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TALVEY - Utilization Patterns - Real-World Evidence

Last Updated: 12/20/2024

SUMMARY

  • Summarized below are real-world, retrospective, observational, descriptive cohort studies that evaluated TALVEY utilization patterns in adult patients with relapsed or refractory multiple myeloma (RRMM).1,2 
    • Banerjee et al (2024)1 evaluated the demographic and clinical characteristics, dosing practices, and clinical use scenarios among patients treated with TALVEY (N=141) from the Komodo Healthcare Map™ database spanning from August 9, 2023 to June 8, 2024.
    • Rodriguez et al (2024)2 described real-world characteristics, step-up dosing (SUD) patterns, dosing schedules, and early safety and effectiveness data in patients with RRMM receiving TALVEY (N=92) from August 9, 2024 to March 31, 2024 using data from Loopback Analytics (formerly Acentrus).

Real-world data

Banerjee et al (2024)1 presented a real-world, retrospective, observational, descriptive cohort study to understand the demographic and clinical characteristics, dosing practices, and clinical use scenarios among patients treated with TALVEY from the Komodo Healthcare Map™ database.

Study Design/Methods

  • This study included patients with RRMM identified from the Komodo Healthcare Map™ database who received TALVEY between August 9, 2023 (United States approval date), and June 8, 2024 (last data cutoff date). See Figure: Study Design: Talquetamab Utilization Patterns and Dose Schedules.
  • Eligibility criteria:
    • Patients aged ≥18 years with ≥1 diagnosis code for multiple myeloma (MM) any time prior to or on the index date and ≥1 medical or pharmacy claim for commercial TALVEY between August 9, 2023, and June 8, 2024.
    • Patients with triple-class-exposed RRMM (≥1 proteasome inhibitor, ≥1 immunomodulatory drug, and ≥1 anti-CD38 therapy).
  • Exclusion criteria: Patients enrolled in clinical trials.

Study Design: Talquetamab Utilization Patterns and Dose Schedules1

Abbreviations: BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell; MM, multiple myeloma; PI, proteasome inhibitor; SUD, step-up dosing; Tal, talquetamab.
aData were collected from the Komodo Healthcare Map™ database.
bThe index date was the date of an inpatient, talquetamab encounter that occurred within 28 days prior to the first talquetamab treatment dose (40 mg/mL) in the outpatient setting or the date of the first outpatient talquetamab SUD (3 mg/1.5 mL) claim.
cDemographic characteristics included age, race, ethnicity, region, and payer channel.
dThe baseline period (used to describe baseline patient demographic and clinical characteristics [eg. MM diagnosis, individual comorbidities]) was 6 months before the index date.
eTreatment history included PI, BCMA, and CAR-T.

Results

Treatment Disposition, Baseline Characteristics, and Disease Characteristics

  • A total of 141 patients treated with TALVEY were included in the study. Baseline characteristics are provided in the Table: Demographic and Clinical Characteristics. n
  • A total of 84 patients (59.6%) had prior exposure to commercial B-cell maturation antigen (BCMA)-targeted therapy, and 78 patients (55.3%) reported prior exposure to T-cell-redirected therapies.

Demographic and Clinical Characteristics1
Characteristica
Patients With RRMM With an Eligible TALVEY Claim
(N=141)

