MajesTEC-1 Study Summary

Key eligibility criteria¹

Inclusion criteria

RRMM, ≥3 prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Exclusion criteria

Stroke, seizure, allogenic stem cell transplantation within the past 6 months
Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2
Known active central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma
Active or documented history of autoimmune disease, with the exception of vitiligo, type 1 diabetes, and prior autoimmune thyroiditis

Design: Single-arm, open-label, multicenter study, (MajesTEC-1; NCT03145181; NCT04557098)¹

Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI® followed by TECVAYLI® 1.5 mg/kg subcutaneously (SC) once weekly until disease progression or unacceptable toxicity.¹

For the step-up dosing schedule (step-up doses and first treatment dose), the MajesTEC-1 trial protocol (Part 3) required hospitalization and pretreatment medications.³

Teclistamab-cqyv is initiated with a step-up dosing schedule¹

Remember: Dose is based on each patient’s actual body weight. Please refer to Tables 7, 8, and 9 in the full Prescribing Information to determine the dosage, injection volume and number of vials required based on predetermined weight ranges. Dose reductions are not recommended, and dose delays may be required to manage toxicities

^aSee TECVAYLI® Prescribing Information for recommendations on restarting TECVAYLI® after dose delays.
^bStep-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.
^cFirst treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.
^dMaintain a minimum of 5 days between 1.5 mg/kg once weekly doses.
^eMaintain a minimum of 12 days between 1.5 mg/kg every two week doses.

Primary endpoint⁴

Overall response rate (ORR), defined as partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria

Key secondary endpoints⁴

Duration of response (DOR)
≥CR
Time to response
Safety

Baseline patient characteristics and treatment history in patients with multiple myeloma who received TECVAYLI® in MajesTEC-1¹:

Baseline patient characteristics	TECVAYLI® (N = 110)
Age
Median age, years (range)	66 (33-82)
≥75 years, %	16
Sex
Male, %	56
Race, %
White	91
Black or African American	5
Asian	3
ISS stage at study entry, %
Stage I	50
Stage II	38
Stage III	12
Other characteristics, %
High-risk cytogenetics^*	25
Extramedullary plasmacytomas	17
Treatment history
Prior lines of therapy, median (range)	5 (2-14)
Received ≥4 prior lines of therapy, %	78
Received prior therapy with a PI, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, %	100
Prior stem cell transplantation, %	81
Refractory to proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody, %	76
^*Presence of del(17p), t(4;14), and t(14;16).

You are now viewing a subsequent follow-up analysis of the MajesTEC-1 trial. This information is not included in the current full Prescribing Information.

At the time of the follow-up report, 25/110 (22.7%) of subjects were still on treatment⁶
46.4% of patients experienced ≥CR^§ with TECVAYLI® in the MajesTEC-1 trial⁵
Patients achieved ≥CR^§ at a median time of 6.0 months (range: 1.7-18.5 months)⁶

^*Based on a median duration of follow-up of 29.9 months.⁶
^†Results were based on ORR as determined by the Independent Review Committee assessment using IMWG 2016 criteria.⁶
^‡ORR: sCR+CR+VGPR+PR.
^§≥CR: sCR+CR.
^||≥VGPR: sCR+CR+VGPR.

You are now viewing a subsequent follow-up analysis of the MajesTEC-1 trial. This information is not included in the current full Prescribing Information.

^*Based on a median duration of follow-up of 29.9 months.⁶

^†≥CR: sCR+CR.

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

See full prescribing information for complete boxed warning

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI®. Initiate treatment with TECVAYLI® step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI® until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI®. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI® until neurologic toxicity resolves or permanently discontinue based on severity.

TECVAYLI® is available only through a restricted program called the TECVAYLI® and TALVEY® Risk Evaluation and Mitigation Strategy (REMS).

Contraindications¹:

None

Warnings and precautions¹:

Please see the full Prescribing Information for more details.

Cytokine release syndrome

TECVAYLI® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions.

In the clinical trials (monotherapy and combination therapy; N=448), CRS occurred in 64% of patients who received TECVAYLI® at the recommended dosage, with Grade 1 CRS occurring in 46% of patients, Grade 2 in 18%, and Grade 3 in 0.2%. Recurrent CRS occurred in 27% of patients. Most patients experienced CRS during the initial step-up dosing schedule (step-up dose 1 [37%], step-up dose 2 [32%], or the initial treatment dose [20%]). CRS first occurred following subsequent doses of TECVAYLI® in 2.5% of patients. The median time to onset of CRS was 2 (range: 1 to 9) days after the most recent dose and the median duration of CRS was 2 (range: 1 to 22) days.

Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation).

Initiate therapy according to TECVAYLI® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI® accordingly.

At the first sign of CRS, immediately evaluate the patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold until CRS resolves or permanently discontinue TECVAYLI® based on severity.

TECVAYLI® is available only through a restricted program under a REMS.

Neurologic toxicity including ICANS

TECVAYLI® can cause serious, life-threatening, or fatal neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).

In the clinical trials (monotherapy and combination therapy trials; N=448), neurologic toxicity occurred in 60% of patients who received TECVAYLI® at the recommended dosage, with Grade 3 or 4 neurologic toxicity in 6%. Neurologic toxicities reported in ≥5% of patients included headache (27%), sensory neuropathy (16%), motor dysfunction (15%), insomnia (12%), encephalopathy (11%), and dizziness (8%). Fatal neurologic toxicity occurred in 0.4% of patients, including Guillain-Barré syndrome and status epilepticus (one patient each).

In MajesTEC-1, ICANS was reported in 6% of patients who received TECVAYLI® as monotherapy at the recommended dosage. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent TECVAYLI® doses. The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia.

In MajesTEC-3, ICANS was reported in 1.1% of patients who received the recommended TECVAYLI® dosage in combination with daratumumab and hyaluronidase-fihj, including Grade 4 ICANS in 1 patient. All events of ICANS occurred during the step-up dosing schedule. The median time to onset of ICANS was 2 (range: 1 to 3) days after the most recent dose and the median duration of ICANS was 2 (range: 1 to 2) days. The clinical manifestations of ICANS reported were amnesia, encephalopathy and delirium.

The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during TECVAYLI® treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold until neurologic toxicity resolves or permanently discontinue TECVAYLI® based on severity per recommendations and consider further management per current practice guidelines.

Due to the potential for neurologic toxicity, patients receiving TECVAYLI® are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.

TECVAYLI® is available only through a restricted program under a REMS.

TECVAYLI® and TALVEY® REMS

TECVAYLI® is available only through a restricted program under a REMS called the TECVAYLI® and TALVEY® REMS because of the risks of CRS and neurologic toxicity, including ICANS.

Further information about the TECVAYLI® and TALVEY® REMS is available at www.TEC-TALREMS.com or by telephone at 1-855-810-8064.

Hepatotoxicity

TECVAYLI® can cause hepatotoxicity, including fatalities. There was one fatal case of hepatic failure in MajesTEC-1. In patients who received TECVAYLI® at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448) elevated aspartate aminotransferase (AST) occurred in 47% of patients, with Grade 3 or 4 elevations in 2.9%. Elevated alanine aminotransferase (ALT) occurred in 48% of patients, with Grade 3 or 4 elevations in 3.8%. Elevated total bilirubin occurred in 10% of patients with Grade 3 or 4 elevations in 0.7%. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity.

Infections

TECVAYLI® can cause severe, life-threatening, or fatal infections.

In MajesTEC-1 (N=165), in patients who received the recommended TECVAYLI® dosage, serious infections, including opportunistic infections, occurred in 30% of patients, Grade 3 or 4 infections in 35% of patients, and fatal infections in 4.2% of patients.

In MajesTEC-3 (N=283), in patients who received TECVAYLI® in combination with daratumumab and hyaluronidase-fihj at the recommended dosage, serious infections, including opportunistic infections, occurred in 54% of patients, Grade 3 or Grade 4 infections in 54% of patients, and fatal infections in 4.6% of patients.

Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI® and treat appropriately. Administer prophylactic antimicrobials according to current practice guidelines.

Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity.

Monitor immunoglobulin levels prior to and during treatment with TECVAYLI® and administer subcutaneous or intravenous immunoglobulin (IVIG) to maintain the serum levels >400 mg/dL.

Neutropenia

TECVAYLI® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI® at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients.

Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines.

Monitor patients with neutropenia for signs of infection.

Withhold TECVAYLI® based on severity.

Hypersensitivity and other administration reactions

TECVAYLI® can cause both systemic administration-related and local injection-site reactions.

Systemic reactions - In patients who received the recommended TECVAYLI® dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic-administration reactions, which included recurrent pyrexia and rash.

