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Last Updated: 04/27/2026
| Characteristic | N=113a |
|---|---|
| Median age, years (range) | 66 (43-83) |
| <65 years, n (%) | 47 (41.6) |
| ≥65 to <75 years, n (%) | 49 (43.4) |
| ≥75 years, n (%) | 17 (15.0) |
| Male, n (%) | 57 (50.4) |
| Median weight, kg (range) | 71.9 (42.0-118.1) |
| Race, n (%) | |
| White | 83 (73.5) |
| Black | 3 (2.7) |
| Multiple | 1 (0.9) |
| Unknown/not reported | 26 (23.0) |
| ECOG PS ≥1, n/N (%) | 27/49 (55.1) |
| ISS stage, n/N (%) | |
| I | 32/94 (34.0) |
| II | 41/94 (43.6) |
| III | 21/94 (22.3) |
| High-risk cytogeneticsb | 32/62 (51.6) |
| t (4;14) | 12/62 (19.4) |
| t (14;16) | 1/62 (1.6) |
| del17p13 | 18/62 (29.0) |
| amp1q21 | 13/62 (21.0) |
| Extramedullary plasmacytoma, n (%) | 9/59 (15.3) |
| LDH >245 U/Lc | 28/86 (32.6) |
| Median time since diagnosis, years (range) | 7.4 (0.7-24.2) |
| Median prior lines of therapy, n (range) | 6 (2-12) |
| Triple-refractory, n (%) | 89 (78.8) |
| Penta-refractory, n (%) | 50 (44.2) |
| Refractory to last line of therapy, n (%) | 86 (76.1) |
| Prior autologous SCT, n (%) | 86 (76.1) |
| Prior allogeneic SCT, n (%) | 8 (7.1) |
| Prior BCMA therapy, n (%) | 40 (35.4) |
| Prior BCMA therapies, n | 45 |
| CAR-T | 10 |
| ADC | 32 |
| BsAbs | 3 |
| Patients ineligible for MajesTEC-1, n (%) | 80 (70.8) |
| Creatinine clearance/GFR, mL/min or mL/min/1.73 m2 | |
| <30 | 3/104 (2.9) |
| ≥30 to <40 | 11/104 (10.6) |
| ≥40 | 90/104 (86.5) |
| Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; ECOG PS, Eastern Cooperative Oncology Group performance status; GFR, glomerular filtration rate; ISS, International Staging System; LDH, lactate dehydrogenase; SCT, stem cell transplant; ULN, upper limit of normal. aData available added as denominators if some were missing and not available in the clinical chart for the whole cohort. bHigh-risk cytogenetics defined as having presence of t(4;14), t(14;16), del17p13, and amp1q21 by fluorescent in situ hybridization. cBaseline LDH stratification value of 245 U/L represents the institutional ULN. | |
| Responsea | N=113 |
|---|---|
| Overall responseb, % (95% CI) | 60.2 (50.5-69.3) |
| sCR | 5.3 (2.0-11.2) |
| CR | 21.2 (14.1-29.9) |
| VGPR | 25.7 (17.9-34.7) |
| PR | 8.0 (3.7-14.6) |
| ≥VGPRc, % (95% CI) | 52.2 (42.6-61.7) |
| ≥CRd | 26.5 (18.7-35.7) |
| Near CRe | 17.7 (11.2-26.0) |
| Minimal response, % (95% CI) | 0.9 (0.0-4.8) |
| Stable disease, % (95% CI) | 9.7 (5.0-16.8) |
| Progressive disease, % (95% CI) | 15.9 (9.7-24.0) |
| Not available/not reported, % (95% CI) | 13.3 (7.6-20.9) |
| Median time to first response, months (95% CI) | 1.6 (1.2-1.9) |
| Median time to best response, months (95% CI) | 3.8 (2.8-5.0) |
| Median TTNT, % (95% CI) | NR (24.4-NE) |
| 12-month TTNT, % (95% CI) | 74.3 (65.2-81.4) |
| Median DOR, months (95% CI) | 20.3 (14.8-NE) |
| Median PFS, months (95% CI) | 9.7 (5.6-18.8) |
| Estimated 12-month PFS, % (95% CI) | 47.4 (38.0-56.3) |
| Median PFS2f | NR (NE–NE) |
| Estimated 12-month PFS2, % (95% CI) | 80.5 (72-86.7) |
| Median OS, months (95% CI) | 26.3 (16.5-NE) |
| Estimated 12-month OS, % (95% CI) | 61.9 (52.3-70.2) |
| Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; NE, not estimated; OS; overall survival; PFS, progression-free survival; PFS2, progression‑free survival 2; PR, partial response; sCR, stringent complete response; VGPR, very good partial response; TTNT, time to next treatment. aResponses were as assessed by the investigator as per IMWG response criteria. bDefined as sCR+CR+VGPR+PR. cDefined as sCR+CR+VGPR. dDefined as sCR+CR. eDefined as a patient meeting all criteria for CR except for confirmatory bone marrow assessment. fDefined as the time interval from the date of first dose of TECVAYLI to the date of disease progression occurring after initiation of subsequent antimyeloma therapy, as assessed by the investigator based on available data, or death from any cause, whichever occurred first. | |
| Parameter | ≥VGPR | <VGPR |
|---|---|---|
| Median DOR, months (95% CI) | 26.1 (16.7-NE) | 3.8 (0.8-NE) |
| Median PFS, months (95% CI) | NR (17.3-NE) | 2.6 (1.6-3.3) |
| Estimated 12-month PFS, % (95% CI) | 71.2 (57.8-81.0) | - |
| Median OS, months (95% CI) | NR (26.3-NE) | 6.2 (3.6-16.5) |
| Estimated 12-month PFS, % (95% CI) | 83.1 (70.8-90.5) | - |
| Abbreviations: CI, confidence interval; DOR, duration of response; NE, not estimated; NR, not reached; OS, overall survival; PFS, progression-free survival; VGPR, very good partial response. | ||
| Response Rates | PCR (n=50) | HR (n=32) | ≥75 Years (n=17) | ISS III (n=21) | MajesTEC-1 Ineligible (n=80) |
|---|---|---|---|---|---|
| ORR, % (95% CI) | 58.0 (43.2-71.8) | 68.8 (50.0-83.9) | 64.7 (38.3-85.8) | 52.4 (29.8-74.3) | 57.5 (45.9-68.5) |
| CR/sCR, % | 22.0 | 28.1 | 29.4 | 23.8 | 25.0 |
| VGPR, % | 28.0 | 37.5 | 35.3 | 23.8 | 26.3 |
| PR, % | 8.0 | 3.1 | 0 | 4.8 | 6.3 |
| ≥VGPR, % (95% CI) | 50.0 (35.5-64.5) | 65.6 (46.8-81.4) | 64.7 (38.3-85.8) | 47.6 (25.7-70.2) | 51.3 (39.8-62.6) |
| Abbreviations: CR, complete response; HR, high-risk cytogenetics; ISS, International Staging System; ORR, overall response rate; PCR, penta-class refractory; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. | |||||
| Response Rates | BCMA-naïve (n=73) | Prior BCMA (n=40) | Prior ADC (n=32) | Prior CAR-T (n=10) |
|---|---|---|---|---|
| ORR, % (95% CI) | 63.0 (50.9-74.0) | 55.0 (38.5-70.7) | 53.1 (34.7-70.9) | 50.0 (18.7-81.3) |
| CR/sCR, % | 28.8 | 22.5 | 25.0 | 10.0 |
| VGPR, % | 24.7 | 27.5 | 21.9 | 40.0 |
| PR, % | 9.6 | 5.3 | 6.3 | 0 |
| ≥VGPR, % (95% CI) | 53.1 (41.4-65.2) | 50.0 (33.8-66.2) | 46.9 (29.1-65.3) | 50.0 (18.7-81.3) |
| Median DOR, months (95% CI) | 20.3 (12.4-NE) | 17.4 (6.6-NE) | - | - |
| Median PFS, months (95% CI) | 13.8 (7.5-NE) | 3.4 (2.6-18.8) | - | - |
| Median OS, months (95% CI) | NR (26.3-NE) | 15.2 (4.7-NE) | - | - |
| Estimated 12-month OS, % (95% CI) | 65.8 (53.7-75.4) | - | - | - |
| Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell therapy; CI, confidence interval; CR, complete response; NE, not estimated; NR, not reached; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. | ||||
| DOR | PFS | OS | ||||
|---|---|---|---|---|---|---|
| HR (95% CI) | P Value | HR (95% CI) | P Value | HR (95% CI) | P Value | |
| Age (<75 vs ≥75 years) | 1.03 (0.40-2.69) | 0.950 | 1.17 (0.58-2.36) | 0.663 | 1.05 (0.47-2.33) | 0.904 |