Age at index, years
   Median (IQR)
67 (59.0-74.0)
   <65, n (%)
60 (42.6)
   65-69, n (%)
26 (18.4)
   70-74, n (%)
24 (17.0)
   ≥75, n (%)
31 (22.0)
Sex, n (%)
   Male
76 (53.9)
   Female
65 (46.1)
Race, n (%)
   White
86 (61.0)
   Black
26 (18.4)
   Hispanic
8 (5.7)
   Other/unknown
21 (14.9)
Median duration of MM diagnosis, years (IQR)
5.9 (4.0-7.9)
Median duration of post-index follow-upb, months (IQR)
3.3 (1.5-5.5)
Median prior lines of therapy, n (IQR)
5 (4-6)
Treatment historyc, n (%)
   Prior penta-drug exposedd
64 (45.4)
   Teclistamab
50 (35.5)
   Idecabtagene vicleucel
25 (17.7)
   Belantamab mafodotin-blmf
20 (14.2)
   Ciltacabtagene autoleucel
11 (7.8)
   Elranatamab
3 (2.1)
Key comorbidities of intereste, n (%)
   Infections
67 (47.5)
   Hypogammaglobulinemia
62 (44.0)
   Peripheral neuropathy
59 (41.8)
   Solitary plasmacytoma
12 (8.5)
   Extramedullary plasmacytoma
8 (5.7)
   Plasma cell leukemia
5 (3.5)
Abbreviations: IQR, interquartile range; MM, multiple myeloma; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma.
aPatient demographic and clinical characteristics were described for a baseline period of 6 months prior to the index date.
bPost-index follow-up was determined by the last medical claim activity, death date, or end of data.cSome patients had prior treatment with ≥1 therapy.
cExposed to ≥2 PIs, ≥2 immunomodulatory drugs, and ≥1 anti-CD38 therapy.
dConditions present within 6 months prior to the index date.

Utilization Patterns

  • Most patients (n=130; 92.2%) received TALVEY as monotherapy. A relatively smaller number of patients (n=3; 2.1%) received TALVEY in combination regimens, including teclistamab or other therapies, with the combination medications initiated within 2 months of the index date.
  • TALVEY served as a bridging therapy for a small proportion of patients, with 19 (13.5%) receiving TALVEY following apheresis and 4 (2.8%) receiving a chimeric antigen receptor T-cell infusion by the data cutoff. See Table: TALVEY Utilization as Monotherapy and Combination Therapy in Patients With RRMM and an Eligible TALVEY Claim.

TALVEY Utilization as Monotherapy and Combination Therapy in Patients With RRMM and an Eligible TALVEY Claim1
TALVEY Regimen, n (%)a
Patients
(N=141)

TALVEY
130 (92.2)
TALVEY + teclistamab
3 (2.1)
TALVEY + bortezomib
1 (0.7)
TALVEY + daratumumab
1 (0.7)
TALVEY + daratumumab + carfilzomib + ixazomib
1 (0.7)
TALVEY + pomalidomide
1 (0.7)
TALVEY + cyclophosphamide + pomalidomide
1 (0.7)
TALVEY + carfilzomib + isatuximab
1 (0.7)
TALVEY + isatuximab + pomalidomide
1 (0.7)
TALVEY + selinexor
1 (0.7)
Abbreviations: RRMM, relapsed/refractory multiple myeloma.
aCombination regimens were identified within 2 months after TALVEY initiation.

Dosing Patterns


Dosing Frequency at the End of Follow-upa,1
Frequency at End of Follow-up, n (%)
QW
(6-11 days)

Q2W
(12-17 days)

Q3W
(18-24 days)

Q4W
(25-31 days)

Other
(≥32 days)

14 (14.9)
62 (66.0)
5 (5.3)
9 (9.6)
- (4.3)
Abbreviations: QW, weekly; Q2W, every other week; Q3W, every 3 weeks; Q4W, once every 4 weeks; SUD, step-up dosing.
aAmong patients with ≥3 treatment doses after SUD (n=94).


Dosing Frequency at the End of Follow-up by Initial Dosing Schedulea,1
Frequency of First Treatment
Frequency at End of Follow-up, n (%)
QW
(6-11 days)

Q2W
(12-17 days)

Q3W
(18-24 days)

Q4W
(25-31 days)

Other
(≥32 days)

QW (6-11 days; n=25)
10 (40.0)
11 (44.0)
2 (8.0)
0
2 (8.0)
Q2W (12-17 days; n=58)
4 (6.9)
42 (72.4)
3 (5.2)
8 (13.8)
1 (1.7)
Abbreviations: QW, weekly; Q2W, every other week; Q3W, every 3 weeks; Q4W, once every 4 weeks; SUD, step-up dosing.
aAmong patients with ≥3 treatment doses after SUD.

