SUMMARY

• Johnson & Johnson does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
• MajesTEC-1 is a phase 1/2, multicohort study evaluating the efficacy and safety 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
    • Costa et al (2024)² presented a subgroup analysis of the MajesTEC-1 study, evaluating the efficacy and safety of TECVAYLI in patients with high-risk (HR) features, including patients ≥75 years of age at the data cutoff of August 22, 2023.
• Manier et al (2025)³ presented results from cohort A of the Intergroupe Francophone du Myelome (IFM) 2021‑01 TecLille study evaluating efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO (Tec-Dara subcutaneous [SC]) in elderly patients (age ≥65 years) with transplant non-eligible newly diagnosed multiple myeloma (TNE-NDMM) at the data cutoff of November 4, 2025.
• Mian et al (2025)⁴ published a retrospective, multicenter study of older adults (age ≥70 years) including frail patients treated in the real-world with TECVAYLI.
• Pasvolsky (2025)⁵ published a retrospective, multicenter study of real-world outcomes of a large cohort of elderly patients (<75 years and ≥75 years) with RRMM receiving standard of care (SOC) TECVAYLI.
• Dima et al (2023)⁶ evaluated the efficacy and safety of TECVAYLI in patients >70 years of age compared to those ≤70 years of age in a retrospective, real-world study.
• Dieterle et al (2023)⁷ described the use of TECVAYLI in 3 patients, >80 years of age, with RRMM who received ≥3 prior lines of therapy (LOTs).

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.

CLINICAL DATA - MAJESTEC-1 STUDY

MajesTEC-1 (NCT03145181, NCT04557098) is evaluating the efficacy and safety 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 at RP2D; and part 3 (phase 2 component), to evaluate the efficacy of TECVAYLI at RP2D.^1,8
• Key eligibility criteria:
  • Cohort A: received ≥3 prior LOTs (including a PI, an immunomodulatory drug, and an anti-CD38 mAb) and no prior B-cell maturation antigen (BCMA)-targeted therapy use.¹
• Primary endpoint for Cohort A: overall response rate (ORR).¹
• Key secondary endpoint for Cohort A: safety.¹

Cohort A

Costa et al (2024)² presented a subgroup analysis from the MajesTEC-1 study evaluating the efficacy and safety of TECVAYLI in patients with HR features. Results specific to patients ≥75 years of age are summarized below.

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

• By the data cutoff date of August 22, 2023, a total of 165 patients had received TECVAYLI at RP2D; 24 patients (14.5%) were aged ≥75 years.

Efficacy

• Select efficacy outcomes, including the response rate and duration of response (DOR), were evaluated. The response rate in the overall population and in patients aged ≥75 years is presented in Table: MajesTEC-1 Study (Cohort A): Summary of ORR. DOR in the overall population and in patients aged ≥75 years is presented in Table: MajesTEC-1 Study (Cohort A): DOR to TECVAYLI.

Safety

• A summary of safety outcomes in the overall population and in patients in patients aged ≥75 years is provided in Table: MajesTEC-1 Study (Cohort A): Summary of Safety Outcomes.

CLINICAL DATA - IFM2021 01 STUDY

IFM2021-01 (NCT05572229) is an open label, multicenter, non-comparative, 2-cohort, 2-stage, interventional phase 2 study evaluating the efficacy and safety of Tec-Dara SC and Tec-Len.³

Study Design/Methods³:

• IFM2021-01 TecLille study design is shown in Figure: IFM2021-01 TecLille Study Design: Phase 2 Study of Tec-Dara SC and Tec-Len.
• Data cutoff date for the study was November 04, 2025, and the median follow‑up was 10.3 months.
  • Part 1 included 18 patients from March 18, 2024, to June 10, 2024; median follow‑up was 17 months.
  • Part 2 included 19 patients from November 21, 2024, to January 21, 2025; median follow‑up was 9.5 months.

Manier et al (2025)³ presented results from cohort A of the phase 2 study of IFM2021‑01 TecLille evaluating efficacy and safety of Tec-Dara SC in TE-NDMM elderly patients (age >65 years).

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

• A total of 37 patients were included cohort A of this study. See Table: IFM2021-01 TecLille Study (Cohort A): Patients and Disease Characteristics.

Treatment Exposure (Cohort A, n=37)

• Median treatment duration in patients was 10.3 months (quartile 1 [Q1]-Q3: 9.3-16.6).
• Median total number of cycles received in patients was 12 cycles (Q1-Q3: 10-18).
• Median relative dose intensity in patients was 95% for TECVAYLI (Q1-Q3: 89-100) and 96.6% for DARZALEX FASPRO (Q1-Q3; 90.5-100).

