(teclistamab-cqyv)
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TECVAYLI® (teclistamab-cqyv)
Medical Information
TECVAYLI - MajesTEC-1 Study (Cohort A)
Last Updated: 12/09/2025
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
- 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: 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
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.
| 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 | 18 (11.3) |
| Extramedullary plasmacytomas ≥1c | 28 (17.0) |
| High cytogenetic riskd | 38 (25.9) |
| ISS stagee | |
| 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. a 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.
| 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.
| 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. | ||
| 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. | |
| 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
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
- At a median follow-up of 30.4 months, ORR was 63.0%. Additional details are provided in Table: MajesTEC-1 Study (Cohort A): Summary of ORR.
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
- DOR, PFS, and OS in select patient subgroups are summarized in Table: MajesTEC-1 Study (Cohort A): DOR, PFS, and OS in Select Patient Subgroups.
| N=165 | |
|---|---|
| ORRa,b | 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). | |
| 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.
| 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
- 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.
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.
| (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.
A literature search of Ovid MEDLINE®
REFERENCES
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.
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