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TECVAYLI® (teclistamab-cqyv)

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TECVAYLI - Occurrence of Cytokine Release Syndrome (CRS)

Last Updated: 10/10/2025

SUMMARY

  • Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
  • 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.1-13
  • 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).1-3,9,14-16
    • Cohort A (triple-class exposed) included 165 patients previously treated with a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody (mAb).1
      • Moreau et al (2022)1,17 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)14 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 mAb and anti-B-cell maturation antigen (BCMA)-targeted therapies.9,18
      • 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.3,19
      • van de Donk et al (2024)19 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 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).4-6,20,21
    • Cohort A included 17 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase) and pomalidomide.21
      • D’Souza et al (2024)21 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 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).10,22 
    • 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 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).11,13,23
    • Raab et al (2025)13 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 at a median follow-up of 7.3 months (range, 3.1-14.5).
      • 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 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.8,24
    • Touzeau et al (2024)24 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 is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of TALVEY and TECVAYLI combination in patients with RRMM, including those with extramedullary disease (EMD).12,25-28
    • Kumar et al (2025)28 presented the incidence of CRS from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 12.6 months. CRS of any grade was reported in 77.8% of the patients. All CRS events were grade 1/2.
    • Cohen et al (2025)12 published the incidence of CRS from the phase 1 dose-escalation segment of the RedirecTT-1 study in patients with RRMM, with and without EMD.
      • 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 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.7,21,29
    • D’Souza et al (2024)21 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

clinical data - majestec-1 study

MajesTEC-1 (MMY1001; NCT03145181; NCT04557098) is evaluating the safety and efficacy of TECVAYLI in patients with RRMM.1-3,9,14-16

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.1,30

  • 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.1,2
    • 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.31
  • 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.19

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)31 published a detailed overview of the incidence and management of CRS with TECVAYLI in the MajesTEC-1 study. Garfall et al (2024)14 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.1,31
    • 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).31
      • 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).31
    • 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.31
    • 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).31
    • All CRS events resolved without discontinuation of treatment.31
Subsequent CRS Events After Management of First CRS Event
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.31 
  • Baseline cytokine levels were not found to be associated with CRS incidence or grade.31
  • No apparent relationship between patient baseline characteristics and CRS severity or incidence was observed.31

MajesTEC-1 Study (Cohort A): Overall Characteristics and Management of CRS1,31
Parameter, n (%)
All patients
First CRS event
(N=165)
Patients with CRS event
119 (72.1)
119 (72.1)
Maximum toxicity gradea
   Grade 1
83 (50.3)
87 (52.7)
   Grade 2
35 (21.2)
32 (19.4)
   Grade 3
1 (0.6)
0
   Grade 4
0
0
   Grade 5
0
0
Timing of CRS occurrenceb
   Step-up dose 1
72 (43.6)
72 (43.6)
   Step-up dose 2
58 (35.2)
32 (19.4)
   Repeat step-upc
1 (0.6)
1 (0.6)
   Cycle 1 day 1
40 (24.2)
10 (6.1)
   Cycle 1 day 8
8 (4.8)
2 (1.2)
   Cycle 1 day 15
4 (2.4)
0
   Cycle 1 day 22
2 (1.2)
2 (1.2)
   Cycle 2+d
6 (3.6)
0
Patients who received supportive measurese
110 (66.7)
-
   Tocilizumab
60 (36.4)
-
      >1 dose at any time during the study
5 (3.0)
-
      >1 dose for a single CRS event
4 (2.4)
-
   Corticosteroids
14 (8.5)
-
   Low-flow oxygen by nasal cannulaf
21 (12.7)
-
   Single vasopressor
1 (0.6)
-
Patients with multiple CRS events
55 (33.3)
-
   Worse grade of any subsequent CRS event
4 (2.4)
-
Discontinuation due to CRS
0
-
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
aAssessed per ASTCT criteria.
bBreakdown of CRS occurrence by independent event. Patients may appear in more than 1 category.
cDose prior to cycle 1. Occurrence was based on the last treatment visit on or before the day in which the event occurred.
dGrade 1 CRS occurred in 1 patient after a repeat step-up dose in cycle 6; grade 2 CRS occurred in 1 patient after a repeat step-up dose in cycle 2.
ePatients may have received ≥1 supportive measure for CRS. Other supportive measures not listed included intravenous fluids and acetaminophen.
fFlow rate ≤6 L/min.

