SUMMARY

• Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
• Cytokine release syndrome (CRS) has been reported as an adverse event (AE) in the MajesTEC-1, MajesTEC-2, MajesTEC-4, MajesTEC-5, MajesTEC-7, RedirecTT-1, and TRIMM-2 studies.^1-12
• 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).^1-3,9,13-15
  • Cohort A (triple-class exposed) included 165 patients previously treated with a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody.¹
    • Moreau et al (2022)^1,16 published the incidence of CRS at a median follow-up of 14.1 months. CRS of any grade was reported in 72.1% of patients; grade 3 CRS occurred in 1 patient.
    • Garfall et al (2024)¹³ presented the incidence of CRS at a median follow-up of 30.4 months. No changes in CRS were reported.
  • 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.^9,17
    • Touzeau et al (2024)⁹ published the incidence of CRS at a median follow-up of 28.0 months. CRS of any grade was reported in 65% of patients.
  • The prophylactic tocilizumab cohort is evaluating the administration of intravenous (IV) tocilizumab (8 mg/kg) prior to TECVAYLI dosing for the reduction of CRS in 24 patients.^3,18
    • van de Donk et al (2024)¹⁸ presented the incidence of CRS at a median follow-up of 8.1 months. CRS of any grade was reported in 25% of patients; all CRS events were grade 1/2.
• 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).^4-6,19,20
  • Cohort A included 17 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO^® (daratumumab and hyaluronidase) and pomalidomide.²⁰
    • D’Souza et al (2024)²⁰ presented the incidence of CRS at a median follow-up of 16.2 months. CRS of any grade was reported in 47.1% of patients; all CRS events were grade 1/2.
  • Cohort C included 28 patients with RRMM who received TECVAYLI and nirogacestat.⁴
    • Offner et al (2023)⁴ presented the incidence of CRS at a median follow-up of 14.7 months. CRS of any grade was reported in 75% of patients. One grade 3 CRS event was reported.
  • Cohort D included 31 patients with MM who received TECVAYLI in combination with lenalidomide (Tec-Len).⁵
    • Tan et al (2023)⁵ presented the incidence of CRS at a median follow-up of 10.8 months. CRS of any grade was reported in 67.7% of patients. One grade 3 CRS event was reported.
  • Cohort E included 32 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO and lenalidomide (Tec-DR).⁶
    • Searle et al (2022)⁶ presented the incidence of CRS at a median follow-up of 8.4 months. CRS of any grade was reported in 81.3% of patients.
• 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).^10,21 
  • Zamagni et al (2024)¹⁰ presented the incidence of CRS from safety run-in (SRI)  Cohort 1 (Tec-Len; TECVAYLI weekly [QW] to once every 4 weeks [Q4W]) at a median follow-up of 21.1 months, SRI Cohort 2 (Tec-Len; TECVAYLI Q4W) at a median follow-up of 9.2 months, and SRI Cohort 3 (TECVAYLI Q4W) at a median follow-up of 9.2 months.
    • CRS of any grade was reported in 50% of patients in Cohort 1, 40.6% of patients in Cohort 2, and 43.3% of patients in Cohort 3. All CRS events were grade 1/2.
• 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).^11,22
  • Raab et al (2024)¹¹ presented the incidence of CRS from the 3 induction cohorts of arm A (Tec [QW]-DR; n=10), arm A1 (Tec [Q4W]-DR; n=20), and arm B (TECVAYLI Q4W in combination with DARZALEX FASPRO, bortezomib, and lenalidomide; Tec [Q4W]-DVR; n=19) in the MajesTEC-5 study.
    • CRS of any grade was reported in 65.3% of patients overall; 60% of patients in arm A, 70% of patients in arm A1, and 63.2% of patients in arm B. All CRS events were grade 1/2.
• MajesTEC-7 (MMY3005) is a randomized, phase 3, open-label, multicenter study comparing 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.^8,23
  • Touzeau et al (2024)²³ presented the incidence of CRS from SRI Cohort 1 (Tec-DR) at a median follow-up of 13.8 months. CRS of any grade was reported 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.
• 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.^12,24-26
  • Cohen et al (2025)¹² published the incidence of CRS 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, CRS of any grade was reported in 79% of patients.
• 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.^7,20,27
  • D’Souza et al (2024)²⁰ presented the incidence of CRS in the TECVAYLI + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 38.3 months. CRS of any grade was reported in 70% of patients; all CRS events were grade 1/2.
  • Rodriguez-Otero et al (2022)⁷ presented the incidence of CRS in the TECVAYLI and DARZALEX FASPRO cohort at a median follow-up of 8.6 months. CRS of any grade was reported in 67.7% of patients; all CRS events were grade 1/2.

