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 who were previously treated with a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody (mAb).¹
    • Nooka et al (2023)^2,3 published the incidence, timing, and management of neutropenia in patients receiving TECVAYLI in the MajesTEC-1 study. At a median follow-up of 22.8 months, grade 3/4 neutropenia was reported in 65.5% of patients and grade 3/4 febrile neutropenia was reported in 3.6% of patients.
    • Garfall et al (2024)⁴ presented the incidence of hematologic treatment-emergent adverse events (TEAEs) at a longer-term median follow-up of 30.4 months. Grade 3/4 hematologic TEAEs included neutropenia (65.5%), anemia (37.6%), lymphopenia (34.5%), thrombocytopenia (23.0%), and leukopenia (9.1%).
  • Cohort C included 40 patients, previously treated with a PI, an immunomodulatory agent, an anti-CD38 mAb and anti-B-cell maturation antigen (BCMA)-targeted therapies.⁵
    • Touzeau et al (2024)⁵ published the incidence of hematologic adverse events (AE) at a median follow-up of 28.0 months. Grade 3/4 hematologic AEs included neutropenia (65%), lymphopenia (42.5%), anemia (35%), and thrombocytopenia (30.0%).
  • The prophylactic tocilizumab cohort is evaluating the administration of intravenous (IV) tocilizumab (8 mg/kg) prior to TECVAYLI dosing for the reduction of cytokine release syndrome (CRS) in 24 patients with RRMM.^6,7
    • van de Donk et al (2024)⁷ presented the incidence of hematologic TEAEs at a median follow-up of8.1 months. Grade 3/4 hematologic TEAEs included neutropenia (62.5%), lymphopenia (37.5%), anemia (25.0%), thrombocytopenia (25.0%), and leukopenia (20.8%).
  • Miao et al (2023)⁸ presented the analysis of exposure/safety relationships of TECVAYLI in patients with RRMM in the MajesTEC-1 study for the occurrence of select grade ≥3 TEAEs including anemia, neutropenia, lymphopenia, and thrombocytopenia.
• 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).⁹
  • Cohort A included 17 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO^® (daratumumab and hyaluronidase) and pomalidomide.¹⁰
    • D’Souza et al (2024)¹⁰ presented the incidence of hematologic AEs at a median follow-up of 16.2 months. The most common grade 3/4 hematologic AEs included neutropenia (88.2%), anemia (23.5%), and lymphopenia (17.6%).
  • Cohort C included 28 patients who received TECVAYLI and nirogacestat.¹¹
    • Offner et al (2023)¹¹ presented the incidence of hematologic AEs at a median follow-up of 14.7 months. The most common grade 3/4 hematologic AEs included neutropenia (75.0%), anemia (32.1%), and thrombocytopenia (14.3%).
  • Cohort D included 31 patients with MM who received TECVAYLI in combination with lenalidomide (Tec-Len).¹²
    • Tan et al (2023)¹² presented the incidence of hematologic AEs at a median follow-up of 10.8 months. Grade 3/4 hematologic AEs included neutropenia (67.7%), anemia (19.4%), and thrombocytopenia (16.1%).
  • Cohort E included 32 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO and lenalidomide (Tec-DR).¹³
    • Searle et al (2022)¹³ presented the incidence of hematologic AEs at a median follow-up of 8.4 months. Grade 3/4 hematologic AEs (≥10%) included neutropenia (78.1%), thrombocytopenia (15.6%), anemia (12.5%), febrile neutropenia (12.5%), and lymphopenia (12.5%).
