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TECVAYLI® (teclistamab-cqyv)

Medical Information

TECVAYLI - MajesTEC-5 (MMY2003) Study - TECVAYLI-Based Regimens

Last Updated: 10/08/2025

Summary

Johnson & Johnson does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by regulatory agencies.
MajesTEC-5 is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI- and TALVEY^®-based combination regimens in patients with transplant-eligible (TE), newly diagnosed multiple myeloma (NDMM).¹^-³
- Raab et al (2025)³ presented the updated efficacy and safety results of TECVAYLI in combination with DARZALEX FASPRO^® and lenalidomide (Tec-DR) and TECVAYLI in combination with DARZALEX FASPRO, bortezomib, and lenalidomide (Tec-DVR) in patients with TE-NDMM from 3 induction cohorts of the MajesTEC-5 study at a median follow-up of 7.3 months (range, 3.1-14.5).
- Raab et al (2024)² presented the initial efficacy and safety results from the 3 induction cohorts of the MajesTEC-5 study.

PRODUCT LABELING

TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.
TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.

CLINICAL DATA - MAJESTEC-5 STUDY

MajesTEC-5 (GMMG-HD10; DSMM-XX; MMY2003; NCT05695508) 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.¹^-³

Study Design/Methods

The study design is presented in Figure: MajesTEC-5 Study Design.

MajesTEC-5 Study Design¹^-³

A screenshot of a computer screen

AI-generated content may be incorrect.

Abbreviations: ADA, antidrug antibody; ASCT, autologous stem cell transplant; CNS, central nervous system; CR, complete response; Dara, daratumumab and hyaluronidase; DOR, duration of response; DR, daratumumab and hyaluronidase and lenalidomide; DVR, daratumumab and hyaluronidase, bortezomib, and lenalidomide; ECOG PS, Eastern Cooperative Oncology Group performance status; HDT, high-dose therapy; IV, intravenous; IMWG; International Myeloma Working Group; LOT, line of therapy; mAb, monoclonal antibody; MM, multiple myeloma; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; PFS, progression-free survival; PI, proteasome inhibitor; PO, by mouth; PR, partial response; Q2W, every other week; Q4W, every 4 weeks; QW, weekly; R, lenalidomide; SC, subcutaneous; SoC, standard of care; SUD, step-up dosing; Tec, teclistamab; V, bortezomib; VGPR, very good partial response.
^aIncludes a PI and/or an immunomodulatory drug with or without anti-CD38 mAb and single or tandem ASCT. Post-ASCT consolidation was permitted for up to 2 cycles as long as the total number of inductions plus consolidation cycles did not exceed 6.
^bEach cycle was 28 days. Stem cell collection was planned after 3 cycles of induction.
^cDexamethasone 20 mg PO or IV was administered in cycles 1-4 (arm A) or cycles 1-2 (arm A1/B) only.
^dPatients received Tec SUDs of 0.06 mg/kg and 0.3 mg/kg on days 2 and 4.
^ePatients in arm A received an additional dose of Tec 1.5 mg/kg on day 22.
^fAdministered QW during cycles 1-2, Q2W during cycles 3-6.
^gAdministered starting in cycle 2 (days 1-21).
^hFollowing maintenance therapy, patients could receive additional SoC maintenance treatment per institutional standards and the local investigator’s decision. Maintenance treatment could be discontinued when 12 months of sustained MRD negativity (10^-5) was observed, beginning in induction.
ⁱPlanned maintenance treatment in arm A was Tec-DR. Following a protocol amendment, patients who were initially assigned to receive Tec-DR maintenance were permitted to receive Tec-D maintenance per the investigator’s choice (patients who started Tec-DR might have discontinued R to receive Tec-D per the investigator’s choice).

Raab et al (2025)³ presented the updated efficacy and safety results of Tec-DR and Tec-DVR in patients with TE-NDMM from 3 induction cohorts of the MajesTEC-5 study at a median follow-up of 7.3 months (range, 3.1-14.5).

