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TALVEY® (talquetamab-tgvs)

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TALVEY - MonumenTAL-1 Subgroup Analysis

Last Updated: 04/24/2025

SUMMARY

  • MonumenTAL-1 (MMY1001) is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody.1-3
    • Chari et al (2025)3,4 published post hoc analyses of overall response rate (ORR) and progression-free survival (PFS) in clinically relevant subgroups of patients who received TALVEY at the recommended phase 2 doses (RP2Ds) of 0.4 mg/kg subcutaneously (SC) weekly (QW) or 0.8 mg/kg SC once every other week (Q2W), including patients who had received prior T-cell redirection therapy (TCR; chimeric antigen receptor T-cell [CAR-T] therapy or bispecific antibodies [BsAbs]). Safety data for these subgroups were not reported.
    • Schinke et al (2024)5 presented a subgroup analysis of the efficacy and safety in Black patients who received TALVEY at the RP2Ds of 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W. Clinical outcomes in Black patients were compared to White patients.
    • Krishnan et al (2023)6 presented a subgroup analysis of the efficacy and safety results in patients who received TALVEY at the RP2Ds of 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W, including those who were naïve or exposed to TCR therapy. This subgroup analysis evaluated the efficacy and safety of high-risk and B-cell maturation antigen (BCMA) exposed subgroups.

CLINICAL DATA - Monumental-1 study

MonumenTAL-1 (MMY1001; NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.7,8

Study Design/Methods (Phase 2)

Patients were enrolled into 1 of the following 3 cohorts1,9 :

  • TCR naive: 0.4 mg/kg SC QW, not previously exposed to TCR such as CAR-T or BsAbs (prior BCMA antibody-drug conjugate [ADC] allowed).
  • TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).
  • Prior TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.
    • Among the prior TCR-exposed cohort, patients were divided based on type of TCR (CAR-T, BsAb, or CAR-T and BsAb).
  • Key eligibility criteria3:
    • ≥18 years of age, measurable multiple myeloma (MM) per International Myeloma Working Group (IMWG) criteria.
    • ≥3 LOTs including a PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
    • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.
  • Key exclusion criteria10:
    • Prior grade 3 or higher cytokine release syndrome (CRS; per Lee criteria 201411) related to any TCR or any prior G protein-coupled receptor class C group 5 member D (GPRC5D)-targeting therapy. 
    • Central nervous system (CNS) or clinical signs of meningeal involvement of MM.
    • Received cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days prior to study drug (not including premedication).
  • Primary endpoint: ORR.3
  • Key secondary endpoints: duration of response (DOR), PFS, overall survival (OS), safety, pharmacokinetics, patient-reported outcomes, and minimal residual disease.3

Chari et al (2025)3,4 published post hoc analyses of ORR and PFS in a clinically relevant subgroups of patients who received TALVEY at the RP2Ds of 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, including patients who had received prior TCR therapy (CAR-T therapy or bispecific antibodies).

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics


MonumenTAL-1 Study: Select Baseline Demographics and Clinical Characteristics3
Characteristic
0.4 mg/kg SC QWa
(N=143)
0.8 mg/kg SC Q2Wa
(N=154)
Prior TCRa,b
(N=78)
Median age, years (IQR)
67 (58-72)
67 (58-74)
61 (55-68)
Extramedullary plasmacytomas ≥1, n (%)c
33 (23)
41 (27)
25 (32)
High-risk cytogenetics, n (%)d
41 (31)
40 (30)
25 (37)
Exposure status, n (%)
   BsAb
-
-
26 (33)
   CAR-T
-
-
57 (73)
   BsAb + CAR-T
-
-
5 (6)
Abbreviations: BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell therapy; IQR, interquartile range; Q2W, every other week; QW, weekly; SC, subcutaneous; TCR, T-cell redirection.
aReceived 2-3 SUDs.
bPrior TCR-therapy was primarily targeting BCMA (96%; n=75); other targets included CD38 (n=2) and MAGE-A1 (n=1).
cSoft tissue plasmacytomas not associated with the bone were included.
ddel(17p), t(4;14), or t(14;16). Evaluated in 132, 133, and 67 patients in the 0.4 mg/kg SC QW, 0.8 mg/kg SC Q2W, and prior TCR cohorts, respectively.