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.^1-3,9,13-15

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; and Part 3 (phase 2 component) to evaluate the safety and efficacy of TECVAYLI at the RP2D.^1,28

• Key eligibility criteria:
  • Cohort A: ≥3 prior lines of therapy (LOTs) including a PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb); no prior BCMA-targeted therapy use.^1,2
  • Cohort C: ≥3 prior LOTs including 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]).⁹
  • Prophylactic tocilizumab cohort: ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.³
• For the overall study population (phase 1/2), the time to onset and duration of CRS was determined in days. For the phase 2 portion, the time to onset and duration of CRS was determined in hours.²⁹
• Prophylactic tocilizumab cohort: CRS as an AE was graded as per the criteria by Lee et al. CRS management with tocilizumab treatment was permitted for grade 1 CRS and was recommended for grade ≥2 CRS.¹⁸

Cohort A Safety Results

Moreau et al (2022)¹ published the incidence of CRS at a median follow-up of 14.1 months (range, 0.3-24.4). Martin et al (2023)²⁹ published a detailed overview of the incidence and management of CRS with TECVAYLI in the MajesTEC-1 study. Garfall et al (2024)¹³ presented the incidence of CRS at a median follow-up of 30.4 months.

Median Follow-up: 14.1 Months

• A total of 195 CRS events occurred in 119 patients (72.1%). Details are summarized in Tables: MajesTEC-1 Study (Cohort A): Overall Characteristics and Management of CRS and MajesTEC-1 Study (Cohort A): Incidence of CRS by Grade and Timing.^1,29
  • After the first treatment cycle, CRS events were reported in 6 of 119 patients (5%); all 6 patients had prior CRS events (4 patients had grade 1 CRS, 1 patient had grade 2 CRS and 1 patient had grades 1 and 3 CRS).²⁹
    • Subsequent grade 1 CRS events occurred in 3 patients on cycle 2 day 1 (1 patient had a urinary tract infection 1 week earlier) and in a fourth patient on cycle 2 days 1 and 8. A fifth patient experienced grade 1 CRS after repeat step-up dosing before cycle 6 (this patient had a 6-week interruption in TECVAYLI treatment at the end of cycle 5 due to Pseudomonas aeruginosa and Clostridium difficile infections); the patient had another grade 1 CRS event on cycle 6 day 1. Grade 1 CRS was also reported in a sixth patient at step up dose (SUD) 1 followed by a grade 3 CRS event with concurrent grade 3 pneumonia after cycle 1 day 1. Treatment with TECVAYLI for this patient was interrupted until the pneumonia resolved and was restarted 5 weeks later with repeat step-up dosing. The patient experienced 2 subsequent grade 2 CRS events (after repeat SUD 2 before cycle 2 and on cycle 3 day 8 at the time of disease progression).²⁹
  • After subsequent TECVAYLI doses, 55 patients experienced recurrent CRS events out of the 119 patients with CRS events. Of these, 4 patients had a worse CRS grade in their subsequent event (3 patients had grade 1 CRS followed by grade 2 CRS and 1 patient had grade 1 CRS followed by grade 3 CRS). The recurrence of subsequent CRS events by grade is presented in Table: MajesTEC-1 Study (Cohort A): Recurrent CRS Events by Grade After Subsequent Doses.²⁹
  • The median time to CRS onset (relative to the most recent TECVAYLI dose) was 2 days (range, 1-6), with a median duration of 2 days (range, 1-9) for the overall study.¹
  • For the phase 2 part of the study, the median time to onset of CRS (relative to the most recent TECVAYLI dose) was 31.13 hours (range, 3.83-120.50), with a median duration of 11.79 hours (0.33-151.05).²⁹
  • All CRS events resolved without discontinuation of treatment.²⁹