Rodriguez et al (2024)2 presented real-world characteristics, SUD patterns, dosing schedules, and early safety and effectiveness data in patients with RRMM receiving TALVEY using data from Loopback Analytics (formerly Acentrus), an electronic medical records database.

Study Design/Methods

  • A chart review was conducted to supplement information from structured data, representing the safety data analysis set. See Figure: Study Design: Talquetamab SUD Patterns.
  • Eligibility criteria:
    • Patients who received TALVEY after Food and Drug Administration (FDA) approval
    • Patients with ≥2 diagnostic codes for MM, with ≥1 prior to the index date
    • Patients ≥18 years of age
    • Patients who had ≥6 months of clinical activity prior to the index date
    • Patients did not have clinical trial enrollment during SUD

Study Design: Talquetamab SUD Patterns2

Abbreviations: LOT, line of therapy; MM, multiple myeloma; SUD, step-up dosing; Tal, talquetamab.

Results

Treatment Disposition, Baseline Characteristics, and Disease Characteristics


Baseline Patient Characteristics2
Characteristic
All Patients
(N=92)

Safety Data Analysis Set
(n=50)

Effectiveness Analysis Seta
(n=33)

Age (years), mean (median)
66.4 (69)
66.2 (68)
65.4 (67)
   ≥75, n (%)
18 (19.6)
7 (14.0)
4 (12.1)
Female, n (%)
43 (46.7)
25 (50.0)
17 (51.5)
Race, n (%)
   Asian
7 (7.6)
6 (12.0)
6 (18.2)
   Black or African American
8 (8.7)
4 (8.0)
3 (9.1)
   White
64 (69.6)
37 (74.0)
21 (63.6)
   Other
13 (14.1)
3 (6.0)
3 (9.1)
Quan-Charlson Comorbidity Index, mean (median)
2.9 (2.0)
3.3 (2.0)
3.7 (2.0)
Comorbidities, n (%)
   Hypertension
31 (33.7)
19 (38.0)
12 (36.4)
   Renal impairment
21 (22.8)
12 (24.0)
9 (27.3)
   Anemia
49 (53.3)
28 (56.0)
19 (57.6)
   Peripheral neuropathy
35 (38.0)
17 (34.0)
13 (39.4)
   Hypogammaglobulinemia
29 (31.5)
15 (30.0)
10 (30.3)
   Pneumonia
11 (12.0)
8 (16.0)
6 (18.2)
   Fracture
20 (21.7)
11 (22.0)
8 (24.2)
Prior BCMA exposure, n (%)
55 (59.8)
28 (56.0)
19 (57.6)
   CAR-T
26 (28.3)
14 (28.0)
10 (30.3)
   Bispecific antibodies (teclistamab,
   elranatamab)

38 (41.3)
19 (38.0)
13 (39.4)
   Belantamab mafodotin
11 (12.0)
6 (12.0)
5 (15.2)
ECOG score ≥2b, n (%)
-
14 (32.6)
12 (36.4)
High-risk cytogenetic abnormalitiesc,
n (%)

-
24 (48.0)
15 (45.5)
Extramedullary diseased, n (%)
-
10 (20.0)
8 (24.2)
Abbreviations: BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell; ECOG, Eastern Cooperative Oncology Group.
aConsists of 33 patients from the safety analysis dataset (ie, with chart review data) with an evaluable response.
bThe ECOG score was reported for those with ECOG data (n=43); 7 patients had unknown/missing ECOG data. Based on the ECOG score, 38/43 (88.4%) patients would have met the eligibility criteria for the MonumenTAL-1 trial.
cIncludes patients with del17p, t[14;16], t[14;20], and t[4;14] abnormalities.
dAll patients without reported extramedullary disease were reported as missing/unknown.