• MajesTEC-3 is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO (Tec-Dara subcutaneous [SC]) vs investigator’s choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with RRMM after 1-3 prior lines of therapy (LOTs).¹⁴ 
  • Costa et al (2025)^14,15 published the incidence of hematologic events from the MajesTEC-3 study. At a median follow-up of 34.5 months, grade 3/4 hematologic events included neutropenia (75.6% vs 78.6%), anemia (20.5% vs 17.2%), thrombocytopenia (19.4% vs 23.4%), lymphopenia (20.8% vs 11%), and leukopenia (10.6% vs 15.9%) in the Tec-Dara SC and DPd/DVd arms, respectively.
• MajesTEC-4 is an open-label, randomized, multicenter, phase 3 study assessing the safety and efficacy of 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).¹⁶
  • Zamagni et al (2024)¹⁶ presented the incidence of hematologic AEs 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, the most common grade 3/4 hematologic AEs included neutropenia (93.8%), leukopenia (9.4%), and febrile neutropenia (9.4%).
    • Cohort 2 (Tec-Len; TECVAYLI Q4W; N=32): At a median follow-up of 9.2 months, the most common grade 3/4 hematologic AEs included neutropenia (62.5%), lymphopenia (12.5%), and febrile neutropenia (9.4%).
    • Cohort 3 (TECVAYLI Q4W; N=30): At a median follow-up of 9.2 months, grade 3/4 hematologic AEs included neutropenia (46.7%), lymphopenia (13.3%), and leukopenia (3.3%). 
• MajesTEC-5 is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI-based combination regimens in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM).¹⁷
  • Raab et al (2025)¹⁸ presented the incidence of hematologic AEs from 3 induction cohorts of the MajesTEC-5 study at a median follow-up of 7.3 months.
    • Arm A (Tec [QW]-DR; n=10): The most common grade 3/4 hematologic AEs included lymphopenia (80%), neutropenia (30%), and leukopenia (20%).
    • Arm A1 (Tec [Q4W]-DR; n=20): The most common grade 3/4 hematologic AEs included neutropenia (65%), lymphopenia (45%), and anemia (20%).
    • Arm B (Tec Q4W in combination with DARZALEX FASPRO, bortezomib, and lenalidomide; Tec [Q4W]-DVR; n=19): The most common grade 3/4 hematologic AEs included neutropenia (63.2%), lymphopenia (63.2%), and leukopenia (26.3%).
• MajesTEC-7 is a randomized, phase 3 study evaluating the safety and efficacy of 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 NDMM who are ineligible or not intended for transplant as initial therapy.¹⁹
  • Touzeau et al (2024)¹⁹ presented the incidence of hematologic AEs from SRI cohort 1 (Tec-DR) at a median follow-up of 13.8 months. Grade 3/4 hematologic TEAEs were reported in 65.4% of patients overall and included neutropenia (57.7%), thrombocytopenia (15.4%), febrile neutropenia (11.5%), and anemia (3.8%).
• 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.²⁰
  • D’Souza et al (2024)¹⁰ presented the incidence of hematologic AEs in the TECVAYLI + DARZALEX FASPRO + pomalidomide cohort (N=10) at a median follow-up of 38.3 months. The most common grade 3/4 hematologic AEs included neutropenia (60%), lymphopenia (30%), thrombocytopenia (20%), and febrile neutropenia (20%).
  • Rodriguez-Otero et al (2022)²⁰ presented the incidence of hematologic AEs in the TECVAYLI and DARZALEX FASPRO cohort (N=65) at a median follow-up of 8.6 months. Grade 3/4 hematologic AEs included neutropenia (41.5%), anemia (27.7%), and thrombocytopenia (24.6%).