| MM diagnosis (≤6 vs >6 years ago) | 1.29 (0.63-2.64) | 0.485 | 1.07 (0.66-1.75) | 0.771 | 1.23 (0.71-2.13) | 0.454 |
| ISS stage (I vs II/III) | 0.84 (0.33-2.12) | 0.712 | 1.05 (0.60-1.86) | 0.858 | 0.88 (0.45-1.71) | 0.712 |
| EMD (with vs without) | 0.61 (0.14-2.69) | 0.511 | 0.48 (0.21-1.10) | 0.084 | 0.48 (0.19-1.19) | 0.112 |
| Prior lines of therapy (≤3 vs >3) | 0.80 (0.24-2.66) | 0.720 | 0.85 (0.42-1.72) | 0.651 | 0.94 (0.42-2.10) | 0.887 |
| Prior BCMA therapy (with vs without) | 0.80 (0.38-1.67) | 0.549 | 0.75 (0.46-1.23) | 0.250 | 0.55 (0.32-0.96) | 0.034 |
| Prior BCMA (ADC) (with vs without) | 0.51 (0.24-1.09) | 0.083 | 0.51 (0.31-0.85) | 0.009 | 0.42 (0.24-0.73) | 0.002 |
| Prior BCMA (CAR-T) (with vs without) | 0.98 (0.23-4.10) | 0.973 | 0.98 (0.39-2.44) | 0.966 | 0.61 (0.26-1.44) | 0.263 |
| Triple-class refractory (with vs without) | 1.12 (0.48-2.61) | 0.791 | 0.89 (0.49-1.60) | 0.686 | 0.62 (0.29-1.31) | 0.207 |
| Triple-class exposed (with vs without) | NE | NE | NE | NE | NE | NE |
| Penta-drug refractory (with vs without) | 1.27 (0.62-2.60) | 0.517 | 0.79 (0.49-1.28) | 0.347 | 0.89 (0.51-1.53) | 0.661 |
| Penta-drug exposed (with vs without) | 0.48 (0.11-2.03) | 0.320 | 0.93 (0.43-2.04) | 0.861 | 1.35 (0.61-3.01) | 0.457 |
| Cytogenetic risk (standard vs high) | 0.84 (0.35-1.99) | 0.687 | 1.37 (0.72-2.61) | 0.341 | 0.89 (0.40-2.02) | 0.789 |
| Risk-minus amp1q21 (standard vs high) | 0.53 (0.22-1.26) | 0.149 | 1.02 (0.53-1.94) | 0.963 | 0.59 (0.26-1.34) | 0.206 |
| ECOG PS (0 vs ≥1) | 0.44 (0.15-1.29) | 0.134 | 0.44 (0.19-1.01) | 0.053 | 0.74 (0.30-1.82) | 0.516 |
| Baseline thrombocytopenia (with vs without) | 0.56 (0.24-1.28) | 0.168 | 0.60 (0.35-1.03) | 0.062 | 0.61 (0.33-1.12) | 0.109 |
| LDH level (≤245 U/L vs >245 U/L) | 0.46 (0.21-1.01) | 0.054 | 0.59 (0.33-1.04) | 0.070 | 0.43 (0.22-0.84) | 0.013 |
| Response (≥VGPR vs <VGPR) | 0.42 (0.17-1.04) | 0.061 | 0.23 (0.14-0.39) | <0.001 | 0.21 (0.11-0.40) | <0.001 |
| MajesTEC-1 (eligible vs ineligible) | 0.46 (0.20-1.07) | 0.070 | 0.47 (0.26-0.85) | 0.013 | 0.47 (0.24-0.94) | 0.033 |
| Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell herapy; CI, confidence interval; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; HR, hazard ratio; ISS, International Staging System; LDH, lactate dehydrogenase; MM, multiple myeloma; NE, not estimated; OS, overall survival; PFS, progression-free survival; VGPR, very good partial response. | ||||||
| Parameter | Switch to Biweekly (n=45) | Switch to Monthly (n=26) |
|---|---|---|
| Patients who switched of total cohort, % | 39.8 | 23 |
| Median time to switch, months (range) | 7.0 (0-18) | 10.5 (1-22) |
| Overall response, % (95% CI) | 82.2 (67.9-92.0) | 88.5 (69.8-97.6) |
| ≥VGPR, % (95% CI) | 80.0 (65.4-90.4) | 84.6 (65.1-95.6) |
| ≥CR, % (95% CI) | 44.4 (29.6-60.0) | 42.3 (23.4-63.1) |
| Near CR, % (95% CI) | 31.1 (18.2-46.6) | 34.6 (17.2-55.7) |
| Median duration of treatment, months (range) | 18.9 (2.6-35.8) | 18.1 (1.4-35.8) |
| Median DOR, months (range) | NE (20.3-NE) | NE (20.3-NE) |
| Estimated 12month DOR, % (95% CI) | 85.7 (68.9-93.8) | 95.0 (69.5-99.3) |
| Median PFS, months (range) | NE (22.2-NE) | NE (22.2-NE) |
| Estimated 12month PFS, % (95% CI) | 86.7 (72.7-93.8) | 92.3 (72.6-98.0) |
