(teclistamab-cqyv)
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Last Updated: 06/25/2025
EMD was defined as ≥1 soft tissue plasmacytoma measuring ≥2 in its largest dimension, as confirmed by central Positron Emission Tomography (PET)-Computed Tomography (CT) scan review.5
Abbreviations: DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; LOT, line of therapy; mAb, monoclonal antibody; MM, multiple myeloma; ORR, overall response rate; PD, pharmacodynamics; PFS, progression-free survival; PI, proteosome inhibitor; PK, pharmacokinetic; PR, partial response; Q2W, every other week; Q4W, once every 4 weeks; QW, weekly, RP2R, recommended phase 2 regimen; SUD, step-up dose; Tal, talquetamab; Tec, teclistamab.
a
b
c
d
Abbreviations: BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor; T-cell; CR, complete response; CT, Computed Tomography; DOR, duration of response; EMD, extramedullary disease; GPCRD5, G protein-coupled receptor class C group 5 member; IMWG, International Myeloma Working Group; mAb, monoclonal antibody; MM, multiple myeloma; ORR, overall response rate; OS, overall survival; PET, Positron Emission Tomography; PFS, progression-free survival; PI, proteosome inhibitor; PK, pharmacokinetic; Q2W, every other week; Q4W, once every 4 weeks; RRMM, relapsed/refractory multiple myeloma; SC, subcutaneous; sCR, stringent complete response; SUD, step-up dose; Tal, talquetamab; Tec, teclistamab; VGPR, very good partial response.
bWhole body MRI permitted with sponsor approval.
cPrior PI, immunomodulatory drug, and anti-CD38 mAb.
dTal and Tec administered on the same day, 30 (±10) minutes apart, for all step-up and full treatment doses.
e
f
Characteristic | TALVEY + TECVAYLI (N=90) |
---|---|
Median age, years (range) | 64.5 (42-84) |
Male, n (%) | 57 (63.3) |
Race, n (%) | |
White | 64 (71.1) |
Black/African American | 8 (8.9) |
Asian | 13 (14.4) |
Not reported | 5 (5.6) |
True extramedullary plasmacytomas ≥1a, n (%) | 90 (100)b |
Number of extramedullary plasmacytomasa, median (range) | 2 (1-7) |
Number of extramedullary plasmacytomasa, median (range) | |
1 | 38 (42.2) |
2-3 | 29 (32.2) |
≥4 | 23 (25.6) |
High-risk cytogeneticsc, n (%) | 14 (21.5) |
Measurable diseased, n (%) | |
Nonsecretory | 4 (4.4) |
Oligosecretory | 31 (34.4) |
ECOG PS, n (%) | |
0 | 32 (35.6) |
1 | 50 (55.6) |
2 | 8 (8.9) |
Median years since diagnosise, years (range) | 4.7 (0.7-21.4) |
Median prior lines of therapy, n (range) | 4.0 (1-10) |
Exposure status, n (%) | |
Belantamab mafodotin | 11 (12.2) |
Anti-BCMA CAR-T therapy | 18 (20.0) |
BsAb therapyf | 8 (8.9) |
Triple-class | 90 (100) |
Penta-drug | 51 (56.7) |
Refractory status, n (%) | |
PI | 86 (95.6) |
Immunomodulatory drug | 84 (93.3) |
Anti-CD38 mAb | 85 (94.4) |
Triple-class | 76 (84.4) |
Penta-drug | 32 (35.6) |
To last line of therapy | 75 (83.3) |
Abbreviations: BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; FcRH5, Fc receptor-homolog 5; FISH, fluorescence in situ hybridization; IMWG, International Myeloma Working Group; mAb, monoclonal antibody; PET, positron emission tomography; PI, proteasome inhibitor. Clinical data cutoff date of March 18, 2025. aEMD defined as ≥1 nonradiated bone-independent soft tissue plasmacytoma ≥2 cm in greatest dimension, confirmed by PET-CT scans. A total of 6 patients had data on the number of EMD lesions based on investigator assessment only. bParaskeletal lesions were also present in 19 patients. cAssessed using FISH or karyotype testing in 65 patients. Defined as del(17p), t(4;14), or t(14;16) abnormality. dPer IMWG criteria. eEvaluated in 89 patients. fAll patients received anti-FcRH5 BsAbs. |
Response Rate | TALVEY + TECVAYLI (N=90) |
---|---|
Median follow-up, months (range) | 12.6 (0.5-19.5) |