MajesTEC-1 Study (Cohort A): Incidence of CRS by Grade and Timing31
Parameter, n (%)
N=165
Patients with CRS event
119 (72.1)
Grade 1 CRSa
   Step-up dose 1
49 (29.7)
   Step-up dose 2
49 (29.7)
   Repeat step-upb
1 (0.6)
   Cycle 1 day 1
33 (20.0)
   Cycle 1 day 8
7 (4.2)
   Cycle 1 day 15
4 (2.4)
   Cycle 1 day 22
2 (1.2)
   Cycle 2+c
5 (3.0)
Grade 2 CRSa
   Step-up dose 1
23 (13.9)
   Step-up dose 2
9 (5.5)
   Repeat step-upb
0
   Cycle 1 day 1
6 (3.6)
   Cycle 1 day 8
1 (0.6)
   Cycle 1 day 15
0
   Cycle 1 day 22
0
   Cycle 2+d
1 (0.6)
Grade 3 CRSa
   Step-up dose 1
0
   Step-up dose 2
0
   Repeat step-upb
0
   Cycle 1 day 1
1 (0.6)
   Cycle 1 day 8
0
   Cycle 1 day 15
0
   Cycle 1 day 22
0
   Cycle 2+
0
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
aAssessed per ASTCT criteria.
bDose prior to cycle 1.
cGrade 1 CRS occurred in 1 patient after a repeat step-up dose in cycle 6.
dGrade 2 CRS occurred in 1 patient after a repeat step-up dose in cycle 2.

MajesTEC-1 Study (Cohort A): Recurrent CRS Events by Grade After Subsequent Doses31
Parameter
Patients with recurrent CRS eventsa, n
55
   First CRS events (grade 1), n (%)
47 (85.5)
   First CRS events (grade 2), n (%)
8 (14.5)
   Subsequent CRS events (≥grade 2), n
8
Abbreviation: CRS, cytokine release syndrome.
aA total of 119 patients experienced CRS overall.

MajesTEC-1 Study (Cohort A): Occurrence of Subsequent CRS Events in Patients Managed With Tocilizumab and/or Steroids31
Patient
CRS Event 1
CRS Event 2
CRS Event 3
CRS Event 4
Timing
Gradea
Tocib
Steroidb
Timing
Gradea
Tocib
Steroidb
Timing
Gradea
Tocib
Steroidb
Timing
Gradea
Tocib
Steroidb
1
Step-up 1
2
Yes
-
C1D1
2
Yes
-
2
Step-up 2
1
Yes
-
C1D1
1
-
-
3
Step-up 2
2
Yes
-
C1D8
2
Yes
-
4
Step-up 1
2
Yes
-
Step-up 2
1
-
-
5
Step-up 1
1
Yes
-
C1D15
1
-
-
6
Step-up 1
2
Yes
-
Step-up 2
2
Yes
-
7
Step-up 1
2
Yes
(2 doses)
-
Step-up 2
1
-
-
C1D1
1
Yes
-
8
Step-up 1
1
-
-
Step-up 2
1
Yes
-
C1D1
1
-
-
9
Step-up 1
2
Yes
-
C1D1
2
Yes
-
10
Step-up 1
1
Yes
-
C1D1
3
Yes
(3 doses)
-
C2 repeat step-up
2
Yes
Yes
C3D8
2
Yes
-
11
Step-up 1
1
-
-
Step-up 2
2
Yes
-
C1D1
1
-
-
12
C1D1
1
-
Yes
C1D8
1
-
Yes
C1D15
1
-
Yes
C2D1
1
-
Yes
(2 doses)
13
Step-up 1
1
-
Yes
Step-up 2
1
-
Yes
(3 doses)
C1D1
1
-
Yes
14
Step-up 1
1
-
Yes
C2D1
1
-
Yes
15
Step-up 1
1
-
Yes
Step-up 2
1
-
Yes
16
Step-up 1
1
-
Yes
Step-up 2
1
-
Yes
C1D1
1
-
Yes
17
Step-up 1
1
-
Yes
Step-up 2
1
-
Yes
C1D1
1
-
Yes
18
Step-up 1
1
-
Yes
C1D1
1
-
Yes
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; C, cycle; CRS, cytokine release syndrome; D, day; Toci, tocilizumab.
aAssessed per ASTCT criteria.
bPatients received 1 dose of tocilizumab or steroids for a specific CRS event as indicated by “Yes”.

