J&J Medical Connect
TECVAYLI®

(teclistamab-cqyv)

J&J Medical Connect

Connect with us

Connect with us

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TECVAYLI® (teclistamab-cqyv)
Medical Information

TECVAYLI - MajesTEC-1 Study (Cohort A)

Last Updated: 04/03/2026

SUMMARY

  • 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). Cohort A (triple-class exposed) evaluated the safety and efficacy of TECVAYLI in RRMM after prior exposure to a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody (mAb).1-6
    • Moreau et al (2021)1 presented the primary efficacy and safety results from the phase 1/2 MajesTEC-1 study cohort A at a median follow-up of 7.8 months. The overall response rate (ORR) was 62.0%. The most common adverse events (AEs; any grade) were cytokine release syndrome (CRS; 71.5%) and neutropenia (65.5%).
    • Garfall et al (2024)6 presented longer-term efficacy and safety results from the phase 1/2 MajesTEC-1 study cohort A at a median follow-up of 30.4 months. The ORR was 63.0%. The most commonly reported treatment-emergent adverse events (TEAEs; any grade) were infections (78.8%), CRS (72.1%), and neutropenia (71.5%).
  • Usmani et al (2023)7 presented efficacy and safety data for 63 patients who switched from weekly (QW) to a less frequent dosing interval of TECVAYLI (every other week [Q2W] or every 4 weeks [Q4W]) in the MajesTEC-1 study. At a median follow-up of 12.6 months (range, 1-25), the median duration of response (DOR) was not reached in patients who received TECVAYLI at less frequent dosing intervals.
  • Other relevant analyses of the MajesTEC-1 Study have been included in the references section for your review.8-16

CLINICAL DATA - majestec-1 study - cohort a

MajesTEC-1 (NCT04557098) is evaluating the safety and efficacy of TECVAYLI in patients with RRMM.1-6

  • Cohort A of the MajesTEC-1 study evaluated the efficacy and safety of TECVAYLI in 165 patients with RRMM after ≥3 prior LOTs, including triple-class exposure to a PI, an immunomodulatory drug and an anti-CD38 mAb. Of the 165 patients enrolled in the RP2D cohort, 40 patients were enrolled in phase 1 and 125 patients were enrolled in phase 2.3

Study Design/Methods

  • The main objectives of MajesTEC-1 are as follows: Part 1 (dose escalation) to determine the 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 efficacy of TECVAYLI at the RP2D.2,3,17
  • Key eligibility criteria: ≥18 years of age, documented RRMM per International Myeloma Working Group (IMWG) criteria, ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.3,17
  • Key exclusion criteria17:
    • B-cell maturation antigen (BCMA) therapy, targeted therapy, epigenetic therapy, or treatment with an investigational drug or use of an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less.
    • mAb or cytotoxic therapy within 21 days.
    • PI therapy within 14 days.
    • Immunomodulatory drug therapy within 7 days.
    • Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, natural killer cells) within 3 months.
    • Radiotherapy within 14 days or focal radiation within 7 days.
    • Vaccination with live, attenuated vaccine within 4 weeks prior to the first dose of TECVAYLI, during treatment, and for 30 days after the last dose of TECVAYLI, unless first discussed with sponsor.
    • Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days prior to first dose of TECVAYLI (does not include pretreatment medication).
    • Allogeneic stem cell transplant within 6 months before the first dose of TECVAYLI (patient who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease) or autologous stem cell transplant within 12 weeks before the first dose of TECVAYLI.
  • Primary endpoint: ORR (defined as partial response or better [≥PR] according to IMWG criteria).3,4
  • Key secondary endpoints: DOR, very good partial response or better (≥VGPR), complete response or better (≥CR), stringent complete response (sCR), time to response, minimal residual disease (MRD) status, progression-free survival (PFS), overall survival (OS), safety, PK, immunogenicity, and PROs.3,4
  • Exploratory endpoints: soluble BCMA levels, cytokines, and T-cell activation markers.3
  • Dosing:
    • Step-up doses of TECVAYLI (0.06 mg/kg and 0.3 mg/kg subcutaneously [SC]) were administered 2-4 days apart and completed 2-4 days prior to the first full treatment dose of TECVAYLI 1.5 mg/kg SC.3
    • Subsequent treatment doses: TECVAYLI 1.5 mg/kg SC QW until progressive disease or unacceptable toxicity.3,4
    • The option to switch to Q2W if patients achieved the following response:
      • Phase 1: ≥PR for ≥4 cycles.4,7
      • Phase 2: ≥CR for ≥6 months.4,7
    • Patients could then switch to Q4W dosing if they exhibited continued response on the Q2W schedule.4,7
    • Premedications: dexamethasone, acetaminophen, and diphenhydramine were required to be administered for each step-up dose and the first full treatment dose of TECVAYLI.3
  • Patients were required to be hospitalized for at least 48 hours from the start of the injection, for each step-up dose and the first full treatment dose of TECVAYLI.17