Efficacy

• Summary of responses are presented in the Tables: IFM2021-01 TecLille Study (Cohort A): Efficacy Outcomes.
• Minimal residual disease (MRD) evaluation by next-generation sequencing (NGS; Clononseq) was performed in 37 patients at 6 months, and for technical reasons (missing causes: calibration failure, n=4; missing samples, n=3; and only evaluable at 10^-⁵, n=3) only 27 patients were evaluable at 10^-6; no patients had a positive MRD status.
  • MRD negativity at 10^-6 at 6 months in the intentiontotreat (ITT) population (n=37) occurred in 73% of patients.
  • MRD negativity at 10^-6 at 6 months in evaluable samples (n=27) occurred in 100% of patients.
• All evaluable samples were MRD negative at 10^-6 by NGS at 6 months.
• At a median follow up of 10.3 months, no event of progression or death was reported.

Safety

• Summary of adverse events (AEs) is presented in Tables: IFM2021-01 TecLille Study (Cohort A): Grade ≥3 AE and IFM2021-01 TecLille Study (Cohort A): Adverse Events of Special Interest .
• Immunoglobulin (Ig) supplementation was received by 95% of patients (n=35) and not received by 5% of patients (n=2), and the median cycle of initiation was 1-cycle (Q1-Q3: 1-2).
• Cytomegalovirus (CMV) reactivation occurred in 8% of patients (n=3).
• Treatment discontinuation due to AEs was reported in 3% of patients (n=1), and the reported AE leading to discontinuation was gastrointestinal infection due to Salmonella.

Tumor Burden and Immune Remodeling

• Deep decrease of clonotypes and soluble Bcell maturation antigen (sBMCA) was reported at 6 months, and only 3 patients had a clonotype <5 mg/L (equivalent MRD 10⁻⁵) at this early time-point.
• Immune remodeling was reported at 6 months with increase of terminal effector memory T cells and decrease of Tregs and natural killer (NK) cells.

Real-world data

Mian et al (2025)⁴ published a retrospective, multicenter study of older adults (age ≥70) including frail patients treated in the real-world with TECVAYLI.

Study Design/Methods

• This was a multicenter, retrospective analysis of patients with RRMM included in the International Myeloma Foundation (IMF) immunotherapy database and treated with TECVAYLI across 7 academic institutions in 5 countries between May 2022 and December 2023.
• Frailty categorization was done using the simplified frailty index and patients categorized as fit (score 0-1) or frail (≥ score 2).

Results

Select Baseline Characteristics

• Among the 81 patients analyzed, the median age was 76 years (range, 70-91), with 45.7% of patients (37/81) aged ≤75 years, 25.9% of patients (21/81) aged 76-80 years and 28.4% (23/81) aged ≥80 years.
• High-risk cytogenetics was reported in 55.3% (26/47) of frail patients and 61.1% (11/18) of fit patients; denominators reflect available data.
• BCMA-refractory disease was present in 30.2% (16/53) of frail patients and 25% (4/16) of fit patients; denominators reflect available data.
• Prior exposure to an anti-BCMA agent was reported in 33.9% (20/59) of frail patients and 50.0% (11/22) of fit patients; denominators reflect available data.
• Creatinine clearance <30 mL/min was reported in 15.3% (9/59) of frail patients and 4.6% (1/22) of fit patients.
• Eastern Cooperative Oncology Group (ECOG) ≥ 2 was reported in 45.8% (27/59) of frail patients (32.2% ECOG 2; 13.6% ECOG 3) and 0% of fit patients.
• Frailty categorization:
  • Fit (frailty score 0-1): 22 patients (27.2%).
  • Frail (frailty score ≥2): 59 patients (72.8%).
  • Ultra-frail (frailty score ≥3): 38 patients (64.4%).

Efficacy

• At a median follow-up of 13.1 months, ORR was 63% for the 73 patients with evaluable disease response. See Table: Summary of Efficacy Outcomes.

Dosing Interval Changes

• Dosing interval modifications were reported in 38.3% of patients (n=31), including 40.9% of fit patients (n=9) and 37.3% of frail patients (n=22).
• The most common revised dosing schedule was every 2 weeks (n=26); less frequent adjustments included every 3 weeks (n=4) and every 4 weeks (n=1).
• Primary reasons for modifying the dosing interval were achievement of a good disease response (n=23), toxicity (n=7), and convenience (n=1).

Safety

• AEs are summarized in the Table: Summary of Safety Outcomes.

Pasvolsky et al (2025)^5,9 published a retrospective, multicenter study of a large cohort of elderly patients (<75 years and ≥75 years) with RRMM receiving SOC TECVAYLI.

