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TECVAYLI® (teclistamab-cqyv)

Medical Information

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

Last Updated: 06/25/2025

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 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), including those with extramedullary disease (EMD).¹^-⁵
- Kumar et al (2025)⁵ presented efficacy and safety results from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD. At a median follow-up of 12.6 months (range, 0.5-19.5), overall response rate (ORR) was 78.9% in the TALVEY + TECVAYLI cohort. The most common any-grade adverse events (AEs) in the TALVEY + TECVAYLI cohort were taste changes (78.9%), cytokine release syndrome (CRS; 77.8%), and neutropenia (72.2%).
- Cohen et al (2025)³^,⁶ published early safety and efficacy results from the phase 1 dose-escalation segment of the RedirecTT-1 study in RRMM patients with and without EMD.
  - All dose levels (dose levels 1-5; N=94): At a median follow-up of 20.3 months (range, 0.5-37.1), the ORR was 78%. Any-grade 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 all dose levels cohort (N=93) at a median follow up of 13.4 months, and the RP2R cohort (n=34) at a median follow-up of 8.1 months.

PRODUCT LABELING

TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.
TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.

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 including those with EMD.¹^-⁵

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

Study Design/Methods

The phase 1 and phase 2 study design is presented in Figures: RedirecTT-1 (Phase 1): Study Design and RedirecTT-1 (Phase 2: Tal + Tec in EMD): Study Design.

RedirecTT-1 (Phase 1): Study Design¹^,³^,⁶^,⁷

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 Design⁵

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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.

^aPatients may have had paraskeletal plasmacytomas in addition to true EMD.
^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.
^eResponse was assessed by independent review committee per IMWG criteria.

^fEMD response assessed by central radiology review of whole-body PET-CT scans.

Kumar et al (2025)⁵ presented efficacy and safety results from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD.

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

A total of 90 patients received TALVEY and TECVAYLI. See Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Baseline Characteristics.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Baseline Characteristics⁵

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 ≥1^a, n (%)	90 (100)^b
Number of extramedullary plasmacytomas^a, median (range)	2 (1-7)
Number of extramedullary plasmacytomas^a, median (range)
1	38 (42.2)
2-3	29 (32.2)
≥4	23 (25.6)
High-risk cytogenetics^c, n (%)	14 (21.5)
Measurable disease^d, 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 diagnosis^e, 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 therapy^f	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.

Efficacy

Efficacy outcomes are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Summary of Efficacy Outcomes.
ORR by prior therapy is presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): ORR by Prior Therapy.
At a median follow-up of 13.4 months, 66.2% of responders remained on therapy at the data cutoff.
- Of the 71 responders, 55 (77.5%) switched to monthly dosing (TALVEY 0.8 mg/kg once every 4 weeks [Q4W] + TECVAYLI 3.0 mg/kg Q4W, following discontinuation of TALVEY).
  - Most patients switched to Q4W dosing after cycles 4-6.
  - Following the switch, 92.7% of responses were either maintained or further deepened.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Summary of Efficacy Outcomes⁵

Response Rate	TALVEY + TECVAYLI (N=90)
Median follow-up, months (range)	12.6 (0.5-19.5)
ORR^a, % (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.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): ORR by Prior Therapy⁵

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.

Safety

Summary of AEs in the TALVEY + TECVAYLI cohort are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Summary of Hematologic and Nonhematologic AEs (≥30% Overall).

Treatment Discontinuation

Discontinuation due to treatment-emergent adverse events (TEAEs) was reported in 3 patients (pseudomonal pneumonia and pseudomonal sepsis, n=1; dry mouth, dysphagia, and decreased weight, n=1; immune effector cell-associated neurotoxicity syndrome [ICANS], n=1) for TALVEY + TECVAYLI.
For TALVEY only, discontinuation due to TEAEs was reported in 2 patients (dysgeusia and dysphagia, n=1; hypohidrosis, n=1).

Mortality

Deaths due to AEs were reported in 11.1% of patients (n=10), including 5 from treatment-emergent infections and 5 from noninfectious AEs (related: aspiration, n=1; unrelated: respiratory failure, euthanasia, general physical health deterioration, and cerebellar hemorrhage, n=1 each).

Cytokine Release Syndrome

Details on occurrence and management of CRS are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Incidence and Management of CRS.

Neurotoxicity

Details on occurrence and management of ICANS are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Incidence and Management of ICANS.