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 (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 safety and efficacy of TECVAYLI at the RP2D.^1,21

• Key eligibility criteria:
  • Cohort A: ≥3 prior 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 T-cell [CAR-T] therapy and/or antibody drug conjugate [ADC]).⁵
  • Prophylactic tocilizumab cohort: ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.⁶

Cohort A Safety Results

Nooka et al (2023)^2,3 published the incidence, timing, and management of neutropenia in patients receiving TECVAYLI in the MajesTEC-1 study, based on a data cutoff date of January 4, 2023.

• Neutropenia was reported in 71.5% of patients overall with grade 3/4 neutropenia reported in 65.5% of patients. Febrile neutropenia was reported in 4.8% of patients (n=8) with grade 3/4 febrile neutropenia reported in 3.6% of patients (n=6).²
• No patients discontinued TECVAYLI treatment due to neutropenia.²
• The median time to onset of grade ≥3 neutropenia or febrile neutropenia was 2.3 months (range, 0.0-18.1). Within 2-4 months following TECVAYLI initiation, neutropenia was reported most frequently during this time period compared with other time points. See Table: MajesTEC-1 Study (Cohort A): Occurrence of Neutropenia and Febrile Neutropenia by Onset Time.²
• The median duration per event of any-grade neutropenia/febrile neutropenia was 0.26 months (range, 0-9.5) and grade ≥3 neutropenia/febrile neutropenia was 0.26 months (range, 0-3.4).³
• Median absolute neutrophil count (ANC) within 2 and 4 weeks before onset of grade ≥3 infection was 2915/mm³ (range, 0-10,400/mm³) and 2900/mm³ (range, 0-10,400/mm³), respectively.²
• Granulocyte-colony stimulating factor (G-CSF) therapy was administered (for prophylaxis and management) to 54.5% of patients (n=90).²
  • Filgrastim was used in 47.3% of patients, unspecified G-CSF in 10.3% of patients, pegfilgrastim in 9.1% of patients and lenograstim in 0.6% of patients.²

Garfall et al (2024)⁴ presented the incidence of hematologic TEAEs from cohort A of the MajesTEC-1 study at a longer-term median follow-up of 30.4 months.

• The incidence of hematologic TEAEs is summarized in Table: MajesTEC-1 Study (Cohort A): Hematologic TEAEs.

Cohort C Safety Results

Touzeau et al (2024)⁵ published the incidence of hematologic AEs in cohort C of the MajesTEC-1 study at a median follow-up of 28.0 months (range, 0.7-31.1).

• The incidence of hematologic AEs is summarized in Table: MajesTEC-1 Study (Cohort C): Hematologic AEs (≥10%).

Prophylactic Tocilizumab Cohort Safety Results

van de Donk et al (2024)⁷ presented the incidence of hematologic AEs in the prophylactic tocilizumab cohort of the MajesTEC-1 study at a median follow-up of 8.1 months (range, 0.9-13.2).

• The incidence of hematologic TEAEs is summarized in Table: MajesTEC-1 Study (Prophylactic Tocilizumab Cohort): Hematologic TEAEs.

Population Pharmacokinetics (PK) and Exposure-Relationships in MajesTEC-1

Miao et al (2023)⁸ developed a population PK model to evaluate the exposure of TECVAYLI in baseline demographic subgroups and other covariates. In addition, the exposure-safety relationships were explored using available data from 338 patients in the phase 1/2 MajesTEC-1 study.

Methods

• Select safety analysis: The occurrence of grade ≥3 TEAEs, including anemia, neutropenia, lymphopenia, leukopenia and thrombocytopenia were estimated in patients who received TECVAYLI subcutaneous (SC) dosing in the phase 1/2 (cohort A) portion of the trial (n=217). The analysis used predicted maximum concentration following the first treatment dose (C_max,1stdose) and predicted maximum concentration following the first four QW treatment doses (C_max,4doses) to characterize the exposure-safety relationship.

Results

Population PK Analysis

• Among 338 patients (4840 PK observations) from the phase 1/2 MajesTEC-1 study, 83 patients (1976 PK observations) were administered TECVAYLI IV, and 255 patients (2864 PK observations) were administered TECVAYLI SC.
• Among patients who received TECVAYLI SC, 28 patients (604 PK observations) received doses <RP2D, 203 (1679 PK observations) received RP2D, 21 patients (502 PK observations) received doses >RP2D, and 3 patients (79 PK observations) received flat dosing.

Exposure-response Safety Analysis - Hematologic AEs

• Among the 217 patients who received SC doses of TECVAYLI, the rates of grade ≥3 neutropenia, lymphopenia, leukopenia, and thrombocytopenia were not associated with concentrations of TECVAYLI when assessed in the predicted exposure quartiles. A decreasing trend was observed in the incidence of anemia, the highest rate was observed in the lowest quartile group.

