Summary

• Janssen does not recommend any practices, procedures or usage that deviate from the approved labeling.
• Please consult your local health authority for approval status of TECVAYLI or TALVEY^® in multiple myeloma (MM). DARZALEX FASPRO^® (daratumumab and hyaluronidase) for subcutaneous (SC) use in combination with TECVAYLI or TALVEY is not approved by regulatory agencies.
• MajesTEC-7 (MMY3005) is a randomized, phase 3, open-label, multicenter study comparing the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO and lenalidomide (Tec-DR) and TALVEY in combination with DARZALEX FASPRO and lenalidomide (Tal-DR) vs DARZALEX FASPRO in combination with lenalidomide and dexamethasone (DRd) in patients with newly diagnosed multiple myeloma (NDMM) who are ineligible or not intended for transplant as initial therapy.^1,2
  • Touzeau et al (2024)¹ presented initial results from the safety run-in of 26 patients in Cohort 1 (Tec-DR) of the MajesTEC-7 study. At a median follow-up of 13.8 months, the overall response rate (ORR) was 92.3%. The most commonly reported treatment-emergent adverse events (TEAEs; any grade) were infections (100%), hematological disorders (84.6%), hypogammaglobulinemia (80.8%), diarrhea (69.2%), and cytokine release syndrome (CRS; 61.5%).

PRODUCT LABELING

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

CLINICAL DATA – MAJEStec-7 STUDY

MajesTEC-7 (MMY3005; clinicaltrials.gov identifier NCT05552222) is a randomized, phase 3, open-label, multicenter study comparing the efficacy and safety of Tec-DR and Tal-DR vs DRd in patients with NDMM who are ineligible or not intended for transplant as initial therapy.^1,2

Study Design/Methods

• A safety run-in period consisting of 3 cohorts was used to establish safety prior to enrolling the randomized phase of the study.¹
  • Details on Cohort 1 (Tec-DR) are provided in Figure: MajesTEC-7 Study Design (Safety Run-in Cohort 1).¹
  • A lead-in cycle of DRd was utilized in Cohort 2 (Tec-DR) and Cohort 3 (Tal-DR) as a debulking strategy to reduce CRS. The DRd lead-in resulted in a suboptimal safety profile with an increased risk of neutropenia, grade 3 CRS and serious/fatal infections (Cohort 2 only) observed. The randomized phase of MajesTEC-7 will not use the DRd lead-in.¹
• The study design for the randomized phase of the MajesTEC-7 study is presented in Figure: MajesTEC-7 Study Design (Randomized Phase).²
• The targeted enrollment is approximately 1590 patients.²
• The total duration of this study will be up to 9 years.²

Touzeau et al (2024)¹ presented initial results from the safety run-in of 26 patients in Cohort 1 (Tec-DR) of the MajesTEC-7 study.

Safety Run-in Cohort 1 (Tec-DR)

Treatment Disposition, Baseline Demographics, and Disease Characteristics

• At a median follow-up of 13.8 months (range, 2.0-15.4), 26 patients had received a median of 15 cycles (range, 2-17) of Tec-DR.
• At the data cutoff of March 18, 2024, 88.5% of patients (n=23) remained on treatment.
• Median relative dose intensity was 97% for TECVAYLI, 95.8% for DARZALEX FASPRO, and 58.6% for lenalidomide, with 17 patients undergoing lenalidomide dose reduction.
• Baseline characteristics and demographics are presented in Table: MajesTEC-7 Safety Run-in Cohort 1 (Tec-DR): Baseline Demographics and Disease Characteristics.

Efficacy

• At a median follow-up of 13.8 months, ORR was 92.3%. See details in Table: MajesTEC-7 Safety Run-in Cohort 1 (Tec-DR): Response Rate.
• One progression-free survival (PFS) event was also observed; all patients achieved very good partial response or better (≥VGPR).

Safety

• At a median follow-up of 13.8 months, TEAEs occurring in Cohort 1 are presented in Table: MajesTEC-7 Safety Run-in Cohort 1 (Tec-DR): Summary of TEAEs.
  • CRS of any grade occurred in 61.5% of patients with grade 1 CRS occurring in 57.7% of patients and grade 2 CRS occurring in 3.8% of patients. Most events occurred in cycle 1 of treatment. All cases resolved.
  • One grade 1 immune effector-cell associated neurotoxicity syndrome (ICANS) event was noted in a patient during cycle 1, which subsequently resolved.
  • Any-grade infections occurred in all patients, with grade 3-4 infections occurring in 30.8% of patients. Grade 3/4 infections did not increase with cumulative exposure to Tec-DR and most grade 3/4 infections had first onset within the first 3 treatment cycles.
  • Hypogammaglobulinemia (including patients with ≥1 treatment-emergent hypogammaglobulinemia or post-baseline immunoglobulin G [IgG] <500 mg/dL) was reported in 80.8% (n=21) of patients. Overall, 73.1% of the patients (n=19) received at least one dose of intravenous immunoglobulin (IVIG).
• Three patients discontinued all study treatment (n=1, death in cycle 3 due to influenza pneumonia; n=1, secondary primary malignancy [bladder neoplasm]; n=1, withdrawal of consent).

Literature Search

A literature search of Ovid MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 17 June 2024.