Efficacy


MonumenTAL-1 Study: ORR in Subgroups4 
Subgroup
0.4 mg/kg QW
0.8 mg/kg Q2W
ORR, n/N (%)
95% CI
ORR, n/N (%)
95% CI
All treated patients
106/143 (74)
66.1-81.1
107/154 (69)
61.6-76.6
Sex
   Male
58/78 (74)
63.2-83.6
55/90 (61)
50.3-71.2
   Female
48/65 (74)
61.5-84.0
52/64 (81)
69.5-89.9
Age
   <65 years
48/65 (74)
61.5-84.0
45/66 (68)
55.6-79.1
   65 to <75 years
43/57 (75)
62.2-85.9
37/55 (67)
53.3-79.3
   ≥75 years
15/21 (71)
47.8-88.7
25/33 (76)
57.7-88.9
Baseline renal function
   <60 mL/min/1.73 m²
26/40 (65)
48.3-79.4
30/46 (65)
49.8-78.6
   ≥60 mL/min/1.73 m²
80/103 (78)
68.4-85.3
77/108 (71)
61.8-79.6
Race
   White
92/128 (72)
63.2-79.5
90/126 (71)
62.7-79.1
   African American/Black
12/12 (100)
73.5-100.0
9/17 (53)
27.8-77.0
   Other
2/3 (67)
9.4-99.2
8/11 (73)
39.0-94.0
Baseline ECOG PS
   0
37/44 (84)
69.9-93.4
44/58 (76)
62.8-86.1
   ≥1
69/99 (70)
59.6-78.5
63/96 (66)
55.2-75.0
Number of prior therapy lines
   <4
22/26 (85)
65.1-95.6
27/38 (71)
54.1-84.6
   ≥4
84/117 (72)
62.7-79.7
80/116 (69)
59.7-77.2
Refractory to
   PI+immunomodulatory drug
79/111 (71)
61.8-79.4
79/119 (66)
57.2-74.8
   Triple
78/107 (73)
63.4-81.0
74/110 (67)
57.7-75.9
   Penta
32/45 (71)
55.7-83.6
27/39 (69)
52.4-83.0
   Last line of prior therapy
99/134 (74)
65.6-81.1
100/145 (69)
60.8-76.4
Prior ASCT
   Yes
83/112 (74)
65.0-81.9
84/121 (69)
60.4-77.5
   No
23/31 (74)
55.4-88.1
23/33 (70)
51.3-84.4
Type of myeloma
   IgG
53/76 (70)
58.1-79.8
55/83 (66)
55.1-76.3
   Non-IgG
53/67 (79)
67.4-88.1
52/71 (73)
61.4-83.1
Baseline ISS
   I
51/62 (82)
70.5-90.8
52/68 (76)
64.6-85.9
   II
37/53 (70)
55.7-81.7
32/48 (67)
51.6-79.6
   III
18/28 (64)
44.1-81.4
22/37 (59)
42.1-75.2
Baseline R-ISS
   R-ISS I
26/28 (93)
76.5-99.1
27/34 (79)
62.1-91.3
   R-ISS II
70/96 (73)
62.9-81.5
63/90 (70)
59.4-79.2
   R-ISS III
7/14 (50)
23.0-77.0
9/21 (43)
21.8-66.0
Cytogenetic risk
   High
29/41 (71)
54.5-83.9
30/40 (75)
58.8-87.3
   Standard
72/91 (79)
69.3-86.9
65/93 (70)
59.5-79.0
Bone marrow % plasma cells
   ≤30
83/106 (78)
69.2-85.7
59/88 (67)
56.2-76.7
   30 to <60
8/15 (53)
26.6-78.7
19/28 (68)
47.6-84.1
   ≥60
12/17 (71)
44.0-89.7
25/34 (74)
55.6-87.1
Baseline tumor GPRC5D expression
   ≥Median
54/69 (78)
66.7-87.3
-
NE-NE
   <Median
48/66 (73)
60.4-83.0
-
NE-NE
Baseline extramedullary plasmacytomas
   0
90/110 (82)
73.3-88.5
90/113 (80)
71.0-86.6
   ≥1
16/33 (48)
30.8-66.5
17/41 (41)
26.3-57.9
Prior ADC
   Yes
15/22 (68)
45.1-86.1
11/17 (65)
38.3-85.8
   No
91/121 (75)
66.5-82.6
96/137 (70)
61.7-77.6
Prior lines of therapy and refractory status
   ≥4 lines and triple refractory
65/90 (72)
61.8-81.1
58/88 (66)
55.0-75.7
Abbreviations: ADC, antibody-drug conjugate; ASCT, autologous stem cell transplant; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group Performance Status; GPRC5D, G Protein-Coupled Receptor Class C Group 5 Member D; IgG, immunoglobulin G; ISS, International Staging System; NE, not evaluable; ORR, overall response rate; PI, proteasome inhibitor; Q2W, every other week; QW, weekly; R-ISS, Revised International Staging System; TCR, T-cell redirection therapy.
Clinical data cutoff date of October 11, 2023.

