View SELECT primary and key secondary endpoint data
A real-world evidence study of first-line (1L) LENVIMA monotherapy in RAI-R DTC in the United States1
Objective
• To describe the real-world treatment patterns and clinical outcomes in patients with RAI-R DTC treated with 1L LENVIMA monotherapy in the United States*
Study Design
• A retrospective patient medical chart review was conducted. Data from 308 adult patients who initiated LENVIMA monotherapy for RAI-R DTC in 1L between February 13, 2015 and September 30, 2020 were included
• Data were extracted from patient charts by physicians from academic and community practices across the United States. Up to a maximum of 3 physicians from the same practice were allowed to participate. Each physician was allowed to provide data for ≈5 randomly selected eligible patients
• The study was approved by an institutional review board (IRB)
• All patient data were de-identified and compliant with Health Insurance Portability and Accountability Act (HIPAA) guidelines
Clinical Outcomes
• Clinical outcomes assessed included real-world best overall response (rwBOR), real-world progression-free survival (rwPFS), and overall survival (OS), as reported by physicians, based on patient medical records
SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid; RAI-R=radioactive iodine-refractory; DTC=differentiated thyroid cancer.
* LENVIMA is indicated for the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).2
Select patient demographics and baseline characteristics1,3
ECOG=Eastern Cooperative Oncology Group.
Sites of metastases included lymph nodes (42.9%), lung (33.1%), bone (20.1%), liver (15.3%), brain (4.2%), breast (2.9%), and skin (1.3%).3
Physician-reported real-world DCR and BOR1-4
Physician-Reported Real-World Response1,3
In this retrospective real-world study of patients with RAI-R DTC (N=308)1,3
•Physician-reported rwDCR (CR + PR + SD)* = 90.6%
•Physician-reported rwBOR (CR + PR)* = 72.4%
Physician-reported responses were assessed either per RECIST criteria (RECIST v1.0, RECIST v1.1, iRECIST, or physician judgment based on radiology reports), imaging, patient/clinical factors, or a combination of these criteria.†
* rwCR=26.9%; rwPR=45.5%; rwSD=18.2%; rwPD=6.5%.
† Imaging criteria included MRI, PET, CT, MRS, ultrasound, and skeletal scintigraphy. Patient/clinical factors included patient symptoms, performance status, basal thyroglobulin (Tg), Tg antibodies, and recombinant human thyrotropin (rhTSH)-stimulated Tg levels.
LENVIMA clinical trial results (SELECT)
• ORR (CR + PR): 65% ORR with LENVIMA (95% CI: 59%-71%) (2% CR [n=4]; 63% PR [n=165]) vs 2% ORR with placebo (95% CI: 0%-4%) (no CR; 2% PR [n=2]); P<0.0012,4
• In LENVIMA treated patients, 23.0% SD (n=60); 6.9% PD (n=18); 5.4% not evaluated (n=14)4
• DCR (CR + PR + SD): 87.7% (n=229) with LENVIMA vs 55.7% (n=73) with placebo (odds ratio: 5.05 [95% CI: 2.98-8.54])4
• Responses evaluated using RECIST 1.12,4RAI-R=radioactive iodine-refractory; DTC=differentiated thyroid cancer; rwDCR=real-world disease control rate; CR=complete response; PR=partial response; SD=stable disease; rwBOR=real-world best overall response; RECIST=Response Evaluation Criteria In Solid Tumors; iRECIST=immune Response Evaluation Criteria in Solid Tumors; rwCR=real-world complete response; rwPR=real-world partial response; rwSD=real-world stable disease; rwPD=real-world progressive disease; MRI=magnetic resonance imaging; PET=positron emission tomography; CT=computed tomography; MRS=magnetic resonance spectrometry; SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid; PD=progressive disease; CI=confidence interval.
Limitations: No direct comparisons between results from the pivotal clinical trial and the real-world data study should be made, as there could be potential differences in patient populations, patient characteristics, follow-up duration, response assessment timing, frequency, and criteria that are used in clinical trials versus real-world settings. This is a retrospective, non-interventional study and could be subject to potential provider selection bias, as only providers who consent to participate in the research study would have contributed de-identified patient data to be used for analyses. As this was a single cohort non-interventional study, no data on comparative therapies were included. Information on adverse events was not collected in this study.
Limitations apply to all data shown below, including real-world PFS, OS, and treatment patterns.
Progression-free survival (PFS)
In this retrospective study of LENVIMA monotherapy in patients with RAI-R DTC (N=308), median rwPFS was 49.0 months (95% Cl: 37.0-NE).1
PFS1
LENVIMA clinical trial results (SELECT)
• 18.3 months median PFS (95% CI: 15.1-NE) with LENVIMA vs 3.6 months (95% CI: 2.2-3.7) with placebo (HR: 0.21 [95% CI: 0.16-0.28]); P<0.0012
RAI-R=radioactive iodine-refractory; DTC=differentiated thyroid cancer; rwPFS=real-world progression-free survival; CI=confidence interval; NE=not estimable; SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid.
Overall survival (OS)
In this retrospective real-world study of LENVIMA monotherapy in patients with RAI-R DTC, median OS was not reached over the available follow-up period.1
OS1
• Estimated OS rates were1:
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– 90.8% (95% CI: 87.0-93.6) at 12 months
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– 78.4% (95% CI: 73.0-82.8) at 24 months
• At the end of the follow-up, 75% of patients were still alive
LENVIMA clinical trial results (SELECT)
• Median OS was not estimable at data cutoff (HR: 0.73 [95% CI: 0.50-1.07]; P=0.10)2
• Kaplan-Meier estimates were*
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– 12-month OS rate, % (95% CI): 81.6 (76.2-85.8) for LENVIMA4
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– 24-month OS rate, % (95% CI): 58.2 (46.0-68.6) for LENVIMA4
RAI-R=radioactive iodine-refractory; DTC=differentiated thyroid cancer; SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid; CI=confidence interval.
* OS was adjusted for potential crossover with the use of rank-preserving structural failure time (RPSFT) model.4
LENVIMA treatment patterns1
LENVIMA real-world treatment patterns
• Among the 100 patients who discontinued LENVIMA, the most common reasons were disease progression (38.0%) and death (33.0%)
• Among patients who discontinued LENVIMA, 19 initiated a second-line treatment
By descriptive analysis, median duration of LENVIMA treatment at end of follow-up was 17.5 months (IQR: 8.8-25.0) for the overall population. Among those who discontinued LENVIMA, median duration was 9.1 months (IQR: 5.1-16.1). Among those still receiving LENVIMA, median duration was 20.1 months (IQR: 15.9-27.8).
62% of patients initiated LENVIMA at the recommended 24 mg daily dose; the remaining patients initiated at 14 mg to 20 mg daily doses. Approximately 8% of patients required a dose alteration during LENVIMA treatment.
IQR=interquartile range.