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TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - Outpatient Administration - Real-world Evidence
Last Updated: 10/21/2026
SUMMARY
- Summarized below is a real-world, observational and retrospective study which evaluated the outpatient (OP) administration of TALVEY in adult patients with multiple myeloma (MM).
- Pan et al (2026)1
presented a longitudinal, retrospective, observational, multisite chart review evaluating real-world treatment patterns, efficacy and safety outcomes of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) treated predominantly in community-based oncology settings at a median follow-up of 14.9 months.
- Pan et al (2026)1
Cardinal Health OPEN Network Experience: Real-world Effectiveness and Safety Outcomes of TALVEY in Predominantly Community-Based Settings
Study Design/Methods
- Adult patients aged ≥18 years with confirmed RRMM who initiated TALVEY between August 9, 2023, and May 14, 2025, outside the clinical trial setting were included. See Figure: Real-world Study Design and Data Collection Timeline.
- Data were obtained through the Cardinal Health Oncology Provider Extended Network (OPEN).
- Descriptive analyses were conducted for:
- The overall study population and for a subset of patients treated per US Prescribing Information (USPI) criteria.
- The USPI cohort, defined as triple-class exposed patients who initiated TALVEY monotherapy after ≥4 prior lines of therapy, were not bridged to chimeric antigen receptor T-cell (CAR-T) therapy, received inpatient-only step-up dosing, and did not switch to a less frequent dosing schedule.
- The overall study population and for a subset of patients treated per US Prescribing Information (USPI) criteria.
- The Kaplan-Meier method was used to estimate real-world overall response rate (rwORR), duration of response (rwDOR), progression-free survival (rwPFS), and overall survival (OS).
Abbreviations: eCRF, electronic case report form; US FDA, United States Food and Drugs Administration.
a
Note: Follow-up is the management of the patient by the provider completing the eCRF at their practice
Results
Physician and Practice Characteristics
- At baseline, 25 physicians were enrolled, including 18 (72%) from community practices and 7 (28%) from academic centers.
- Urban settings accounted for the largest proportion of practice locations (56%), followed by suburban (40%) and rural (4%) areas.
- A total of 96% of physicians were medical oncologists; 84% were hematologists. The median duration of clinical practice was 13 years.
Patient Characteristics
- A total of 176 patients were included in the study. See Table: Patient Characteristics.
At the 2nd data refresh, 139/176 patients remained alive and had an abstracting physician participating in the Cardinal Health OPEN network. - Longitudinal follow-up data were available for 110/139 eligible patients (79.1%) at 2nd data refresh. At the time of the 2nd data refresh, the median duration of follow-up was 14.9 months (IQR, 9.8-16.8).
Patient Characteristics1
| Characteristic | All Patients (N=176) | USPI Cohort (n=95) |
|---|---|---|
| Median follow-up from TALVEY initiation, months (IQR) | 14.9 (9.8-16.8) | 15.5 (13.7-17.5) |
| Age at initiation, years, median (IQR) | 68.6 (63.6-73.5) | 68.6 (64.2-72.7) |
| Male, n (%) | 105 (59.7) | 60 (63.2) |
| Race, n (%) | ||
| White | 124 (70.5) | 59 (62.1) |
| Black or African American | 41 (23.3) | 31 (32.6) |
| Community setting, n (%) | 127 (72.2) | 73 (76.8) |
| ISS stage, n (%) | 19 (10.8) | 11 (11.6) |
| Stage Ia | 1 (5.3) | 1 (9.1) |
| Stage IIb | 8 (42.1) | 4 (36.4) |
| Stage IIIc | 10 (52.6) | 6 (54.6) |
| R-ISS stage, n (%) | 140 (79.6) | 75 (79) |