Infections and Hypogammaglobulinemia

Details on infections are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Infections (≥10% Overall).
Grade 3/4 infections were primarily observed during early treatment cycles.
Deaths due to infections were reported in 5.6% of patients, with coronavirus disease 2019 (COVID-19) pneumonia, Klebsiella sepsis, pneumonia, Klebsiella pneumonia, and pseudomonal sepsis reported in 1 patient each.
Antiviral prophylaxis was administered to 96.7% of patients.
Treatment-emergent hypogammaglobulinemia or post-treatment immunoglobulin G (IgG) levels below 400 mg/dL were reported in 70% of patients.
A total of 86.7% of patients received ≥1 dose of intravenous immunoglobulin (IVIG).

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Summary of Hematologic and Nonhematologic AEs (≥30% Overall)⁵

AE^a, n (%)	TALVEY + TECVAYLI (N=90)
AE^a, n (%)	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 changes^b	71 (78.9)	NA
CRS	70 (77.8)	0 (0)
Nonrash skin AEs^c	62 (68.9)	0 (0)
Nail-related AEs^d	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)
Pyrexia^e	28 (31.1)	1 (1.1)
Hypokalemia	27 (30.0)	7 (7.8)
Fatigue	27 (30.0)	3 (3.3)
Nausea^e	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.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Incidence and Management of CRS⁵

AE	TALVEY + TECVAYLI (N=90)
Patients with CRS^a, n (%)	70 (77.8)
Grade 1	53 (58.9)
Grade 2	17 (18.9)
Grade 3	0 (0)
Occurrence of CRS^b, 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 onset^c, days (range)	2 (1-29)
Median duration, days (range)	2 (1-8)
Supportive measures^d, %
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.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Incidence and Management of ICANS⁵

AE	TALVEY + TECVAYLI (N=90)
Patients with ICANS^a, 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 ICANS^b, 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 onset^c, days (range)	3 (1-7)
Median duration, days (range)	2 (1-7)
Supportive measure^d, %
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.

RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Infections (≥10% Overall)⁵

AE^a, n (%)	TALVEY + TECVAYLI (N=90)
AE^a, n (%)	Any Grade	Grade 3/4^b
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.

Cohen et al (2025)³^,⁶ 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 in RRMM patients, including those with EMD.

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 Levels^a (N=94)	RP2R^a (n=44)
Age, years, median (range)	64.5 (39-81)	63.0 (41-80)
Male, n (%)	49 (52)	23 (52)
Race^b, 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 ≥1^d, n (%)	34 (36)	18 (41)
High-risk cytogenetics^e, n/N (%)	21/51 (41)	8/19 (42)
ISS stage^f, 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 score^g, 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 antibodies^h	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, n (%)	81 (86)	37 (84)
Penta-refractory disease^j, 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; 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.

Efficacy

Efficacy outcomes are presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of Efficacy Outcomes.
All 28 patients who transitioned from an administration of every other week (Q2W) to Q4W at the RP2R maintained or experienced deepened responses.
Overall response across clinically relevant subgroups is presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Overall Response in Clinically Relevant Subgroups.

Extramedullary Disease

Efficacy outcomes in all dose levels, dose levels 1-4, and RP2R cohorts in patients with EMD are presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Response Summary in Patients With EMD.

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 Subgroups⁶

Parameter	All Dose levels		RP2R
Parameter	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 plasmacytomas^a
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.

RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Response Summary in Patients With EMD^a,¹^,³

Response Rate	All Dose Levels (N=34)	Dose Level 1-4 (n=16)	RP2R (n=18)
ORR^b, 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

TEAEs are presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of Hematologic and Nonhematologic AEs (>25% Overall).
A total of 3 patients had dose-limiting toxicities at dose level 1 (grade 3 oral herpes), dose level 3 (grade 3 elevated alanine aminotransaminase /aspartate aminotransferase), and at the RP2R (grade 4 thrombocytopenia).
G protein-coupled receptor class C, group 5, member D (GPRC5D)-related AEs are detailed in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of GPRC5D-Related AEs in Patients Across All Dose Levels.
Grade 3 tumor flare reaction was reported in 1 patient (1%).