MajesTEC-1 Study (Cohort A): CRS Events and Subsequent CRS Events by Grade According to Management with Tocilizumab31
Parameter, n (%)
CRS Events Managed With Tocilizumab
(N=68)
CRS Events Not Managed With Tocilizumab
(N=127)
CRSa events, any grade
68 (100)
127 (100)
   Subsequent CRS events
13 (19.1)
63 (49.6)
Grade 1 CRSa Events
31 (45.6)
122 (96.1)
   Subsequent CRS events (any grade)b
4 (12.9)
61 (50.0)
   Subsequent CRS events (grade ≥2)b
1 (3.2)
3 (2.5)
Grade ≥2 CRSa Events
37 (54.4)
5 (3.9)
   Subsequent CRS events (any grade)c
9 (24.3)
2 (40.0)
   Subsequent CRS events (grade ≥2)c
6 (16.2)
0
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
Note: Table shows numbers of events (overall, 119 patients experienced 195 CRS events in the study).
aAssessed per ASTCT criteria.
bPercentages based on the number of grade 1 CRS events as denominator.
cPercentages based on the number of grade ≥2 CRS events as denominator.

Median Follow-up: 30.4 Months

  • At a longer median follow-up, no changes in CRS were reported.14 

Cohort C Safety Results

Touzeau et al (2024)99 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).


MajesTEC-1 Study (Cohort C): Characteristics and Management of CRS Events9
Parameter
N=40
Patients with CRSa, n (%)
26 (65.0)
   Grade 1
21 (52.5)
   Grade 2
5 (12.5)
   Grade ≥3
0
Patients with ≥2 CRS events, n (%)
12 (30.0)
   2 events
7
   3 events
4
   4 events
1
Time to onset, days, median (range)
2 (2-6)
Duration, days, median (range)
2 (1-4)
Received supportive measures for CRSb, n (%)
23 (57.5)
   Tocilizumab
12 (30.0)
   Low-flow oxygen by nasal cannulac
4 (10.0)
   Intravenous fluids
2 (5.0)
   Corticosteroids
1 (2.5)
Abbreviation: CRS, cytokine release syndrome.
Note: Data cutoff August 22, 2023.
aCRS was graded using American Society for Transplantation and Cellular Therapy criteria in phase 2.
bA patient could receive >1 supportive therapy.
c≤6 L/min.

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).


MajesTEC-1 (Prophylactic Tocilizumab Cohort): CRS Incidence and Severity3
CRS Gradea, n (%)
Prophylactic Tocilizumab Cohortb
(N=23)
MajesTEC-1 Population
(N=165)
Overall
6 (26.1)
119 (72.1)
   Grade 1
2 (8.7)
83 (50.3)
   Grade 2
4 (17.4)
35 (21.2)
   Grade 3
0
1 (0.6)
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
aCRS was graded using ASTCT criteria.
bAs of April 28, 2023.

