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RedirecTT-1 (MMY1003) Study - TALVEY AND TECVAYLI Cohort

Last Updated: 02/14/2025

SUMMARY

  • Janssen does not recommend the use of TALVEY or TECVAYLI® (teclistamab-cqyv) in a manner that is inconsistent with the approved labeling.
  • RedirecTT-1 (MMY1003) is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of the TALVEY and TECVAYLI combination in patients with relapsed or refractory multiple myeloma (RRMM).1-4
    • Cohen et al (2025)3,5 published early safety and efficacy results from the phase 1 dose-escalation segment of the RedirecTT-1 study.
      • All dose levels (dose levels 1-5; N=94): At a median follow-up of 20.3 months (range, 0.5-37.1), the overall response rate (ORR) was 78%. Any-grade adverse events (AEs) were reported in all patients, with grade 3/4 AEs reported in 96% of patients (n=90).
      • Recommended phase 2 regimen (RP2R; dose level 5; n=44): At a median follow-up of 18.2 months (range, 0.7-27.0), the ORR was 80%.
    • Cohen et al (2023)2 presented the preliminary efficacy and safety results in the evaluated cohorts.
      • All dose levels (N=93): At a median follow-up of 13.4 months (range, 0.3-25.6), the ORR was 86.6% in response-evaluable patients (n=71/82). Any-grade AEs were reported in 96% of patients (n=90) with grade 3/4 AEs reported in 88.2% of patients (n=82).
      • RP2R (n=34): At a median follow-up of 8.1 months (range, 0.7-15.0), ORR was 96.3% in response-evaluable patients (n=26/27). Any-grade AEs were reported in 94.1% of patients (n=32) with grade 3/4 AEs reported in 79.4% of patients (n=27).

PRODUCT LABELING

CLINICAL DATA - Redirectt-1 study - TALVEY + TECVAYLI Cohort

RedirecTT-1 (MMY1003; clinicaltrials.gov identifier: NCT04586426) is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of the combination of TALVEY and TECVAYLI in patients with RRMM.1-4

Study Design/Methods

RedirecTT-1 (Phase 1): Study Design1,3,5,6

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.
aNonsecretory or oligosecretory EMD were permitted.

bTal and Tec were administered on the same day, 30 (±10) minutes apart, for all step-up and full treatment doses.
cThere was no protocol-specified order of administration of each therapy. SUD was administered 2-4 days apart and prior to full treatment doses. Hospitalization and pretreatment with dexamethasone, diphenhydramine, and acetaminophen were required before all SUD and first treatment dose.
dPer protocol, although the Tal SUD #3 was 0.3 mg/kg in parts 1 and 2 (phase 1), the RP2D was determined to be 0.4 mg/kg based on PK, PD, safety, and efficacy findings, and this dose will be used for SUD #3 in part 3 (phase 2).

RedirecTT-1 (Phase 2 Tal + Tec in EMD): Study Design1  

Abbreviations: C, cycle; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; Q2W, every other week; Q4W, once every 4 weeks; RRMM, relapsed/refractory multiple myeloma; Tal, talquetamab; Tec, teclistamab; VGPR, very good partial response.

aOptional switch to Q4W dosing from C5+ if response is ≥VGPR and for any response C7+.

Cohen et al (2025)3,5 published early safety and efficacy results from the phase 1 dose-escalation segment of the RedirecTT-1 study across all dose levels (dose levels 1-5) and RP2R (dose level 5) cohorts.

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

  • A total of 94 patients were enrolled and received TALVEY and TECVAYLI; 44 patients received the RP2R.
  • The median duration of follow-up was 20.3 months (range, 0.5-37.1) in the all dose levels and 18.2 months (range, 0.7-27.0) in the RP2R cohorts. See Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Baseline Characteristics for additional details.
  • Overall, 49 patients (52%) at all dose levels remained on dual therapy, while 1 patient (1%) discontinued TALVEY but continued with TECVAYLI monotherapy.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Baseline Characteristics3 
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, n (%)
   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 (%)
   Proteasome inhibitor
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, n (%)
81 (86)
37 (84)
Penta-refractory diseasej, n (%)
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; 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 proteasome inhibitor, and an anti-CD38 therapy.
jRefractory to ≥2 immunomodulatory drugs, ≥2 proteasome inhibitors, and ≥1 anti-CD38 therapies.