ORRa, % (95% CI) | 78.9 (69-86.8) |
sCR, % | 43.3 |
CR, % | 11.1 |
VGPR, % | 15.6 |
PR, % | 8.9 |
≥CR, % | 54.4 |
≥VGPR, % | 70 |
Median time to first response, months (range) | 2.6 (1.0-5.8) |
Median time to best response, months (range) | 4.7 (1.0-11.9) |
Median PFS, months (95% CI) | 15.4 (10.8-NE) |
12-month PFS rate, % (95% CI) | 61 (49.6-70.6) |
Median DOR, months (95% CI) | 13.8 (11.5-NE) |
12-month DOR rate, % (95% CI) | 64.1 (48.3-76.3) |
Median OS, months (95% CI) | NR (NE-NE) |
12-month OS rate, % (95% CI) | 74.5 (63.4-82.7) |
Abbreviations: BsAb, bispecific antibody; CI, confidence interval; CR, complete response; DOR, duration of response; EMD, extramedullary disease; IMWG, International Myeloma Working Group; NE, not estimable; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. Clinical data cutoff date of March 18, 2025. aAssessed by independent review committee per IMWG criteria. Due to rounding, individual response rates may not sum to the ORR. |
Prior therapy, % (n/N) | ORR | 95% CI |
---|---|---|
Anti-BCMA CAR-T | 83.3 (15/18) | 58.6-96.4 |
Anti-FcRH5 bispecific antibody | 75.0 (6/8) | 34.9-96.8 |
Belantamab mafodotin | 90.9 (10/11) | 58.7-99.8 |
Abbreviations: BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell therapy; CI, confidence interval; EMD, extramedullary disease; FcRH5, Fc receptor homolog 5; ORR, overall response rate. Clinical data cutoff date of March 18, 2025. |
AEa, n (%) | TALVEY + TECVAYLI (N=90) | |
---|---|---|
Any Grade | Grade 3/4 | |
Hematologic | ||
Neutropenia | 65 (72.2) | 56 (62.2) |
Anemia | 46 (51.1) | 28 (31.1) |
Thrombocytopenia | 34 (37.8) | 23 (25.6) |
Nonhematologic | ||
Taste changesb | 71 (78.9) | NA |
CRS | 70 (77.8) | 0 (0) |
Nonrash skin AEsc | 62 (68.9) | 0 (0) |
Nail-related AEsd | 50 (55.6) | 0 (0) |
Weight decrease | 48 (53.3) | 10 (11.1) |
Dry mouth | 40 (44.4) | 0 (0) |
Cough | 33 (36.7) | 0 (0) |
Diarrhea | 30 (33.3) | 3 (3.3) |
Pyrexiae | 28 (31.1) | 1 (1.1) |
Hypokalemia | 27 (30.0) | 7 (7.8) |
Fatigue | 27 (30.0) | 3 (3.3) |
Nauseae | 27 (30.0) | 0 (0) |
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; EMD, extramedullary disease. Clinical data cutoff date of March 18, 2025. Median follow-up of 12.6 months. aAEs graded by CTCAE v5.0; CRS graded per ASTCT criteria. bIncludes dysgeusia, ageusia, hypogeusia, and taste disorder; maximum grade for taste changes is 2 per CTCAE. cIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. dIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. eExcludes symptoms of CRS or ICANS. |
AE | TALVEY + TECVAYLI (N=90) |
---|---|
Patients with CRSa, n (%) | 70 (77.8) |
Grade 1 | 53 (58.9) |
Grade 2 | 17 (18.9) |
Grade 3 | 0 (0) |
Occurrence of CRSb, n (%) | |
SUD 1 | 40 (44.4) |
SUD 2 | 51 (56.7) |
SUD 3 | 24 (26.7) |
Cycle 1 | 5 (5.6) |
Cycle 2 onwards | 1 (1.1) |
Median days to onsetc, days (range) | 2 (1-29) |
Median duration, days (range) | 2 (1-8) |
Supportive measuresd, % | |
Tocilizumab | 56.7 |
Acetaminophen | 56.7 |
Corticosteroids | 18.9 |
IV fluids | 17.8 |
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; EMD, extramedullary disease; IV, intravenous; SUD, step-up dose. Clinical data cutoff date of March 18, 2025. Median follow-up of 12.6 months. aCRS was graded per ASTCT criteria. bPatients could experience ≥1 CRS event. cRelative to the most recent dose. dPatients could receive ≥1 supportive therapy. |
AE | TALVEY + TECVAYLI (N=90) |
---|---|
Patients with ICANSa, n (%) | 11 (12.2) |
Grade 1 | 5 (5.6) |
Grade 2 | 4 (4.4) |
Grade 3 | 1 (1.1) |
Grade 4 | 1 (1.1) |
Occurrence of ICANSb, n (%) | |
SUD 1 | 2 (2.2) |
SUD 2 | 4 (4.4) |
SUD 3 | 7 (7.8) |
Cycle 1 | 2 (2.2) |
Cycle 2 onwards | 0 |
Median days to onsetc, days (range) | 3 (1-7) |