MonumenTAL-1 Study: Subgroup Analysis of ORR by BCMA-Targeting Prior Therapy3,4 
Subgroup
ORR, n/N (%)
95% CI
CAR-T
 41/57 (72)
59-83
   Immediate prior line
26/35 (74)
57-88
   Before last line
15/22 (68)
45-86
Time before TALVEY administration
      <6 months
 14/16 (88)
62-98
      6-9 months
4/4 (100)
40-100
      ≥9 months
23/37 (62)
45-78
BsAb
15/26 (58)
37-77
   Immediate prior line
2/7 (29)
4-71
   Before last line
13/19 (68)
43-87
   Time before TALVEY administration
      ≥9 months
 6/8 (75)
35-97
      6-9 months
3/6 (50)
12-88
      <6 months
6/12 (50)
21-79
Abbreviations: BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; CI, confidence interval; ORR, overall response rate.
Clinical data cutoff date of October 11, 2023.

MonumenTAL-1 Study: PFS in High-Risk Subgroups3,4 
Subgroup
0.4 mg/kg QW
(N=143)
Median PFS, Months (95% CI)
0.8 mg/kg Q2W
(N=154)
Median PFS, Months (95% CI)
Prior TCR
(N=78)
Median PFS, Months (95% CI)
Cytogenetic risk
   High
6.7 (4.6-11.6)
18.0 (6.0-NE)
-
   Standard
8.5 (6.7-10.9)
10.3 (7.0-14.2)
-
Plasmacytomas
   ≥1
4.6 (2.8-5.6)
3.4 (2.1-5.4)
-
   Total plasmacytomas
9.2 (7.0-11.8)
16.9 (11.3-NE)
-
Age
   <75 years
7.0 (5.7-9.2)
9.6 (5.7-12.1)
-
   ≥75 years
8.8 (2.8-NE)
21.0 (12.4-NE)
-
Prior exposure
   BCMA-directed CAR-T
-
-
13.0 (4.2-NE)
   BCMA-directed BsAb
-
-
3.9 (2.9-7.7)
Abbreviations: BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; CI, confidence interval; CR, complete response; NE, not estimable; PFS, progression-free survival; Q2W, every other week; QW, weekly; TCR, T-cell redirection therapy.
Clinical data cutoff date of October 11, 2023.
aPatients who died or did not progress were censored at their last disease assessment prior to subsequent antimyeloma therapy. Patients without post-baseline assessments were censored as of the date of first dose study treatment. Relapse from ≥CR was not considered disease progression.

Safety

  • Safety data for subgroups were not reported.

Schinke et al (2024)5 evaluated the efficacy and safety of TALVEY in a subgroup analysis of Black patients from phases 1/2 of the MonumenTAL-1 study.

Study Design/Methods

MonumenTAL-1 Study: Assessment in Black and White Patients5

Abbreviations: ASTCT, American Society of Transplantation and Cellular Therapy; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; ECOG PS, Eastern Cooperative Oncology Group performance status; IRC, independent review committee; LOT, line of therapy; mAb, monoclonal antibody; PD, pharmacodynamics; PFS, progression-free survival; PI, proteasome inhibitor; PK, pharmacokinetics; PRO, patient-reported outcome; Q2W, every other week; QW, weekly; SC, subcutaneous.
aWith 2–3 step-up doses.
bORR assessed by IRC using International Myeloma Working Group criteria. PFS based on IRC assessment.
cCRS was graded by ASTCT criteria; all other AEs were graded by CTCAE v4.03.

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics


MonumenTAL-1 Study Baseline Characteristics in Black vs White Patients5
Characteristic
White
(N=254)
Black
(N=29)
Age (years), median (range)
67 (38–84)
67 (46–86)
Male, n (%)
144 (56.7)
17 (58.6)
High-risk cytogeneticsa, n (%)
75 (32.8)
5 (22.7)
ISS stage IIIb, n (%)
56 (22.1)
6 (20.7)
Extramedullary plasmacytomasc, n (%)
63 (24.8)
9 (31.0)
Median prior LOT (range)
5(2–17)
4 (3–10)
Refractory status, n (%)
   Triple-class refractoryd
191 (75.2)
17 (58.6)
   Penta-drug refractorye
73 (28.7)
7 (24.1)
Abbreviations: ISS, International Staging System; LOT, line of therapy; mAb, monoclonal antibody.
Clinical data cutoff date of June 20, 2024.
adel(17p), t(4;14), and/or t(14;16); percentages calculated from n=229 for White and n=22 for Black patients.
bCalculated from n=253 for White patients.
cSoft tissue plasmacytomas not associated with the bone were included.
d≥1 PI, ≥1 immunomodulatory drugs, and ≥1 anti-CD38 mAb.
e≥2 PIs, ≥2 immunomodulatory drugs, and ≥1 anti-CD38 mAb.

