SUMMARY

• Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
• Hematologic adverse events (AEs) have been reported in the MajesTEC-1, MajesTEC-2, MajesTEC-4, MajesTEC-5, MajesTEC-7, RedirecTT-1, and TRIMM-2 studies.^1-14
• MajesTEC-1 (MMY1001) is a phase 1/2, multicohort study evaluating the safety and efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).^1-4,15-17
  • 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.¹
    • Nooka et al (2023)^18,19 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)¹⁷ 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 monoclonal antibody and anti-B-cell maturation antigen (BCMA)-targeted therapies.^3,20
    • Touzeau et al (2024)²⁰ published the incidence of hematologic AEs 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.^4,21
    • van de Donk et al (2024)²¹ 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)²² 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.
  • Per protocol: Dose interruption was the primary method for managing AEs in the MajesTEC-1 Study. Please see below for a summary of permitted medications, mitigation strategies and dose interruption strategies from the MajesTEC-1 protocol for the management of hematologic AEs.^23,24
• MajesTEC-2 (MMY1004) 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).^5-7,12,25
  • Cohort A included 17 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO^® (daratumumab and hyaluronidase) and pomalidomide.¹²
    • D’Souza et al (2024)¹² 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.⁵
    • Offner et al (2023)⁵ 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).⁶
    • Tan et al (2023)⁶ 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).⁷
    • Searle et al (2022)⁷ 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-4 (EMN30; MMY3003) 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).^11,26
  • Zamagni et al (2024)¹¹ 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 (GMMG-HD10; DSMM-XX; MMY2003) is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI- and TALVEY^® (talquetamab-tgvs)-based combination regimens in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM).^13,27
  • Raab et al (2024)¹³ presented the incidence of hematologic AEs from 3 induction cohorts of the MajesTEC-5 study.
    • Arm A (Tec [QW]-DR; n=10): The most common grade 3/4 hematologic AEs included lymphopenia (70%), neutropenia (30%), and leukopenia (20%).
    • Arm A1 (Tec [Q4W]-DR; n=20): The most common grade 3/4 hematologic AEs included neutropenia (65%), lymphopenia (35%), and anemia (20%).
    • Arm B (TECVAYLI 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 (36.8%), and leukopenia (26.3%).
• MajesTEC-7 (MMY3005) is a randomized, phase 3, open-label, multicenter 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.^10,28
  • Touzeau et al (2024)²⁸ 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%).
• RedirecTT-1 (MMY1003) is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of TALVEY and TECVAYLI combination in patients with RRMM.^8,14,29,30
  • Cohen et al (2025)¹⁴ published the incidence of hematologic AEs from the phase 1 dose-escalation segment of the RedirecTT-1 study.
    • All dose levels (dose levels 1-5; N=94): At a median follow-up of 20.3 months, grade 3/4 hematologic AEs included neutropenia (68%), anemia (38%), and thrombocytopenia (30%).
• TRIMM-2 (MMY1002) 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.^9,12,31
  • D’Souza et al (2024)¹² 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)⁹ 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 (MMY1001; clinicaltrials.gov identifiers: NCT03145181; NCT04557098) is evaluating the safety and efficacy of TECVAYLI in patients with RRMM.^{1,2,4,15-17,20}

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.^1,24

• Key eligibility criteria:
  • Cohort A: ≥3 prior lines of therapy (LOTs) including a PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody, no prior BCMA-targeted therapy use.^1,2
  • Cohort C: ≥3 prior LOTs, a prior PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody, enrolled patients who had prior exposure to BCMA-targeted treatment (chimeric antigen receptor T-cell [CAR-T] therapy and/or antibody drug conjugate [ADC]).³
  • Prophylactic tocilizumab cohort: ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.⁴
• Primary endpoint for Cohort A and Cohort C: overall response rate (ORR).^1-3
• Key secondary endpoint for Cohort A and Cohort C: safety.^1-3
• Endpoint for prophylactic tocilizumab cohort: incidence of CRS.⁴

MajesTEC-1 Study Protocol - Key Permitted Medications Related to Hematologic AEs

• Patients were to receive full supportive care during the study.²³ The following are examples of supportive therapies related to hematologic events that may have been used during the study:
  • Growth factor support, erythropoietin-stimulating agents, and transfusions were permitted to treat symptoms or signs of neutropenia, anemia, or thrombocytopenia according to local standards of care; these agents were not allowed as prophylactic treatment during the dose-limiting toxicity (DLT) period in Part 1.²³
  • Growth factor support should have been avoided during step-up doses, during the first treatment dose and during CRS. Granulocyte-colony stimulating factor (G-CSF) should have been considered for grade 3 neutropenia with infection or fever or any-grade 4 neutropenia.²³

MajesTEC-1 Study Protocol - Potential Risks Associated with TECVAYLI and Mitigation Strategies for Cytopenias

• Mitigation strategies for risk of cytopenias included: Frequent monitoring of hematological parameters and supportive care (eg, transfusions) per institutional standards. Prolonged neutropenia may increase the risk of infection. Severe thrombocytopenia may increase the risk of bleeding.²³

MajesTEC-1 Study Protocol (Parts 1, 2, and 3) - Dose Interruption

• Dose interruption was the primary method for management of AEs. Schedule changes to less frequent dosing could be used for management of recurrent/persistent AEs with sponsor approval.²³
• Select criteria for a dose interruption in Parts 1, 2, and 3 related to hematologic events were²⁴:
  • Grade 4 hematologic toxicity except lymphopenia.
  • Grade 3 thrombocytopenia with bleeding.
  • Febrile neutropenia.
  • Grade 3 neutropenia with infection.

