SUMMARY

• Johnson & Johnson does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
• This response provides relevant data from company-sponsored clinical trials, and the content is limited to the studies included below.
• MajesTEC-1 is a phase 1/2, multicohort study evaluating the safety and efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).¹
  • Cohort A (triple-class exposed) included 165 patients with RRMM who were previously treated with a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody (mAb).¹
    • Moreau et al (2022)¹ published the incidence of injection site reactions at a median follow-up of 14.1 months. Injection site reactions were reported in 36.4% of patients (n=60); all events were grade 1/2.
    • Garfall et al (2024)² presented the incidence of injection site reactions at a longer-term median follow-up of 30.4 months. Injection site erythema was reported in 26.7% of patients overall (n=44). No grade 3/4 injection site erythema was reported.
  • Cohort C included 40 patients with RRMM, previously treated with a PI, an immunomodulatory agent, an anti-CD38 mAb, and anti-B-cell maturation antigen (BCMA)-targeted therapies.³
    • Touzeau et al (2024)³ published the incidence of injection site reactions at a median follow-up of 28.0 months. Injection site erythema was reported in 32.5% of patients (n=13); all events were grade 1/2. Injection site pruritus was reported in 15.0% of patients (n=6); all events were grade 1/2.
• MajesTEC-2 is an ongoing, phase 1b, multicohort study evaluating the safety and efficacy of TECVAYLI in combination with other anticancer therapies in patients with multiple myeloma (MM).⁴
  • Cohort A included 17 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO and pomalidomide.⁵
    • D’Souza et al (2024)⁵ presented incidence of injection site reactions at a median follow-up of 16.2 months. Injection site erythema of any grade was reported in 41.2% of patients (n=7). No grade 3/4 injection site erythema was reported.
  • Cohort C included 28 patients with RRMM who received TECVAYLI and nirogacestat.⁶
    • Offner et al (2023)⁶ presented the incidence of injection site reactions at a median follow-up of 14.7 months. Injection site erythema of any grade was reported in 53.6% of patients (n=15). No grade 3/4 injection site erythema was reported.
• MajesTEC-4 is an open-label, randomized, multicenter, phase 3 study assessing the safety and efficacy of TECVAYLI in combination with lenalidomide (Tec-Len) and TECVAYLI alone vs lenalidomide alone as maintenance therapy after an autologous stem cell transplant (ASCT) in patients with newly diagnosed multiple myeloma (NDMM).⁷ 
  • Zamagni et al (2024)⁷ presented the incidence of injection site reactions from a safety run-in (SRI) consisting of 3 cohorts.
    • Cohort 1 (Tec-Len; TECVAYLI weekly [QW] to once every 4 weeks [Q4W]; N=32): At a median follow-up of 21.1 months, injection site erythema of any grade was reported in 21.9% of patients (n=7). No grade 3/4 injection site erythema was reported.
    • Cohort 2 (Tec-Len; TECVAYLI Q4W; N=32): At a median follow-up of 9.2 months, injection site erythema of any grade was reported in 37.5% of patients (n=12). No grade 3/4 injection site erythema was reported.
    • Cohort 3 (TECVAYLI Q4W; N=30): At a median follow-up of 9.2 months, injection site erythema of any grade was reported in 26.7% of patients (n=8). No grade 3/4 injection site erythema was reported.
• MajesTEC-7 is a randomized, phase 3, open-label study comparing the safety and efficacy of TECVAYLI in combination with DARZALEX FASPRO and lenalidomide (Tec-DR) and TALVEY^® (talquetamab-tgvs) in combination with DARZALEX FASPRO and lenalidomide (Tal-DR) vs DARZALEX FASPRO in combination with lenalidomide and dexamethasone (DRd) in patients with NDMM who are ineligible or not intended for transplant as initial therapy.⁸
  • Touzeau et al (2024)⁸ presented the incidence of injection site reactions from SRI cohort 1 (Tec-DR) at a median follow-up of 13.8 months. Injection site erythema of any grade was reported in 34.6% of patients (n=9). No grade 3/4 injection site erythema was reported.
• TRIMM-2 is an ongoing, phase 1b, multicohort study evaluating the safety and efficacy of DARZALEX FASPRO regimens in combination with bispecific T-cell redirecting antibodies in patients with RRMM.⁹
  • D’Souza et al (2024)⁵ presented the incidence of injection site reactions in the TECVAYLI + DARZALEX FASPRO + pomalidomide cohort (N=10) at a median follow-up of 38.3 months. Injection site erythema of any grade was reported in 30% of patients (n=3). No grade 3/4 injection site erythema was reported.

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

CLINICAL DATA - majestec-1 study

MajesTEC-1 study (NCT03145181; NCT04557098) is evaluating the safety and efficacy of TECVAYLI in patients with RRMM.¹

Study Design/Methods

The main objectives are as follows: part 1 (dose escalation) to determine the recommended phase 2 dose (RP2D) for TECVAYLI; part 2 (dose expansion) to distinguish safety and tolerability of TECVAYLI at the RP2D; part 3 (the phase 2 component) to evaluate the efficacy of TECVAYLI at the RP2D.^1,10

• Key eligibility criteria:
  • Cohort A: ≥3 prior lines of therapy (LOTs) including a PI, an immunomodulatory drug, and an anti-CD38 mAb, no prior BCMA-targeted therapy use.¹
  • Cohort C: ≥3 prior LOTs, a prior PI, an immunomodulatory drug, and an anti-CD38 mAb, enrolled patients who had prior exposure to BCMA-targeted treatment (chimeric antigen receptor [CAR]-T cell therapy and/or antibody drug conjugate [ADC]).³

Cohort A Safety Results

Moreau et al (2022)¹ published the incidence of injection site reactions at a median follow-up of 14.1 months (range, 0.3-24.4).