| Stage Id | 21 (15) | 6 (8) |
| Stage IIe | 55 (39.3) | 30 (40) |
| Stage IIIf | 64 (45.7) | 39 (52) |
| Cytogenetic risk, n (%) | ||
| Standard risk | 77 (45.8) | 35 (38.9) |
| High risk | 86 (51.2) | 51 (56.7) |
| Unknown | 5 (3) | 4 (4.4) |
| Extramedullary disease, n (%) | 9 (5.1) | 7 (7.4) |
| ECOG PS at TALVEY initiation, n (%) | ||
| 0 | 11 (6.3) | 5 (5.3) |
| 1 | 118 (67) | 75 (79) |
| 2 | 46 (26.1) | 15 (15.8) |
| 3 | 1 (0.6) | 0 |
| Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; iFISH, immunofluorescenceand fluorescence in situ hybridization; ISS, International Staging System; IQR, interquartile range; LDH, lactate dehydrogenase; R-ISS, Revised International Staging System; Sβ2M, serum β₂-microglobulin; USPI, United States Prescribing Information. aSβ2M <3.5 mg/L; serum albumin ≥3.5 g/dL. bSβ2M <3.5 mg/L; serum albumin <3.5 g/dL; or β2M 3.5 to 5.5 mg/L, irrespective of serum albumin. cSβ2M >5.5 mg/L. dSβ2M <3.5 mg/L, serum albumin ≥3.5 g/dL, standard-risk chromosomal abnormalities by iFISH, normal LDH. eNot R-ISS Stage I or III. fSβ2M ≥5.5 mg/L and either, high-risk chromosomal abnormalities by FISH OR high LDH. | ||
Treatment Patterns
- Treatment patterns are shown in Table: Treatment Patterns.
- At the end of follow-up, 79.6% of patients (140/176) were alive and 52.3% (92/176) remained on TALVEY treatment.
| Characteristic | All Patients (N=176) | USPI Cohort (n=95) |
|---|---|---|
| Number of prior LOTs before TALVEY initiation, median (IQR) | 4 (3-4) | 4 (4-5) |
| Prior BCMA exposure, n (%) | 92 (52.3) | 58 (61.1) |
| ADC only | 1 (0.6) | 1 (1.1) |
| CAR-T only | 60 (34.1) | 35 (36.8) |
| ADC + CAR-T | 1 (0.6) | 0 |
| Bispecific antibodies | 30 (17) | 22 (23.2) |
| No prior BCMA exposure | 84 (47.7) | 37 (38.9) |
| Initiated TALVEY as monotherapy, n (%) | 173 (98.3) | 95 (100) |
| Initial dosing schedule, n (%) | ||
| QW | 88 (50) | 54 (56.8) |
| Q2W | 88 (50) | 41 (43.2) |
| Duration of therapy, median (IQR), months | 13.6 (6.0-15.6) | 14.2 (8-15.9) |
| Treatment discontinuation after follow-up, n (%) | 84 (47.7) | 38 (40) |
| Reason for discontinuationa, n (%) | ||
| Adverse event/toxicity/unacceptable side effects | 11 (6.3) | 2 (2.1) |
| Desired response achieved | 3 (1.7) | 0 |
| Disease progression | 53 (30.1) | 29 (30.5) |
| Financial factors | 1 (0.6) | 0 |
| Patient choice | 10 (5.7) | 3 (3.2) |
| Patient comorbidities | 3 (1.7) | 1 (1.1) |
| Patient performance status | 3 (1.7) | 1 (1.1) |
| Death | 7 (4) | 4 (4.2) |
| Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell; IQR, interquartile range; LOT, line of therapy; QW, weekly; Q2W, every other week; USPI, United States Prescribing Information. aCategories of response not mutually exclusive. | ||
Efficacy
- Efficacy outcomes are presented in Table: Summary of Efficacy Outcomes.
| Parameter | All Patients (n=158) | USPI Cohort (n=79) |
|---|---|---|
| rwORR, % (95% CI) | 85.5 (79.1-90.6) | 89.8 (81.5-95.2) |
| sCR | 5.7 | 3.4 |
| CR | 23.3 | 30.7 |
| VGPR | 27 | 35.2 |
| PR | 29.6 | 20.5 |
| ≥VGPR, % | 56 | 69.3 |
| Minimal response or stable disease, % | 13.8 | 10.2 |
| 12-month DOR, % (95% CI) | 65.8 (55.9-74) | 70 (57.8-79.4) |
| 12-month rwPFS, % (95% CI) | 75 (67.5-81) | 81.7 (71.9-88.4) |
| 12-month OS, % (95% CI) | 82 (75.0-87.1) | 89.9 (81.5-94.6) |
| Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; OS, overall survival; PR, partial response; rwORR, real-world overall response rate; rwPFS, real-world progression-free survival; sCR, stringent complete response; USPI, United States Prescribing Information; VGPR, very good partial response. | ||
Safety
- Summary of safety events is presented in Table: Summary of Adverse Events.