Subsequent CRS Events After Management of First CRS Event

• Of the 119 patients with CRS, patients who experienced a subsequent CRS event after management of the first CRS event is presented in Table: MajesTEC-1 Study (Cohort A): Occurrence of Subsequent CRS Events in Patients Managed With Tocilizumab and/or Steroids.²⁹
  • The median duration of a CRS event was 2 days in the 60 patients managed with tocilizumab. Median time from the start of a CRS event to administration of tocilizumab was 1 day (range, 1-9) and median time from administration of tocilizumab to resolution of CRS was 1 day (range, 1-5).²⁹
• CRS events managed with tocilizumab are summarized in the Table: MajesTEC-1 Study (Cohort A): CRS Events and Subsequent CRS Events by Grade According to Management With Tocilizumab.²⁹
  • Forty-five patients received tocilizumab for their first CRS event. Of these, 9 patients (20%) had a subsequent CRS event. A subsequent CRS event was reported in 46 of 74 patients (62%) who were not managed with tocilizumab for their first CRS event.²⁹

Incidence and Severity of CRS Events by Baseline Characteristics

• An increased risk of CRS was not observed with higher baseline tumor burden (≥60% bone marrow plasma cells, plasmacytomas, or high soluble BCMA levels) and higher tumor BCMA expression.²⁹ 
• Baseline cytokine levels were not found to be associated with CRS incidence or grade.²⁹
• No apparent relationship between patient baseline characteristics and CRS severity or incidence was observed.²⁹

Median Follow-up: 30.4 Months

• At a longer median follow-up, no changes in CRS were reported.¹³ 

Cohort C Safety Results

Touzeau et al (2024)⁹ published the incidence of CRS in Cohort C of the MajesTEC-1 study at a median follow-up of 28.0 months (range, 0.7-31.1).

• CRS of any grade was reported in 65% of patients (n=26) overall. See Table: MajesTEC-1 Study (Cohort C): Characteristics and Management of CRS Events for additional details.
• All first events of CRS were confined to the step-up dosing schedule or cycle 1.
• All CRS events resolved without TECVAYLI discontinuation.

Prophylactic Tocilizumab Cohort Safety Results

van de Donk et al (2023)³ presented the incidence of CRS in the prophylactic tocilizumab cohort of the MajesTEC-1 study at a median follow-up of 2.6 months (range, 0.1-7.0).

• Among the 23 patients who received prophylactic tocilizumab, 6 patients (26.1%) experienced CRS. See Table: MajesTEC-1 (Prophylactic Tocilizumab Cohort): CRS Incidence and Severity for additional details.
• The median time to CRS onset was 2.0 days (range, 1-3), with a median duration of 2.0 days (range, 2-4).
• Tocilizumab was used after the first CRS event in 4 patients, with 1 patient also receiving dexamethasone.
• All CRS events resolved without treatment discontinuation.
• All CRS events occurred during step-up dosing schedule through cycle 2. See Table: MajesTEC-1 (Prophylactic Tocilizumab Cohort): CRS Incidence and Baseline Characteristics for additional details.
• An association was not clearly observed between the occurrence of CRS of any grade and patient or disease characteristic.

van de Donk et al (2024)¹⁸ presented the incidence of CRS in the prophylactic tocilizumab cohort of the MajesTEC-1 study at a median follow-up of 8.1 months (range, 0.9-13.2).