Efficacy


MonumenTAL-1 Study: Efficacy Outcomes in Black vs White Patients5
Response Rate
White
(N=254)
Black
(N=29)
ORRa, % (n/N)
71.7 (182/254)
72.4 (21/29)
   sCR, %
27.2
27.6
   CR, %
9.1
13.8
   VGPR, %
23.2
13.8
   PR, %
12.2
17.2
≥VGPR, %
59.4
55.2
Median PFS, months (95% CI)
8.5 (6.6-10.9)
9.1 (4.8-20.0)
12-month PFS, %
41.0
42.9
Abbreviations: CR, complete response; ORR, overall response rate; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.
Clinical data cutoff date of June 20, 2024.
aDue to rounding, individual response rates may not sum to the ORR.

Safety


MonumenTAL-1 Study: Summary of AEs in Black vs White Patients5
AE, n (%)
White
(N=254)
Black
(N=29)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Hematological AEs (≥30% in either group)
Anemia
119 (46.9)
75 (29.5)
9 (31.0)
7 (24.1)
Lymphopenia
67 (26.4)
59 (23.2)
11 (37.9)
11 (37.9)
Neutropenia
77 (30.3)
62 (24.4)
9 (31.0)
8 (27.6)
Thrombocytopenia
77 (30.3)
53 (20.9)
5 (17.2)
3 (10.3)
Nonhematological AEs (≥30% in either group)
Dysgeusiaa
178 (70.1)
NA
26 (89.7)
NA
Skin relatedb
163 (64.2)
0
25 (86.2)
0
CRS
193 (76.0)
4 (1.6)
21 (72.4)
0
Infections
168 (66.1)
57 (22.4)
18 (62.1)
6 (20.7)
Nail relatedc
142 (55.9)
0
17 (58.6)
0
Weight decreased
100 (39.4)
10 (3.9)
15 (51.7)
2 (6.9)
Fatigue
63 (24.8)
0
12 (41.4)
0
Dry mouth
80 (31.5)
0
11 (37.9)
0
Decreased appetite
60 (23.6)
0
11 (37.9)
0
Constipation
43 (16.9)
0
11 (37.9)
0
Rash relatedd
95 (37.4)
8 (3.1)
7 (24.1)
1 (3.4)
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; NA, not applicable.Clinical data cutoff date of June 20, 2024.
aIncludes dysgeusia, ageusia, taste disorder, and hypogeusia. Per CTCAE v4.03, the maximum grade of dysgeusia is 2.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes nail discoloration, nail disorder, nail toxicity, nail dystrophy, nail ridging, onychoclasis, onycholysis, and onychomadesis.
dIncludes rash, maculopapular rash, erythematous rash, and erythema.

MonumenTAL-1 Study: Characterization of Dysgeusia and Skin-related AEs in Black vs White patients5
AE
White (N=254)
Black (N=29)
Dysgeusia
  Median durationa, days
147.0
183.0
  Dose modificationsb, n (%)
14 (5.5)
6 (20.7)
  Concomitant medicationsc,n (%)
25 (9.8)
3 (10.3)
  Resolvedd, n (%)
123 (56.2)
10 (33.3)
Skin-related
  Median durationa, days
36.0
52.5
  Dose modificationsb, n (%)
11 (4.3)
4 (13.8)
  Concomitant medicationsc,n (%)
93 (36.6)
19 (65.5)
  Resolvedd, n (%)
174 (60.4)
34 (56.7)
Abbreviations: AE, adverse event.
Clinical data cutoff date of June 20, 2024.
aMedian duration is based on events with both start and end time/dates available.
bDose modifications include cycle delays, dose reductions, and skipped doses.
cPatients could receive ≥1 concomitant medication.
dPatients could have ≥1 event. Percentages are calculated with the number of events as the denominator.

Pharmacokinetics/Pharmacodynamics

  • Race as a covariate was not found to impact the pharmacokinetics (PK) of talquetamab.
  • There were no differences in pharmacodynamics (PD) between Black and White patients.
  • Although patient numbers were small, baseline GPRC5D expression was higher in Black patients experiencing skin-related AEs compared with those who did not. No such differences were observed in White patients.

Patient Reported Outcomes

  • At baseline, Black patients had worse values for appetite loss, constipation, dyspnea, pain, and social functioning compared to White patients. However, Black patients reported greater improvements from baseline for all values including diarrhea (after cycle 1), fatigue and global health status when compared to White patients.
  • By cycle 3, White and Black patients reported disease severity as “moderate,” “mild” or “none.”

Krishnan et al (2023)6 evaluated the efficacy and safety of TALVEY in key high-risk and BCMA-exposed subgroups of patients from phases 1/2 of the MonumenTAL-1 study.