Treatment Patterns

  • TALVEY initiation dates are presented in Table: TALVEY Initiation Dates.
  • During a median follow-up period of 3.4 months, 83.7% of patients had complete SUD data. Of these, 79.2% (n=61 out of 77) completed the SUD phase within 7 to 8 days, and the most common TALVEY SUD phase was Q2W (67.5%).
  • In the TALVEY treatment phase, 57.1% of patients received ≥3 doses. Most patients were on a QW (11.9%) or Q2W (64.3%) dosing schedule at the end of follow-up. See Table: Dosing Frequency at the End of Follow-up by Initial Dosing Schedule for additional details.

TALVEY Initiation Dates2
Dates, n (%)
All Patients
(N=92)

Safety Data Analysis Set
(n=50)

Effectiveness Analysis Set
(n=33)

August 2023 to December 2023
56 (60.9)
46 (92.0)
29 (87.8)
January 2024 to March 2024
36 (39.1)
4 (8.0)
4 (12.1)

Dosing Frequency at the End of Follow-up by Initial Dosing Schedulea,2
Initial Dosing Schedule
QW
(6-11 days)

Q2W
(12-17 days)

Q3W
(18-24 days)

Q4W
(25-31 days)

QW (6-11 days; n=14)
4
7
2
1
Q2W (12-17 days; n=28)
1
20
1
6
Abbreviations: QW, weekly; Q2W, every other week; Q3W, every 3 weeks; Q4W, once every 4 weeks; SUD, step-up dosing.
aAmong patients with ≥3 treatment doses after SUD who received both QW and Q2W doses (n=42). There were 2 patients who received each of the Q3W and Q4W doses.

Adverse Events


Adverse Events of Interest2
Safety Data Analysis Set
n=50
CRSa, n (%)
23 (46.0)
   Grade 1 (mild)
10 (20.0)
   Grade 2 (moderate)
10 (20.0)
   Grade 3 (severe)
1 (2.0)
   Grade 4 (life threatening)
0 (0.0)
   Grade 5 (death)
0 (0.0)
   Missing/unknown
2 (4.0)
Use of tocilizumab, n (%)
14 (28.0)
   Therapeutic
13 (92.9)
   Prophylactic
1 (7.1)
Use of dexamethasoneb, n (%)
9 (18.0)
Dysgeusia, n (%)
34 (68.0)
   Improvement
      Yes, n (%)
21 (61.8)
         Days to improvement, mean (median)
79.0 (77.5)
      No, n (%)
6 (17.6)
      Missing/unknown, n (%)
7 (20.6)
Decrease in weight, n (%)
24 (48.0)
   Median relative change (first to last TAL administration), %
-6.5
      <5 kg, n (%)
9 (37.5)
      5 to <10 kg, n (%)
12 (50.0)
      10 to <20 kg, n (%)
3 (12.5)
      ≥20 kg, n (%)
0 (0.0)
Abbreviations: CRS, cytokine release syndrome; TAL, TALVEY.
aOf patients without reported CRS, 5 had no CRS and 22 were reported as missing/unknown. CRS grading is reported as the highest grade (ie, mutually exclusive).
bAll dexamethasone use was therapeutic.

Physician-Reported Response

  • At a median follow-up of 5.3 months, the ORR was 81.8% for all patients with an evaluable response. The ORR was 84.2% and 78.6% for patients with and without prior BCMA exposure, respectively.

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 10 December 2024.

 

References

1 Banerjee R, Wang R, Liu YH, et al. Real-world talquetamab utilization patterns and dose schedules in the United States: an analysis using claims data. Poster presented at: 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA.  
2 Rodriguez C, Chang HY, Liu YH, et al. Patient characteristics, treatment patterns, and early outcomes of patients with relapsed or refractory multiple myeloma (RRMM) initiated on talquetamab (TAL): an electronic medical record and chart review study. Poster presented at: 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA.