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TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - MajesTEC-5 Study - TALVEY-Based Induction Regimen
Last Updated: 10/15/2026
Summary
- Johnson & Johnson does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by regulatory agencies.
- MajesTEC-5 is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TALVEY- and TECVAYLI®
(teclistamab-cqyv)-based combination regimens in patients with transplant-eligible (TE), newly diagnosed multiple myeloma (NDMM).1 - Rasche et al (2026)1 presented efficacy and safety results of the MajesTEC-5 study evaluating TALVEY in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase) and lenalidomide (Tal-DR) induction therapy in patients with TE-NDMM at a median follow-up of 12.5 months (range, 3.4-14.9 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.
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.
CLINICAL DATA - MAJESTEC-5 STUDY
Study Design/Methods
- The study design is presented in Figure: MajesTEC-5 Study Design - Tal-DR Induction.
Abbreviations: AE, adverse event; ASCT, autologous stem cell transplant; C, cycle; CR, complete response; d, dexamethasone; Dara, daratumumab; ECOG PS, Eastern Cooperative Oncology Group performance status; HDT, high-dose therapy; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; NGF, next-generation flow cytometry; ORR, overall response rate; Q4W, every 4 weeks; Q2W, every 2 weeks; QD, once daily; QW, weekly; R, lenalidomide; SAE, serious adverse event; SoC, standard of care; SUD, step-up dosing; Tal, talquetamab; Tal-DR, talquetamab + daratumumab + lenalidomide; TE, transplant-eligible; Tec, teclistamab; VGPR, very good partial response.
a
b
c
Results
- A total of 21 patients were enrolled; 20 patients received ≥1 treatment dose, while 1 patient did not receive treatment.
- Of the 20 treated patients, 19 patients completed 6 cycles of Tal-DR induction (one patient completed only 3 cycles of induction).
- Nineteen patients underwent successful stem cell mobilization, and 18 patients subsequently underwent autologous stem cell transplant. Two patients discontinued treatment (1 each due to adverse event [AEs] after completing 6 cycles prior to autologous stem cell transplant and insufficient response during induction).
- At the time of data cutoff, 17 patients continued to maintenance therapy.
Treatment Disposition, Baseline Demographics, and Disease Characteristics
- A total of 20 patients were included in the study.
- Baseline demographic and disease characteristics are shown in Table: MajesTEC-5 Study: Select Baseline Demographics.
| Characteristic | Tal-DR (N=20) |
|---|---|
| Median age, years (range) | 57.5 (45-69) |
| ≥65, n (%) | 5 (25) |
| Male, n (%) | 15 (75) |
| Race, n (%) | |
| White | 20 (100) |
| ECOG PS score, n (%) | |
| ≤1 | 18 (90) |
| 2 | 2 (10) |
| ≥60% BMPCs, n (%) | 11 (55) |
| ≥1 soft tissue plasmacytoma, n (%) | 1 (5) |
| ISS disease stage, n (%) | |
| I | 9 (45) |
| II | 5 (25) |
| III | 6 (30) |
| High cytogenetic riska, n (%) | 6 (30) |
| Abbreviations: BMPC, bone marrow plasma cell; ECOG PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescence in situ hybridization; ISS, International Staging System; Tal-DR, TALVEY + DARZALEX FASPRO + lenalidomide. aCytogenetic risk is based on central FISH or local FISH if central FISH is unavailable. High cytogenetic risk is defined as the presence of ≥1 of the following abnormalities: del(17p), t(4;14), or t(14;16). | |
Safety
- Summary of AEs is shown in Table: MajesTEC-5 Study: Summary of AEs.