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics


MonumenTAL-1 Study: High-Risk Subgroups6
Subgroup, n (%)
0.4 mg/kg SC QW (N=143)
0.8 mg/kg SC Q2W (N=145)
Age ≥75 years
21 (14.7)
32 (22.1)
Renal impairmenta
40 (28.0)
45 (31.0)
High-risk cytogeneticsb
41 (28.7)
37 (25.5)
ISS stage III
28 (19.6)
35 (24.1)
EMD
33 (23.1)
37 (25.5)
Triple-class refractoryc
106 (74.1)
100 (69.0)
Abbreviations: EMD, extramedullary disease; ISS, International Staging System; PI: proteasome inhibitor; Q2W, every other week; QW, weekly; SC, subcutaneous.
Clinical data cutoff date of January 17, 2023.
aRenal impairment defined as baseline function ≤60 mL/min/1.73 m2.
bHigh-risk cytogenetics include del(17p), t(4;14), and/or t(14;16).
cTriple-class refractory included refractory to PI, immunomodulatory drug, and anti-CD38 monoclonal antibody.

MonumenTAL-1 Study: Baseline Demographic Characteristics in High-risk Subgroups6
TALVEY 0.4 mg/kg SC QW Dose
Parameter
Overall (N=143)
Age ≥75 years (n=21)
Renal impairment (n=40)
High-risk cytogenetics (n=41)
ISS stage III (n=28)
EMD (n=33)
Triple-class refractory (n=106)
Median age, years
67.0
77.0
69.0
68.0
66.0
60.0
67.0
Male, n (%)
78 (54.5)
12 (57.1)
19 (47.5)
15 (36.6)
15 (53.6)
20 (60.6)
55 (51.9)
Race, n (%)
   White
   Black/AA
   Asian
   Native
   Hawaiian/OPI
   Not reported/
   unknown
128 (89.5)
12 (8.4)
1 (0.7)
0
2 (1.4)
19 (90.5)
2 (9.5)
0
0
0
37 (92.5)
2 (5.0)
0
0
1 (2.5)
38 (92.7)
3 (7.3)
0
0
0
26 (92.9)
2 (7.1)
0
0
0
31 (93.9)
2 (6.1)
0
0
0
97 (91.5)
7 (6.6)
0
0
2 (1.9)
Ethnicitya, n (%)
   Non-Hispanic/
   Latino
   Hispanic or
   Latino
132 (92.3)
11 (7.7)
20 (95.2)
1 (4.8)
38 (95.0)
2 (5.0)
40 (97.6)
1 (2.4)
25 (89.3)
3 (10.7)
28 (84.8)
5 (15.2)
98 (92.5)
8 (7.5)
ECOG PS, n (%)
   0
   1
   2
44 (30.8)
86 (60.1)
13 (9.1)
5 (23.8)
11 (52.4)
5 (23.8)
7 (17.5)
28 (70.0)
5 (12.5)
9 (22.0)
29 (70.7)
3 (7.3)
6 (21.4)
16 (57.1)
6 (21.4)
10 (30.3)
21 (63.6)
2 (6.1)
30 (28.3)
67 (63.2)
9 (8.5)
TALVEY 0.8 mg/kg SC Q2W Dose
Parameter
Overall (N=145)
Age ≥75 years (n=32)
Renal impairment (n=45)
High-risk cytogenetics (n=37)
ISS stage III (n=35)
EMD (n=37)
Triple-class refractory (n=100)
Median age, years
67.0
77.5
68.0
68.0
68.0
63.0
67.0
Male, n (%)
83 (57.2)
19 (59.4)
23 (51.1)
21 (56.8)
21 (60.0)
23 (62.2)
62 (62.0)
Race, n (%)
   White
   Black/AA
   Asian
   Native
   Hawaiian/OPI
   Not reported/
   unknown
125 (86.2)
9 (6.2)
6 (4.1)
1 (0.7)
3 (2.1)
26 (81.3)
2 (6.3)
1 (3.1)
1 (3.1)
2 (6.3)
41 (91.1)
3 (6.7)
0
1 (2.2)
0
36 (97.3)
0
0
1 (2.7)
0
30 (85.7)
2 (5.7)
3 (8.6)
0
0
32 (86.5)
3 (8.1)
1 (2.7)
0
1 (2.7)
88 (88.0)
5 (5.0)
4 (4.0)
1 (1.0)
2 (2.0)
Ethnicitya, n (%)
   Non-Hispanic/
   Latino
   Hispanic or
   Latino
127 (87.6)
17 (11.7)
28 (87.5)
4 (12.5)
41 (91.1)
4 (8.9)
35 (94.6)
2 (5.4)
29 (82.9)
6 (17.1)
31 (83.8)
6 (16.2)
87 (87.0)
12 (12.0)
ECOG PS, n (%)
   0
   1
   2
56 (38.6)
81 (55.9)
8 (5.5)
8 (25.0)
21 (65.6)
3 (9.4)
13 (28.9)
31 (68.9)
1 (2.2)
17 (45.9)
20 (54.1)
0
8 (22.9)
24 (68.6)
3 (8.6)
16 (43.2)
18 (48.6)
3 (8.1)
40 (40.0)
56 (56.0)
4 (4.0)
Abbreviations: AA, African American; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; ISS, International Staging System; OPI, other Pacific Islander; Q2W, every other week; QW, weekly; SC, subcutaneous.
Clinical data cutoff date of January 17, 2023.
aEthnicity was not reported for 1 patient in the overall Q2W population (N=145) and in the triple-class refractory Q2W subgroup (n=100).

MonumenTAL-1 Study: Baseline Demographic Characteristics in Prior BCMA Subgroups6
Characteristic
TCR naïve (BCMA ADC allowed)
QW
(n=22)
TCR naïve (BCMA ADC allowed)
Q2W
(n=16)
TCR exposed (BCMA ADC allowed, CAR-T, BsAb)
QW & Q2W
(n=48)
Median age, years
66.5
67.5
61.0
Male, n (%)
11 (50.0)
10 (62.5)
30 (62.5)
Race,n (%)
   White
22 (100.0)
13 (81.3)
44 (91.7)
   Black/AA
0
3 (18.8)
3 (6.3)
   Asian
0
0
1 (2.1)
Ethnicity, n (%)
   Non-Hispanic/Latino
22 (100.0)
14 (87.5)
44 (91.7)
   Hispanic or Latino
0
2 (12.5)
3 (6.3)
   Not reported
0
0
1 (2.1)
ECOG PS, n (%)
   0
6 (27.3)
5 (31.3)
20 (41.7)
   1
10 (45.5)
9 (56.3)
27 (56.3)
   2
6 (27.3)
2 (12.5)
1 (2.1)
Abbreviations: AA, African American; 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; Q2W, every other week; QW, weekly; TCR, T-cell redirection therapy.Clinical data cutoff date of January 17, 2023.

Efficacy

High-Risk Subgroups
  • The median follow-up varied for each of the high-risk subgroups, ranging from 18.4-19.5 months in the 0.4 mg/kg QW cohort, and from 11.9-13.3 months in the 0.8 mg/kg Q2W cohort.
  • The ORR in high-risk subgroups of the 0.4 mg/kg QW and 0.8 mg/kg Q2W dosing cohorts is presented in the Table: MonumenTAL-1 Study: ORR in High-Risk Subgroups.
    • A total of 92 patients (64.3%) in the QW cohort and 99 patients (68.3%) in the Q2W cohort had ≥2 high-risk features; ORR in these patients was 66.3% and 46.9%, respectively.
  • Select efficacy outcomes comparing high-risk vs standard-risk patients in the 0.8 mg/kg Q2W cohort are summarized in the Table: MonumenTAL-1 Study: Outcomes Among Select High-risk Subgroups in the 0.8 mg/kg Q2W Cohort.
Prior BCMA Subgroups
  • In patients who received prior BCMA therapies, median follow-up was 15.0, 16.3, 14.8, and 14.5 months in the all BCMA, BCMA ADC, BCMA CAR-T and BCMA BsAb groups, respectively.
  • The ORR in prior BCMA subgroups is presented in the Table: MonumenTAL-1 Study: ORR in Prior BCMA Subgroups.
    • ORR was 83.3% in the 6 patients receiving prior BCMA ADC who also received BCMA CAR-T or BsAb.
    • Median DOR was 12.3, NE, 11.9 and 3.5 months in the all BCMA, BCMA ADC, BCMA CAR-T, and BCMA BsAb groups, respectively.

MonumenTAL-1 Study: ORR in High-Risk Subgroups6
TALVEY 0.4 mg/kg SC QW Dose
Parameter
Overall (N=143)
Age ≥75 years (n=21)
Renal impairment (n=40)
High-risk cytogenetics (n=41)
ISS stage III (n=28)
EMD (n=33)
Triple-class refractory (n=106)
Median follow-up, months
18.8
18.7
19.5
19.2
18.5
18.4
18.7
ORR, n (%)
106 (74.1)
15
(71.4)
26
(65.0)
29
(70.7)
18
(64.3)
16 (48.5)
77
(72.6)
TALVEY 0.8 mg/kg SC Q2W Dose
Parameter
Overall (N=145)
Age ≥75 years (n=32)
Renal impairment (n=45)
High-risk cytogenetics (n=37)
ISS stage III (n=35)
EMD (n=37)
Triple-class refractory (n=100)
Median follow-up, months
12.7
11.9
13.0
12.5
13.3
12.1
12.8
ORR, n (%)
104 (71.7)
24
(75.0)
30
(66.7)
28
(75.7)
21
(60.0)
16 (43.2)
69
(69.0)
Abbreviations: EMD, extramedullary disease; ISS, internation staging system; ORR, overall response rate; QW, once weekly; Q2W, every other week; SC, subcutaneous.
Clinical data cutoff date of January 17, 2023.

