TECVAYLI®
(teclistamab-cqyv)
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TECVAYLI® (teclistamab-cqyv)
Medical Information
TECVAYLI – Prior and Subsequent Antimyeloma Therapy in the MajesTEC-3 Study
Last Updated: 03/02/2026
SUMMARY
- MajesTEC-3 is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO (daratumumab and hyaluronidase; Tec-Dara subcutaneous [SC]) vs investigator’s choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) after 1-3 prior lines of therapy (LOT).1
- Details pertaining to prior antimyeloma therapies and subsequent antimyeloma therapies from the MajesTEC-3 study are summarized below.2
- Details pertaining to prior antimyeloma therapies and subsequent antimyeloma therapies from the MajesTEC-3 study are summarized below.2
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.
CLINICAL DATA - majestec-3 STUDY
Study Design/Methods
- Key eligibility criteria: RRMM, 1-3 prior LOT, including a proteasome inhibitor and lenalidomide, patients with only 1 prior LOT must have been lenalidomide refractory per International Myeloma Working Group criteria, and Eastern Cooperative Oncology Group Performance status 0-2.1
- In the intention to treat (ITT) population, patients had received a median of 2 prior LOT, with 37.8% having received 1 prior LOT.2
- Details pertaining to prior antimyeloma therapy from the MajesTEC-3 study are summarized in Table: MajesTEC-3 Study - Summary of Prior Antimyeloma Therapies (ITT Population).
| Tec-Dara SC (n=291) | DPd/DVd (n=296) | Total (N=587) | |
|---|---|---|---|
| Number of prior LOT | |||
| 1, n (%) | 108 (37.1) | 114 (38.5) | 222 (37.8) |
| 2, n (%) | 134 (46.0) | 134 (45.3) | 268 (45.7) |
| 3, n (%) | 49 (16.8) | 48 (16.2) | 97 (16.5) |
| 2-3, n (%) | 183 (62.9) | 182 (61.5) | 365 (62.2) |
| Mean, (SD) | 1.8 (0.71) | 1.8 (0.71) | 1.8 (0.71) |
| Median, (range) | 2 (1-3) | 2 (1-3) | 2 (1-3) |
| Prior PI, n (%) | 290 (99.7) | 296 (100) | 586 (99.8) |
| Bortezomib | 281 (96.6) | 287 (97) | 568 (96.8) |
| Carfilzomib | 60 (20.6) | 81 (27.4) | 141 (24.0) |
| Ixazomib | 49 (16.8) | 36 (12.2) | 85 (14.5) |
| Prior immunomodulatory drug, n (%) | 291 (100.0) | 296 (100) | 587 (100.0) |
| Lenalidomide | 291 (100.0) | 296 (100) | 587 (100.0) |
| Pomalidomide | 11 (3.8) | 14 (4.7) | 25 (4.3) |
| Thalidomide | 108 (37.1) | 95 (32.1) | 203 (34.6) |
| Prior anti-CD38, n (%) | 15 (5.2) | 16 (5.4) | 31 (5.3) |
| Daratumumab | 15 (5.2) | 16 (5.4) | 31 (5.3) |
| Isatuximab | 0 | 1 (0.3) | 1 (0.2) |
| Prior PI + immunomodulatory drug, n (%) | 290 (99.7) | 296 (100) | 586 (99.8) |
| Prior PI + immunomodulatory drug + anti-CD38, n (%) | 15 (5.2) | 16 (5.4) | 31 (5.3) |
| Prior penta-exposed, n (%) | 1 (0.3) | 2 (0.7) | 3 (0.5) |
| Prior transplantation, n (%) | 210 (72.2) | 226 (76.4) | 436 (74.3) |
| Autologous | 210 (72.2) | 225 (76.0) | 435 (74.1) |
| 1 | 154 (52.9) | 170 (57.4) | 324 (55.2) |
| ≥2 | 56 (19.2) | 55 (18.6) | 111 (18.9) |
| Allogeneic | 2 (0.7) | 2 (0.7) | 4 (0.7) |
| Prior radiotherapy, n (%) | 54 (18.6) | 54 (18.2) | 108 (18.4) |
| Prior cancer-related surgery/procedure, n (%) | 27 (9.3) | 26 (8.8) | 53 (9.0) |
| Abbreviations: CD38, cluster of differentiation 38; Dara, DARZALEX FASPRO; DPd, daratumumab+pomalidomide+dexamethasone; DVd, daratumumab+bortezomib+dexamethasone; ITT, intention-to-treat; LOT, line of therapy; PI, proteasome inhibitor; SC, subcutaneous; SD, standard deviation; Tec, TECVAYLI. Note: Penta includes at least 2 proteasome inhibitors, at least 2 immunomodulatory drugs, and an anti-CD38 monoclonal antibody, if applicable.Note: Percentages calculated with the number of patients in each treatment group as denominator. | |||
- Details pertaining to subsequent antimyeloma therapies from the MajesTEC-3 study are summarized in Table: MajesTEC-3 Study – Summary of Subsequent Antimyeloma Therapies (ITT Population).