Local reactions - In patients who received TECVAYLI® at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients, with Grade 1 injection-site reactions in 29% and Grade 2 in 9%.

Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity.

Embryo-fetal toxicity

Based on its mechanism of action, TECVAYLI® may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI® and for 5 months after the last dose.

Adverse reactions

The most common adverse reactions (≥20%) in patients who received TECVAYLI® monotherapy were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common adverse reactions (≥20%) in patients who received TECVAYLI® in combination with daratumumab and hyaluronidase-fihj were hypogammaglobulinemia, upper respiratory tract infection, CRS, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased.

The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI® (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI®.

cp-322928v6

Among patients who received TECVAYLI monotherapy, 47% were exposed for 6 months or longer and 7% were exposed for one year or longer¹
Serious adverse reactions occurred in 54% of patients who received TECVAYLI®. Serious adverse reactions in ≥2% of patients included¹:

Fatal adverse reactions occurred in 5% of patients who received TECVAYLI®, including COVID-19 (1.8%), pneumonia (1.8%), septic shock (0.6%), acute renal failure (0.6%), and hemoperitoneum (0.6%)¹
Permanent discontinuation of TECVAYLI® due to adverse reactions occurred in 1.2% of patients. Adverse reactions resulting in permanent discontinuation of TECVAYLI® included pneumonia (adenoviral and pneumocystis jirovecii pneumonia in the same patient) and hypercalcemia¹
Dosage interruptions of TECVAYLI® due to an adverse reaction occurred in 73% of patients. Adverse reactions which required dosage interruption in >5% of patients included neutropenia, pneumonia, pyrexia, cytokine release syndrome, upper respiratory tract infection, and COVID-19¹

The most common adverse reactions (≥20%) included¹:
- Pyrexia
- CRS
- Musculoskeletal pain
- Injection site reaction
- Fatigue
- Upper respiratory tract infection
- Nausea
- Headache
- Pneumonia
- Diarrhea

The most common Grade 3 or 4 laboratory abnormalities (≥20%) were¹:
- Decreased lymphocytes
- Decreased neutrophils
- Decreased white blood cells
- Decreased hemoglobin
- Decreased platelets

Adverse reaction	TECVAYLI® (N=165)
Adverse reaction	Any grade (%)	Grade 3 or 4 (%)
General disorders and administration site conditions
Pyrexia	76	3^#
Injection site reaction^*	37	0.6^#
Fatigue^*	33	2.4^#
Chills	16	0
Pain^*	15	1.8^#
Edema^*	13	0
Immune system disorders
CRS	72	0.6^#
Hypogammaglobulinemia^a	11	1.2^#
Musculoskeletal and connective tissue disorders
Musculoskeletal pain^*	44	4.2^#
Bone pain	16	3^#
Infections
Upper respiratory tract infection^b	26	2.4^#
Pneumonia^c†	24	15
Upper tract infection^*	11	5^#
Gastrointestinal disorders
Nausea	25	0.6^#
Diarrhea	21	2.4^#
Constipation	18	0
Vomiting	12	0.6^#
Nervous system disorders
Headache	25	0.6^#
Motor dysfunction^d	16	0
Sensory neuropathy^e	15	1.2^#
Encephalopathy^f	13	0
Vascular disorders
Hypotension	18	1.2^#
Hemorrhage^*†	12	1.8
Hypertension^*	12	4.8^#
Respiratory, thoracic, and mediastinal disorders
Hypoxia	18	1.8
Cough^*	15	0
Cardiac disorders
Cardiac arrythmia^*	16	1.8
Metabolism and nutrition disorders
Decreased appetite	11	0.6^#
Renal and urinary disorders
Acute kidney injury^*	11	3.6
^*Includes other related terms. ^aHypogammaglobulinemia includes hypogammaglobulinemia and hypoglobulinemia. ^bUpper respiratory tract infection includes bronchitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, tracheitis and other related terms. ^cPneumonia includes bacterial pneumonia, viral pneumonia, and other related terms. ^dMotor dysfunction includes cogwheel rigidity, dysgraphia, dysphonia, gait disturbance, hypokinesia, muscle rigidity, muscle spasms, muscular weakness, peroneal nerve palsy, psychomotor hyperactivity, tremor and VIth nerve paralysis. ^eSensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis. ^fEncephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence. ^†Only Grade 3 adverse reactions occurred. ^‡Includes the following fatal adverse reactions: hemorrhage (n=1), pneumonia (n=3).