Median duration, days (range) | 2 (1-7) |
Supportive measured, % | |
Corticosteroids | 10.0 |
Levetiracetam | 4.4 |
Anakinra | 2.2 |
Tocilizumab | 1.1 |
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; EMD, extramedullary disease; ICANS, immune effector cell-associated neurotoxicity syndrome; SUD, step-up dose. Clinical data cutoff date of March 18, 2025. Median follow-up of 12.6 months. aICANS was graded per ASTCT criteria. bPatients could experience ≥1 CRS event. cRelative to the most recent dose. dPatients could receive ≥1 supportive therapy. |
AEa, n (%) | TALVEY + TECVAYLI (N=90) | |
---|---|---|
Any Grade | Grade 3/4b | |
Infections | 71 (78.9) | 28 (31.1) |
Upper respiratory tract infection | 22 (24.4) | 3 (3.3) |
COVID-19 | 20 (22.2) | 5 (5.6) |
Pneumonia | 16 (17.8) | 4 (4.4) |
Urinary tract infection | 12 (13.3) | 3 (3.3) |
Viral upper respiratory tract infection | 9 (10.0) | 2 (2.2) |
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; CTCAE, Common Terminology Criteria for Adverse Events; EMD, extramedullary disease. Clinical data cutoff date of March 18, 2025. Median follow-up of 12.6 months. aAEs were graded by CTCAE v5.0. bMaximum toxicity. |
Characteristic | All Dose Levelsa (N=94) | RP2Ra (n=44) |
---|---|---|
Age, years, median (range) | 64.5 (39-81) | 63.0 (41-80) |
Male, n (%) | 49 (52) | 23 (52) |
Raceb, n (%) | ||
White | 75 (80) | 32 (73) |
Black | 1 (1) | 0 (0) |
Asian | 17 (18) | 12 (27) |
Unknown | 1 (1) | 0 (0) |
Bone marrow plasma cells ≥60%c, n/N (%) | 19/89 (21) | 9/40 (22) |
Extramedullary plasmacytoma ≥1d, n (%) | 34 (36) | 18 (41) |
High-risk cytogeneticse, n/N (%) | 21/51 (41) | 8/19 (42) |
ISS stagef, n/N (%) | ||
I | 38/85 (45) | 19/41 (46) |
II | 26/85 (31) | 14/41(34) |
III | 21/85 (25) | 8/41(20) |
ECOG PS scoreg | ||
0 | 34 (36) | 15 (34) |
1 | 60 (64) | 29 (66) |
Time since diagnosis, years, median (range) | 6.1 (0.3-14.6) | 5.5 (0.3-12.9) |
Prior lines of therapy, n, median (range) | 4 (1-11) | 4 (2-10) |
Stem cell transplant, n (%) | 74 (79) | 33 (75) |
Exposure status, n (%) | ||
Triple class | 94 (100) | 44 (100) |
Penta drug | 61 (65) | 28 (64) |
Belantamab mafodotin | 18 (19) | 5 (11) |
Bispecific antibodiesh | 7 (7) | 2 (5) |
CAR-T therapy | 4 (4) | 2 (5) |
Refractory status, n (%) | ||
PI | 85 (90) | 41 (93) |
Carfilzomib | 62 (66) | 27 (61) |
Bortezomib | 58 (62) | 30 (68) |
Ixazomib | 10 (11) | 6 (14) |
Immunomodulatory drug | 91 (97) | 41 (93) |
Lenalidomide | 83 (88) | 36 (82) |
Pomalidomide | 62 (66) | 28 (64) |
Thalidomide | 18 (19) | 8 (18) |
Anti-CD38 mAb | 93 (99) | 43 (98) |
Daratumumab | 91 (97) | 42 (95) |
Isatuximab | 5 (5) | 4 (9) |
Last line of therapy | 87 (93) | 39 (89) |
Triple-class refractory diseasei | 81 (86) | 37 (84) |
Penta-refractory diseasej | 31 (33) | 13 (30) |
Abbreviations: BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; ECOG PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescence in situ hybridization; ISS, International Staging System; mAb, monoclonal antibody; PI, proteasome inhibitor; RP2R, recommended phase 2 regimen. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months and 18.2 months for the all dose levels and RP2R cohorts, respectively. aPercentages may not sum to 100% due to rounding. bRace was self-reported by the patient, and the data were entered by the investigators or research staff. cThe percentage of bone marrow plasma cells was assessed with the use of bone marrow biopsies or aspirates in patients with available data. dDefined as ≥1 bone-independent lesion (≥2 cm in the greatest dimension) that had not been previously exposed to radiation therapy. eAssessed using FISH or karyotype testing. Defined as del(17p), t(4;14), or t(14;16) abnormality. fThe ISS class was assessed per combination of serum β2-microglobulin and albumin. gECOG PS score assessments were conducted on a scale ranging from 0 to 5, where higher scores reflected greater disability. hPatients had received previous therapy withreceived a BCMA-directed BsAb (alnuctamab, n=4; WVT078, n=2; TECVAYLI, n=1); 2 out of 4 patients across all dose levels who had received alnuctamab were in the RP2R cohort. iRefractory to an immunomodulatory drug, a PI, and an anti-CD38 therapy. jRefractory to ≥2 immunomodulatory drugs, ≥2 PIs, and ≥1 anti-CD38 therapies. |
Response Rate | All Dose Levels (N=94) | RP2R (n=44) | |
---|---|---|---|
ORR, n/N (%) | 73/94 (78) | 35/44 (80) | |
sCR, % | 27 | 30 | |
CR, % | 21 | 23 | |
VGPR, % | 27 | 25 | |
PR, % | 3 | 2 | |
≥CR, n (%) | 45 (48) | 23 (52) | |
≥VGPR, n (%) | 70 (74) | 34 (77) | |
DOR, % (95% CI) | |||
12-month DOR | 86 (75-92) | 91 (75-97) | |
18-month DOR | 77 (64-85) | 86 (66-95) | |
Median time to first response, months (range) | 1.8 (0.3-7.7) | 1.4 (0.3-5.1) | |
Estimated PFS, % (95% CI) | |||
12-month PFS | 71 (60-79) | 74 (57-84) | |
18-month PFS | 62 (51-72) | 70 (52-82) | |
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; ORR, overall response rate; PFS, progression-free survival; PR, partial response; RP2R, recommended phase 2 regimen; sCR, stringent complete response; VGPR, very good partial response. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) and 18.2 months (range, 0.7-27.0) for the all dose levels and RP2R cohorts, respectively. |
Parameter | All Dose levels | RP2R | ||
---|---|---|---|---|
n/N (%) | 95% CI | n/N (%) | 95% CI | |
All patients | 73/94 (77.7) | 67.9-85.6 | 35/44 (79.5) | 64.7-90.2 |
Sex | ||||
Male | 38/49 (77.6) | 63.4-88.2 | 16/23 (69.6) | 47.1-86.8 |
Female | 35/45 (77.8) | 62.9-88.8 | 19/21 (90.5) | 69.6-98.8 |
Age | ||||
<65 years | 37/47 (78.7) | 64.3-89.3 | 22/25 (88) | 68.8-97.5 |
≥65 to <75 years | 27/34 (79.4) | 62.1-91.3 | 8/12 (66.7) | 34.9-90.1 |
≥75 years | 9/13 (69.2) | 38.6-90.9 | 5/7 (71.4) | 29.0-96.3 |
Race | ||||
White | 61/75 (81.3) | 70.7-89.4 | 27/32 (84.4) | 67.2-94.7 |
African American/Black | 0/1 (0) | NE-NE | 0/0 | NE-NE |
Asian | 11/17 (64.7) | 38.3-85.8 | 8/12 (66.7) | 34.9-90.1 |
Other | 1/1 (100.0) | 2.5-100.0 | 0/0 | NE-NE |
Baseline ECOG PS score | ||||
0 | 31/34 (91.2) | 76.3-98.1 | 14/15 (93.3) | 68.1-99.8 |
≥1 | 42/60 (70.0) | 56.8-81.2 | 21/29 (72.4) | 52.8-87.3 |
Number of lines of prior therapy | ||||
<3 | 11/11 (100.0) | 71.5-100.0 | 6/6 (100.0) | 54.1-100.0 |
≥3 | 62/83 (74.7) | 64.0-83.6 | 29/38 (76.3) | 59.8-88.6 |
Refractory | ||||
PI + immunomodulatory drug | 64/82 (78.0) | 67.5-86.4 | 29/38 (76.3) | 59.8-88.6 |
Triple | 63/81 (77.8) | 67.2-86.3 | 28/37 (75.7) | 58.8-88.2 |
Penta | 22/31 (71.0) | 52.0-85.8 | 8/13 (61.5) | 31.6-86.1 |
Last line of prior therapy | 66/87 (75.9) | 65.5-84.4 | 30/39 (76.9) | 60.7-88.9 |
Type of myeloma | ||||
IgG | 33/41 (80.5) | 65.1-91.2 | 17/20 (85.0) | 62.1-96.8 |
Non-IgG | 40/53 (75.5) | 61.7-86.2 | 18/24 (75.0) | 53.3-90.2 |
Baseline ISS | ||||
I | 30/38 (78.9) | 62.7-90.4 | 14/19 (73.7) | 48.8-90.9 |
II | 20/26 (76.9) | 56.4-91.0 | 11/14 (78.6) | 49.2-95.3 |
III | 16/21 (76.2) | 52.8-91.8 | 7/8 (87.5) | 47.3-99.7 |
Missing | 7/9 (77.8) | 40.0-97.2 | 3/3 (100.0) | 29.2-100.0 |
Cytogenetic risk | ||||
High Risk | 16/21 (76.2) | 52.8-91.8 | 6/8 (75.0) | 34.9-96.8 |
Standard Risk | 25/30 (83.3) | 65.3-94.4 | 11/11 (100.0) | 71.5-100.0 |
Missing | 32/43 (74.4) | 58.8-86.5 | 18/25 (72.0) | 50.6-87.9 |
Bone marrow % plasma cells | ||||
≤30 | 51/71 (71.8) | 59.9-81.9 | 25/34 (73.5) | 55.6-87.1 |
>30 to <60 | 4/4 (100.0) | 39.8-100.0 | 1/1 (100.0) | 2.5-100.0 |
≥60 | 18/19 (94.7) | 74.0-99.9 | 9/9 (100.0) | 66.4-100.0 |