Efficacy

Extramedullary Disease

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of Efficacy Outcomes3 
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.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Overall Response in Clinically Relevant Subgroups5 
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. 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.
aEMD was assessed by physical examination every 4 weeks and radiologic assessment every 12 weeks.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Response Summary in Patients With EMDa,1,3
Response Rate
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.

Safety

Treatment Discontinuation or Dose Modifications
Mortality
Cytokine Release Syndrome
Neurotoxicity
  • Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 3 patients (3%), including 1 grade 3 ICANS event; 1 patient had 2 events.
  • Two out of 4 ICANS events were concurrent with CRS. All ICANS events occurred during SUD.
  • The median time to onset of ICANS was 2.5 days; the median duration of ICANS was 3 days. All events recovered.
Infections
  • Details on infections are presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Infections (≥5% Overall).
  • Across all dose levels, the incidence of first onset of grade ≥3 infections was higher in the first 6 months of study treatment and then plateaued. The timing of the first onset of grade ≥3 infections is shown in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Timing of First Onset of Grade ≥3 Infections in Patients Across All Dose Levels.
  • Infection prophylaxis was administered as per institutional guidelines. A total of 82% of patients (n=77) across all dose levels received antiviral prophylaxis, and 49% of the patients (n=46) received prophylaxis against Pneumocystis jirovecii pneumonia.
  • In total, 63% of patients (n=59) received a COVID-19 vaccine.
  • Immunoglobulin replacement therapy (0.4 g/kg every 3-6 weeks) was recommended to maintain serum immunoglobulin G (IgG) levels above 400 mg/dL, regardless of current or past infections, with monitoring recommended at least every 3 months after reaching steady state.
  • Immunoglobulin replacement was provided per institutional guidelines for managing serious, recurrent, or chronic infections.
Hypogammaglobulinemia
  • At baseline, 56% of patients across all dose levels (n=53) had non-IgG myeloma.
    • Of these patients, 70% of patients (n=37) had hypogammaglobulinemia (defined as IgG <400 mg/dL) at baseline and 57% of patients (n=30) had post-treatment hypogammaglobulinemia.
  • The assessments excluded patients with IgG myeloma and those who received intravenous immunoglobulin (IVIG) replacement.
  • A total of 57% of patients (n=30) with non-IgG myeloma received IVIG.
Pyrexia

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of Hematologic and Nonhematologic AEs (>25% Overall)3 
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.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of GPRC5D-Related AEs in Patients Across All Dose Levels3,5 
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).

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): AEs Leading to Discontinuation in Patients Across Dose Levels 1-55 
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 pneunomia
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.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): AEs Leading to Death in Patients Across Dose Levels 1-55
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.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Incidence and Management of CRS1,3 
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.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Infections (≥5% Overall)3,5 
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).

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Timing of First Onset of Grade ≥3 Infections in Patients Across All Dose Levels5 
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.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of Pyrexia in Patients Across All Dose Levels5 
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

  • At RP2R, TALVEY and TECVAYLI exposures were similar to those observed with each agent as monotherapy.
  • T-cell activation was highly variable but consistent across all dose levels.

Cohen et al (2023)2  presented the preliminary efficacy and safety results for the all-dose levels cohort and the TALVEY and TECVAYLI RP2R cohort in the RedirecTT-1 study.

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics


RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Baseline Characteristics and Demographics2
Characteristic
All Dose Levels
(N=93)
RP2R
(n=34)
Age (years), median (range)
65.0 (39-81)
65.0 (41-80)
Male, n (%)
48 (51.6)
18 (52.9)
Race, n (%)
   White
74 (79.6)
24 (70.6)
   Asian
17 (18.3)
10 (29.4)
   Black/African American
1 (1.1)
0
   Unknown
1 (1.1)
0
Bone marrow plasma cells ≥60%, n/N (%)
19/87 (21.8)
7/29 (24.1)
Extramedullary plasmacytoma(s)a, n (%)
35 (37.6)
11 (32.4)
High-risk cytogeneticsb, n/N (%)
21/63 (33.3)
7/21 (33.3)
ISS stagec, n/N (%)
   I
39/85 (45.9)
16/32 (50.0)
   II
25/85 (29.4)
10/32 (31.3)
   III
21/85 (24.7)
6/32 (18.8)
Time since diagnosis (years), median (range)