- In the overall population, 33% of patients (58/176) experienced adverse events of special interest (AESI) comprising dry mouth, dysgeusia, dysphagia, fatigue and loss of appetite.
- In USPI cohort, AESI was reported in 19% of patients.
| AE, n (%) | All Patients (N=176) | USPI Cohort (n=95) |
|---|---|---|
| CRSa | 65 (36.9) | 32 (33.7) |
| Grade 1 | 42 (23.9) | 26 (27.4) |
| Grade 2 | 20 (11.4) | 6 (6.3) |
| Grade 3 | 2 (1.1) | 0 |
| Grade 4 | 1 (0.6) | 0 |
| ICANSa | 11 (6.3) | 5 (5.3) |
| Grade 1 | 9 (5.1) | 5 (5.3) |
| Grade 2 | 1 (0.6) | 0 |
| Grade 3 | 1 (0.6) | 0 |
| Infectionsa | 36 (20.5) | 21 (22.1) |
| Grade 1 | 13 (7.4) | 10 (10.3) |
| Grade 2 | 17 (9.7) | 9 (9.3) |
| Grade 3 | 5 (2.8) | 1 (1) |
| Unknown grade | 1 (0.6) | 1 (1.1) |
| GPRC5D-related AEs | ||
| Ataxia | 0 | 0 |
| Dry mouth | 36 (20.5) | 12 (12.6) |
| Dysgeusia | 35 (19.9) | 13 (13.7) |
| Dysphagia | 5 (2.8) | 2 (2.1) |
| Abbreviations: AE, adverse event; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; GPRC5D, G protein-coupled receptor class C group 5 member D; ICANS, immune effector cell-associated neurotoxicity syndrome; USPI, United States Prescribing Information. aAEs were reported according to the highest grade documented according to CTCAE. | ||
Weight Change
- Changes in body weight according to baseline body mass index (BMI) category are summarized in Table: Mean Weight by Baseline BMI Category Over Time.
- At the 1st
data refresh, the mean (standard deviation [SD]) change in body weight relative to baseline was -2.8% (6.3) among 120 evaluated patients. Weight loss was observed in 70% of patients, whereas 23.3% experienced weight gain and 6.7% had no change in weight. - At the 2nd data refresh, the mean (SD) percentage change in body weight from baseline was -3.6% (9) among 110 evaluated patients. Weight loss, weight gain, and no change in weight were reported in 70%, 24.6%, and 5.5% of patients, respectively.
- Greater and more frequent reductions in weight were observed among patients with higher baseline BMI.
| Baseline BMI Category | Baseline Mean Weight (n=175) | First Data Refresh Mean Weight (n=120) | Second Data Refresh Mean Weight (n=110) |
|---|---|---|---|
| Healthy weight, lbs (n) | 145.9 (71) | 142.6 (53) | 143.4 (53) |
| Overweight, lbs (n) | 180.7 (83) | 174.8 (59) | 169.6 (49) |
| Obese, lbs (n) | 206.5 (21) | 197.3 (8) | 184.9 (8) |
| Abbreviations: BMI, body mass index; lbs, pounds. Note: Patients were categorized as healthy weight (18.5 to <25.0 kg/m²), overweight (25.0 to <30.0 kg/m²), and obese (≥30.0 kg/m²). One patient met the underweight BMI category (<18.5 kg/m²) criterion at baseline but did not have refresh data available. | |||
Literature Search
A literature search of MEDLINE®
References
| 1 | Pan D, Parikh R, Tai MH, et al. Real-world efficacy and safety outcomes of talquetamab: an updated analysis in predominantly community-based setting. Poster presented at: The 23rd Annual Meeting & Exposition of the International Myeloma Society; September 23-26, 2026; Glasgow, Scotland. |
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