Prior CAR-T | ||||
Yes | 4/4 (100.0) | 39.8-100.0 | 2/2 (100.0) | 15.8-100.0 |
No | 69/90 (76.7) | 66.6-84.9 | 33/42 (78.6) | 63.2-89.7 |
Prior BsAb | ||||
Yes | 3/7 (42.9) | 9.9-81.6 | 1/2 (50.0) | 1.3-98.7 |
No | 70/87 (80.5) | 70.6-88.2 | 34/42 (81.0) | 65.9-91.4 |
Prior belantamab mafodotin | ||||
Yes | 12/18 (66.7) | 41.0-86.7 | 4/5 (80.0) | 28.4-99.5 |
No | 61/76 (80.3) | 69.5-88.5 | 31/39 (79.5) | 63.5-90.7 |
Baseline extramedullary plasmacytomasa | ||||
0 | 53/60 (88.3) | 77.4-95.2 | 24/26 (92.3) | 74.9-99.1 |
≥1 | 20/34 (58.8) | 40.7-75.4 | 11/18 (61.1) | 35.7-82.7 |
Abbreviations: BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; IgG, immunoglobulin G; ISS, International Staging System; NE, not estimable; PI, proteasome inhibitor; RP2R, recommended phase 2 regimen. Clinical data cutoff date of March 15, 2024. aEMD was assessed by physical examination every 4 weeks and radiologic assessment every 12 weeks. |
All Dose Levels (N=34) | Dose Level 1-4 (n=16) | RP2R (n=18) | |
---|---|---|---|
ORRb, n/N (% [95% CI]) | 20/34 (58.8 [40.7-75.4]) | 9/16 (56.3) | 11/18 (61.1 [35.7-82.7]) |
sCR, % | - | 6.3 | 11.1 |
CR, % | - | 12.5 | 22.2 |
VGPR, % | - | 25.0 | 27.8 |
PR, % | - | 12.5 | 0 |
≥CR, % | - | 18.8 | 33.3 |
Median DOR, months (95% CI) | - | 12.9 (1.2-NE) | NE (5.95-NE) |
12-month DOR, % (95% CI) | 70 (45-85) | 55.6 (-) | 82 (45-95) |
18-month DOR, % (95% CI) | 52 (25-74) | - | 82 (45-95) |
Median time to first response, months (range) | - | 2.6 (2.1-3.8) | 3.0 (1.4-5.1) |
Median time to best response, months (range) | - | 3.9 (2.1-10.7) | 6.3 (3.0-10.7) |
Median PFS, months, (95% CI) | - | 6.1 (2.5-15.3) | NE (2.4-NE) |
12-month PFS, % (95% CI) | - | 36.1 (-) | 53 (28-73) |
18-month PFS, % (95% CI) | - | - | 53 (28-73) |
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; EMD, extramedullary disease; IMWG, International Myeloma Working Group; NE, not estimable; ORR, overall response rate; PFS, progression-free survival; PR, partial response; RP2R, recommended phase 2 regimen; sCR, stringent complete response; VGPR, very good partial response. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) for all dose levels, 18.7 months (range, 0.5-33.8 [0.5 denotes patients who died]) for dose levels 1-4, and 13.6 months (range, 0.7-25.9) for the RP2R cohorts. aEMD defined as ≥1 nonradiated, bone-independent lesion ≥2 cm. bResponses were assessed by the investigator per IMWG 2016 criteria. Data shown are confirmed responses and calculated in all treated patients. |
AEa, n (%) | All Dose Levels (N=94) | |
---|---|---|
Any Grade | Grade 3/4 | |
Any AE | 94 (100) | 90 (96) |
Hematologic AE | ||
Neutropenia | 69 (73) | 64 (68) |
Anemia | 53 (56) | 36 (38) |
Thrombocytopenia | 40 (43) | 28 (30) |
Nonhematologic AE | ||
CRS | 74 (79) | 2 (2) |
Taste changesb | 61 (65) | - |
Nonrash skin AEsc | 57 (61) | 0 |
Nail-related AEsd | 49 (52) | 0 |
Pyrexiae | 48 (51) | 2 (2) |
Diarrhea | 45 (48) | 3 (3) |
Cough | 42 (45) | 1 (1) |
Dry mouth | 40 (43) | 0 |
COVID-19 | 38 (40) | 17 (18) |
Rash AEsf | 37 (39) | 1 (1) |
Pneumonia | 34 (36) | 19 (20) |
Weight decrease | 32 (34) | 5 (5) |
Fatigue | 26 (28) | 8 (9) |
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) for the all dose levels cohort. aAEs were graded per CTCAE v5.0, and CRS events were graded per the ASTCT criteria. AEs were reported up to 30 days after the patient received the last dose of study treatment. Patients could have had multiple AEs. bIncludes ageusia, dysgeusia, hypogeusia, and taste disorder per CTCAE v5.0; the maximum grade for taste changes is 2 per CTCAE. cIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. dIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. eTwo patients had grade 3 pyrexia that was not considered by the investigators to be serious. Neither event occurred concurrently with an infection of grade 3 or higher. fIncludes rash, maculopapular rash, erythematous rash, and erythema. |