| Tec-Dara SC (n=291) | DPd/DVd (n=296) | Total (N=587) | |
|---|---|---|---|
| Patients with ≥1 subsequent antimyeloma therapies | 30 (10.3) | 165 (55.7) | 195 (33.2) |
| Antineoplastic agents | 28 (9.6) | 164 (55.4) | 192 (32.7) |
| Other antineoplastic agents | 20 (6.9) | 114 (38.5) | 134 (22.8) |
| Carfilzomib | 11 (3.8) | 81 (27.4) | 92 (15.7) |
| Bortezomib | 10 (3.4) | 24 (8.1) | 34 (5.8) |
| Cisplatin | 2 (0.7) | 15 (5.1) | 17 (2.9) |
| Selinexor | 1 (0.3) | 14 (4.7) | 15 (2.6) |
| Car T-Cells Nos | 0 | 11 (3.7) | 11 (1.9) |
| Mezigdomide | 0 | 8 (2.7) | 8 (1.4) |
| Venetoclax | 1 (0.3) | 7 (2.4) | 8 (1.4) |
| Idecabtagene Vicleucel | 0 | 7 (2.4) | 7 (1.2) |
| Ciltacabtagene Autoleucel | 0 | 6 (2.0) | 6 (1.0) |
| Panobinostat | 1 (0.3) | 1 (0.3) | 2 (0.3) |
| Carboplatin | 0 | 1 (0.3) | 1 (0.2) |
| Chidamide | 0 | 1 (0.3) | 1 (0.2) |
| Ixazomib | 0 | 1 (0.3) | 1 (0.2) |
| Ixazomib Citrate | 0 | 1 (0.3) | 1 (0.2) |
| Ktx 1001 | 0 | 1 (0.3) | 1 (0.2) |
| Nirogacestat | 0 | 1 (0.3) | 1 (0.2) |
| Other Antineoplastic Agents | 0 | 1 (0.3) | 1 (0.2) |
| Monoclonal antibodies and antibody drug conjugates | 18 (6.2) | 105 (35.5) | 123 (21.0) |
| Teclistamab | 2 (0.7) | 39 (13.2) | 41 (7.0) |
| Talquetamab | 3 (1.0) | 28 (9.5) | 31 (5.3) |
| Daratumumab | 8 (2.7) | 19 (6.4) | 27 (4.6) |
| Belantamab Mafodotin | 0 | 9 (3.0) | 9 (1.5) |
| Elotuzumab | 0 | 9 (3.0) | 9 (1.5) |
| Elranatamab | 0 | 9 (3.0) | 9 (1.5) |
| Isatuximab | 4 (1.4) | 4 (1.4) | 8 (1.4) |
| Linvoseltamab | 0 | 6 (2.0) | 6 (1.0) |
| Cevostamab | 1 (0.3) | 2 (0.7) | 3 (0.5) |
| Daratumumab hyaluronidase Fihj | 0 | 2 (0.7) | 2 (0.3) |
| Forimtamig | 0 | 2 (0.7) | 2 (0.3) |
| Alnuctamab | 0 | 1 (0.3) | 1 (0.2) |
| Cetrelimab | 0 | 1 (0.3) | 1 (0.2) |
| Daratumumab vorhyaluronidase Alfa | 1 (0.3) | 0 | 1 (0.2) |
| Durvalumab | 0 | 1 (0.3) | 1 (0.2) |
| Etentamig | 0 | 1 (0.3) | 1 (0.2) |
| Gemtuzumab Ozogamicin | 1 (0.3) | 0 | 1 (0.2) |
| JNJ 79635322 | 0 | 1 (0.3) | 1 (0.2) |
| Other Monoclonal Antibodies And Antibody Drug Conjugates | 0 | 1 (0.3) | 1 (0.2) |
| Pembrolizumab | 0 | 1 (0.3) | 1 (0.2) |
| Pembrolizumab;vibostolimab | 0 | 1 (0.3) | 1 (0.2) |
| Rituximab | 0 | 1 (0.3) | 1 (0.2) |
| Alkylating agents | 8 (2.7) | 59 (19.9) | 67 (11.4) |
| Cyclophosphamide | 8 (2.7) | 52 (17.6) | 60 (10.2) |
| Bendamustine | 0 | 5 (1.7) | 5 (0.9) |
| Melphalan | 0 | 5 (1.7) | 5 (0.9) |
| Carmustine | 0 | 1 (0.3) | 1 (0.2) |
| Cyclophosphamide Monohydrate | 0 | 1 (0.3) | 1 (0.2) |
| Melphalan Flufenamide Hydrochloride | 0 | 1 (0.3) | 1 (0.2) |
| Cytotoxic antibiotics and related substances | 5 (1.7) | 21 (7.1) | 26 (4.4) |
| Doxorubicin | 3 (1.0) | 14 (4.7) | 17 (2.9) |
