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TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - BiTAL Study
Last Updated: 09/08/2026
SUMMARY
Johnson & Johnson does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling. - BiTAL is an ongoing, retrospective, observational, non-interventional study that aims to describe the management and outcomes of patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who were treated with TALVEY monotherapy outside of clinical trials.1
- Mateos et al (2025)1 presented efficacy and safety results from 163 patients treated with TALVEY at a median follow-up of 10.9 months in the overall population and 12.2 months in the biweekly (Q2W) dosing cohort.
- Blanchard et al (2025)2
presented a subgroup analysis of the BiTAL study to evaluate the outcomes of TALVEY monotherapy in patients with TCE RRMM based on prior B-cell maturation antigen (BCMA) exposure.
bital study
Study Design
- Data were collected from patient medical records, including demographics, disease characteristics, prior therapies, effectiveness, and safety, from 68 sites across Spain.
- Treatment outcomes were assessed based on response rates, progression free survival, and overall survival.
- Responses were evaluated according to the International Myeloma Working Group criteria.
- All patients received TALVEY as part of a pre-approval access program.
Results
Treatment Disposition, Baseline Demographics, and Disease Characteristics
- At data cutoff of May 2025, 163 patients who started TALVEY treatment were included in the analysis.
- Of the evaluable patients analyzed, 87.8% (n=129) received Q2W dosing; the rest of the patients received weekly dosing.
- Median treatment duration with TALVEY was 7.8 and 8.2 months in the overall and Q2W cohorts, respectively.
- Most patients in each cohort completed their first treatment dose after the initial step-up doses.
- Baseline characteristics, treatment disposition, and disease characteristics are summarized in Table: BiTAL Study: Patients’ Demographic and Clinical Characteristics at TALVEY Initiation.
BiTAL Study: Patients’ Demographic and Clinical Characteristics at TALVEY Initiation1
| Characteristic | Overall population (N=163)a | Biweekly (Q2W) (N=129)a |
|---|---|---|
| Median age, years | 66 (40-84)b | 67 (40-84) |
| 65-75 years, n/N (%) | 63/153 (41.2) | 50 (38.8) |
| >75 years, n/N (%) | 23/153 (15) | 21 (16.3) |
| Female, n/N (%) | 78/154 (50.6) | 66 (51.2) |
| ECOG, n/N (%) | ||
| 0-1 | 104/130 (80) | 89/110 (80.9) |
| ≥2 | 26/130 (20) | 21/110 (19.1) |
| Charlson index, n/N (%) | ||
| 0-1 | 116/152 (76.3) | 98 (76) |
| ≥2 | 36/152 (23.7) | 31 (24.0) |
| Frailtyc | ||
| Fit+Intermediate | 81/129 (62.8) | 69/110 (62.7) |
| Frail | 48/129 (37.2) | 41/110 (37.3) |
| CRAB, n/N (%) | 135/149 (90.6) | 114/127 (89.8) |
| ISS Stage, n/N (%) | ||
| I | 37/128 (28.9) | 34/108 (31.5) |
| II | 48/128 (37.5) | 37/108 (34.3) |
| III | 43/128 (33.6) | 37/108 (34.3) |
| High risk cytogeneticsd | 15/52 (28.8) | 15/43 (34.9) |
| Extramedullarye | 22/76 (28.9) | 18/63 (28.6) |
| Creatinine clearance, n/N (%) | ||
| <30 mL/min | 13/138 (9.4) | 9/117 (7.7) |
| ≥30 to <60 mL/min | 27/138 (19.6) | 25/117 (21.4) |
| Patients ineligible for MonumenTAL-1f | 64/124 (51.6) | 50/106 (47.2) |
| Years since diagnosis, median (range) | 5.3 (0.7-25.3)g | 5.4 (0.7-25.3)h |
| Previous lines of therapy, median (range) | 4.0 (1-9)i | 4 (1-9) |
| Triple-class exposed, n/N (%) | 152/152 (100) | 129/129 (100) |
| Penta-class exposed, n/N (%) | 103/152 (67.8) | 85 (65.9) |
| Triple refractory, n/N (%) | 119/119 (100) | 102/102 (100) |
| Penta refractory, n/N (%) | 40/139 (28.8) | 33/119 (27.7) |
| Autologous SCT, n (%) | 110 (67.5) | 91 (70.5) |
| Patients receiving prior BCMA, n (%) | 54 (33.1) | 47 (36.4) |
| CAR-T | 6 (3.7) | 5 (3.9) |
| Belantamab | 42 (25.8) | 39 (30.2) |
| BCMA BsABs | 6 (3.7) | 3 (2.3) |
| Abbreviations: BCMA, B-cell maturation antigen; BsAbs, bispecific antibody; CAR-T, chimeric antigen T-cell therapy; CCI, Charlson Comorbidity Index; CRAB, calcium elevation, renal impairment, anemia, and bone lesions; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System. aData available added as denominators (n/N) if some were missing or not available in the clinical chart for the whole cohort. bN=153. cFragility assessment was performed retrospectively using age, CCI, and ECOG PS score. dIncludes del(17p), t(4;14), or t(14;16). eExtramedullary disease was defined exclusively by the presence of extramedullary soft tissue lesions. fMain reasons for ineligibility were non-measurable disease, creatinine clearance <40 mL/min, and hemoglobin level <8 g/dL. gN=144. hN=126. iN=151. | ||
Efficacy
- Details of the efficacy outcomes from this analysis are described in Table: BiTAL Study: Efficacy Outcomes and Response.