Study Design/Methods

• This retrospective, multicenter study included data of patients with RRMM who received SOC TECVAYLI at 13 centers of the United States (US) Multiple Myeloma Immunotherapy Consortium with a data cutoff date of April 30, 2024.
• TECVAYLI was administered per institutional SOC practices, including step‑up dosing schedules, supportive care measures, and response assessment timing.
• Patients were divided into the following groups: age <75 years and age ≥75 years.

Results

Select Baseline Patient Characteristics

• Among the 385 patients analyzed, 83 (22%) were aged ≥75 years and 302 (78%) were <75 years.
• Compared to <75 years group, those in the ≥75‑year group had fewer adverse baseline disease features, including a lower frequency of high‑risk cytogenetics (44.6% vs 57.9%; P=0.0301) and extramedullary disease at baseline (22% vs 40%; P=0.0018).
• Prior exposure to an anti‑BCMA agent was also less common in the ≥75 years compared to <75 years group (33% vs 55%; P=0.0003).

Efficacy

• Efficacy outcomes are shown in Table: Summary of Efficacy Response.
• Multivariable analysis of the study population is presented in the Tables: Multivariable Analysis of Survival Outcomes (<75 Years vs ≥75 Years): PFS and Multivariable Analysis of Survival Outcomes (<75 Years vs ≥75 Years): OS.

Safety

• CRS and ICANS are detailed in Tables: Summary of CRS Events and Summary of ICANS Events.
• Causes of deaths reported in the study population are detailed in Table: Causes of Death.

Dima et al (2023)⁶ presented efficacy and safety data from a retrospective, real-world study evaluating the use of TECVAYLI in older patients (>70 years) with RRMM compared to younger patients (≤70 years).  

Study Design/Methods

• The study population consisted of patients with RRMM who received TECVAYLI as of July 1, 2023 at 5 US academic centers, part of the US Myeloma Innovations Research Collaboration.
• Outcomes assessed included ORR, complete response or better (≥CR), and safety. Responses were assessed using the International Myeloma Working Group (IMWG) criteria.

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

• A total of 102 patients were included in the study, including 33 patients (32%), who were >70 years of age and 69 (68%) who were ≤70 years of age.
• Additional baseline characteristics are summarized in Table: Baseline Characteristics.⁴

Efficacy

• At a median follow-up of 3.2 months, ORR (70% vs 61%, P=0.37) and ≥CR (30% vs 28%, P=0.8) were comparable in patients >70 years vs ≤70 years.
• Median estimated progression-free survival was 5.4 vs 3.8 months in patients >70 years vs ≤70 years respectively (P=0.61).

Safety

• Detailed safety data is reported in the Table: Safety Outcomes for Patients >70 years of Age vs Patients ≤70 Years of Age.⁶

CLINICAL DATA - case reports

Dieterle et al (2023)⁷ reported on the efficacy and safety of TECVAYLI administered at the recommended dosing schedule in patients (N=3) aged >80 years after ≥3 prior LOT. A case report of an octogenarian is summarized below.

• Disease characteristics: An elderly patient (80 years) presented with initial cervical pain and high lambda free serum light chains (FSLCs). The patient fulfilled 3 of 4 CRAB criteria (hypercalcemia, renal dysfunction, anemia, and bone lesions) and was diagnosed with multiple myeloma. Bone marrow biopsy revealed 80% plasma cell infiltration and unfavorable cytogenetics (t[11;14]; monosomy 13; CKS1B gene amplification in 1q21).
• Treatment: After an initial course of radiation, the patient received a first LOT of bortezomib-cyclophosphamide-dexamethasone (5 cycles), a second LOT of daratumumab-lenalidomide-dexamethasone (10 cycles), and a third LOT of daratumumab-pomalidomide-dexamethasone (6 cycles). Prior to TECVAYLI initiation, bridging therapy with cyclophosphamide and dexamethasone was administered to limit disease progression. At the age of 82 years, the patient received step-up doses of TECVAYLI subcutaneously (SC; day 1, 0.06 mg/kg; day 3, 0.3 mg/kg, and day 5, 1.5 mg/kg) in cycle 1. Subsequent TECVAYLI doses (1.5 mg/kg SC weekly) were administered in an outpatient setting.
• Response: The patient achieved complete remission (lambda FSLCs <0.5 mg/L, immunofixation negativity in serum and urine) 1 and 2 months after TECVAYLI initiation.
• Safety: Hematologic adverse events were reported as Grade 1 pancytopenia. No CRS or ICANS events were reported.

Two additional patients >80 years suffering from symptomatic RRMM after proteosome inhibitor, immunomodulatory agent, and anti-CD38 mAb therapy were treated with TECVAYLI. Data on disease characteristics, treatment duration, response, and safety are summarized in the Table: Detailed Patient Characteristics of Octogenarians Treated With TECVAYLI.¹⁰

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 24 February 2026.