| Daunorubicin | 2 (0.7) | 0 | 2 (0.3) |
| Liposomal Doxorubicin Hydrochloride | 0 | 2 (0.7) | 2 (0.3) |
| Doxorubicin Hydrochloride | 0 | 1 (0.3) | 1 (0.2) |
| Liposomal Doxorubicin | 0 | 1 (0.3) | 1 (0.2) |
| Mitoxantrone | 0 | 1 (0.3) | 1 (0.2) |
| Pegylated Liposomal Doxorubicin Hydrochloride | 0 | 1 (0.3) | 1 (0.2) |
| Pirarubicin | 0 | 1 (0.3) | 1 (0.2) |
| Plant alkaloids and other natural products | 3 (1.0) | 23 (7.8) | 26 (4.4) |
| Etoposide | 2 (0.7) | 18 (6.1) | 20 (3.4) |
| Vincristine | 1 (0.3) | 3 (1.0) | 4 (0.7) |
| Paclitaxel | 0 | 1 (0.3) | 1 (0.2) |
| Vincristine Sulfate | 0 | 1 (0.3) | 1 (0.2) |
| Antimetabolites | 3 (1.0) | 14 (4.7) | 17 (2.9) |
| Fludarabine | 0 | 9 (3.0) | 9 (1.5) |
| Azacitidine | 1 (0.3) | 2 (0.7) | 3 (0.5) |
| Cytarabine | 2 (0.7) | 0 | 2 (0.3) |
| Capecitabine | 0 | 1 (0.3) | 1 (0.2) |
| Fludarabine Phosphate | 0 | 1 (0.3) | 1 (0.2) |
| Gemcitabine Hydrochloride | 0 | 1 (0.3) | 1 (0.2) |
| Methotrexate | 0 | 1 (0.3) | 1 (0.2) |
| Antineoplastic agents | 0 | 3 (1.0) | 3 (0.5) |
| Investigational Antineoplastic Drugs | 0 | 3 (1.0) | 3 (0.5) |
| Protein kinase inhibitors | 0 | 3 (1.0) | 3 (0.5) |
| Ibrutinib | 0 | 1 (0.3) | 1 (0.2) |
| Orelabrutinib | 0 | 1 (0.3) | 1 (0.2) |
| Trametinib | 0 | 1 (0.3) | 1 (0.2) |
| Corticosteroids for systemic use | 17 (5.8) | 106 (35.8) | 123 (21.0) |
| Dexamethasone | 15 (5.2) | 105 (35.5) | 120 (20.4) |
| Prednisone | 1 (0.3) | 3 (1.0) | 4 (0.7) |
| Prednisolone | 0 | 3 (1.0) | 3 (0.5) |
| Dexamethasone Sodium Phosphate | 0 | 1 (0.3) | 1 (0.2) |
| Meprednisone | 1 (0.3) | 0 | 1 (0.2) |
| Methylprednisolone | 0 | 1 (0.3) | 1 (0.2) |
| Immunosuppressants | 14 (4.8) | 35 (11.8) | 49 (8.3) |
| Pomalidomide | 12 (4.1) | 27 (9.1) | 39 (6.6) |
| Lenalidomide | 2 (0.7) | 6 (2.0) | 8 (1.4) |
| Thalidomide | 3 (1.0) | 3 (1.0) | 6 (1.0) |
| Investigational drug | 0 | 5 (1.7%) | 5 (0.9%) |
| JNJ 79635322 | 0 | 3 (1.0%) | 3 (0.5%) |
| Investigational Drug | 0 | 2 (0.7%) | 2 (0.3%) |
| All other therapeutic products | 0 | 1 (0.3%) | 1 (0.2%) |
| Autologous Stem Cells Nos | 0 | 1 (0.3%) | 1 (0.2%) |
| Abbreviations: Dara, DARZALEX FASPRO; DPd, daratumumab+pomalidomide+dexamethasone; DVd, daratumumab+bortezomib+dexamethasone; ITT, intention-to-treat; Nos, not otherwise specified; PI, proteasome inhibitor; SC, subcutaneous; Tec, TECVAYLI.Note: Percentages calculated with the number of patients in each treatment group as denominator. | |||
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | Costa LJ, Bahlis NJ, Perrot A, et al. Teclistamab plus daratumumab in relapsed or refractory multiple myeloma. [published online ahead of print December 09, 2025]. N Engl J Med. doi:10.1056/nejmoa2514663. |
| 2 |