• Injection site reactions were reported in 36.4% of patients (60/165); all events were grade 1/2.

Garfall et al (2024)² presented the incidence of injection site reactions at a longer-term median follow-up of 30.4 months.

• Injection site erythema was reported in 26.7% of patients overall (44/165). No grade 3/4 injection site erythema was reported.

Cohort C Safety Results

Touzeau et al (2024)³ published the incidence of injection site reactions in cohort C of the MajesTEC-1 study at a median follow-up of 28.0 months (range, 0.7-31.1).

• Injection site erythema was reported in 32.5% of patients (13/40); all events were grade 1/2. Injection site pruritus was reported in 15.0% of patients (6/40); all events were grade 1/2.

CLINICAL DATA - MAJESTEC-2 STUDY

MajesTEC-2 (NCT04722146) is an ongoing, phase 1b, multicohort, open-label study evaluating the safety and efficacy of TECVAYLI in combination with other anticancer treatments in patients with MM.⁴

Study Design/Methods

Key Eligibility Criteria

• Cohort A (TECVAYLI and DARZALEX FASPRO and pomalidomide): received 1 to 3 prior LOTs, including a PI and lenalidomide.⁵
• Cohort C (TECVAYLI and nirogacestat): disease progression within 12 months of last LOT; ≥3 prior LOTs or double refractory to a PI and an immunomodulatory drug; and triple-class exposed to a PI, an immunomodulatory drug, and an anti-CD38 mAb. Patients with prior exposure to BCMA-targeted therapy were permitted.^4,6

Cohort A Safety Results

D’Souza et al (2024)⁵ presented the incidence of injection site reactions in cohort A of the MajesTEC-2 study at a median follow-up of 16.2 months (range, 0.5-34.5).

• Injection site erythema of any grade was reported in 41.2% of patients (7/17). No grade 3/4 injection site erythema was reported.

Cohort C Safety Results

Offner et al (2023)⁶ presented the incidence of injection site reactions at a median follow-up of 14.7 months (range, 0.5-22.9).

• Injection site erythema of any grade was reported in 53.6% of patients (15/28). No grade 3/4 injection site erythema was reported.

CLINICAL DATA - MajesTEC-4 study

MajesTEC-4 (NCT05243797) is an open-label, randomized, multicenter, phase 3 study evaluating the safety and efficacy of Tec-Len and TECVAYLI alone vs lenalidomide alone as maintenance therapy in patients with NDMM.⁷

Study Design/Methods

SRI Cohorts

• A SRI period consisting of 3 cohorts was used to establish safety prior to enrolling the randomized phase of the study.⁷
• Maintenance regimen (2-year fixed duration): patients who achieved a complete response (CR) on Tec-Len after 1-year discontinued TECVAYLI and continued lenalidomide for an additional year.⁷
• Key eligibility criteria: NDMM, receipt of 4 to 6 cycles of 3- or 4-drug induction therapy (PI and/or immunomodulatory drug ± anti-CD38 antibody), and ASCT (single or tandem ASCT permitted) ± consolidation with partial response (PR) or better.⁷

Safety Results

Zamagni et al (2024)⁷ presented the incidence of injection site reactions from SRI cohort 1 (Tec-Len; TECVAYLI QW to Q4W) at a median follow-up of 21.1 months (range, 14.8-23.8), SRI cohort 2 (Tec-Len; TECVAYLI Q4W) at a median follow-up of 9.2 months (range, 1.2-12.2), and SRI cohort 3 (TECVAYLI Q4W) at a median follow-up of 9.2 months (range, 3.7-11.5).

• Any-grade injection site erythema was reported in 21.9% of patients (7/32) in cohort 1, 37.5% of patients (12/32) in cohort 2, and 26.7% of patients (8/30) in cohort 3. No grade 3/4 injection site erythema was reported.

CLINICAL DATA - MAJESTEC-7 STUDY

MajesTEC-7 (NCT05552222) is a randomized, phase 3, open-label, multicenter study comparing the safety and efficacy of Tec-DR and Tal-DR vs DRd in patients with NDMM who are ineligible or not intended for transplant as initial therapy.⁸

Study Design/Methods

SRI Cohort 1 (Tec-DR)

• A SRI period was used to establish safety prior to enrolling the randomized phase of the study.⁸
• Key eligibility criteria: NDMM either ineligible or not intended for ASCT.⁸

Safety Results

Touzeau et al (2024)⁸ presented the initial results from the SRI of 26 patients in cohort 1 (Tec-DR) of the MajesTEC-7 study at a median follow-up of 13.8 months (range, 2.0-15.4).

• Injection site erythema of any grade was reported in 34.6% of patients (9/26). No grade 3/4 injection site erythema was reported.

clinical data - Trimm-2 study

TRIMM-2 (NCT04108195) is an ongoing, phase 1b, 2-part, multicohort, open-label study evaluating safety and efficacy of DARZALEX FASPRO regimens in combination with bispecific T-cell redirection antibodies in patients with RRMM.¹¹

Study Design/Methods

• Key eligibility criteria: ≥3 prior LOTs (including a PI and an immunomodulatory drug) or double refractory to a PI and an immunomodulatory drug, anti-CD38 mAb >90 days prior allowed, and prior bispecific antibodies (BsAbs) and CAR-T were allowed.¹¹

Safety Results

D'Souza et al (2024)⁵ presented the incidence of injection site reactions in the TECVAYLI + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 38.3 months (range, 1.2-39.6).

• Injection site erythema was reported in 30% of patients (3/10). No grade 3/4 injection site erythema was reported.

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 15 January 2026.