PRIMARY EFFICACY AND SAFETY ANALYSIS

Moreau et al (2021)1 presented the primary efficacy and safety results from the phase 1/2 MajesTEC-1 study cohort A at a median follow-up of 7.8 months (range, 0.5-18).

Results

Treatment Disposition

  • At clinical data cutoff, the median treatment duration was 5.9 months (range, 0.2-18.0) for the primary safety analysis set (N=165). Of these patients, 46.7% (n=77) received treatment for ≥6 months and 16.4% (n=27) received treatment for ≥9 months. There were no TECVAYLI dose reductions.
  • The pivotal cohort included 165 patients. The phase 1 RP2D cohort included 40 patients; of these, 20 patients continued TECVAYLI treatment and 20 discontinued due to progressive disease (n=16), physician decision (n=3), or patient withdrawal (n=1).
  • In the phase 2 RP2D cohort (n=125), 75 patients continued treatment and 50 patients discontinued due to progressive disease (n=29), death (n=9), physician decision (n=7), patient withdrawal (n=4), or AE (n=1).
  • Baseline characteristics and demographics for cohort A are presented in Table: MajesTEC-1 Study (Cohort A): Baseline Characteristics and Demographics.

MajesTEC-1 Study (Cohort A): Baseline Characteristics and Demographics1
Characteristic
Safety Analysis Set (N=165)
Age (years), median (range)
64.0 (33-84)
   Age ≥75 years, n (%)
24 (14.5)
Male, n (%)
96 (58.2)
Race, n (%)
   White
134 (81.2)
   African American/Black
21 (12.7)
   Othera
10 (6.1)
Bone marrow plasma cells ≥60%b, n (%)
18 (11.3)
Extramedullary plasmacytomas ≥1c, n (%)
28 (17.0)
High cytogenetic riskd, n (%)
38 (25.9)
ISS stagee, n (%)
   I
85 (52.5)
   II
57 (35.2)
   III
20 (12.3)
Baseline renal function, n (%)
   <60 mL/min/1.73 m2
44 (26.7)
   ≥60 mL/min/1.73 m2
121 (73.3)
Time since diagnosis (years), median (range)
6.0 (0.8-22.7)
Prior lines of therapy, median (range)
5.0 (2-14)
Prior stem cell transplantation, n (%)
135 (81.8)
Exposure status, n (%)
   Triple-class exposedf
165 (100)
   Penta-drug exposedg
116 (70.3)
   Selinexor
6 (3.6)
Refractory status, n (%)
   Triple-class refractoryf
128 (77.6)
   Penta-drug refractoryg
50 (30.3)
   Refractory to last line of therapy
148 (89.7)
Abbreviations: CD, cluster of differentiation; ISS, international Staging System; mAb, monoclonal antibody.
aReported as Asian, other, multiple, or not reported.
bPercentages calculated from n=160; includes bone marrow biopsy and aspirate.
cSoft-tissue plasmacytomas not associated with the bone were included.
ddel(17p), t(4:14), and/or t(14;16) (n=147).
eAt baseline, percentages calculated from n=162.
f≥1 proteasome inhibitor, ≥1 immunomodulatory drug, and ≥1 anti-CD38 mAb.
g≥2 proteasome inhibitors, ≥2 immunomodulatory drugs, and ≥1 anti-CD38 mAb.

