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MajesTEC-5 Latest data: Teclistamab-DR ± bortezomib for TE-NDMM
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The first-in-class BCMA–directed bispecific antibody teclistamab is approved for the treatment of patients with triple-class exposed RRMM and is now under investigation in earlier lines of therapy. Daratumumab-based triplet and quadruplet therapies (DRd and DVRd) have demonstrated improved survival in transplant-eligible (TE) NDMM. MajesTEC-5 (NCT05695508) is a phase II study evaluating teclistamab in combination with DR, with or without bortezomib, for TE-NDMM. During ASH 2024, Marc Raab presented initial outcome data from three induction cohorts in the MajesTEC-5 trial (Arm A: Tec-DR QW (n = 10); Arm A1: Tec-DR Q4W (n = 20); Arm B: Tec-DVR Q4W (n = 19).1 |
| Key learnings |
| The ORRs were 100%, 90%, and 89.5% in Arms A, A1, and B, respectively. An sCR rate of 100% was observed in Arm A, with deepening responses in maturing cohorts. 100% of evaluable patients achieved MRD negativity by Cycle 3. |
| Neutropenia was the most common hematologic TEAE. Notably, the addition of bortezomib in Arm B did not lead to a higher incidence of thrombocytopenia. Among the most common nonhematologic TEAEs, rates of Grade 3/4 events were low. |
| 34.7% of patients experienced Grade 3/4 infections, primarily URTI and COVID-19, with no discontinuations or Grade 5 infections. Hypogammaglobulinemia occurred in 91.8% of patients, with 89.8% receiving IVIG as infection prophylaxis. |
| Overall, induction with Tec-DR and Tec-DVR for TE-NDMM showed high efficacy with 100% MRD-negativity after Cycle 3 maintained to Cycle 6, no TEAE-related discontinuations, and feasible stem cell mobilization. |
Abbreviations: BCMA, B-cell maturation agent; D, daratumumab; DRd, daratumumab, lenalidomide, and dexamethasone; DVRd, daratumumab, bortezomib, lenalidomide, and dexamethasone; IVIG, intravenous immunoglobulin; MRD, measurable residual disease; n, number; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; QW, once per week; Q4W, once every 4 weeks; R, lenalidomide; RRMM, relapsed/refractory multiple myeloma; sCR, stringent complete response; TE, transplant-eligible; TEAE, treatment-emergent adverse event; Tec, teclistamab; URTI, upper respiratory tract infection; V, bortezomib.
- Raab M. 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 Abstract #493. Presented at: 66th American Society of Hematology Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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