DPd (3.1%)
• T-cell-redirecting therapies (CAR-T therapies, bispecific antibodies, and trispecific antibodies) were reported in 6.6% (n=19), 7.3% (n=21), and 19% (n=55) of patients in the Tal‑DP, Tal‑D, and DPd arms, respectively.⁴
• B-cell maturation antigen (BCMA)‑targeted therapies (CAR-T therapies, bispecific antibodies, trispecific antibodies, and antibody-drug conjugates) were reported in 5.9% (n=17), 7.3% (n=21), and 14.5% (n=42) of patients in the Tal‑DP, Tal‑D, and DPd arms, respectively.⁴
• Other subsequent therapy classes reported in the Tal‑DP, Tal‑D, and DPd arms, respectively, included⁴:
  • Alkylating agents: 6.3%, 5.6%, and 14.1%
  • Plant alkaloids and other natural products: 2.8%, 1.7%, and 3.8%
  • Antimetabolites: 2.8%, 2.1%, and 2.4%
  • Cytotoxic antibiotics and related substances: 3.8%, 2.1%, and 2.4%
  • Corticosteroids: 13.2%, 12.9%, and 23.8%
  • Immunosuppressants: 2.8%, 10.1%, and 6.6%
  • Investigational drugs: 0%, 0.7%, and 0.3%

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent^® (and/or other resources, including internal/external databases) was conducted on 10 July 2026.