MonumenTAL-1 Study: Outcomes Among Select High-Risk Subgroups in the 0.8 mg/kg Q2W Cohort6
Subgroup
Median DOR, months (95% CI)
Age
   ≥75 years (n=24)
NE (NE, NE)
   <75 years (n=80)
NE (13.0, NE)
Cytogenetic risk
   High (n=28)
NE (NE, NE)
   Standard (n=65)
NE (13.0, NE)
EMD
≥1 (n=16)
9.3 (2.3, NE)
   0 (n=88)
NE (NE, NE)
Subgroup
Median PFS, months (95% CI)
Age
   ≥75 years (n=32)
NE (11.3, NE)
   <75 years (n=113)
11.9 (5.8, NE)
Cytogenetic risk
   High (n=37)
NE (6.0, NE)
   Standard (n=91)
14.2 (8.4, NE)
EMD
   ≥1 (n=37)
3.9 (2.1, 5.7)
   0 (n=108)
NE (14.2, NE)
Abbreviations: CI, confidence interval; DOR, duration of response; EMD, extramedullary disease NE, not estimable; PFS, progression-free survival; Q2W, every other week.Clinical data cutoff date of January 17, 2023.

MonumenTAL-1 Study: ORR in Prior BCMA Subgroups6
Parameter
All BCMA
BCMA ADC
BCMA CAR-T
BCMA BsAb
Median follow-up, months
15.0
16.3
14.8
14.5
ORR, n/N (%)
55/86 (64.0)
30/44a (68.2)
25/34a (73.5)
8/17a (47.1)
Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; ORR, overall response rate.
Clinical data cutoff date of January 17, 2023.
aSome patients received >1 prior BCMA therapy, leading to differences in total patient count.

Safety

  • AEs observed in the RP2Ds of 0.4 mg/kg QW and 0.8 mg/kg Q2W are summarized in the Table: MonumenTAL-1 Study: Summary of AEs in High-risk Subgroups.
    • Discontinuation rates were higher in the age ≥75 years and ISS Stage III subgroups in the 0.4 mg/kg QW cohort, and in the ISS Stage III and renal impairment subgroups in the 0.8 mg/kg Q2W cohort.
    • Rates of AEs (dysgeusia, nail AEs and skin AEs) were lower in the ISS Stage III and EMD subgroups in the 0.4 mg/kg QW cohort. Nail AEs were lower in the ISS Stage III and renal impairment subgroups in the 0.8 mg/kg Q2W cohort.
    • Rates of infection were lower in the EMD subgroup in both cohorts and higher in the ≥75 years subgroup in the 0.8 mg/kg Q2W cohort.
  • AEs observed in the BCMA subgroups of TCR-naïve (BCMA ADC allowed) and TCR-exposed (BCMA ADC, BCMA CAR-T, BCMA BsAb) cohorts are summarized in the Table:  MonumenTAL-1 Study: Summary of AEs in Prior BCMA Subgroups.

MonumenTAL-1 Study: Summary of AEs in High-Risk Subgroups6
TALVEY 0.4 mg/kg SC QW Dose
AE, n (%)
Overall (N=143)
Age ≥75 years (n=21)
Renal impairment (n=40)
High-risk cytogenetics (n=41)
ISS stage III (n=28)
EMD (n=33)
Triple-class refractory (n=106)
Any grade
143 (100.0)
21 (100.0)
40 (100.0)
41 (100.0)
28 (100.0)
33 (100.0)
106 (100.0)
Grade 3/4
111 (77.6)
14 (66.7)
30 (75.0)
29 (70.7)
20 (71.4)
24 (72.7)
80 (75.5)
Discontinuations
7 (4.9)
3 (14.3)
2 (5.0)
3 (7.3)
3 (10.7)
0
4 (3.8)
CRS
113 (79.0)
 18 (85.7)
 29 (72.5)
 32 (78.0)
 24 (85.7)
 27 (81.8)
 85 (80.2)
Dysgeusiaa
103 (72.0)
 15 (71.4)
 27 (67.5)
29 (70.7)
13 (46.4)
 17 (51.5)
 75 (70.8)
Infections
84 (58.7)
 13 (61.9)
 27 (67.5)
25 (61.0)
 14 (50.0)
 15 (45.5)
 57 (53.8)
Skin relatedb
80 (55.9)
 12 (57.1)
 18 (45.0)
23 (56.1)
 9 (32.1)
 14 (42.4)
 60 (56.6)
Nail relatedc
78 (54.5)
 13 (61.9)
 26 (65.0)
25 (61.0)
12 (42.9)
 12 (36.4)
 53 (50.0)
Rash relatedd
57 (39.9)
8 (38.1)
12 (30.0)
16 (39.0)
11 (39.3)
11 (33.3)
44 (41.5)
TALVEY 0.8 mg/kg SC Q2W Dose
AE, n (%)
Overall (N=145)
Age ≥75 years (n=32)
Renal impairment (n=45)
High-risk cytogenetics (n=37)
ISS stage III (n=35)
EMD (n=37)
Triple-class refractory (n=100)
Any grade
145 (100.0)
32 (100.0)
45 (100.0)
37 (100.0)
35 (100.0)
37 (100.0)
100 (100.0)
Grade 3/4
113 (77.9)
18 (56.3)
34 (75.6)
24 (64.9)
27 (77.1)
 29 (78.4)
75 (75.0)
Discontinuations
12 (8.3)
3 (9.4)
6 (13.3)
3 (8.1)
5 (14.3)
1 (2.7)
8 (8.0)
CRS
108 (74.5)
 22 (68.8)
 33 (73.3)
28 (75.7)
22 (62.9)
 29 (78.4)
 71 (71.0)
Dysgeusiaa
103 (71.0)
25 (78.1)
30 (66.7)
25 (67.6)
22 (62.9)
25 (67.6)
66 (66.0)
Infections
96 (66.2)
 25 (78.1)
 30 (66.7)
 26 (70.3)
 26 (74.3)
 17 (45.9)
 63 (63.0)
Skin relatedb
106 (73.1)
 26 (81.3)
 33 (73.3)
 29 (78.4)
 24 (68.6)
 26 (70.3)
 70 (70.0)
Nail relatedc
78 (53.8)
 20 (62.5)
 16 (35.6)
 22 (59.5)
 12 (34.3)
 22 (59.5)
 53 (53.0)
Rash relatedd
43 (29.7)
 11 (34.4)
 16 (35.6)
 7 (18.9)
 12 (34.3)
 11 (29.7)
 24 (24.0)
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; EMD, extramedullary disease; ISS, International Staging System; Q2W, every other week; QW, weekly; SC, subcutaneous.
Clinical data cutoff date of January 17, 2023.
aIncludes ageusia, dysgeusia, hypogeusia, and taste disorder. Per CTCAE, the maximum possible grade of dysgeusia is 2.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging.
dIncludes rash, maculopapular rash, erythematous rash, and erythema.