| TEAE, n (%) | Tal-DR (N=20) | |
|---|---|---|
| Any Grade | Grade 3/4 | |
| Any AE | 20 (100) | 13 (65) |
| Hematologic | ||
| Neutropenia | 7 (35) | 6 (30) |
| Leukopenia | 8 (40) | 6 (30) |
| Lymphopenia | 5 (25) | 5 (25) |
| Thrombocytopenia | 4 (20) | 2 (10) |
| Anemia | 3 (15) | 2 (10) |
| Non-hematologica | ||
| Taste changesb | 16 (80) | - |
| Infections | 14 (70) | 4 (20) |
| CRS | 14 (70) | 0 |
| Hypogammaglobulinemia | 11 (55) | 1 (5) |
| Rash AEc | 11 (55) | 2 (10) |
| Fatigue | 9 (45) | 1 (5) |
| Decreased weight | 8 (40) | 3 (15) |
| Nausea | 7 (35) | 0 |
| Hypokalemia | 7 (35) | 0 |
| Abbreviations: AE, adverse event; CRS, cytokine release syndrome; G, Grade; ICANS, immune effector cell-associated neurotoxicity syndrome; Tal-DR, TALVEY + DARZALEX FASPRO + lenalidomide; TEAE, treatment emergent adverse event. Note: Median follow-up: 12.5 months (range, 3.4-14.9). Data cutoff: March 2, 2026. aAEs shown are those occurring in >30% of patients. bTaste changes included dysgeusia, ageusia, hypogeusia, and taste disorder. Per the Common Terminology Criteria for Adverse Events, the maximum severity for taste changes is grade 2. cRash AEs included rash, maculopapular rash, erythematous rash, and erythema. | ||
AEs of Clinical Interest
- AEs of clinical interest are shown in Table: MajesTEC-5 Study: AEs of Clinical Interest.
- Ataxia/balance disorders were reported in 3 patients; all were grade 1 or 2 and recovered or were recovering.
| AE | Tal-DR (N=20) |
|---|---|
| Taste changesa (any grade), n (%) | 16 (80) |
| Grade 1 | 10 (50) |
| Grade 2 | 6 (30) |
| Leading to discontinuation of TALVEYb | 0 |
| Events recovered or recoveringc | 12 (71) |
| Non-rash skind (any grade), n (%) | 3 (15) |
| Grade 3/4 | 0 |
| Leading to discontinuation of TALVEYb | 0 |
| Events recovered or recoveringc | 2 (67) |
| Nail relatede | 4 (20) |
| Leading to discontinuation of TALVEYb | 0 |
| Events recovered or recoveringc | 2 (50) |
| Rash relatedf | 11 (55) |
| Grade 3g | 2 (10) |
| Leading to discontinuation of TALVEYb | 1 (5) |
| Events recovered or recoveringc | 15 (94) |
| Ataxia/balance disordersh | 3 (15) |
| Grade 3/4 | 0 |
| Leading to discontinuation of TALVEYb | 2 (10) |
| Events recovered or recoveringc | 4 (100) |
| Weight decreased (any grade) | 8 (40) |
| Grade 3/4g, n (%) | 2 (10) |
| Leading to discontinuation of TALVEYb, n (%) | 1 (3) |
| Events recovered or recoveringc, n | 5 |
| Abbreviations: AE, adverse event; Tal-DR, TALVEY + DARZALEX FASPRO + lenalidomide. Note: Median follow-up: 12.5 months (range, 3.4-14.9). Data cutoff: March 2, 2026. aTaste changes included dysgeusia, ageusia, hypogeusia, and taste disorder. Per the Common Terminology Criteria for Adverse Events, the maximum severity for taste changes is grade 2. bPatients could report multiple AEs that lead to discontinuation of TALVEY. cPercent of events resolved is calculated using the total number of events for the respective AE as the denominator. A total of 17 patients were evaluated for taste change AEs, 3 for non-rash skin AEs, 4 for nail-related AEs, 16 for rash-related AEs, 4 for ataxia/balance disorder AEs, and 9 for weight decreased AEs. dNon-rash skin AEs included skin exfoliation, dry skin, palmar plantar erythrodysesthesia, and pruritus. eNail-related AEs included nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, and nail ridging. fRash AE included rash, rash maculo-papular, rash erythematous, erythema, rash pruritic, and eczema. gThere were no grade ≥4 events. hAtaxia/balance disorders included ataxia, dysarthria, balance disorder, nystagmus, cerebellar ataxia, cerebellar syndrome, dysmetria, and gait disturbance. | |
CRS and Neurotoxicity
- All cytokine release syndrome (CRS) events were grade 1/2; 30% of patients received tocilizumab, and all CRS events resolved with no discontinuations.
- Two patients received multiple doses of tocilizumab to treat CRS during the study. One patient received tocilizumab as prophylaxis due to repetitive CRS after each TALVEY injection.
- No immune effector cell-associated neurotoxicity syndrome (ICANS) events were reported.
Infections
- Summary of infection outcomes is presented in Table: MajesTEC-5 Study: Summary of Infections.
- No fatal or opportunistic infections were reported.
- No patients discontinued treatment due to an infection.
- All patients with treatment-emergent hypogammaglobulinemia (n=17 [85%]), defined based on AE criteria or post-baseline IgG values <400 mg/dL, received immunoglobulin G (IgG) replacement therapy.
| Infection | Tal-DR (N=20) | |
|---|---|---|
| Any Grade | Grade 3/4 | |
| Patients with ≥1 treatment-emergent infections or infestations, n (%) | 14 (70) | 4 (20) |
| Patients with opportunistic infections, n (%) | 0 | 0 |
| Most common treatment-emergent infection and infestationsa, n (%) | ||
| Upper respiratory tract | 5 (25) | 0 |
| Nasopharyngitis | 2 (10) | 0 |
| Pneumonia | 2 (10) | 2 (10) |
| Urinary tract | 2 (10) | 1 (5) |
| Abbreviation: Tal-DR, TALVEY + DARZALEX FASPRO + lenalidomide. Note: Median follow-up: 12.5 months (range, 3.4-14.9). Data cutoff: March 2, 2026. aAEs shown are those occurring in ≥10% of patients. | ||
Treatment Discontinuation
- Four patients discontinued TALVEY due to treatment-emergent adverse events (TEAE) and remained on other study treatment.
- Events leading to discontinuation included grade 1 vertigo (n=1), grade 3 vertigo (n=1; this patient also experienced grade 1 diplopia, grade 1 gait disturbance, grade 1 tremor, and grade 2 nausea), grade 3 eczema and grade 3 weight loss (n=1), grade 2 balance disorder and grade 2 aphasia (n=1).
Deaths
- Two deaths were reported (1 due to trauma and 1 due to progressive disease).
Efficacy
- Summary of efficacy is shown in Table: MajesTEC-5 Study: Efficacy Outcomes.
| Parameter | Tal-DR (N=20) |
|---|---|
| ORRa, % (n) | 90 (18) |
| sCR, % | 55 |
| CR, % | 15 |
| VGPR, % | 15 |
| PR, % | 5 |
| ≥CR, % | 70 |
| ≥VGPR, % | 85 |
| MRD negativity rate (10-5 | 90 |
| Abbreviations: ASCT, autologous stem cell transplant; CR, complete response; IMWG, International Myeloma Working Group; MRD, minimal residual disease; ORR, overall response rate; PR, partial response; sCR, stringent complete response; Tal-DR, TALVEY+DARZALEX FASPRO + lenalidomide; VGPR, very good partial response. Note: Median follow-up: 12.5 months (range, 3.4-14.9). Data cutoff: March 2, 2026. aResponse was assessed by computerized algorithm, based on IMWG Criteria. Confirmed response requires at least 2 consecutive identical algorithm response assessments. bTwo patients remained MRD-positive throughout treatment (1 had progressive disease after cycle 3 and 1 had refractory disease). Two additional patients became MRD-positive after cycle 6 but converted back to MRD negativity after ASCT. | |
Stem-Cell Mobilization
- Stem cell collection was performed after induction cycle 3 according to local standard of care. See Table: MajesTEC-5 Study: Stem Cell Mobilization and ASCT.
- Per protocol, it was recommended to collect 2.5×10⁶ to 5×10⁶ CD34+ cells/kg body weight. One patient had a yield below 2.5×10⁶ CD34+ cells/kg body weight.
- In the pooled Tal-DR cohort, 95% of patients underwent successful stem cell mobilization and 90% underwent stem cell transplantation.
| Parameter | Tal-DR (N=20) |
|---|---|
| Underwent stem cell mobilization, n (%) | 19 (95) |
| Stem cell yield (106 | |
| Median (range) | 6.4 (1.4–54.0) |
| Stem cell transplanted, n (%) | 18 (90) |
| Days to engraftment, median (range) | |
| Neutrophils (0.5 x 109 | 14 (3-67) |
| Platelets (20 x 109 /L) | 14 (4–57) |
| Abbreviation: ASCT, autologous stem cell transplant; Tal-DR, TALVEY + DARZALEX FASPRO + lenalidomide. Note: Median follow-up: 12.5 months (range, 3.4-14.9). Data cutoff: March 2, 2026. | |
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 12 October 2026.
References
| 1 | Rasche L, Weinhold N, Kortüm KM, et al. Phase 2 study of talquetamab, daratumumab, and lenalidomide as induction therapy in patients with transplant-eligible newly diagnosed multiple myeloma: MajesTEC-5. Oral presentation presented at: The 23rd International Myeloma Society (IMS) Annual Meeting; September 23-26, 2026; Glasgow, Scotland. |
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