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TECVAYLI® (teclistamab-cqyv)

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

Last Updated: 01/02/2025

Summary

Janssen does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by regulatory agencies.
MajesTEC-5 (GMMG-HD10; DSMM-XX; MMY2003) is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI- and TALVEY^®-based combination regimens in patients with transplant-eligible (TE), newly diagnosed multiple myeloma (NDMM).¹^,²
- Raab et al (2024)² presented the initial 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.

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; clinicaltrials.gov identifier NCT05695508) 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 NDMM.¹^,²

Study Design/Methods

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

MajesTEC-5 Study Design¹^,²

Abbreviations: ADA, antidrug antibody; ASCT, autologous stem cell transplant; Btz, bortezomib; 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; Len, lenalidomide; 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; SC, subcutaneous; SoC, standard of care; SUD, step-up dosing; Tec, teclistamab; 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 of 28 days. Dexamethasone was administered in cycles 1 and 2. Stem cell collection was planned after 3 cycles of induction.
^cDexamethasone 20 mg PO or IV was administered in cycle 1 and cycle 2 (days 1-2, 8-9, 15-16 and 22-23).
^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-Dara maintenance per the investigator’s choice (patients who started Tec-DR might have discontinued Len to receive Tec-Dara per the investigator’s choice).

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% BMPC, n (%)	4 (40)	10 (50)	8 (42.1)	22 (44.9)
≥1 Soft-tissue plasmacytoma^a, n (%)	0	5 (25)	3 (15.8)	8 (16.3)
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^b, 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. ^bCytogenetic 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 minimal residual disease (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

Treatment-emergent adverse events (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 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.

Cytokine Release Syndrome

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 intravenous immunoglobulin (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 18 December 2024.

References

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European Myeloma Network. 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 2024 December 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT05695508 NLM Identifier: NCT05695508.

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.