| Median OS, months (range) | NE (26.3-NE) | NE (NE-NE) |
| Estimated 12month OS, % (95% CI) | 97.8 (85.3-99.7) | 96.2 (75.7-99.4) |
| Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; NE, not estimated; OS, overall survival; PFS, progression‑free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. | ||
| TEAE, n (%) | N=113 | |
|---|---|---|
| Any grade | Grade 3/4 | |
| Patients with any TEAE | 108 (95.6) | 83 (73.5) |
| Hematologic | ||
| Neutropenia | 40 (35.4) | 37 (32.7) |
| Anemia | 29 (25.7) | 19 (16.8) |
| Thrombocytopenia | 21 (18.6) | 17 (15.0) |
| Nonhematologic | ||
| CRS | 63 (55.8) | 2 (1.8) |
| Diarrhea | 17 (15.0) | 0 |
| Neurologic TEAEs of interest | ||
| Peripheral sensory neuropathy | 5 (4.4) | 0 |
| ICANS | 4 (3.5) | 0 |
| Motor dysfunction | 1 (0.9) | 0 |
| Encephalopathya | 3 (2.7) | 1 (0.9) |
| Infections | 80 (70.8) | 49 (43.4) |
| Pneumonia | 24 (21.2) | 16 (14.2) |
| SARSCoV2 virus (COVID19) | 17 (15.0) | 8 (7.1) |
| Infection (unknown) | 12 (10.6) | 2 (1.8) |
| Upper respiratory tract infection | 11 (9.7) | 0 |
| CMV reactivation | 3 (2.7) | 1 (0.9) |
| Abbreviations: COVID-19, coronavirus disease 19; CMV, cytomegalovirus; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; TEAE, treatment-emergent adverse event. aIncludes toxic encephalopathy and encephalopathy. | ||
| Event | Total | Bacteriala | Virala |
|---|---|---|---|
| Patients with any event, n (%) | 80 (70.8) | 36 (31.9) | 36 (31.9) |
| Patients with multiple events | 60 (53.1) | 18 (15.9) | 17 (15.0) |
| Patients with grade 3/4 events | 44 (38.9) | 25 (22.1) | 14 (12.4) |
| Patients with grade 5 events | 6 (5.3) | 2 (1.8) | 1 (0.9) |
| Number of infection events | 261 | 66a | 70a |
| Median time to onset of events, days (range) | 128.0 (1-1062) | 101.0 (2-1062) | 126.0 (1-859) |
| Median time to onset of grade 3/4 infection event, days (range) | 99.0 (2-820) | 63.5 (2-734) | 148.0 (4-820) |
| Median duration, days (range) | 15.0 (1-300) | 14.0 (1-181) | 15.5 (1-273) |
| Patients with AE leading to dose interruption, n (%) | 52 (46.0) | 19 (16.8) | 25 (22.1) |
| Patients with AE leading to discontinuation, n (%) | 10 (8.8) | 2 (1.8) | 4 (3.5) |
| Events recovering, recovered, or resolvedb, n/N (%) | 236/261 (90.4) | 62/66 (93.9) | 64/70 (91.4) |
| Abbreviation: AE, adverse event. aClassifications of some infections (n=120) were not recorded due to unavailability of medical records; 5 fungal infections were also reported. bIncludes recovered/resolved, recovered/resolved with sequelae, recovering/resolving. | |||
| Event | N=113 |
|---|---|
| Patients with any event, n (%) | 63 (55.8) |
| Grade 1-2, % | 98.2 |
| Grade 3 events, n | 2 |
| Multiple CRS events, n (%) | 16.8 (19) |
| Median duration of CRS, days (range) | 2.0 (1-23) |
| Management | |
| Antipyretics | 33 (29.2) |
| Tocilizumab | 17 (15.0) |
| Corticosteroids | 11 (9.7) |
| Intravenous fluids | 6 (5.3) |
| Vasopressor | 1 (0.9) |
| Other | 18 (15.9) |
| Abbreviation: CRS, cytokine release syndrome. | |
A literature search of MEDLINE®
| 1 | Uttervall K, Kortum MK, Perrot A, et al. REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials. [published online ahead of print March 05, 2026]. Haematologica. doi:10.3324/haematol.2025.289281. |