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

A total of 49 patients were included in this study. Baseline characteristics and demographics are presented in Table: MajesTEC-5 Study: Baseline Characteristics and Demographics and treatment dispositions are presented in Table: MajesTEC-5 Study: Treatment Disposition.
The median induction treatment duration was 7.0 months (range, 2.5 to 13.2).
No new study discontinuations were reported since the prior analysis, following an additional 7 months of follow-up.

MajesTEC-5 Study: Treatment Disposition³

	Arm A Tec (QW)-DR (n=10)	Arm A1 Tec (Q4W)-DR (n=20)	Arm B Tec (Q4W)-DVR (n=19)	Total (N=49)
Patients that started induction, n	10	20	19	49
Study treatment discontinuation during induction, n (%)	0	1 (5)^a	1 (5)^a	2 (4)
Induction completed, n	10	19	18^b	47
Abbreviations: DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; Q4W, once every 4 weeks; QW, weekly; Tec, TECVAYLI. Note: The median follow-up was 7.3 months (range, 3.1-14.5).^aBoth patients (arm A1, n=1; arm B, n=1) discontinued induction after cycle 3 due to refusal of further study treatment. ^bOne patient skipped cycle 6 due to neutropenia, received ASCT and maintenance and was considered to have completed induction.

Safety

Treatment-emergent adverse events (TEAEs) reported in the 3 induction cohorts are presented in Table: MajesTEC-5 Study: Hematologic TEAEs (≥25% in Any Arm) and Table: MajesTEC-5 Study: Nonhematologic TEAEs (≥25% in Any Arm).
No grade 5 TEAEs were reported.

Infections and Hypogammaglobulinemia

Grade 3/4 infections were reported in 36.7% of patients (n=18). See Table: MajesTEC-5 Study: Infections (>10% in Any Arm) for additional details.
No treatment discontinuations were reported due to infection.
No grade 5 infections were reported.
Hypogammaglobulinemia (including patients with ≥1 TEAE of hypogammaglobulinemia or post-baseline immunoglobulin G [IgG] <400 mg/dL) was reported in 91.8% of patients (n=45).
- Of the total patients, 89.8% of patients (n=44) received ≥1 dose of intravenous immunoglobulin (IVIG).
Stringent infection prophylaxis, including Ig replacement, was strongly recommended.
- Prophylaxis was recommended for Pneumocystis jirovecii pneumonia and herpes zoster reactivation, along with routine antibiotic prophylaxis.

Cytokine Release Syndrome and Neurotoxicity

All cytokine release syndrome (CRS) events were grade 1 or 2 and fully resolved.
Grade 2 CRS was reported in 20.4% of patients (n=10), with most cases occurring during cycle 1.
No patients discontinued treatment due to CRS.
No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported.
Peripheral neuropathy (PN) rates remained stable with bortezomib administration.

MajesTEC-5 Study: Hematologic TEAEs (≥25% in Any Arm)³

Hematologic TEAE^a, n (%)	Arm A Tec (QW)-DR (n=10)		Arm A1 Tec (Q4W)-DR (n=20)		Arm B Tec (Q4W)-DVR (n=19)		Total (N=49)
Hematologic TEAE^a, n (%)	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4
Neutropenia	4 (40)	3 (30)	13 (65)	13 (65)	14 (73.7)	12 (63.2)	31 (63.3)	28 (57.1)
Lymphopenia	9 (90)	8 (80)	9 (45)	9 (45)	12 (63.2)	12 (63.2)	30 (61.2)	29 (59.2)
Anemia	5 (50)	0	8 (40)	4 (20)	7 (36.8)	1 (5.3)	20 (40.8)	5 (10.2)
Thrombocytopenia	3 (30)	1 (10)	7 (35)	2 (10)	7 (36.8)	1 (5.3)	17 (34.7)	4 (8.2)
Leukopenia	5 (50)	2 (20)	3 (15)	2 (10)	6 (31.6)	5 (26.3)	14 (28.6)	9 (18.4)
Abbreviations: DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, once every 4 weeks; QW, weekly; TEAE, treatment-emergent adverse event; Tec, TECVAYLI. Note: The median follow-up was 7.3 months (range, 3.1-14.5). ^aAdverse events were graded according to NCI-CTCAE version 5.0.