MonumenTAL-1 Study: Summary of AEs in Prior BCMA Subgroups6
AE, n (%)
Prior BCMA
Overall
TCR naïve (BCMA ADC allowed)
QW
(n=22)
TCR naïve (BCMA ADC allowed)
Q2W
(n=16)
TCR exposed (BCMA ADC allowed,
CAR-T, BsAb)
QW & Q2W
(n=48)
TCR naïve (BCMA ADC allowed)
QW  
(N=143)
TCR naïve (BCMA ADC allowed)
Q2W
(N=145)
TCR exposed (BCMA ADC allowed,
CAR-T, BsAb)
QW & Q2W (N=51)
Any grade
22 (100.0)
16 (100.0)
48 (100.0)
143 (100.0)
145 (100.0)
51 (100.0)
Grade 3/4
19 (86.4)
12 (75.0)
44 (91.7)
111 (77.6)
113 (77.9)
46 (90.2)
Discontinuations
0
0
3 (6.3)
7 (4.9)
12 (8.3)
4 (7.8)
CRS
17 (77.3)
13 (81.3)
36 (75.0)
113 (79.0)
108 (74.5)
39 (76.5)
Dysgeusiaa
15 (68.2)
9 (56.3)
36 (75.0)
103 (72.0)
103 (71.0)
39 (76.5)
Infections
9 (40.9)
11 (68.8)
34 (70.8)
84 (58.7)
96 (66.2)
37 (72.5)
Skin relatedb
9 (40.9)
13 (81.3)
33 (68.8)
80 (55.9)
106 (73.1)
35 (68.6)
Nail relatedc
9 (40.9)
10 (62.5)
29 (60.4)
78 (54.5)
78 (53.8)
32 (62.7)
Rash relatedd
13 (59.1)
5 (31.3)
17 (35.4)
57 (39.9)
43 (29.7)
18 (35.3)
Abbreviations: ADC, antibody-drug conjugate; AE, adverse event; BCMA, B-cell maturation antigen; BsAb, bispecific antibody; CAR-T, chimeric antigen receptor T-cell; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; Q2W, every other week; QW, weekly; TCR, T-cell redirection therapy.
Clinical data cutoff date of January 17, 2023.
aIncludes ageusia, dysgeusia, hypogeusia, and taste disorder. Per CTCAE, the maximum possible grade of dysgeusia is 2.
bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome.
cIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. dIncludes rash, maculopapular rash, erythematous rash, and erythema.

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 21 April 2025.

 

References

Show
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9 Jakubowiak AJ, Anguille S, Karlin L, et al. Updated results of talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma with prior exposure to T-cell redirecting therapies: results of the phase 1/2 MonumenTAL-1 study. Poster presented at: The 65th American Society of Hematology (ASH) Annual Meeting; December 9-12, 2023; San Diego, CA/Virtual.  
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