Treatment Discontinuation or Dose Modifications

Cycle delays or dose modification due to AEs were reported in 93% of patients (n=87), primarily due to infections (68%, n=64).
Discontinuation of one or both agents due to AEs was reported in 16% of patients (n=15). See Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): AEs Leading to Discontinuation in Patients Across Dose Levels 1-5.
A total of 7% of discontinuations (n=7) were considered by the investigator to be related to a study drug, of which 5% of discontinuations (n=5) were due to infections.

Mortality

Deaths due to AEs were reported in 15% of patients (n=14) across all dose levels, of which 11 deaths were due to infections. See Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): AEs Leading to Death in Patients Across Dose Levels 1-5.
The investigator attributed 6 deaths due to a study drug, but there is insufficient evidence to confirm whether the other events were related to treatment.
A total of 4 patients (4%) died due to disease progression.

Cytokine Release Syndrome

Details on occurrence and management of CRS are presented in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Incidence and Management of CRS.
Most CRS events occurred during step-up dosing (SUD) and early cycles of treatment administration.

Neurotoxicity

ICANS was reported 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 IgG levels above 400 mg/dL, regardless of current or past infections, with monitoring recommended at least every 3 months after reaching steady state.
Ig 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 IVIG replacement.
A total of 57% of patients (n=30) with non-IgG myeloma received IVIG.

Pyrexia

The majority of pyrexia events occurring within the first 6 months of study treatment were concurrent with other AEs, including infections, CRS, and injection-site reactions. See Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Summary of Pyrexia in Patients Across All Dose Levels.

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

AE^a, n (%)	All Dose Levels (N=94)
AE^a, n (%)	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 changes^b	61 (65)	-
Nonrash skin AEs^c	57 (61)	0
Nail-related AEs^d	49 (52)	0
Pyrexia^e	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 AEs^f	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^,⁶

Event^a	All Dose Levels (N=94)
Event^a	Taste-Change AE^b	Skin-Related AE^c	Rash AE^d	Nail-Related AE^e
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 1-5⁶

Events^a, 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 infection^b	1 (16.7)	0	0	0	0
COVID-19 pneumonia^b	0	0	0	0	1 (2.3)
Aspiration pneumonia	0	0	0	1 (9.1)	0
Cytomegaloviral pneumonia^b	0	0	1 (3.6)	0	0
Respiratory tract infection^b	0	0	1 (3.6)	0	0
Sepsis^b	0	0	1 (3.6)	0	0
Septic shock	0	0	1 (3.6)	0	0
Pulmonary toxicity^b,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 bleeding^b,d	0	0	0	0	1 (2.3)
Tongue discomfort^b,d	0	0	0	0	1 (2.3)
Multiple organ dysfunction syndrome	1 (16.7)	0	0	0	0
Pain in extremity^d	0	0	0	0	1 (2.3)
Myelodysplastic syndrome^c	0	0	1 (3.6)	0	0
Dysgeusia^b,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 1-5⁶

Events^a, 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 infection^b	1 (16.7)	0	0	0	0
COVID-19	1 (16.7)	0	0	0	0
COVID-19 pneumonia^b	0	0	0	0	1 (2.3)
JC virus infection^b,c	0	0	1 (3.6)	0	0
Aspiration pneumonia	0	0	0	1 (9.1)	0
Cytomegaloviral pneumonia^b	0	0	1 (3.6)	0	0
Respiratory tract infection^b	0	0	1 (3.6)	0	0
Sepsis^b	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 event^a, 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 onset^b, days (range)	2 (1-733)
Median duration, days (range)	2 (1-8)
Patients who received supportive measures^c, 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^,⁶

AE^a, n (%)	All Dose Levels (N=94)
AE^a, n (%)	Any Grade	Grade 3/4
Infections^b	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 infection^c	5 (5.3)	2 (2.1)
Opportunistic infections^d	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 resolved^e, 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 Levels⁶

Parameter	Event Onset Within Time Periods
Parameter	Total	≤6 Months	>6 to ≤12 Months	>12 to ≤18 Months	>18 to ≤24 Months	>24 Months
Total number of patients treated within window^a, 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 Levels⁶

Events^a, 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.

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 23 June 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 June 23]. Available from: https://clinicaltrials.gov/ct2/show/NCT04586426 NLM Identifier: NCT04586426.
5	Kumar S, Mateos MV, Ye JC, et al. Phase 2 study of talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma and extramedullary disease: RedirecTT-1. Oral Presentation presented at: the 2025 European Hematology Association (EHA) Annual Meeting; June 12-15, 2025; Milan, Italy.
6	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.
7	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.

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