5.9 (0.04-14.2)

5.8 (0.3-12.8)
Prior lines of therapy, n, median (range)
4 (1-11)
4 (2-10)
Prior ASCT, n (%)
73 (78.5)
24 (70.6)
Exposure status, n (%)
   Penta-drug
61 (65.6)
20 (58.8)
   Belantamab mafodotin
18 (19.4)
4 (11.8)
   Idecabtagene vicleucel
1 (1.1)
1 (2.9)
   Bispecific antibodies
7 (7.5)
1 (2.9)
Refractory status, n (%)
   Triple-class
74 (79.6)
26 (76.5)
   Penta-drug
24 (25.8)
7 (20.6)
   To last line of therapy
83 (89.2)
30 (88.2)
Abbreviations: ASCT, autologous stem-cell transplantation; FISH, fluorescence in situ hybridization; ISS, International Staging System; RP2R, recommended phase 2 regimen.
Clinical data cutoff date of cutoff March 16, 2023.
aOrigin in soft tissue, measuring ≥2 cm.
bCytogenetic risk based on FISH or karyotype testing; high-risk includes del(17p), t(4;14), and/or t(14;16).
cISS staging derived based on the combination of serum β2-macroglobulin and albumin.

Efficacy

Extramedullary Disease

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Efficacy Outcomes2
Response Ratea
All Dose Levels
(N=93)
RP2R
(n=34)
ORR, n/N (% [95% CI])
71/82 (86.6 [77.3-93.1])
26/27 (96.3 [81.0-99.9])
   sCR, %
18.3
18.5
   CR, %
22.0
22.2
   VGPR, %
36.6
48.1
   PR, %
9.8
7.4
≥CR, % (95% CI)
40.2 (29.6-51.7)
40.7 (22.4-61.2)
Median DORb, months (95% CI)
NE (NE-NE)
NE (NE-NE)
Median time to first responseb, months (range)
1.97 (0-7.7)
1.48 (0-4.0)
Median time to best responseb, months (range)
3.98 (1.1-15.7)
3.22 (1.4-10.7)
Median PFSc, months (95% CI)
20.9 (13.0-NE)
NE (9.9-NE)
   9-month PFS ratec, (95% CI)
70.1 (58.0-79.4)
77.1 (50.8-90.5)
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; IMWG, International Myeloma Working Group; NE, not estimable; ORR, overall response rate; PFS, progression-free survival; PR, partial response; Q2W, every other week; RP2R, recommended phase 2 regimen; sCR, stringent complete response; VGPR, very good partial response.
Clinical data cutoff date of March 16, 2023. The median follow-up time was 13.4 months and 8.1 months for all dose levels and RP2R cohorts, respectively.
aResponse was assessed by investigators based on the IMWG criteria; response-evaluable patients have received ≥1 study treatment and have ≥1 postbaseline response evaluation by investigator.
bIncludes patients with confirmed response.
cAll treated patients.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Response Summary in Patients With EMDa,2
Response Rateb
All Dose Levels
(n=35)
RP2R
(n=11)
ORR, n/N (% [95% CI])
20/28 (71.4 [51.3-86.8])
6/7 (85.7 [42.1-99.6])
   sCR, %
3.6
0
   CR, %
17.9
28.6
   VGPR, %
28.6
42.9
   PR, %
21.4
14.3
≥CR, % (95% CI)
21.2 (8.3-41.0)
28.6 (3.7-71.0)
Median DORc, months (95% CI)
12.9 (4.17-NE)
NE (4.17-NE)
Median PFSd, months (95% CI)
6.1 (2.5-9.9)
9.9 (2.4-NE)
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 16, 2023. The median follow-up time was 13.4 months and 7.2 months (range, 0.7-14.2) months for all dose levels and RP2R cohorts, respectively.
aAll were soft tissue plasmacytomas.
bResponse was assessed by investigators based on the IMWG criteria; response-evaluable patients have received ≥1 study treatment and have ≥1 postbaseline response evaluation by investigator.
cIncludes patients with confirmed response.
dAll treated patients.  