MajesTEC-1 (Prophylactic Tocilizumab Cohort): CRS Incidence and Baseline Characteristics3
Patient number
CRS Gradea
Dose Prior to CRS
BMPCs
ISS Staged
EMPs
1
1
Step-up dose 1
30%b
I
0
2
1
Step-up dose 1
8%c
II
0
3
2
Step-up dose 1
80%b
II
0
4
2
1
Step-up dose 1
Step-up dose 2
60%b
I
0
5
1
2
Step-up dose 2
cycle 1, day 1
65%b
I
0
6
2
1
Step-up dose 2
cycle 2, day 8
30%c
II
2
7-23
No CRS
-
0-80%b,c
I-III
0-4
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; BMPC, bone marrow plasma cell; CRS, cytokine release syndrome; EMP, extramedullary plasmacytoma; ISS, International Staging System.
aCRS was graded using ASTCT criteria.
bBiopsy.
cAspirate.
dDerived based on the combination of serum β2-microglobulin and albumin.

van de Donk et al (2024)19 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.

MajesTEC-1 (Prophylactic Tocilizumab Cohort): CRS Incidence and Severity19,31
CRS Grade, n (%)
Prophylactic Tocilizumab Cohorta
(N=24)
MajesTEC-1 Populationb
(N=165)
Overall
6 (25)
119 (72.1)
   Grade 1
2 (8.3)
83 (50.3)
   Grade 2
4 (16.7)
35 (21.2)
   Grade 3
0
1 (0.6)
Abbreviation: CRS, cytokine release syndrome.
aAs of November 1, 2023.
bMedian follow-up of 14.1 months.

CLINICAL DATA - MajestEC-2 STudy

MajesTEC-2 (MMY1004; 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.4-6,20,21

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.21
  • 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 mAb. Patients with prior exposure to BCMA-targeted therapy were permitted.4,20
  • Cohort D (Tec-Len): received ≥2 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb, 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)21 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.

MajesTEC-2 (Cohort C: TECVAYLI + nirogacestat): Incidence and Management of CRS4
Parametera
Total
(N=28)
Patients with CRS, n (%)
21 (75.0)
Maximum CRS grade, %
   Grade 1
57.1
   Grade 2
14.3
   Grade 3
3.6
Patients who received supportive measuresb, n (%)
   Tocilizumabc
10 (35.7)
   Steroids
0
   Oxygen
4 (14.3)
   Vasopressor
1 (3.6)
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
Note: Clinical data cutoff date of March 16, 2023.
aGraded according to ASTCT criteria.
bPatients could receive >1 supportive therapy.
cTocilizumab was allowed for all CRS events and was allowed at grade 1 CRS; the protocol did not recommend prophylactic tocilizumab use.

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).


MajesTEC-2 (Cohort E: TECVAYLI + DARZALEX FASPRO + lenalidomide): Characteristics and Management of CRS6
Parameter, n (%)
N=32
Patients with CRSa event
26 (81.3)
   Grade 1
21 (65.6)
   Grade 2
5 (15.6)
Patients who received supportive measuresb
25 (78.1)
   Tocilizumabc
13 (40.6)
   Corticosteroids
5 (15.6)
   Anakinra
4 (12.5)
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
aGraded according to ASTCT guidelines.
bAlso includes antibiotics and supportive care.
cPer protocol, tocilizumab was given for all grade 2 CRS events and at the investigator’s discretion for grade 1 events. Prophylactic tocilizumab was not required per protocol.

CLINICAL DATA - MajesTEC-4 study

MajesTEC-4 (EMN30; MMY3003; 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.10,22

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.11,13,23

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 (2025)13 presented the incidence of CRS from 3 induction cohorts of the MajesTEC-5 study at a median follow-up of 7.3 months (range, 3.1-14.5).

  • All CRS events were grade 1 or 2 and fully resolved.
  • Grade 2 CRS was reported in 20.4% of patients (n=10).
    • Most CRS events occurred during cycle 1.
  • No patients discontinued treatment due to CRS.

CLINICAL DATA - MajesTEC-7 study - tecvayli + talvey cohort

MajesTEC-7 (MMY3005; 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.8,24

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.24
  • Key eligibility Criteria: NDMM either ineligible or not intended for ASCT.8,24

Safety Results

Touzeau et al (2024)24 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; 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, including those with EMD.12,25-28

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 mAb.12,27

Safety Results

Kumar et al (2025)28 presented the incidence of CRS from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 12.6 months (range 0.5-19.5).


RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Incidence and Management of CRS28
AE
TALVEY + TECVAYLI
(N=90)
Patients with CRSa, n (%)
70 (77.8)
   Grade 1
53 (58.9)
   Grade 2
17 (18.9)
   Grade 3
0 (0)
Occurrence of CRSb, n (%)
   SUD 1
40 (44.4)
   SUD 2
51 (56.7)
   SUD 3
24 (26.7)
   Cycle 1
5 (5.6)
   Cycle 2 onwards
1 (1.1)
Median days to onsetc, days (range)
2 (1-29)
Median duration, days (range)
2 (1-8)
Supportive measuresd, %
   Tocilizumab
56.7
   Acetaminophen
56.7
   Corticosteroids
18.9
   IV fluids
17.8
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; EMD, extramedullary disease; IV, intravenous; SUD, step-up dose.
Clinical data cutoff date of March 18, 2025. Median follow-up of 12.6 months.
aCRS was graded per ASTCT criteria.
bPatients could experience ≥1 CRS event.
cRelative to the most recent dose.
dPatients could receive ≥1 supportive therapy.

Cohen et al (2025)12 published the incidence of CRS from the phase 1 dose-escalation segment of the RedirecTT-1 study, in patients with RRMM, with and without EMD, 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.


RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Incidence and Management of CRS12,27 
Parameter
All Dose Levels
(N=94)
RP2R
(n=44)
Patients with a CRS eventa, n (%)
74 (79)
33 (75.0)
   Grade 1
50 (53.2)
23 (52.3)
   Grade 2
22 (23.4)
10 (22.7)
   Grade 3
2 (2)
0 (0)
Cycle delays or dose modification, n (%)
14 (15)
-
Median time to onsetb, days (range)
2 (1-733)
2 (1-4)
Median duration, days (range)
2 (1-8)
2 (1-5)
Patients who received supportive measuresc, n (%)
61 (65)
28 (63.6)
   Tocilizumab
24 (26)
10 (22.7)
   Intravenous fluids
11 (11.7)
8 (18.2)
   Corticosteroids
 3 (3.2)
1 (2.3)
   Oxygen
1 (1.1)
1 (2.3)
   Vasopressor
1 (1.1)
0 (0)
Recovery, %
98
-
   Recovery with sequelae
1
-
   Incomplete recovery
1
-
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; RP2R, recommended phase 2 regimen.
Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) and 18.2 months for the all dose levels cohort and RP2R cohorts, respectively.
aCRS was graded per the ASTCT criteria.
bRelative to the most recent dose.
cPatients could receive >1 supportive therapy. Other forms of supportive measures were received by 12 patients (RP2R) and 26 patients (across all dose levels).

clinical data - TRIMM-2 STUDY

TRIMM-2 (MMY1002; 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.7,21,29

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)21 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).


TRIMM-2 Study (TECVAYLI + DARZALEX FASPRO Cohort): Characteristics and Management of CRS7
Parameter
N=65
Patients with CRSa, n (%)
44 (67.7)
   Grade 1
28 (43.1)
   Grade 2
16 (24.6)
   Grade ≥3
0
Patients who received supportive treatmentsb, n (%)
39 (60.0)
   Tocilizumabc
21 (32.3)
   Corticosteroids
3 (4.6)
   Oxygen
4 (6.2)
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
aGraded according to ASTCT criteria.
bA patient could receive >1 supportive therapy.
cTocilizumab was permitted for all CRS events.

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 06 October 2025.

 

References

Show
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