Cohort A Safety Results

Nooka et al (2023)^18,19 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).¹⁸
• No patients discontinued TECVAYLI treatment due to neutropenia.¹⁸
• 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.¹⁸
• 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).¹⁹
• 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.¹⁸
• Granulocyte-colony stimulating factor (G-CSF) therapy was administered (for prophylaxis and management) to 54.5% of patients (n=90).¹⁸
  • 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.¹⁸

Management of Neutropenia

• TECVAYLI was delayed during febrile neutropenia, grade 3 neutropenia with infection, and grade 4 neutropenia.¹⁸
• G-CSF was recommended for grade ≥3 neutropenia with infection/fever and grade 4 neutropenia.¹⁸
• Growth factors should be avoided during the step-up dosing schedule or during CRS, due to the potential for increased CRS severity from temporal myeloid cell stimulation.¹⁸

Garfall et al (2024)¹⁷ 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)²⁰ 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)²¹ 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 and Exposure-Relationships in MajesTEC-1

Miao et al (2023)²² 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 (MMY1004; clinicaltrials.gov identifier: 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.^5-7,12,32

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.¹²
• 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 monoclonal antibody. Patients with prior exposure to BCMA-targeted therapy were permitted.^5,25
• Cohort D (Tec-Len): received ≥2 prior LOTs including a PI, an immunomodulatory drug and an anti-CD38 monoclonal antibody, no prior BCMA-targeted therapy.⁶
• Cohort E (Tec-DR): received 1-3 prior LOTs including a PI, and an immunomodulatory drug, no prior BCMA-targeted therapy.⁷

Primary Endpoints

• Cohort A: safety and dose-limiting toxicities.¹²
• Cohort C: safety, tolerability, and optimal doses.⁵
• Cohort D: safety.⁶
• Cohort E: safety, dose-limiting toxicities, and laboratory abnormalities.⁷

Cohort A Safety Results

D’Souza et al (2024)¹² 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)⁵ 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)⁶ 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)⁷ 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-4 study

MajesTEC-4 (EMN30; MMY3003; clinicaltrials.gov identifier: 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.^11,26

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.¹¹
• 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.¹¹
• 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.¹¹
• Primary endpoints: progression-free survival (PFS) and 12-month minimal residual disease (MRD)-negative CR.¹¹
• Key secondary endpoint: safety.¹¹

Safety Results

Zamagni et al (2024)¹¹ 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; MMY2003) is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI- and TALVEY-based combination regimens in patients with TE-NDMM.^13,27

Study Design/Methods

• Key eligibility criteria: presence of NDMM for which high-dose therapy (HDT) and ASCT were intended as part of the treatment plan, completion of HDT and ASCT within 12 months of induction start and within 6 months of the last ASCT (7 months if consolidation was received), receipt of only 1 prior LOT, and achievement of at least PR as per International Myeloma Working Group (IMWG) 2016 without evidence of progression at the time of enrollment.¹³
• Primary endpoints: safety and tolerability.¹³

Safety Results

Raab et al (2024)¹³ presented the incidence of hematologic AEs from 3 induction cohorts of the MajesTEC-5 study.

• The incidence of hematologic TEAEs is provided in Table: MajesTEC-5 Study: Hematologic TEAEs.
• No grade 5 hematologic TEAEs were reported.

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

MajesTEC-7 (MMY3005; clinicaltrials.gov identifier: 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.^10,28

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.²⁸
• Key eligibility Criteria: NDMM either ineligible or not intended for ASCT.^10,28
• Primary endpoints: PFS, 12-month MRD-negative CR.^10,28
• Key secondary endpoint: safety.^10,28

Safety Results

Touzeau et al (2024)²⁸ 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 - Redirectt-1 study - TALVEY + TECVAYLI Cohort

RedirecTT-1 (MMY1003; clinicaltrials.gov identifier: NCT04586426) is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of the combination of TALVEY and TECVAYLI in patients with RRMM.^8,14,29,30

Study Design/Methods

• Key inclusion criteria: relapsed or refractory or intolerant to established therapies including the last LOT, prior exposure to a PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.^14,30
• Primary endpoints: dose limiting toxicity and ORR.^14,30

Safety Results

Cohen et al (2025)¹⁴ published the incidence of hematologic AEs from the phase 1 dose-escalation segment of the RedirecTT-1 study.

• The incidence of hematologic AEs at a median follow-up of 20.3 months (range, 0.5-37.1) for all dose levels and 18.2 months for RP2R cohorts is presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Hematologic AEs.^14,30
• Febrile neutropenia was reported in 12.8% of patients.³⁰

CLinical data - TRIMM-2 Study

TRIMM-2 (MMY1002; clinicaltrials.gov identifier: 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.^9,12,31

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 monoclonal antibody >90 days prior allowed, prior bispecific antibodies (BsAbs) and CAR-T therapy allowed.³¹
• Key primary endpoint: safety.³¹

Safety Results

D'Souza et al (2024)¹² 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)⁹ 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 12 February 2025.