Laboratory abnormality	TECVAYLI® (N=165)^*
Laboratory abnormality	All grades (%)	Grade 3 or 4 (%)
Hematology
Lymphocyte count decreased	92	84
White blood cell decreased	86	41
Neutrophil decreased	84	56
Platelet count decreased	71	22
Hemoglobin decreased	67	33
Chemistry
Albumin decreased	68	6
Alkaline phosphatase increased	42	2.4
Phosphorus decreased	38	13
Gamma-glutamyl transferase increased	37	8
Sodium decreased	35	10
Aspartate aminotransferase increased	34	1.2
Calcium (corrected) decreased	31	1.2
Creatinine increased	30	3
^*The denominator used to calculate the rate varied from 164 to 165 based on the number of patients with a baseline value and at least one post-treatment value. Laboratory toxicity grades are derived based on the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03.

You are now viewing a subsequent follow-up analysis of the MajesTEC-1 trial. This information is not included in the current full Prescribing Information.

MajesTEC-1 safety analysis at a median follow-up of 30.4 months^5,6

At the time of the follow-up report, 38/165 (23%) of subjects were still on treatment

Reported since end of primary analysis:

One patient experienced 2 recurrent CRS events after a treatment delay
No additional events of ICANS

Reported since study initiation:

Eight treatment-related deaths occurred (4 due to COVID-19)
Permanent discontinuation due to adverse reactions occurred in 5.5% of patients

Adverse reaction, n (%)	(N=165)
Adverse reaction, n (%)	Any grade	Grade 3 or 4
Any TEAE	165 (100.0)	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)

TECVAYLI® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
U.S. FDA approves TECVAYLI® (teclistamab-cqyv) the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. News release. Janssen Biotech, Inc.; October 25, 2022. Accessed May 12, 2026. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma
Protocol for: Moreau P, Garfall A, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387:495-505.
Moreau P, Garfall A, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387:495-505.
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. Poster. Presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL.
Data on File. Janssen Biotech, Inc.

ALT	Alanine aminotransferase	mDOR	Median duration of response
AST	Aspartate aminotransferase	mFU	Median follow-up
CI	Confidence interval	N/A	Not applicable
COVID-19	Coronavirus disease 2019	NE	Not estimable
CR	Complete response	ORR	Overall response rate
CRS	Cytokine release syndrome	PI	Proteasome inhibitor
CTCAE	Common Terminology Criteria for Adverse Events	PR	Partial response
DOR	Duration of response	REMS	Risk Evaluation and Mitigation Strategy
ECOG PS	Eastern Cooperative Oncology Group performance status	RRMM	Relapsed or refractory multiple myeloma
FDA	U.S. Food and Drug Administration	SC	Subcutaneous
ICANS	Immune effector cell-associated neurotoxicity syndrome	sCR	Stringent complete response
IMWG	International Myeloma Working Group	TEAE	Treatment-emergent adverse event
IV	Intravenous	VGPR	Very good partial response
LTFU	Long term follow-up

Teclistamab-cqyv is initiated with a step-up dosing schedule¹

Baseline patient characteristics and treatment history in patients with multiple myeloma who received TECVAYLI® in MajesTEC-1¹:

Contraindications¹:

Warnings and precautions¹:

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Teclistamab-cqyv is initiated with a step-up dosing schedule1

Baseline patient characteristics and treatment history in patients with multiple myeloma who received TECVAYLI® in MajesTEC-11:

Efficacy was based on ORR as assessed by Independent Review Committee using IMWG criteria1

Response rates with 30 months of median follow-up5,6*†

Duration of response with 30 months of median follow-up5*

Contraindications1:

Warnings and precautions1:

Adverse reactions (≥10%) in patients treated with TECVAYLI® in MajesTEC-11:

Select laboratory abnormalities (≥30%) that worsened from baseline in TECVAYLI® treated patients with multiple myeloma in MajesTEC-11

Treatment-emergent adverse events ≥20% at a median follow-up of 30.4 months5

Percentage of patients who discontinued TECVAYLI® due to adverse reactions at a median follow-up 30.4 months6

Connect with us

Teclistamab-cqyv is initiated with a step-up dosing schedule¹

Baseline patient characteristics and treatment history in patients with multiple myeloma who received TECVAYLI® in MajesTEC-1¹:

Contraindications¹:

Warnings and precautions¹: