TALVEY®
(talquetamab-tgvs)
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TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - Step-up Dosing - Real-World Evidence
Last Updated: 12/11/2024
SUMMARY
Real-world data
Study Design/Methods
- The study used de-identified data from the US hospital administrative Premier Healthcare Database.
- Eligibility criteria:
- Adults (age, ≥18 years) with multiple myeloma (MM) who had their first hospital encounter for TALVEY SUD (first use of a 3 mg/1.5 mL TALVEY vial) between August 9, 2023, and June 1, 2024 (date of last data cutoff), were included.
- Patients enrolled in clinical trials or with TALVEY index administration before August 9, 2023 (US Food and Drug Administration-approval date), were excluded.
- Index hospitalization was defined as the earliest TALVEY hospital encounter; the index date was that of the earliest TALVEY administration.
- Primary objective:
- Describe the demographics and clinical characteristics of patients with RRMM, SUD site of care, SUD dosing schedule and strength, inpatient length of stay (if applicable), rates of cytokine release syndrome (CRS), and tocilizumab use.
Patient Characteristics
- A total of 108 patients with RRMM who received TALVEY and met the inclusion criteria were included in the study. See Table: Demographic and Clinical Characteristics for additional details.
| Characteristic | N=108 |
|---|---|
| Age at index | |
| Mean (SD) age at index, years | 61.9 (10.6) |
| ≥75 years, n (%) | 13 (12.0) |
| Sex, n (%) | |
| Male | 71 (65.7) |
| Female | 37 (34.3) |
| Race, n (%) | |
| White | 60 (55.6) |
| Black | 27 (25.0) |
| Asian | 8 (7.4) |
| Other/unknown | 13 (12.0) |
| Payer, n (%) | |
| Medicare | 63 (58.3) |
| Managed care | 23 (21.3) |
| Medicaid | 13 (12.0) |
| Commercial | 8 (7.4) |
| Other | 1 (0.9) |
| Hospital setting, n (%) | |
| Urban | 108 (100.0) |
| Rural | 0 |
| Abbreviations: SD, standard deviation; SUD, step-up dosing. | |
SUD and Schedule
- SUD setting and dose schedule for the 108 patients included in the study is shown in the Table: TALVEY Setting of Care and Schedule of Administration.
| Outpatient SUD only | Inpatient Q2W SUDa | Inpatient QW SUDb | Hybrid SUDc |
|---|---|---|---|
| 14 (13.0) | 43 (39.8) | 37 (34.3) | 14 (13) |
| Abbreviations: QW, weekly; Q2W, every other week; SUD, step-up dosing. Note: Percentages may not sum to 100% due to rounding. aIncludes patients who received 4 inpatient SUD doses. bIncludes patients who received 3 inpatient SUD doses. cIncludes patients who received a combination of inpatient and outpatient SUD doses. | |||
Inpatient Length of Stay
- The length of TALVEY SUD completion is shown in Table: Length of TALVEY SUD Completion: SUD Schedule. The mean inpatient length of stay is presented in Table: Mean Inpatient Length of Stay by SUD Setting.
- The overall mean (median) inpatient length of stay was 8.9 (8) days. It declined over the course of the study from 9.0 (8) days between August 2023 and September 2023 to 8.0 (8) days between December 2023 and March 2024. See Table: Inpatient Length of Stay Over Time for additional details.
| Number of Days Until Completion of the Last SUD | Patients With QW SUD, % (n=37) | Patients with Q2W SUD, % (n=43) |
|---|---|---|
| 5 | 43.2 | - |
| 7 | 83.8a | 23.3 |
| 10 | - | 81.4b |
| Abbreviations: Q2W, every other week; QW, weekly; SUD, step-up dosing. aPatients with QW SUD who completed their last dose within 5 days were also counted as having completed their last dose within 7 days. bPatients with Q2W SUD who completed their last dose within 7 days were also counted as having completed their last dose within 10 days. | ||
| SUD Setting | Mean Length of Stay, Days |
|---|---|
| Overall (n=94) | 8.9 |
| Hybrid SUD (inpatient + outpatient) (n=14) | 5.1 |
| Inpatient QW SUD (n=37) | 7.6 |
| Inpatient Q2W SUD (n=43) | 11.3 |
| Abbreviations: Q2W, every other week; QW, once weekly; SUD, step-up dosing. aLength of stay was calculated as discharge data - index date. | |
| SUD Administration Dateb | Length of Stay, Mean (Median), Days |
|---|---|
| August 2023 to September 2023 (n=24) | 9.0 (8.0) |
| October 2023 (n=26) | 8.6 (9.0) |
| November 2023 (n=23) | 8.5 (8.0) |
| December 2023 to March 2024 (n=20) | 8.0 (8.0) |
| Abbreviations: Q2W every other week; QW, once weekly; SUD, step-up dosing. aOne outlier patient was removed from this analysis. bGrouping was selected to ensure there were sufficient patients in each interval. | |
CRS Incidence and Management
- CRS severity and treatment data are presented in Table: Severity and Treatment of CRS.
| Premier Healthcare Database (N=108) | |
|---|---|
| Patients with CRS, n (%) | 53 (49.1) |
| Grade 1 | 42 (38.9) |
| Grade 2 | 4 (3.7) |
| Grade 3 | 0 |
| Grade 4 | 0 |
| Grade 5 | 0 |
| Grade unknown or unspecified | 7 (6.5) |
| Patients administered tocilizumab, n (%) | 48 (44.4) |
| SUD dose 1 | 15 (13.9) |
| SUD dose 2 | 25 (23.1) |
| SUD dose 3 | 8 (7.4) |
| SUD dose 4 | 1 (0.9) |
| Abbreviations: CRS, cytokine release syndrome; SUD, step-up dosing. aIf multiple grades were reported, the highest grade was chosen for reporting in this table. | |
A literature search of MEDLINE®
References
| 1 | Banerjee R, Chang HY, Liu YH, et al. Real-world step-up dosing practice for patients who initiated talquetamab in US hospitals: an analysis of the all-payer US hospital administrative premier healthcare database. Poster presented at: 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA. |
| 2 |