Eventa | All Dose Levels (N=94) | |||
---|---|---|---|---|
Taste-Change AEb | Skin-Related AEc | Rash AEd | Nail-Related AEe | |
Any AE, n (%) | 61 (64.9) | 57 (60.6) | 37 (39.4) | 49 (52.1) |
Grade 3/4 AE, n (%) | - | 0 | 1 (1.1)f | 0 |
Dose modification, n (%) | 5 (5.3) | 0 | 2 (2.1) | 0 |
Dose discontinuation, n (%) | 1 (1) | 0 | 0 | 0 |
Median time to onset from last administration of study treatment, days (range) | 2.0 (1-85) | 5.0 (1-491) | 4.0 (1-23) | 1.0 (1-29) |
Median duration, days (range) | 161.5 (14-482) | 55.0 (1-880) | 14.0 (1-142) | 149.5 (11-536) |
Patients who received supportive measures, n (%) | 61 (64.9) | 57 (60.6) | 37 (39.4) | 49 (52.1) |
Outcome, n (%)g | ||||
Recovered or resolved | 38 (50.7) | 70 (70.7) | 52 (91.2) | 22 (37.9) |
Not recovered or resolved | 35 (46.7) | 28 (28.3) | 4 (7.0) | 34 (58.6) |
Recovering or resolving | 2 (2.7) | 1 (1.0) | 1 (1.8) | 2 (3.4) |
Abbreviations: AE, adverse event; CTCAE: Common Terminology Criteria for Adverse Events; GPRC5D, G protein-coupled receptor class C, group 5, member D; RP2R, recommended phase 2 regimen; TEAE, treatment- emergent adverse event. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) for the all dose levels cohort. aAEs were reported as TEAEs recorded up to 30 days after the patient received last treatment dose. bIncludes dysgeusia, ageusia, hypogeusia, and taste disorder; per CTCAE, the maximum grade for these events is 2. cIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. dIncludes rash, maculopapular rash, erythematous rash, and erythema. eIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. fOne grade 3 event of rash at the RP2R. gCalculated with number of events as denominator (N=75, taste change AEs; N=99, skin-related AEs; N=57, rash AEs; and N=58, nail-related AEs). |
Eventsa, n (%) | TALVEY 0.2 mg/kg + TECVAYLI 0.75 mg/kg QW (n=6) | TALVEY 0.2 mg/kg + TECVAYLI 1.5 mg/kg QW (n=5) | TALVEY 0.4 mg/kg + TECVAYLI 1.5 mg/kg QW (n=28) | TALVEY 0.8 mg/kg + TECVAYLI 1.5 mg/kg Q2W (n=11) | TALVEY 0.8 mg/kg + TECVAYLI 3.0 mg/kg Q2W (n=44) |
---|---|---|---|---|---|
Pneumonia | 0 | 0 | 0 | 0 | 2 (4.5) |
Adenovirus infectionb | 1 (16.7) | 0 | 0 | 0 | 0 |
COVID-19 pneumoniab | 0 | 0 | 0 | 0 | 1 (2.3) |
Aspiration pneumonia | 0 | 0 | 0 | 1 (9.1) | 0 |
Cytomegaloviral pneumoniab | 0 | 0 | 1 (3.6) | 0 | 0 |
Respiratory tract infectionb | 0 | 0 | 1 (3.6) | 0 | 0 |
Sepsisb | 0 | 0 | 1 (3.6) | 0 | 0 |
Septic shock | 0 | 0 | 1 (3.6) | 0 | 0 |
Pulmonary toxicityb,c | 0 | 1 (20.0) | 0 | 0 | 0 |
Respiratory failure | 0 | 0 | 0 | 0 | 1 (2.3) |
Cardiac arrest | 0 | 0 | 0 | 0 | 1 (2.3) |
Gingival bleedingb,d | 0 | 0 | 0 | 0 | 1 (2.3) |
Tongue discomfortb,d | 0 | 0 | 0 | 0 | 1 (2.3) |
Multiple organ dysfunction syndrome | 1 (16.7) | 0 | 0 | 0 | 0 |
Pain in extremityd | 0 | 0 | 0 | 0 | 1 (2.3) |
Myelodysplastic syndromec | 0 | 0 | 1 (3.6) | 0 | 0 |
Dysgeusiab,d | 0 | 0 | 0 | 0 | 1 (2.3) |
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; Q2W, every other week; QW, weekly; RP2R, recommended phase 2 regimen; TEAE, treatment-emergent adverse event. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) and 18.2 months (range, 0.7-27.0) for the all dose levels and RP2R cohorts, respectively. aAEs were reported as TEAEs recorded up to 30 days after the patient received last treatment dose. Listed are AEs that led to discontinuation of either TALVEY or TECVAYLI. Patients could have experienced multiple AEs. bInvestigators correlated AE to TALVEY or TECVAYLI. cOne patient each discontinued treatment but did not die due to myelodysplastic syndrome and pulmonary toxicity. dOne patient experienced gingival bleeding, tongue discomfort, pain in extremity, and dysgeusia, and discontinued TALVEY only; the patient did not die. |