Efficacy

Response Rates
  • At a median follow-up of 7.8 months (range, 0.5-18), the ORR was 62% (95% confidence interval [CI], 53.7-69.8). Details are provided in Table: MajesTEC-1 Study (Cohort A): Response Rates in the Efficacy Analysis Subset.
    • ORR was consistent in the high cytogenetic risk, triple-class refractory, and penta-drug refractory subgroups.
  • The median time to first response was 1.2 months (range, 0.2-5.5).
MRD Negativity
  • MRD negativity rate at 10-5 threshold was 24.7% (95% CI, 18.0-32.4; n=37).
  • MRD negativity rate at 10-6 threshold was 16.7% (95% CI, 11.1-23.6; n=25).
  • MRD negativity rate was 41.9% in patients who achieved ≥CR.
Duration of Response
  • The median follow-up for responders (n=93) was 8.0 months (range, 2.4-18.0), with 91.4% of patients having at least 6 months of follow-up.
  • Median DOR and OS was not reached.
  • For responders (n=93), the event-free rate was 92.5% (95% CI, 80.6-97.2) at 6 months and 85.9% (95% CI, 70.0-93.7) at 9 months.
  • The 6-month PFS rate was 64.4% (95% CI, 56.0-71.7), and 9-month PFS rate was 58.5% (95% CI, 48.8-67.0).
  • Of the responders, 82 patients were alive without disease progression or subsequent treatment, 11 patients had progressed or died, and 1 patient (no longer on treatment) continued to respond.
  • Nineteen patients changed to less frequent dosing.

MajesTEC-1 Study (Cohort A): Response Rates in the Efficacy Analysis Subset1
Response Rate, %
Efficacy Analysis Subset (N=150)a
ORR
62.0
   sCR
21.3
   VGPR
29.3
   PR
4.0
≥CR
28.7
≥VGPR
58.0
Abbreviations: CR, complete response; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.
aIncludes all patients who received their first dose on or before March 18, 2021.

Safety

  • AEs reported in ≥20% of patients in the safety analysis set are presented in Table: MajesTEC-1 Study (Cohort A): AEs (≥20%) in the Safety Analysis Set.
  • Serious adverse events (SAEs) were reported in 53.3% (n=88) of patients; investigator-assessed TECVAYLI-related SAEs were reported in 33 patients.
  • A total of 63% of patients (n=104) reported infections (grade 3/4, 35.2%; opportunistic, 5.5% [n=9]).
  • Hypogammaglobulinemia was observed in 72.1% of patients (n=119), with 41% of patients receiving intravenous immunoglobulin (IVIG) during the study.
  • A total of 9 deaths due to AEs were reported; none were related to TECVAYLI (COVID-19, n=7; hemoperitoneum, n=1; pneumonia, n=1).
  • No patients required dose reduction, including those who had neurotoxic events.
  • One patient discontinued TECVAYLI due to adenoviral pneumonia; no treatment discontinuations due to CRS or neurotoxicity were reported.
Cytokine Release Syndrome
  • Of the 71.5% all-grade CRS events reported, most were grade 1 (49.7%) or grade 2 (21.2%). One transient grade 3 CRS event was reported, which resolved.
  • CRS events were limited to the step-up dosing phase and cycle 1 in 97% of cases. For detailed parameters as well as mitigation strategies used for CRS, see Table: MajesTEC-1 Study (Cohort A): CRS.
  • More than 1 tocilizumab dose was given to 2.4% of patients for a single CRS event.
  • All CRS events resolved; no treatment discontinuations due to CRS were reported.
Neurotoxicity
  • Headache (8.5%) was the most commonly reported neurotoxic event. Additional details and supportive measures used for neurotoxicity are presented in Table: MajesTEC-1 Study (Cohort A): Neurotoxicity.
  • No grade ≥3 neurotoxicity AEs were reported.

MajesTEC-1 Study (Cohort A): AEs (≥20%) in the Safety Analysis Set1
AE, n (%)
Safety Analysis Set (N=165)
Any Grade
Grade 3/4
Hematologic
   Neutropenia
108 (65.5)
94 (57.0)
   Anemia
82 (49.7)
57 (34.5)
   Thrombocytopenia
63 (38.2)
35 (21.2)
   Lymphopenia
56 (33.9)
53 (32.1)
Nonhematologic
   CRS
118 (71.5)
1 (0.6)
   Injection site erythema
42 (25.5)
0 (0)
   Fatigue
41 (24.8)
3 (1.8)
   Nausea
40 (24.2)
1 (0.6)
   Headache
36 (21.8)
1 (0.6)
   Diarrhea
34 (20.6)
4 (2.4)
Abbreviation: AE, adverse event; CRS, cytokine release syndrome.