Safety

  • All dose levels (N=93): At a median follow-up of 13.4 months (range, 0.3-25.6), any-grade TEAEs were reported in 96.8% of patients (n=90) and ≥1 grade 3/4 TEAEs were reported in 88.2% of patients (n=82).
    • Discontinuations due to TEAEs (any grade) were reported in 6.5% of patients (n=6). No discontinuations were reported due to hematologic TEAEs.
    • Treatment-related deaths were reported in 6.5% of patients (n=6).
  • RP2R (n=34): At a median follow-up of 8.1 months (range, 0.7-15.0), any-grade TEAEs were reported in 94.1% of patients (n=32) and ≥1 grade 3/4 TEAEs were reported in 79.4% of patients (n=27).
    • Discontinuations due to TEAEs (any grade) were reported in 5.9% of patients (n=2). No discontinuations were reported due to hematologic TEAEs.
    • One treatment-related death was reported (2.9%).
Hematologic TEAEs
Nonhematologic TEAEs
  • The incidence of nonhematologic TEAEs is summarized in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Nonhematologic TEAEs (≥25%).
  • All dose levels (N=93): 81.7% of patients reported a hypogammaglobulinemia TEAE or ≥1 postbaseline IgG value <400 mg/dL. All were grade 1 or 2.
  • RP2R (n=34): 85.3% of patients reported a hypogammaglobulinemia TEAE or ≥1 postbaseline IgG value <400 mg/dL.
  • Thirty-seven patients were administered IVIG, including 15 patients in the RP2R group.
Cytokine Release Syndrome
  • Details on CRS occurrence and management are presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Incidence and Management of CRS. The majority of CRS events occurred during SUD or cycle 1. All CRS events resolved at data cutoff.
    • All dose levels (N=93): The median time to onset of CRS (relative to the most recent dose) was 2 days (range, 1-5). The median duration of CRS was 2 days (range, 1-8).
    • RP2R (n=34): The median time to onset of CRS (relative to the most recent dose) was 2 days (range, 1-4). The median duration of CRS was 2 days (range, 1-4).
Neurotoxicity
  • A total of 5 ICANS events were reported in 3 patients. One transient grade 3 ICANS event occurred in a non-RP2R dose group. All other ICANS events were grade 1.
Infections

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Hematologic TEAEs (≥20%)2
TEAEa, n (%)
All Dose Levels
(N=93)
RP2R
(n=34)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Neutropenia
61 (65.6)
57 (61.3)
19 (55.9)
15 (44.1)
Anemia
47 (50.5)
32 (34.4)
11 (32.4)
8 (23.5)
Thrombocytopenia
40 (43.0)
27 (29.0)
11 (32.4)
8 (23.5)
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; RP2R, recommended phase 2 regimen; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of March 16, 2023. The median follow-up time was 13.4 months and 8.1 months for all dose levels and RP2R cohorts, respectively.
aTEAEs were graded per CTCAE v5.0.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Nonhematologic TEAEs (≥25%)2
TEAEa, n (%)
All Dose Levels
(N=93)
RP2R
(n=34)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
CRS
71 (76.3)
3 (3.2)
25 (73.5)
0
Dysgeusiab,c
57 (61.3)
-
16 (47.1)
-
Pyrexia
47 (50.5)
2 (2.2)
13 (38.2)
1 (2.9)
Skin toxicityd
50 (53.8)
0
18 (52.9)
0
Nail disorderse
43 (46.2)
0
14 (41.2)
0
Diarrhea
38 (40.9)
2 (2.2)
14 (41.2)
1 (2.9)
Cough
36 (38.7)
0
8 (23.5)
0
Dry mouth
35 (37.6)
0
11 (32.4)
0
Rashf
32 (34.4)
1 (1.1)
10 (29.4)
1 (2.9)
COVID-19
31 (33.3)
9 (9.7)
14 (41.2)
1 (2.9)
Pneumonia
25 (26.9)
10 (10.8)
4 (11.8)
2 (5.9)
Fatigue
24 (25.8)
7 (7.5)
6 (17.6)
2 (5.9)
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; RP2R, recommended phase 2 regimen; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of March 16, 2023. The median follow-up time was 13.4 months and 8.1 months for all dose levels and RP2R cohorts, respectively.
aTEAEs were graded per CTCAE v5.0 and CRS events were graded per the ASTCT criteria.
bIncludes ageusia, dysgeusia, hypogeusia, and taste disorder.
cPer CTCAE, the maximum grade of dysgeusia is 2.
dIncludes skin exfoliation, dry skin, pruritus, palmar-plantar erythrodysesthesia syndrome.
eIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, nail ridging.
fIncludes rash, rash papular, rash erythematous, erythema.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Incidence and Management of CRS2
Parameter, n (%)
All Dose Levels (N=93)
RP2R
(n=34)
Patients with CRS event
71 (76.3)
25 (73.5)
Maximum toxicity gradea
   Grade 1
44 (47.3)
16 (47.1)
   Grade 2
24 (25.8)
9 (26.5)
   Grade 3
3 (3.2)
0
Patients who received supportive measuresb
   Tocilizumabc
25 (26.9)
7 (20.6)
   Steroids
4 (4.3)
0
   Oxygen
7 (7.5)
0
   Vasopressor
1 (1.1)
0
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; RP2R, recommended phase 2 regimen.
Clinical data cutoff date of March 16, 2023. The median follow-up time was 13.4 months and 8.1 months for all dose levels and RP2R cohorts, respectively.
aCRS was graded by the ASTCT criteria.
bPatients could receive >1 supportive therapy.
cTocilizumab was allowed for all CRS events and was allowed at grade 1 CRS; the protocol did not recommend prophylactic tocilizumab use.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Infections (≥5%)2
TEAEsa, n (%)
All Dose Levels
(N=93)
RP2R
(n=34)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Infections
78 (83.9)
49 (52.7)
27 (79.4)
13 (38.2)
   COVID-19
31 (33.3)
9 (9.7)
14 (41.2)
1 (2.9)
   Pneumonia
25 (26.9)
10 (10.8)
4 (11.8)
2 (5.9)
   Upper respiratory tract infection
11 (11.8)
2 (2.2)
4 (11.8)
0
   Nasopharyngitis
8 (8.6)
0
2 (5.9)
0
   Rhinovirus infection
8 (8.6)
2 (2.2)
2 (5.9)
0
   Oral candidiasis
7 (7.5)
1 (1.1)
2 (5.9)
0
   Septic shock
7 (7.5)
6 (6.5)b
1 (2.9)
1 (2.9)
   Urinary tract infection
7 (7.5)
1 (1.1)
5 (14.7)
1 (2.9)
   COVID-19 pneumonia
6 (6.5)
5 (5.4)
4 (11.8)
3 (8.8)
   Bacteremia
5 (5.4)
2 (2.2)
1 (2.9)
0
   Bronchitis
5 (5.4)
2 (2.2)
0
0
   Sinusitis
5 (5.4)
0
1 (2.9)
0
Abbreviations: COVID-19, coronavirus disease 2019; CTCAE, Common Terminology Criteria for Adverse Events; RP2R, recommended phase 2 regimen; TEAE, treatment-emergent adverse event.
Clinical data cutoff date of March 16, 2023. The median follow-up time was 13.4 months and 8.1 months for all dose levels and RP2R cohorts, respectively.
aTEAEs were graded per CTCAE v5.0.
bThere was 1 grade 5 septic shock.

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 14 February 2025.

References

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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.  
2 Cohen Y, Morillo D, Gatt M, et al. First results from the RedirecTT-1 study with teclistamab + talquetamab simultaneously targeting BCMA and GPRC5D in patients with relapsed/refractory multiple myeloma. Oral presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL, USA & Virtual.  
3 Cohen YC, Magen H, Gatt M, et al. Talquetamab plus teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2025;392(2):138-149.  
4 Janssen Research & Development, LLC. A phase 1b/2 dose escalation and expansion study of the combination of the bispecific T cell redirection antibodies talquetamab and teclistamab in participants with relapsed or refractory multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 February 14]. Available from: https://clinicaltrials.gov/ct2/show/NCT04586426 NLM Identifier: NCT04586426.  
5 Cohen YC, Magen H, Gatt M, et al. Supplement to: Talquetamab plus teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2025;392(2):138-149.  
6 Cohen YC, Magen H, Gatt M, et al. Protocol to: Talquetamab plus teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2025;392(2):138-149.