Eventsa, n (%) | TALVEY 0.2 mg/kg + TECVAYLI 0.75 mg/kg QW (n=6) | TALVEY 0.2 mg/kg + TECVAYLI 1.5 mg/kg QW (n=5) | TALVEY 0.4 mg/kg + TECVAYLI 1.5 mg/kg QW (n=28) | TALVEY 0.8 mg/kg + TECVAYLI 1.5 mg/kg Q2W (n=11) | TALVEY 0.8 mg/kg + TECVAYLI 3.0 mg/kg Q2W (n=44) |
---|---|---|---|---|---|
Pneumonia | 0 | 0 | 0 | 0 | 2 (4.5) |
Adenovirus infectionb | 1 (16.7) | 0 | 0 | 0 | 0 |
COVID-19 | 1 (16.7) | 0 | 0 | 0 | 0 |
COVID-19 pneumoniab | 0 | 0 | 0 | 0 | 1 (2.3) |
JC virus infectionb,c | 0 | 0 | 1 (3.6) | 0 | 0 |
Aspiration pneumonia | 0 | 0 | 0 | 1 (9.1) | 0 |
Cytomegaloviral pneumoniab | 0 | 0 | 1 (3.6) | 0 | 0 |
Respiratory tract infectionb | 0 | 0 | 1 (3.6) | 0 | 0 |
Sepsisb | 0 | 0 | 1 (3.6) | 0 | 0 |
Septic shock | 0 | 0 | 1 (3.6) | 0 | 0 |
Cardiac arrest | 0 | 0 | 0 | 0 | 1 (2.3) |
Leptomeningeal myelomatosis | 0 | 0 | 0 | 1 (9.1) | 0 |
Respiratory failure | 0 | 0 | 0 | 0 | 1 (2.3) |
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; CR, complete response; IgG, immunoglobulin G; IVIG, intravenous immunoglobulin; JC virus; John Cunningham virus; PD, progressive disease; PR, partial response; Q2W, every other week; QW, weekly; RP2R, recommended phase 2 regimen; sCR, stringent complete response; TEAE, treatment-emergent adverse event; VGPR, very good partial response. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) and 18.2 months (range, 0.7-27.0) for the all dose levels and RP2R cohorts, respectively. aAEs were reported as TEAEs recorded up to 30 days after the patient received the last treatment dose. Patients could have experienced multiple AEs. Response at the time of death were as follows: nonevaluable (n=2), PD (n=2), minimal response (n=1), PR (n=2), VGPR (n=3), CR (n=3), and sCR (n=1). bInvestigators correlated AE to TALVEY or TECVAYLI. cPatient had a baseline IgG value of 248 g/dL and hypogammaglobulinemia, with no IVIG administered. Intermittent neutropenia was present prior to the AE. JC virus infection (grade 2) started on day 163 and PD was noted on day 170 when the patient discontinued both TALVEY and TECVAYLI. The patient died on day 217 from grade 5 JC virus infection. |
Parameter | All Dose Levels (N=94) |
---|---|
Patients with a CRS eventa, n (%) | 74 (79) |
Grade 1 | 50 (53.2) |
Grade 2 | 22 (23.4) |
Grade 3 | 2 (2) |
Cycle delays or dose modification, n (%) | 14 (15) |
Median time to onsetb, days (range) | 2 (1-733) |
Median duration, days (range) | 2 (1-8) |
Patients who received supportive measuresc, n (%) | 61 (65) |
Tocilizumab | 24 (26) |
Intravenous fluids | 11 (11.7) |
Corticosteroids | 3 (3.2) |
Oxygen | 1 (1.1) |
Vasopressor | 1 (1.1) |
Recovery, % | 98 |
Recovery with sequelae | 1 |
Incomplete recovery | 1 |
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) for the all dose levels cohort. aCRS was graded per the ASTCT criteria. bRelative to the most recent dose. cPatients could receive >1 supportive therapy. Other forms of supportive measures were received by 26 patients across all dose levels. |
AEa, n (%) | All Dose Levels (N=94) | ||
---|---|---|---|
Any Grade | Grade 3/4 | ||
Infectionsb | 84 (89) | 60 (64) | |
COVID-19 | 38 (40.4) | 17 (18.1) | |
Pneumonia | 34 (36.2) | 19 (20.2) | |
Upper respiratory tract infection | 23 (24.5) | 3 (3.2) | |
Nasopharyngitis | 14 (14.9) | 0 | |
Sinusitis | 12 (12.8) | 1 (1.1) | |
Rhinovirus infection | 10 (10.6) | 3 (3.2) | |
Bronchitis | 9 (9.6) | 3 (3.2) | |
Respiratory tract infection | 9 (9.6) | 5 (5.3) | |
Urinary tract infection | 9 (9.6) | 1 (1.1) | |
