SUMMARY

• Janssen does not recommend any practices, procedures, or usage that deviate from approved labeling.
• MonumenTAL-6 (MMY3009) is a phase 3 study comparing the efficacy of TALVEY in combination with pomalidomide (Tal-Pom) and TALVEY in combination with TECVAYLI (Tal-Tec) vs the investigator’s choice between elotuzumab in combination with pomalidomide and dexamethasone (EPd) and pomalidomide in combination with bortezomib and dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma (RRMM).¹ Enrollment in this study is currently ongoing, and results have not been published at this time.

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

CLINICAL DATA - Monumental-6 study

MonumenTAL-6 (MMY3009; clinicaltrials.gov identifier NCT06208150) is a multicenter, randomized, open-label, phase 3 study comparing the efficacy of Tal-Pom and Tal-Tec vs the investigator’s choice between EPd and PVd in patients with RRMM who have received 1 to 4 prior lines of therapy, including lenalidomide and anti-CD38 monoclonal antibodies.¹

Study Design/Methods

• The study design is presented in Figure: MonumenTAL-6 Study Design.¹
• The study is actively recruiting, with more than 190 locations in 27 countries (across North and South America, Europe, Asia, and Australia).¹
• The study will be conducted in 3 phases: screening phase (up to 28 days before randomization), treatment phase, and follow-up phase.¹
• Interim analyses are scheduled to assess safety, with a review of cumulative safety data planned after 20 patients have completed at least 2 treatment cycles or discontinued. Subsequent reviews will occur approximately every 6 months.¹
• Dosing¹:
  • Patients will receive Tal-Pom (arm A), Tal-Tec (arm B), and EPd in 28-day cycles and PVd in 21-day cycles.
  • In arms A and B, after step-up doses of 0.01 and 0.06 mg/kg, subcutaneous (SC) TALVEY will be administered as a single dose of 0.4 mg/kg, followed by 0.8 mg/kg every other week (Q2W).
    • Patients are allowed to switch TALVEY dosing from Q2W to every 4 weeks (Q4W) after achieving a confirmed very good partial response or better at cycle 5.
  • In arm A, 2 mg of oral pomalidomide will be administered on cycle 2 day 1, with a possibility of escalating the dose to 4 mg at the investigator’s discretion on cycle 3 day 1, as tolerated.
  • In arm B, after step-up doses of 0.06 and 0.3 mg/kg, SC TECVAYLI will be administered as 2 doses of 1.5 mg/kg, followed by 3.0 mg/kg Q4W starting from cycle 2.
  • A finite dosing approach will be followed for both TALVEY and TECVAYLI for up to 26 cycles, as tolerated.
  • In arm C (EPd or PVd), EPd will be administered according to the approved label and PVd will be administered per standard doses used in clinical practice for the treatment of multiple myeloma.
• Patients will continue to receive study treatment until disease progression, death, intolerable toxicity, withdrawal of consent, or the end of the study, whichever occurs first.¹

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 16 December 2024.