| Parameter | Overall (N=123) | Biweekly (Q2W) (N=106) |
|---|---|---|
| Median PFS, months (95% CI) | 8.6 (6.5-10.7) | 9.9 (7.6-12.1) |
| Median PFS for best response ≥CR, months (95% CI) | NR (NE-NE) | NR (NE-NE) |
| Median PFS for best response ≥VGPR, months (95% CI) | 8.3 (6.3-10.3) | 8.4 (6.3-10.4) |
| Median OS, months (95% CI) | 26.2 (15.6-36.7) | 26.2 (17.4-35) |
| Median OS for best response ≥CR, months (95% CI) | 26.2 (NE-NE) | 26.2 (NE-NE) |
| Median OS for best response ≥VGPR, months (95% CI) | 20 (13.9-26.1) | 20 (13.9-26.1) |
| ORR, n/N (%) | 109/130a (83.8) | 100/118a (84.7) |
| ITT | 109/163 (66.9) | 100/129 (77.5) |
| Abbreviation: CI, confidence interval; CR, complete response; ITT, intention-to-treat; NE, not estimable; NR, not reached; ORR, overall response rate; OS, overall survival; Q2W, biweekly dosing; PFS, progression-free survival; VGPR, very good partial response. aPatients with documented disease-response evaluation. | ||
Safety
- Details of the AEs that occurred by the end of the data cutoff are summarized in Table: BiTAL Study: Summary of AEs.
- No new safety signals were identified.
- Overall, 5 patients (5.3%) discontinued therapy due to treatment-emergent adverse events and 5 patients (3.1%) had dose reductions to manage AEs related to TALVEY.
- At last follow-up, 54% of patients were alive in the overall group and 61% in the Q2W group. Disease progression was the most common cause of death (overall, 30.7%; Q2W group, 31.8%). Treatment-emergent adverse events leading to death occurred in 3.7% (6/163) in the overall group and 4.7% (6/129) in the Q2W group.
BiTAL Study: Summary of AEs1
| AEsa, n (%) | Overall population (N=163) | |
|---|---|---|
| Any grade | Grade ≥3 | |
| CRS | 101 (62) | 5 (3.1) |
| ICANS | 13 (8) | 3 (1.8) |
| Infection | 90 (55.2) | 22 (13.5) |
| Weight loss | 17 (10.4) | 2 (1.2) |
| Dysgeusia | 78 (47.9) | 0 |
| Skin-relatedb | 123 (75.5) | 4 (2.5) |
| Nail-relatedc | 73 (44.8) | 0 |
| Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; NCI-CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events Grade according to ASTCT scales for CRS and ICANS. For the rest of the AEs, grade according to NCI-CTCAE v5.0. aPatients with at least one event. bConsidering any of the following events (at least one): skin rash (maculopapular rash, erythema, erythematous rash) and non-eruptive skin reactions (skin exfolidation, dry skin, pruritus, palmo-plantar erythrodysesthesia syndrome, alopecia. cConsidering any of the following events (at least one): nail discoloration, nail disorders, oncholysis, onychomadesis, onycholysis, nail dystrophy, and nail wedges. | ||
Results
Baseline Characteristics
- At the data cutoff date, 163 patients were evaluable for analysis.
- The median follow-up (range) was 12.6 months (0.1-24.0) for the BCMA-exposed group and 10.3 months (0.1-26.2) for the BCMA-naïve group.