Oral candidiasis | 7 (7.4) | 2 (2.1) | |
Sepsis | 7 (7.4) | 7 (7.4) | |
Septic shock | 7 (7.4) | 6 (6.4) | |
Cytomegalovirus infection reactivation | 5 (5.3) | 0 | |
Escherichia coli sepsis | 5 (5.3) | 5 (5.3) | |
Influenza | 5 (5.3) | 1 (1.1) | |
Respiratory syncytial virus infection | 5 (5.3) | 1 (1.1) | |
Staphylococcal infectionc | 5 (5.3) | 2 (2.1) | |
Opportunistic infectionsd | 10 (10.6) | 3 (3.2) | |
Median time to onset from last administration of study treatment, days (range) | 9 (1-89) | ||
Median duration, days (range) | 13 (1-223) | ||
Recovered or resolvede, n (%) | 113 (82.5) | ||
Dose delay or dose modification, n (%) | 64 (68) | ||
Abbreviations: AE, adverse event; CMV, cytomegalovirus; COVID-19, coronavirus disease 2019; CTCAE, Common Terminology Criteria for Adverse Events; JC virus, John Cunningham virus; TEAE, treatment-emergent adverse events. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) for the all dose levels cohort. aAEs were graded per CTCAE v5.0. AEs were reported as TEAEs recorded up to 30 days after the patient received the last treatment dose. Patients could have experienced multiple AEs. bIn total, 11 patients died because of infections (pneumonia, n=2; adenovirus infection, COVID-19, COVID-19 pneumonia, JC virus infection, aspiration pneumonia, cytomegaloviral pneumonia, respiratory tract infection, sepsis, and septic shock, all n=1). cSix events were due to Staphylococcus aureus, 1 event due to methicillin-resistant Staphylococcus aureus, and 1 event due to Staphylococcus epidermidis. Patients could experience multiple AEs. dEncompassing CMV infection reactivation, CMV colitis, cytomegaloviral pneumonia, disseminated varicella zoster virus infection, esophageal candidiasis, herpetic meningoencephalitis, JC virus infection, listeriosis, and pulmonary nocardiosis. eCalculated with number of events as the denominator (N=137). |
Parameter | Event Onset Within Time Periods | |||||
---|---|---|---|---|---|---|
Total | ≤6 Months | >6 to ≤12 Months | >12 to ≤18 Months | >18 to ≤24 Months | >24 Months | |
Total number of patients treated within windowa, n | 94 | 94 | 64 | 55 | 34 | 25 |
Total number of patients with grade ≥3 infections, n (%) | 60 (63.8) | 42 (44.7) | 11 (17.2) | 3 (5.5) | 3 (8.8) | 1 (4.0) |
Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) for the all dose levels cohort. aIncludes patients treated with study treatment within the specified window. AEs were reported as TEAEs recorded up to 30 days after the patient received the last treatment dose. Patients could have experienced multiple AEs. |
Eventsa, n (%) | All Dose Levels (N=94) |
---|---|
Total | 48 (51.1) |
Concurrent with infection | 32 (34.0) |
Concurrent with grade ≥3 infection | 20 (21.3) |
Concurrent with CRS | 12 (12.8) |
Associated with injection-site reaction | 1 (1.1) |
Associated with other AEs | 27 (28.7) |
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; TEAE, treatment-emergent adverse event. Clinical data cutoff date of March 15, 2024. The median follow-up time was 20.3 months (range, 0.5-37.1) for the all dose levels cohort. aReported as TEAEs recorded up to 30 days after the patient received last treatment dose. Patients could have experienced multiple AEs. |
Pharmacokinetics, Pharmacodynamics, and Immunogenicity
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 23 June 2025.
1 | Cohen YC, Magen H, Gatt M, et al. Talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma: updated phase 1b results from RedirecTT-1 with >1 year of follow-up. Oral Presentation presented at: 21st International Myeloma Society (IMS) Annual Meeting; September 25-28, 2024; Rio de Janeiro, Brazil. |
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