MajesTEC-5 Study: Nonhematologic TEAEs (≥25% in Any Arm)³

Nonhematologic TEAE^a,b, n (%)	Arm A Tec (QW)-DR (n=10)		Arm A1 Tec (Q4W)-DR (n=20)		Arm B Tec (Q4W)-DVR (n=19)		Total (N=49)
Nonhematologic TEAE^a,b, n (%)	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4
CRS	6 (60)	0	14 (70)	0	12 (63.2)	0	32 (65.3)	0
Pyrexia	7 (70)	1 (10)	10 (50)	2 (10)	8 (42.1)	0	25 (51)	3 (6.1)
URTI	6 (60)	0	8 (40)	1 (5)	6 (31.6)	0	20 (40.8)	1 (2)
Rash	6 (60)	2 (20)	5 (25)	0	8 (42.1)	0	19 (38.8)	2 (4.1)
GGT increased	3 (30)	0	6 (30)	3 (15)	5 (26.3)	4 (21.1)	14 (28.6)	7 (14.3)
Hypokalemia	1 (10)	0	9 (45)	2 (10)	4 (21.1)	0	14 (28.6)	2 (4.1)
Diarrhea	6 (60)	0	4 (20)	1 (5)	4 (21.1)	0	14 (28.6)	1 (2)
Nausea	1 (10)	0	4 (20)	0	8 (42.1)	0	13 (26.5)	0
PN	1 (10)	0	5 (25)	0	4 (21.1)	0	10 (20.4)	0
BAP increased	4 (40)	0	1 (5)	0	3 (15.8)	1 (5.3)	8 (16.3)	1 (2)
Lipase increased	1 (10)	1 (10)	5 (25)	3 (15)	1 (5.3)	1 (5.3)	7 (14.3)	5 (10.2)
ALT increased	3 (30)	0	2 (10)	1 (5)	2 (10.5)	2 (10.5)	7 (14.3)	3 (6.1)
Nasopharyngitis	3 (30)	0	2 (10)	0	2 (10.5)	0	7 (14.3)	0
Hyperglycemia	3 (30)	0	3 (15)	1 (5)	0	0	6 (12.2)	1 (2)
Abbreviations: ALT, alanine aminotransferase; BAP, blood alkaline phosphatase; CRS, cytokine release syndrome; DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; GGT, gamma-glutamyl transferase; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; PN, peripheral neuropathy; Q4W, once every 4 weeks; QW, weekly; TEAE, treatment-emergent adverse event; Tec, TECVAYLI; URTI, upper respiratory tract infection. Note: The median follow-up was 7.3 months (range, 3.1-14.5).^aAdverse events were graded according to NCI-CTCAE version 5.0. ^bConstipation and hypogammaglobulinemia based on TEAE reporting also met the ≥25% threshold. Hypogammaglobulinemia is reported separately.

MajesTEC-5 Study: Infections (>10% in Any Arm)³

TEAE^a, n (%)	Arm A Tec (QW)-DR (n=10)		Arm A1 Tec (Q4W)-DR (n=20)		Arm B Tec (Q4W)-DVR (n=19)		Total (N=49)
TEAE^a, n (%)	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4
Any infection	10 (100)	4 (40)	18 (90)	10 (50)	11 (57.9)	4 (21.1)^b	39 (79.6)	18 (36.7)^b
Infections
URTI	6 (60)	0	8 (40)	1 (5)	6 (31.6)	0	20 (40.8)	1 (2)
COVID-19	2 (20)	0	4 (20)	1 (5)	3 (15.8)	2 (10.5)	9 (18.4)	3 (6.1)
Nasopharyngitis	3 (30)	0	2 (10)	0	2 (10.5)	0	7 (14.3)	0
Pneumonia	1 (10)	1 (10)	0	0	2 (10.5)	2 (10.5)	3 (6.1)	3 (6.1)
RTI	0	0	1 (5)	0	2 (10.5)	0	3 (6.1)	0
Bronchitis	2 (20)	0	0	0	0	0	2 (4.1)	0
Abbreviations: COVID-19, coronavirus disease 2019; DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, once every 4 weeks; QW, weekly; RTI, respiratory tract infection; Tec, TECVAYLI. Note: The median follow-up was 7.3 months (range, 3.1-14.5). ^aAdverse events were graded according to NCI-CTCAE version 5.0. ^bOne grade 3 “unknown” infection was reported under the “uncoded” category.