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.⁹

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.¹⁰
• 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.^9,11
• Cohort D (Tec-Len): received ≥2 prior LOTs including a PI, an immunomodulatory drug and an anti-CD38 mAb, no prior BCMA-targeted therapy.¹²
• Cohort E (Tec-DR): received 1-3 prior LOTs including a PI, and an immunomodulatory drug, no prior BCMA-targeted therapy.¹³

Cohort A Safety Results

D’Souza et al (2024)¹⁰ presented the incidence of hematologic AEs in cohort A of the MajesTEC-2 study at a median follow-up of 16.2 months (range, 0.5-34.5).

• The incidence of hematologic AEs is presented in Table: MajesTEC-2 Study (Cohort A: TECVAYLI, DARZALEX FASPRO, and Pomalidomide): Hematologic TEAEs.

Cohort C Safety Results

Offner et al (2023)¹¹ presented the incidence of hematologic AEs in cohort C of the MajesTEC-2 study at a median follow-up of 14.7 months (range, 0.5-22.9).

• The incidence of hematologic AEs is presented in Table: MajesTEC-2 Study (Cohort C: TECVAYLI + Nirogacestat): Hematologic AEs (≥20% Overall).
• One patient treated with TECVAYLI discontinued treatment due to AEs of neutropenia and pneumonia.
• Across all dose levels, febrile neutropenia was reported in 1 patient (3.6%).

Cohort D Safety Results

Tan et al (2023)¹² presented the incidence of hematologic AEs in cohort D of the MajesTEC-2 study at a median follow-up 10.8 months (range, 1.1-16.8).

• The incidence of hematologic AEs is presented in Table: MajesTEC-2 Study (Cohort D: Tec-Len): Hematologic AEs (≥25% Overall).
• Grade 3/4 febrile neutropenia was reported in 2 patients (6.5%).

Cohort E Safety Results

Searle et al (2022)¹³ presented the incidence of hematologic AEs in cohort E of the MajesTEC-2 study at a median follow-up of 8.4 months (range, 1.1-12.9).

• The incidence of hematologic AEs is presented in Table: MajesTEC-2 Study (Cohort E: Tec-DR): Hematologic AEs (Any Grade; ≥25% and/or Grade 3/4; ≥10%).

CLINICAL DATA - MajesTEC-3 study

MajesTEC-3 (NCT05083169) is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO vs DPd or DVd (investigator’s choice) in patients with RRMM after 1-3 prior LOTs.¹⁴

Study Design/Methods

• Key eligibility criteria: RRMM, 1-3 prior LOTs, including a PI and lenalidomide, patients with only 1 prior LOT must have been lenalidomide-refractory per International Myeloma Working Group criteria, and Eastern Cooperative Oncology Group performance status 0-2.¹⁴

Safety Results

Costa et al (2025)^14,15 published the incidence of hematologic events from the MajesTEC-3 study at a median follow-up of 34.5 months (range, 0.03 to 45.3).

• Any-grade neutropenia was reported in 78.4% of patients (222/283) in the Tec-Dara SC arm and 82.8% (240/290) in the DPd/DVd arm, respectively.
  • Grade 3/4 neutropenia was reported in 75.6% (214/283) and 78.6% (228/290) of patients, in the Tec-Dara SC arm and DPd/DVd arm, respectively.
• Any-grade anemia was reported in 39.2% of patients (111/283) in the Tec-Dara SC arm and 35.5% (103/290) in the DPd/DVd arm
  • Grade 3/4 anemia was reported in 20.5% (58/283) and 17.2% (50/290) of patients in the Tec-Dara SC arm and DPd/DVd arm, respectively.
• Any-grade thrombocytopenia was reported in 36.4% of patients (103/283) in the Tec-Dara SC arm and 43.4% (126/290) in the DPd/DVd arm
  • Grade 3/4 thrombocytopenia was reported in 19.4% (55/283) and 23.4% (68/290) of patients in the Tec-Dara SC arm and DPd/DVd arm, respectively.
• Any-grade lymphopenia was reported in 22.3% of patients (63/283) in the Tec-Dara SC arm and 17.2% (50/290) in the DPd/DVd arm
  • Grade 3/4 lymphopenia was reported in 20.8% (59/283) and 11.0% (32/290) of patients in the Tec-Dara SC arm and DPd/DVd arm, respectively.  
• Any-grade leukopenia was reported in 18.0% of patients (51/283) in the Tec-Dara SC arm and 21.0% (61/290) in the DPd/DVd arm
  • Grade 3/4 leukopenia was reported in 10.6% (30/283) and 15.9% (46/290) of patients in the Tec-Dara SC arm and DPd/DVd arm, respectively.
• Grade ≥3 cytopenias were reported in 82.3% of patients (233/283) in the Tec-Dara SC arm and 86.9% (252/290) in the DPd/DVd arm.
  • Incidence was highest within 6 months (77.4%, [219/283] and 85.5%, [248/290]) and declined thereafter (at >30 months, 12.2%, [24/196] and 22.0%, [20/91]), in the Tec-Dara SC arm and DPd/DVd arm, respectively.

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.¹⁶

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.¹⁶
• 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.¹⁶
• 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.¹⁶

Safety Results

Zamagni et al (2024)¹⁶ presented the incidence of hematologic AEs from the 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).

• Details on hematologic events are provided in Table: MajesTEC-4/EMN30 Study (SRI Cohorts): Hematologic AEs.
• The cumulative incidence of grade 3/4 neutropenia at 6 months was 81.3% for cohort 1, 56.3% for cohort 2, and 40.0% for cohort 3.

CLINICAL DATA - MajesTEC-5 study

MajesTEC-5 (GMMG-HD10; DSMM-XX) is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI combination regimens in patients with TE-NDMM.¹⁷

Study Design/Methods

• Key eligibility criteria: patients with NDMM per IMWG criteria and measurable disease; highdose therapy (HDT) and ASCT intended (except arms D and G). Arm C/C2 only: received 4-6 cycles of 28‑day PI‑ and/or immunomodulatory‑based induction ± anti‑CD38 mAb and a single/tandem ASCT, 1 prior LOT, at least a PR per IMWG 2016 criteria, and HDT/ASCT within 12 months of induction start and within 6 months of last ASCT (7 months with consolidation).¹⁷

Safety Results

Raab et al (2025)¹⁸ presented the incidence of hematologic AEs from 3 induction cohorts of the MajesTEC-5 study at a median follow-up of 7.3 months (range, 3.1-14.5).

• The incidence of hematologic TEAEs is provided in Table: MajesTEC-5 Study: Hematologic TEAEs (≥25% in Any Arm).

CLINICAL DATA - MajesTEC-7 study - TECVAYLI + TALVEY COHORT

MajesTEC-7 (NCT05552222) is a randomized, phase 3 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.¹⁹

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.¹⁹
• Key eligibility criteria: NDMM either ineligible or not intended for ASCT.¹⁹

Safety Results

Touzeau et al (2024)¹⁹ presented the incidence of hematologic AEs 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).

• The incidence of hematologic TEAEs is summarized in Table: MajesTEC-7 SRI Cohort 1 (Tec-DR): Hematologic TEAEs.

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.²⁰

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, prior bispecific antibodies (BsAbs) and CAR-T therapy allowed.²⁰

Safety Results

D'Souza et al (2024)¹⁰ presented the incidence of hematologic AEs in TECVAYLI + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 38.3 months (range, 1.2-39.6).

• The incidence of hematologic AEs is summarized in Table: TRIMM-2 Study (TECVAYLI + DARZALEX FASPRO + Pomalidomide Cohort): Hematologic TEAEs.

Rodriguez-Otero et al (2022)²⁰ presented the incidence of hematologic AEs in the TECVAYLI and DARZALEX FASPRO cohort in the TRIMM-2 study at a median follow-up of 8.6 months (range, 0.3-19.6).

• The incidence of hematologic AEs (≥20%) is summarized in Table: TRIMM-2 Study (TECVAYLI + DARZALEX FASPRO Cohort): Hematologic AEs (≥20%).

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 14 January 2026.