- TALVEY was administered Q2W to most patients (BCMA-naïve, 47/52; BCMA-exposed, 82/95); the remainder of patients received weekly dosing.
- Among the BCMA-exposed patients assessed for efficacy, 5 received CAR T-cell therapy, 39 received antibody-drug conjugate treatment, and 6 received bispecific antibody therapy.
- Details on baseline characteristics and treatment disposition are in Table: BiTAL Subgroup Analysis: Summary of Baseline Characteristics and Treatment Disposition Based on BCMA Exposure.
| Characteristics | BCMA-naïve (N=109)a | BCMA-exposed (N=54)a |
|---|---|---|
| Median age, years (range) | 67 (42-83)b | 66 (10-84) |
| 65-75 years, n/N (%) | 45/99 (45.5) | 18 (33.3) |
| >75 years, n/N (%) | 12/99 (12.1) | 11 (20.4) |
| Female, n/N (%) | 53/100 (53) | 25 (46.3) |
| ECOG ≥1, n/N (%) | 66/98 (67.3) | 31 (57.4) |
| ISS Stage, n/N (%) | ||
| I | 23/98 (23.5) | 14 (26) |
| II or III | 75/98 (76.5) | 40 (74) |
| High risk cytogeneticsc, n/N (%) | 11/37 (29.7) | 4/15 (26.7) |
| Extramedullary plasmacytomad, n/N (%) | 19/48 (39.6) | 3/26 (11.5) |
| Patients ineligible for MonumenTAL-1e, n/N (%) | 42/77 (54.5) | 22/47 (46.8) |
| Years since diagnosis, median (range) | 4.5 (0.7-23.2)f | 7.0 (1.2-25.3)g |
| Previous lines of therapy, median (range) | 3.0 (1.0-8.0)h | 5 (2.0-9.0) |
| Triple-class exposed, n/N (%) | 98 (89.9) | 54 (100) |
| Penta-class exposed, n/N (%) | 65 (59.6) | 38 (70.4) |
| Triple refractory, n/N (%) | 76 (69.7) | 43 (79.6) |
| Penta refractory, n/N (%) | 28 (25.7) | 12 (22.2) |
| Autologous SCT, n (%) | 69 (63.3) | 41 (75.9) |
| Abbreviations: BCMA, B-cell maturation antigen; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System. aData available added as denominators (n/N) if some were missing or not available in the clinical chart for the whole cohort. bN=89. cIncludes del(17p), t(4;14), or t(14;16). dExtramedullary disease was defined exclusively by the presence of extramedullary soft tissue lesions. eMain reasons for ineligibility were non-measurable disease, creatinine clearance <40 mL/min, and hemoglobin level <8 g/dL. fN=93. gN=51. hN=97. | ||
Efficacy
- The overall response rate and complete response (CR) or better rates were 81.4% (70/86) and 24.4% (21/86) for the BCMA-naïve group, and 88.6% (39/44) and 27.3% (12/44) for the BCMA-exposed group.
- The median time to first and best response (range) were 1.7 months (0.3-10.6) and 2.7 months (0.4-20.5), respectively, for the BCMA-naïve group and 1.6 months (0.3-18.1) and 4.3 months (0.6-18.3), respectively for the BCMA-exposed group.
- The median PFS (95% confidence interval [CI]) was 8.4 months (4.6-12.2) for the BCMA-naïve group and 9.9 months (5.5-14.2) for the BCMA-exposed group.
- The median OS (95% CI) was 20 months (14.9-25.1) for the BCMA-naïve group and not estimable (NE) for the BCMA-exposed group.
- Based on prior BCMA exposure, the median PFS and OS (95% CI) were as follows:
- Prior CAR-T therapy: NE and NE
- Prior ADC therapy: 10 months (8.5-11.5) and NE
- Prior BsAb: 3.8 months (2.07-5.55) and 7.03 months (6.3-7.8)
- After progression on TALVEY therapy, 18 patients in the BCMA-naïve group and 6 patients in the BCMA-exposed group received a BCMA agent.
- The median time to next treatment (95% CI), defined as the interval from the first dose of TALVEY to the initiation of subsequent treatment, was 10.3 months (5.6-15) in the BCMA-naïve group and 10.3 months (6.9-13.8) in the BCMA-exposed group.
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | Mateos MV, Perez ML, Carreres AS, et al. Talquetamab outcomes from practice outside of clinical trials: the BiTAL study. Poster presented at: The 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, FL. |
| 2 |
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