MajesTEC-1 Study (Cohort A): CRS1
Parameter
Safety Analysis Set (N=165)
Patients with CRS, n (%)
118 (77.5)
Patients with ≥2 CRS events, n (%)
54 (32.7)
Time to onset (days), median (range)
2 (1-6)
Duration (days), median (range)
2 (1-9)
Patients who received supportive measuresa, n (%)
109 (66.1)
   Tocilizumab
60 (36.4)
   Low-flow oxygen by nasal cannulab
21 (12.7)
   Steroids
13 (7.9)
   Single vasopressor
1 (0.6)
Abbreviation: CRS, cytokine release syndrome.
aA patient could receive >1 supportive therapy.
b≤6 L/min.

MajesTEC-1 Study (Cohort A): Neurotoxicity1
Parameter
Safety Analysis Set (N=165)
Patients with neurotoxicity, n (%)
21 (12.7)
Headache, n (%)
14 (8.5)
ICANS, n (%)
5 (3.0)
Encephalopathy, n (%)
2 (1.2)
Tremor, n (%)
2 (1.2)
Time to onset, median (range), days
2.5 (1-7)
Duration, median (range), days
3.0 (1-37)
Patients requiring supportive measures, n (%)
12 (7.3)
   Tocilizumab
3 (1.8)
   Dexamethasone
3 (1.8)
   Levetiracetam
1 (0.6)
Abbreviation: ICANS, immune effector cell-associated neurotoxicity syndrome.

PK and Immunogenicity

  • TECVAYLI SC 1.5 mg/kg maintained exposure over the max EC90.
  • At the RP2D, no patients developed anti-teclistamab antibodies (n=146).

LONG-TERM EFFICACY AND SAFETY ANALYSES

Moreau et al (2022)3,17, van de Donk et al (2023)4,5,18, and Garfall et al (2024)6 presented efficacy and safety results at a median follow-up of 14.1 months, 23 months and 30.4 months, respectively.

Results

Treatment Disposition

  • At a median follow-up of 30.4 months, 165 patients had received TECVAYLI at the RP2D. Of these, 65 patients had transitioned to less frequent dosing (eg, Q2W).
    • At the data cutoff of August 22, 2023, 38 patients remained on treatment (37 patients remained on a less frequent dosing schedule).

Efficacy

Response Rates
MRD Negativity
  • Overall, 85.7% of MRD-evaluable patients (48/56) achieved MRD negativity at a threshold of 105; 56.1% of patients (23/41) sustained MRD negativity for ≥6 months, and 38.9% of patients (14/36) sustained MRD negativity for ≥12 months.
Durability of Response

MajesTEC-1 Study (Cohort A): Summary of ORR6
N=165
ORRa,b, n (%)
104 (63.0)
   sCR, %
38.8
   CR, %
7.3
   VGPR, %
13.3
   PR, %
3.6
≥CRb, %
46.1
≥VGPR, %
59.4
Abbreviations: CR, complete response; ORR, overall response rate; PR, partial response; sCR, stringent complete response; USPI, United States Prescribing Information; VGPR, very good partial response.
aResponse assessed by an independent review committee.
bAt the 30-month follow-up of the phase 2 efficacy population (patients enrolled in Cohort A on or before March 18, 2021; n=110 patients supporting the USPI): ORR, 61.8% (n=68); ≥CR, 46.4% (n=51).