Stem Cell Mobilization

The combined induction regimens facilitated successful stem cell mobilization in approximately 96% of patients. See Table: MajesTEC-5 Study: Stem Cell Mobilization for additional details.
The total median stem cell yield exceeded the minimum collection threshold, defined by protocol as 2.5×10⁶/kg CD34+ cells. In addition, an ideal target was also identified as a yield of 5×10⁶/kg CD34+ cells.

MajesTEC-5 Study: Stem Cell Mobilization^a,³

	Arm A Tec (QW)-DR (n=10)	Arm A1 Tec (Q4W)-DR (n=20)	Arm B Tec (Q4W)-DVR (n=19)	Total (N=49)
Undergone stem cell mobilization^b, n (%)	10 (100)	20 (100)	17 (89.5)^c	47 (95.9)
Received plerixafor^d	2 (20)	11 (55)	7 (41.2)	20 (42.6)
Received cyclophosphamide and G-CSF^d	10 (100)	15 (75)	14 (82.4)	39 (83)
Stem cell yield (10⁶ CD34+ cells/kg)
Median (range)	8.6 (5.7-14.9)	7.7 (2.6-15.1)	7.5 (2.9-15.9)	8.1 (2.6-15.9)
Abbreviations: DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; G-CSF, granulocyte colony-stimulating factor; Q4W, once every 4 weeks; QW, weekly; Tec, TECVAYLI. Note: The median follow-up was 7.3 months (range, 3.1-14.5).^aStem cell collection was planned after 3 cycles of induction. ^bPercentages are calculated based on the number of patients in each treatment group as the denominator. ^cTwo patients in the Tec-DVR group did not undergo mobilization; 1 patient withdrew consent after cycle 3 and 1 patient failed to proceed to mobilization due to cytopenia and insufficient circulation of CD34+ cells. ^dPercentages are calculated based on the number of patients who underwent stem cell mobilization as the denominator.

Efficacy

Response rates in the 3 induction cohorts are presented in Table: MajesTEC-5 Study: Response Rates.
MRD Negativity (10^⁻5 or 10⁻⁶) is presented in Table: MajesTEC-5 Study - MRD Negativity in MRD-Evaluable Patients.
One patient was not evaluable for MRD during induction (cycle 3 or 6) due to discontinuation prior to cycle 3.
Across all treatment arms (n=49), the cumulative rate of minimal residual disease (MRD) negativity by the end of induction in the efficacy analysis set was 98.0%.
At cycle 6, 85.7% of patients (42 out of 49) achieved a complete response or better (≥CR) along with MRD negativity (10^-5 or 10^-6 at any time on study [post-induction cycle 3 or cycle 6]) at a sensitivity threshold of ≤10⁻⁵.

MajesTEC-5 Study: Response Rates³

Response rate^a, %	Arm A Tec (QW)-DR (n=10)	Arm A1 Tec (Q4W)-DR (n=20)	Arm B Tec (Q4W)-DVR (n=19)
ORR^b	100.0	100.0	100.0
sCR	100.0	95.0	73.7
CR	-	-	-
VGPR	-	-	21.1
PR	-	5.0	5.3
≥CR	100.0	95.0	73.7
≥VGPR	100.0	95.0	94.7
Abbreviations: CR, complete response; DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; IMWG, International Myeloma Working Group; ORR, overall response rate; PR, partial response; Q4W, once every 4 weeks; QW, weekly; sCR, stringent complete response; Tec, TECVAYLI; VGPR, very good partial response. Note: The median follow-up was 7.3 months (range, 3.1-14.5).^aResponse was assessed by investigators based on IMWG criteria, with a confirmed response requiring ≥2 consecutive identical response assessments. ^bORR was defined as ≥PR.

MajesTEC-5 Study: MRD Negativity in MRD-Evaluable Patients³

	Arm A Tec (QW)-DR		Arm A1 Tec (Q4W)-DR		Arm B Tec (Q4W)-DVR
	Cycle 3 (n=10)	Cycle 6 (n=10)	Cycle 3 (n=19)^a	Cycle 6 (n=19)^b	Cycle 3 (n=17)^c	Cycle 6 (n=17)
MRD negativity (10^-5)^d,%	100	100	100	100	100	100^e
MRD negativity (10^-6)^f,%	-	100	-	100	-	100^g
Abbreviations: DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; MRD, minimal residual disease; NGF, next-generation flow cytometry; NGS, next-generation sequencing; Q4W, once every 4 weeks; QW, weekly; Tec, TECVAYLI. Note: The median follow-up was 7.3 months (range, 3.1-14.5).^aOne patient was not tested. ^bOne patient had discontinued after completing cycle 3. ^cOne patient was not tested, and 1 had discontinued before completing cycle 3.^dMRD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10^-5) per NGF, regardless of response (ie, not all patients achieved CR). Excluding those who were not tested, indeterminate, or had no baseline clone detected (NGS).^eOne patient had discontinued before completing cycle 3, and 1 had an indeterminate result. ^fMRD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10^-6), regardless of response. MRD-evaluable population defined as those patients with an available MRD test with a positive or negative result (excluding those who were not tested, were indeterminate, or had no baseline clone detected [NGS]). ^gOne patient discontinued before completing cycle 3 and 1 had no baseline clone detected for NGS.

Raab et al (2024)² presented the initial efficacy and safety results of Tec-DR and Tec-DVR induction in patients with TE-NDMM from 3 induction cohorts of the MajesTEC-5 study.

Results

Treatment Disposition

A total of 49 patients were included in this study. Baseline characteristics and demographics are presented in Table: MajesTEC-5 Study: Baseline Characteristics and Demographics and treatment dispositions are presented in Table: MajesTEC-5 Study: Treatment Disposition.
Stem cell mobilization was feasible with Tec-DR and Tec-DVR, yielding a median number of 8.4×10⁶/kg CD34-positive cells across the study arms.

MajesTEC-5 Study: Baseline Characteristics and Demographics²

Characteristic	Arm A Tec (QW)-DR (n=10)	Arm A1 Tec (Q4W)-DR (n=20)	Arm B Tec (Q4W)-DVR (n=19)	Total (N=49)
Median age, years (range)	63.0 (54-66)	57.5 (36-65)	56.0 (30-68)	58.0 (30-68)
≥65 years, n (%)	3 (30)	2 (10)	3 (15.8)	8 (16.3)
Male, n (%)	6 (60)	13 (65)	12 (63.2)	31 (63.3)
Ethnicity, n (%)
Caucasian	10 (100)	20 (100)	19 (100)	49 (100)
ECOG PS score, n (%)
≤1	9 (90)	20 (100)	18 (94.7)	47 (95.9)
2	1 (10)	0	1 (5.3)	2 (4.1)
≥60% BMPCs, n (%)	4 (40)	10 (50)	8 (42.1)	22 (44.9)
≥1 Soft-tissue plasmacytoma^a, n (%)	0	5 (25)	3 (15.8)^b	8 (16.3)^c
ISS stage, n (%)
I	8 (80)	10 (50)	10 (52.6)	28 (57.1)
II	1 (10)	7 (35)	7 (36.8)	15 (30.6)
III	1 (10)	3 (15)	2 (10.5)	6 (12.2)
High cytogenetic risk^d, n (%)	1 (10)	5 (25)	4 (21.1)	10 (20.4)
Abbreviations: BMPC, bone marrow plasma cell; DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; ECOG PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescence in situ hybridization; ISS, International Staging System; Q4W, once every 4 weeks; QW, weekly; Tec, TECVAYLI. Note: Data cutoff September 30, 2024. ^aAll were bone-related soft-tissue plasmacytomas; none were extramedullary soft-tissue plasmacytomas. ^bValue at median follow-up of 7.3 months (range, 3.1-14.5), is 4 (21.1%) in arm B.³ ^cValue at median follow-up of 7.3 months (range, 3.1-14.5), is 9 (18.4%) in total population.³ ^dCytogenetic risk was based on the results of central FISH or local FISH and of karyotype testing if central FISH was unavailable. A high cytogenetic risk was defined as the presence of ≥1 of the following abnormalities: del(17p), t(4;14), or t(14;16).

MajesTEC-5 Study: Treatment Disposition²

	Arm A Tec (QW)-DR (n=10)	Arm A1 Tec (Q4W)-DR (n=20)	Arm B Tec (Q4W)-DVR (n=19)	Total (N=49)
Patients starting induction, n	10	20	19	49
Ongoing induction, n (%)	0	14 (70)	10 (52.6)	24 (49)
Study treatment discontinuation during induction, n (%)	0	1 (5)	1 (5.3)	2 (4.1)^a
Induction competed, n	10	5^b	8^b	-
Abbreviations: DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; Q4W, once every 4 weeks; QW, weekly; Tec, TECVAYLI. Note: Data cutoff September 30, 2024. ^aBoth discontinuations were due to patient refusal to continue with further study treatment. ^bOne patient was discontinued due to refusal to undergo further treatment.

Efficacy

Response rates in the 3 induction cohorts are presented in Table: MajesTEC-5 Study: Response Rates.
A total of 2 patients (10%) had stable disease in both Arm A1 (Tec [Q4W]-DR) and Arm B (Tec [Q4W]-DVR).
All evaluable patients achieved MRD negativity (10^-5) by cycle 3 and maintained in evaluable patients through cycle 6. No patients were MRD positive.

MajesTEC-5 Study: Response Rates²

Response rate^a, %	Arm A Tec (QW)-DR (n=10)	Arm A1 Tec (Q4W)-DR (n=20)	Arm B Tec (Q4W)-DVR (n=19)
sCR	100.0	90.0	89.5
≥CR	100.0	70.0	52.6
≥VGPR	100.0	75.0	84.2
Abbreviations: CR, complete response; DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; IMWG, International Myeloma Working Group; Q4W, once every 4 weeks; QW, weekly; sCR, stringent complete response; Tec, TECVAYLI; VGPR, very good partial response. Note: Data cutoff September 30, 2024.^aResponse was assessed by investigators based on IMWG criteria. Confirmed response required ≥2 consecutive identical response assessments. Only response rates during induction are presented.

Safety

TEAEs reported in the 3 induction cohorts are presented in Table: MajesTEC-5 Study: Hematologic TEAEs and Table: MajesTEC-5 Study: Nonhematologic TEAEs.
No grade 5 hematologic or nonhematologic TEAEs were reported.
No ICANS was reported.

Cytokine Release Syndrome

CRS was reported in 65.3% of patients (n=32) overall. All events were grade 1/2. Most CRS events occurred in cycle 1.
All CRS events resolved with no treatment discontinuation due to CRS events.

Infections and Hypogammaglobulinemia

Details on infections are provided in Table: MajesTEC-5 Study: Infections (>10% in any arm). Grade 3/4 infections were reported in 34.7% of patients overall (n=17).
No treatment discontinuations were reported due to infection.
No grade 5 infections were reported.
Hypogammaglobulinemia (including patients with ≥1 TEAE of hypogammaglobulinemia or post-baseline immunoglobulin G [IgG] <400 mg/dL) was reported in 91.8% of patients (n=45).
- Of the total patients, 89.8% (n=44) received ≥1 dose of IVIG,including those who started IVIG prior to receiving TECVAYLI.
Infection prophylaxis, including Ig replacement, was strongly recommended. Prophylaxis for Pneumocystis jirovecii pneumonia, herpes zoster reactivation, and routine antibiotic prophylaxis were recommended.

MajesTEC-5 Study: Hematologic TEAEs²

Hematologic TEAE^a, n (%)	Arm A Tec (QW)-DR (n=10)		Arm A1 Tec (Q4W)-DR (n=20)		Arm B Tec (Q4W)-DVR (n=19)		Total (N=49)
Hematologic TEAE^a, n (%)	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4
Neutropenia	4 (40)	3 (30)	13 (65)	13 (65)	14 (73.7)	12 (63.2)	31 (63.3)	28 (57.1)
Lymphopenia	8 (80)	7 (70)	7 (35)	7 (35)	7 (36.8)	7 (36.8)	22 (44.9)	21 (42.9)
Thrombocytopenia	3 (30)	1 (10)	7 (35)	2 (10)	7 (36.8)	1 (5.3)	17 (34.7)	4 (8.2)
Anemia	5 (50)	0	6 (30)	4 (20)	5 (26.3)	0	16 (32.7)	4 (8.2)
Leukopenia	5 (50)	2 (20)	3 (15)	2 (10)	6 (31.6)	5 (26.3)	14 (28.6)	9 (18.4)
Abbreviations: DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, once every 4 weeks; QW, weekly; TEAE, treatment-emergent adverse event; Tec, TECVAYLI. Note: Data cutoff September 30, 2024. ^aAdverse events were graded according to NCI-CTCAE version 5.0.

MajesTEC-5 Study: Nonhematologic TEAEs²

Nonhematologic TEAE^a,b, n (%)	Arm A Tec (QW)-DR (n=10)		Arm A1 Tec (Q4W)-DR (n=20)		Arm B Tec (Q4W)-DVR (n=19)		Total (N=49)
Nonhematologic TEAE^a,b, n (%)	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4
CRS	6 (60)	0	14 (70)	0	12 (63.2)	0	32 (65.3)	0
Pyrexia	6 (60)	1 (10)	9 (45)	2 (10)	7 (36.8)	0	22 (44.9)	3 (6.1)
URTI	6 (60)	0	8 (40)	1 (5)	6 (31.6)	0	20 (40.8)	1 (2)
Rash	5 (50)	2 (20)	5 (25)	0	7 (36.8)	0	17 (34.7)	2 (4.1)
GGT increased	3 (30)	0	6 (30)	3 (15)	5 (26.3)	3 (15.8)	14 (28.6)	6 (12.2)
Diarrhea	6 (60)	0	4 (20)	1 (5)	4 (21.1)	0	14 (28.6)	1 (2)
Hypokalemia	1 (10)	0	8 (40)	2 (10)	4 (21.1)	0	13 (26.5)	2 (4.1)
Nausea	1 (10)	0	4 (20)	0	7 (36.8)	0	12 (24.5)	0
Peripheral sensory neuropathy	1 (10)	0	5 (25)	0	4 (21.1)	0	10 (20.4)	0
BAP increased	4 (40)	0	1 (5)	0	3 (15.8)	1 (5.3)	8 (16.3)	1 (2)
ALT increased	3 (30)	0	2 (10)	1 (5)	2 (10.5)	2 (10.5)	7 (14.3)	3 (6.1)
Nasopharyngitis	3 (30)	0	2 (10)	0	2 (10.5)	0	7 (14.3)	0
Lipase increased	1 (10)	1 (10)	5 (25)	3 (15)	1 (5.3)	1 (5.3)	7 (14.3)	5 (10.2)
Hyperglycemia	3 (30)	0	3 (15)	1 (5)	0	0	6 (12.2)	1 (2)
Constipation	0	0	1 (5)	0	5 (26)	0	6 (12.2)	0
Abbreviations: ALT, alanine aminotransferase; BAP, blood alkaline phosphatase; CRS, cytokine release syndrome; DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; GGT, gamma-glutamyl transferase; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, once every 4 weeks; QW, weekly; TEAE, treatment-emergent adverse event; Tec, TECVAYLI; URTI, upper respiratory tract infection. Note: Data cutoff September 30, 2024. ^aAdverse events were graded according to NCI-CTCAE version 5.0. ^bHypogammaglobulinemia based on TEAE reporting also met the ≥25% threshold and was reported separately.

MajesTEC-5 Study: Infections (>10% in any arm)²

Infection^a, n (%)	Arm A Tec (QW)-DR (n=10)		Arm A1 Tec (Q4W)-DR (n=20)		Arm B Tec (Q4W)-DVR (n=19)		Total (N=49)
Infection^a, n (%)	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4	Any Grade	Grade 3/4
Any infection	10 (100)	4 (40)	18 (90)	9 (45)	11 (57.9)	4 (21.1)	39 (79.6)	17 (34.7)
Infections
URTI	6 (60)	0	8 (40)	1 (5)	6 (31.6)	0	20 (40.8)	1 (2)
COVID-19	2 (20)	0	4 (20)	1 (5)	3 (15.8)	3 (15.8)	9 (18.4)	4 (8.2)
Nasopharyngitis	3 (30)	0	2 (10)	0	2 (10.5)	0	7 (14.3)	0
Bronchitis	2 (20)	0	0	0	0	0	2 (4.1)	0
Infection (NOS)	0	0	1 (5)	1 (5)	2 (10.5)	1 (5.3)	3 (6.1)	2 (4.1)
Pneumonia	1 (10)	1 (10)	1 (5)	0	2 (10.5)	2 (10.5)	4 (8.2)	3 (6.1)
Abbreviations: COVID-19, coronavirus disease 2019; DR, DARZALEX FASPRO and lenalidomide; DVR, DARZALEX FASPRO, bortezomib, and lenalidomide; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NOS, not otherwise specified; Q4W, once every 4 weeks; QW, weekly; Tec, TECVAYLI; URTI, upper respiratory tract infection. Note: Data cutoff September 30, 2024. ^aAdverse events were graded according to NCI-CTCAE version 5.0.

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 19 September 2025.

References

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1	University of Heidelberg Medical Center. A phase 2 study to evaluate the safety and efficacy of teclistamab- and talquetamab-based combination regimens in participants with newly diagnosed transplant-eligible multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 19]. Available from: https://clinicaltrials.gov/ct2/show/NCT05695508 NLM Identifier: NCT05695508.
2	Raab MS, Weinhold N, Kortüm KM, et al. Phase 2 study of teclistamab-based induction regimens in patients with transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): results from the GMMG-HD10/DSMM-XX (MajesTEC-5) trial. Oral Presentation presented at: The 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024; San Diego, CA.
3	Raab MS, Weinhold N, Kortüm KM, et al. Post-induction outcomes and updated minimal residual disease analysis from GMMG-HD10/DSMM-XX (MajesTEC-5): a study of teclistamab-based induction regimens in newly diagnosed multiple myeloma (NDMM). Oral Presentation presented at: the 22nd International Myeloma Society (IMS) Annual Meeting; September 17-20, 2025; Toronto, Canada.

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TECVAYLI® (teclistamab-cqyv)

Medical Information

TECVAYLI - MajesTEC-5 (MMY2003) Study - TECVAYLI-Based Regimens

Summary

PRODUCT LABELING

CLINICAL DATA - MAJESTEC-5 STUDY

Study Design/Methods

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

Safety

Infections and Hypogammaglobulinemia

Cytokine Release Syndrome and Neurotoxicity

Stem Cell Mobilization

Efficacy

Results

Treatment Disposition

Efficacy

Safety

Cytokine Release Syndrome

Infections and Hypogammaglobulinemia

Literature Search

References

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