• Among the 24 patients who received prophylactic tocilizumab, 25% experienced CRS. See Table: MajesTEC-1 (Prophylactic Tocilizumab Cohort): CRS Incidence and Severity for additional details.
  • All initial CRS events occurred during TECVAYLI step-up dosing 1 and 2. The median time to CRS onset was 2 days (range, 1-3), with a median duration of 2 days (range, 2-4).
  • A total of 3 patients each had 1 recurrent CRS event.
  • All CRS events resolved.
• There was no observed association between CRS and any specific patient or disease characteristic (% of median bone marrow plasma cells [BMPCs], Internation Staging System [ISS] stage and median number of extramedullary plasmacytomas).
• The magnitude of IL-6 induction was higher with prophylactic tocilizumab. Based on modeling data, a single tocilizumab dose inhibits IL-6 signaling for approximately 10 days and the duration of IL-6 blockage spans the TECVAYLI dosing schedule.

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.^4-6,19,20

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.²⁰
• Cohort C (TECVAYLI and nirogacestat): disease progression within 12 months of the 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.^4,19
• Cohort D (Tec-Len): received ≥2 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody, and no prior BCMA-targeted therapy.⁵
• Cohort E (Tec-DR): received 1 to 3 prior LOTs, including a PI, and an immunomodulatory drug, and no prior BCMA-targeted therapy.⁶

Cohort A Safety Results

D’Souza et al (2024)²⁰ presented the incidence of CRS in Cohort A of the MajesTEC-2 study at a median follow-up of 16.2 months (range, 0.5-34.5).

• CRS of any grade was reported in 47.1% of patients (n=8). All CRS events were grade 1/2 and resolved.

Cohort C Safety Results

Offner et al (2023)⁴ presented the incidence of CRS in Cohort C of the MajesTEC-2 study at a median follow-up of 14.7 months (range, 0.5-22.9).

• CRS of any grade was reported in 75.0% of patients (n=21). A grade 3 CRS event occurred in a patient at dose level 1. The incidence and management of CRS is summarized in Table: MajesTEC-2 (Cohort C: TECVAYLI + nirogacestat): Incidence and Management of CRS.
• The median time to onset of CRS (relative to the most recent dose) was 2 days (range, 1-3), with a median duration of 2 days (range, 1-33). All CRS events had resolved at the time of data cutoff.

Cohort D Safety Results

Tan et al (2023)⁵ presented the incidence of CRS in Cohort D of the MajesTEC-2 study at a median follow-up of 10.8 months (range, 1.1-16.8).

• CRS of any grade was reported in 67.7% of patients (n=21). One patient reported a grade 3 CRS event (with associated grade 3 hypotension) that occurred during TECVAYLI step-up dose 2.
• All CRS events occurred during TECVAYLI step-up dosing through cycle 2 (one subsequent CRS event occurred during cycle 2).
• The median time to onset of CRS was 2.0 days (range, 1-4), with a median duration of 2.0 days (range, 1-15).

Cohort E Safety Results

Searle et al (2022)⁶ presented the incidence of CRS in Cohort E of the MajesTEC-2 study at a median follow-up of 8.4 months (range, 1.1-12.9).

• CRS of any grade was reported in 81.3% of patients (n=26). The incidence and management of CRS is presented in Table: MajesTEC-2 (Cohort E: TECVAYLI + DARZALEX FASPRO + lenalidomide): Characteristics and Management of CRS.
• The median time to onset of CRS was 2 days (range, 1-8), with a median duration of 2 days (range, 1-22). The median duration range was confounded by ongoing infection.
• Of the 38 CRS events, 37 events (97%) were reported during cycle 1.

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.^10,21

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.¹⁰
• 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.¹⁰
• Key eligibility criteria: NDMM, receipt of 4 to 6 cycles of 3- or 4-drug induction therapy (PI ± immunomodulatory drug ± anti-CD38 antibody), and ASCT (single or tandem ASCT permitted) ± consolidation with partial response (PR) or better.¹⁰

Safety Results

Zamagni et al (2024)¹⁰ presented the incidence of CRS 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).

• CRS of any grade was reported in 50% of patients (n=16) in Cohort 1, 40.6% of patients (n=13) in Cohort 2, and 43.3% of patients (n=13) in Cohort 3. All CRS events were grade 1/2.
• The incidence of CRS was 37.2% after SUD 1, 8.5% after SUD 2, and 5.3% after treatment dose 1.
• No discontinuations were reported due to CRS.

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.^11,22

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 a PR as per International Myeloma Working Group (IMWG) 2016 criteria without evidence of progression at the time of enrollment.¹¹

Safety Results

Raab et al (2024)¹¹ presented the incidence of CRS from 3 induction cohorts of the MajesTEC-5 study.

• CRS of any grade was reported in 65.3% of patients (n=32) overall; 60% of patients (n=6) in arm A, 70% of patients (n=14) in arm A1, and 65.3% of patients (n=32) in arm B. All events were grade 1/2. Most CRS events occurred in cycle 1.
• All CRS events resolved with no treatment discontinuation due to CRS events.

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.^8,23

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.²³
• Key eligibility Criteria: NDMM either ineligible or not intended for ASCT.^8,23

Safety Results

Touzeau et al (2024)²³ presented the incidence of CRS 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).

• CRS of any grade was reported in 61.5% of patients (n=16), 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.

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.^12,24-26

Study Design/Methods

• Key eligibility 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.^12,26

Safety Results

Cohen et al (2025)¹² published the incidence of CRS from the phase 1 dose-escalation segment of the RedirecTT-1 study at a median follow-up of 20.3 months (range, 0.5-37.1) in the all dose levels (dose levels 1-5) and 18.2 months in the recommended phase 2 regimen (RP2R; dose level 5) cohorts.

• Details on the occurrence and management of CRS are presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Incidence and Management of CRS.^12,26 
• Most CRS events occurred during step-up dosing and cycle 1 day 1 doses.²⁶

clinical data - TRIMM-2 STUDY

TRIMM-2 (MMY1002; clinicaltrials.gov identifier: NCT04108195) is an ongoing, phase 1b, 2-part, multicohort, open-label study evaluating the safety and efficacy of DARZALEX FASPRO regimens in combination with bispecific T-cell redirection antibodies in patients with RRMM.^7,20,27

Study Design/Methods

• Key eligibility criteria: received ≥3 prior LOTs including a PI, immunomodulatory drug or were double refractory to PI and immunomodulatory drug; prior anti-CD38 therapy was permitted with a 90-day washout, prior BCMA-targeted therapies were also permitted.⁷

Safety Results

D'Souza et al (2024)²⁰ presented the incidence of CRS in the TECVAYLI + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 38.3 months (range, 1.2-39.6).

• CRS of any grade was reported in 70% of patients (n=7); all CRS events were grade 1/2 and resolved.

Rodriguez-Otero et al (2022)⁷ presented the incidence of CRS in the TECVAYLI and DARZALEX FASPRO cohort at a median follow-up of 8.6 months (range, 0.3-19.6).

• CRS events occurred during SUDs or the first full treatment dose. All CRS events were grade 1/2 and resolved without stopping treatment.
• The median time to CRS onset (relative to most recent dose) was 2.5 days (range, 1-7), with a median duration of 2.0 days (range, 1-7).
• The incidence and management of CRS are detailed in Table: TRIMM-2 Study (TECVAYLI + DARZALEX FASPRO Cohort): Characteristics and Management of CRS.

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 03 February 2025.