MajesTEC-1 Study (Cohort A): DOR, PFS, and OS in Select Patient Subgroups6
DOR
PFS
OS
mDOR, Months
(95% CI)
30-Month DOR Rate,
%
(95% CI)
mPFS, Months
(95% CI)
30-Month PFS Rate,
%
(95% CI)
mOS, Months
(95% CI)
30-Month OS Rate,
%
(95% CI)
All RP2D (N=165)
24.0
(17.0-NE)
45.0
(34.8-54.7)
11.4
(8.8-16.4)
30.1
(22.9-37.7)
22.2
(15.1-29.9)
41.9
(33.9-49.6)
   ≥CR (n=76)
NR
(26.7-NE)
60.8
(48.7-71.0)
NR
(26.9-NE)
61.0
(48.9-71.1)
NR
(35.5-NE)
74.2
(61.9-83.1)
   ≥VGPR (n=98)
25.6
(18.1-NE)
48.7
(38.3-58.3)
26.7
(19.4-NE)
48.8
(38.5-58.4)
NR
(31.0-NE)
62.4
(51.5-71.6)
   MRD-negative (n=48)
NR
(19.2-NE)
53.0
(37.8-66.1)
NR
(21.0-NE)
53.1
(38.0-66.2)
NR
(29.9-NE)
67.2
(50.0-79.6)
     MRD-negative for
   ≥6 months (n=23)
NR
(NE-NE)
82.0
(58.8-92.8)
NR
(NE-NE)
82.2
(59.2-92.2)
NR
(NE-NE)
80.9
(50.6-93.7)
     MRD-negative for
   ≥12 months (n=14)
NR
(NE-NE)
92.9
(59.1-99.0)
NR
(NE-NE)
92.9
(59.1-99.0)
NR
(29.9-NE)
80.0
(20.4-96.9)
   ≤3 prior LOT (n=43)
24.0
(14.0-NE)
-
21.7
(13.8-NE)
-
NR
(18.3-NE)
-
   >3 prior LOT (n=122)
22.4
(14.9-NE)
-
9.7
(6.4-13.1)
-
17.7
(12.2-29.7)
-
Phase 2 efficacy (n=110)a
22.4b
(14.9-NE)
44.4b
(31.4-56.7)
10.8
(7.4-16.4)
28.9
(20.0-38.4)
21.7
(12.7-29.9)
39.8
(30.0-49.5)
   ≥CR (n=51)
NR
(21.6-NE)
61.9
(47.0-73.8)
NR
(22.8-NE)
62.0
(47.1-73.9)
NR
(NE-NE)
68.1
(50.8-80.5)
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; LOT, lines of therapy; mDOR, median duration of response; mOS, median overall survival; mPFS, median progression-free survival; MRD, minimal residual disease; NE, not estimable; NR, not reached; OS, overall survival; PFS, progression-free survival; RP2D, recommended phase 2 dose; USPI, United States Prescribing Information; VGPR, very good partial response.
aIncludes patients enrolled in Cohort A on or before March 18, 2021; these data reflect the 30-month follow-up of n=110 patients that supported the USPI.
bn=68 for DOR for the Phase 2 efficacy population.

Safety

  • At a median follow-up of 30.4 months, no new safety signals were reported.
  • TEAEs occurring in ≥20% of patients are summarized in Table: MajesTEC-1 Study (Cohort A): Summary of TEAEs (≥20%).
  • No new cases of CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported at the 30.4-month follow-up.
  • A total of 22 deaths due to infection were reported, of which 18 deaths were due to COVID-19.
    • No new deaths due to COVID-19 TEAEs were reported since the 22.8-month follow-up.
  • TEAEs leading to dose reduction were reported in 1 patient (0.6%) and TEAEs leading to discontinuation were reported in 8 patients (4.8%); 5 discontinuations were due to infection.

MajesTEC-1 Study (Cohort A): Summary of TEAEs (≥20%)6
TEAEs, n (%)
N=165
Any Grade
Grade 3/4
Any TEAE
165 (100)
156 (94.5)
Hematologic
      Neutropenia
118 (71.5)
108 (65.5)
      Anemia
91 (55.2)
62 (37.6)
      Thrombocytopenia
69 (41.8)
38 (23.0)
      Lymphopenia
60 (36.4)
57 (34.5)
      Leukopenia
33 (20.0)
15 (9.1)
Nonhematologic
      Infections
130 (78.8)
91 (55.2)
         COVID-19
48 (29.1)
35 (21.2)
      CRS
119 (72.1)
1 (0.6)
      Diarrhea
57 (34.5)
6 (3.6)
      Pyrexia
51 (30.9)
1 (0.6)
      Fatigue
50 (30.3)
4 (2.4)
      Cough
46 (27.9)
0
      Nausea
45 (27.3)
1 (0.6)
      Injection site erythema
44 (26.7)
0
      Arthralgia
42 (25.5)
2 (1.2)
      Headache
40 (24.2)
1 (0.6)
      Constipation
37 (22.4)
0
      Hypogammaglobulinemia
36 (21.8)
3 (1.8)
      Back pain
33 (20.0)
4 (2.4)
Abbreviations: COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; TEAE, treatment-emergent adverse event.

Dosing Interval Adjustment in MajesTEC-1 Study (Cohort A)

Usmani et al 20237 assessed efficacy and safety in 63 patients who switched to a less frequent dosing interval of TECVAYLI (Q2W or Q4W) in the MajesTEC-1 study.

Study Design/Methods

  • In addition to the study design outlined earlier; patients had the option to switch to Q2W if they achieved the following response:
    • Phase 1: ≥PR for ≥4 cycles.
    • Phase 2: ≥CR for ≥6 months.
  • Patients could then switch to Q4W dosing if they exhibited continued response on the Q2W schedule.

Results

Treatment Disposition

  • At a median follow-up of 23 months, 165 patients were treated at TECVAYLI RP2D, with 104 patients achieving a response. Among these responders, 63 patients were switched to TECVAYLI Q2W dosing (Phase 1, n=22; Phase 2, n=41). Of these, 9 patients continued to TECVAYLI Q4W dosing.
    • Among the 63 patients who switched to Q2W dosing, 54 patients were eligible to switch to Q2W dosing per protocol. Additionally, 9 patients who switched were ineligible per protocol (AEs, n=3; other reasons, n=6).
    • The median time to switch from the first TECVAYLI QW dose to the first Q2W dose was 11.3 months (range, 3-30; median 6.8 months in Phase 1; 12.7 months in Phase 2).
  • See Table: MajesTEC-1 Study (Cohort A): Baseline Characteristics of Patients Who Switched to Q2W or Q4W Dosing for additional details.

MajesTEC-1 Study (Cohort A): Baseline Characteristics of Patients Who Switched to Q2W or Q4W Dosing7
Characteristic
(N=63)
Median age, years (range)
64 (40-82)
Male, n (%)
36 (57.1)
Race, n (%)
   White
55 (87.3)
   Black/African American
6 (9.5)
   Asian
1 (1.6)
   Not reported
1 (1.6)
Extramedullary plasmacytomasa, n (%)
5 (7.9)
High-risk cytogenetics, n/N (%)
14/58 (24.1)
ISS stage, n (%)
   I
43 (68.3)
   II
17 (27.0)
   III
3 (4.8)
Time since diagnosis (years), median (range)
5.9 (1.1-20.5)
Number of prior LOT, median (range)
4 (2-14)
Refractory status, n (%)
   Triple-classb
47 (74.6)
   Penta-drugc
22 (34.9)
Abbreviations: CD, cluster of differentiation; ISS, International Staging System; LOT, lines of therapy; mAb, monoclonal antibody; Q2W, every other week; Q4W, every 4 weeks.
aIncludes patients who had ≥1 soft tissue plasmacytoma not associated with bone.
b≥1 proteasome inhibitor, ≥1 immunomodulatory drug, 1 anti-CD38 mAb.
c≥2 proteasome inhibitors, ≥2 immunomodulatory drugs, 1 anti-CD38 mAb.

Efficacy

  • At the time of switching, 54 patients (85.7%) were in ≥CR, 8 patients were in ≥VGPR, and 1 patient had a PR.
  • The median follow-up for patients after switching to TECVAYLI Q2W dosing or Q4W, was 12.6 months (range, 1-25).
  • The median DOR was not reached. Among the patients that switched, 68.7% of patients (95% CI, 53.6-79.7) observed a durable response for ≥2 years since the first response.

Safety

  • Five deaths occurred (4 due to COVID-19).
Infections
  • The incidence of grade ≥3 treatment-emergent infections was 15.6% in patients who switched to TECVAYLI Q2W dosing by 1 year.
  • The incidence of grade ≥ 3 treatment-emergent infections was 33.3% in patients who continued TECVAYLI QW dosing by 1 year.

Literature Search

A literature search of Ovid MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 24 November 2025.

 

References

Show
1 Moreau P, Usmani SZ, Garfall AL, et al. Updated results from MajesTEC-1: phase 1/2 study of teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in relapsed/refractory multiple myeloma. Oral presentation presented at: 63rd American Society of Hematology (ASH) Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual Meeting.  
2 Usmani SZ, Garfall AL, van de Donk NWCJ, et al. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021;398(10301):665-674.  
3 Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505.  
4 van de Donk NWCJ, Moreau P, Garfall AL, et al. Long-term follow-up from MajesTEC-1 of teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). Poster presented at: 2023 American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL, USA & Virtual.  
5 van de Donk NWCJ, Moreau P, Garfall AL, et al. Long-term follow-up from MajesTEC-1 of teclistamab, a BCMA×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. Poster presented at: 11th Annual Meeting of the Society of Hematologic Oncology (SOHO); September 6-9, 2023; Houston, TX, USA.  
6 Garfall AL, Nooka AK, van de Donk NWCJ, et al. Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma. Oral Presentation presented at: The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL.  
7 Usmani SZ, Karlin L, Benboubker L, et al. Durability of responses with biweekly dosing of teclistamab in patients with relapsed/refractory multiple myeloma achieving a clinical response in the MajesTEC-1 study. Poster presented at: 2023 American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL, USA & Virtual.  
8 Costa LJ, van de Donk NWCJ, Rosinal L, et al. Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma: subgroup analysis by lines of therapies. Poster presented at: HEMO 2024; October 23-26, 2024; Sao Paulo, Brazil.  
9 Costa LJ, Bahlis NJ, Usmani SZ, et al. Efficacy and safety of teclistamab in patients with relapsed/refractory multiple myeloma with high-risk features: a subgroup analysis from the phase 1/2 MajesTEC-1 study. Poster presented at: European Hematology Association (EHA) 2024 Hybrid Congress; June 13-16, 2024; Madrid, Spain.  
10 van de Donk NWCJ, Bahlis N, Costa LJ, et al. Impact of COVID-19 on outcomes with teclistamab in patients with relapsed/refractory multiple myeloma in the phase 1/2 MajesTEC-1 study. Blood Cancer J. 2024;14(1):186.  
11 van de Donk NWCJ, Bahlis N, Costa LJ, et al. Impact of COVID-19 on outcomes with teclistamab in the phase 1/2 MajesTEC-1 study in patients with relapsed/refractory multiple myeloma. Poster presented at: 5th European Myeloma Network (EMN); April 18-20, 2024; Torino, Italy. Poster presented at: 5th European Myeloma Network (EMN); April 18-20, 2024; Torino, Italy.  
12 Frerichs KA, Verkleij CPM, Mateos MV, et al. Teclistamab impairs humoral immunity in patients with heavily pretreated myeloma: importance of immunoglobulin supplementation. Blood Adv. 2024;8(1):194-206.  
13 Martin TG, Moreau P, Usmani SZ, et al. Teclistamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: results from the phase II MajesTEC-1 study. Clin Lymphoma Myeloma Leuk. 2024;24(3):194-202.  
14 Matous J, van de Donk, NWCJ, Oriol A, et al. Higher teclistamab step-up dosing in patients with relapsed or refractory multiple myeloma (RRMM): results from the MajesTEC-1 trial. Poster presented at: 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA.  
15 Martin TG, Mateos MV, Nooka A, et al. Detailed overview of incidence and management of cytokine release syndrome observed with teclistamab in the MajesTEC-1 study of patients with relapsed/refractory multiple myeloma. Cancer. 2023;129(13):2035-2046.  
16 Nooka AK, Rodriguez C, Mateos MV, et al. Incidence, timing, and management of infections in patients receiving teclistamab for the treatment of relapsed/refractory multiple myeloma in the MajesTEC‐1 study. Cancer. 2024;130(6):886-900. Cancer. 2024;130(6):886-900.  
17 Moreau P, Garfall AL, van de Donk NWCJ, et al. Protocol to: Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505.  
18 Mateos MV. Long-term follow-up from MajesTEC-1 of teclistamab, a BCMA×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. Oral presentation presented at: Lymphoma Leukemia and Myeloma Congress; October 18-21, 2023; New York, NY.