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LENVIMA® (lenvatinib) for differentiated thyroid cancer
LENVIMA® (lenvatinib) is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor receptors 1-3 (VEGFR 1-3), fibroblast growth factor receptors 1-4 (FGFR 1-4), the platelet derived growth factor receptor (PDGFRα), KIT, and RET.¹

Therapeutic indication:
LENVIMA® is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).¹

NICE guidance:
LENVIMA® is recommended as an option in adults whose disease does not respond to radioactive iodine, only if:²

  • They have not had a tyrosine kinase inhibitor before, or
  • They stopped taking a tyrosine kinase inhibitor within 3 months of starting because of toxicity (specifically, toxicity that cannot be managed by dose delay or dose modification)

NICE guidance

 


Resources

Lenvima (lenvatinib) DTC

Welcome to iCases – Dr Brammer

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Lenvima (lenvatinib) DTC

First Thoughts Bitecast Webninar 30th November 2022 On Demand

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Lenvima (lenvatinib) DTC

ETA 2022 Satellite symposium

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Lenvima (lenvatinib) DTC

First Thoughts Bitecast Webinar – Dr Kate Garcez

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Lenvima (lenvatinib) DTC

Patient guide and treatment diary

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Lenvima (lenvatinib) DTC

AE monitoring & management guide

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Lenvima (lenvatinib) DTC

Dosing & administration guide

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Lenvima (lenvatinib) DTC

Professor Marcia Brose Webinar

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Lenvima (lenvatinib) DTC

Patient Case Study Prof Jon Wadsley

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Lenvima (lenvatinib) DTC

Patient Case Study Dr Vanessa Gill

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References: 1. LENVIMA® Summary of Product Characteristics. 2. NICE guidelines [TA535]. Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine. Available at: https://www.nice.org.uk/guidance/ta535 (accessed January 2023).

UK-LENA-23-00011  Date of preparation  January 2023

The SELECT trial assessed LENVIMA® vs placebo for the treatment of radioiodine-refractory differentiated thyroid cancer (RAI-R DTC)¹

The SELECT trial was a large, multicentre (154 sites), double-blind, randomised, phase 2 study (N=392)¹

  • LENVIMA® significantly increased median PFS by 14.7 months vs placebo (18.3 vs 3.6 months; HR [95% CI]: 0.21 [0.14, 0.31]; log-rank test: P<0.001) (figure 1)¹
    • Median PFS improved across subgroups, e.g. baseline tumour burden, ≥65 years and <65 years, and patients with bone and lung metastases¹¯³
    • Early initiation of LENVIMA® offers optimal patient benefits¹

 

  • LENVIMA® offers an overall response rate of 64.8% vs 1.5% for placebo (OR [95% CI] 28.87 [12.46, 66.86]; P<0.001)¹
    • The size of target lesions reduced by more than half (51.9%) in responders (CR or PR)4
    • Response was rapid (median 2 months) and durable (median 30 months)2,5
  • At the time of the primary analysis, the median OS for LENVIMA® had not been reached in the ITT population4
    • The OS difference between the LENVIMA® and placebo groups was not statistically significant (HR [95% CI]: 0.73 [0.50–1.07]; stratified log-rank: P=0.1032)1
    • In a prespecified subgroup analysis, LENVIMA® showed significant OS benefit in patients aged >65 years (HR [95% CI]: 0.53 [0.31, 0.91]; P=0.020*)3
    • In a prespecified subgroup analysis, LENVIMA® did not show significant OS benefit in patients aged ≤65 years (HR [95% CI]: 0.978 [0.577, 1.656]; P=0.933*)3

*P values for the subset data are nominal as not sufficiently powered.

CI: confidence interval, CR: complete response, HR: hazard ratio, ITT: intention-to-treat, OR: odds ratio, OS: overall survival, PFS: progression-free survival, PR: partial response, RAI-R DTC: radioiodine-refractory differentiated thyroid cancer.

References: 1. Schlumberger M et al. New Engl J Med 2015;372:621–630. 2. Schlumberger M et al. New Engl J Med 2015;372:621–630. Supplementary Appendix. 3. Brose MS et al. J Clin Oncol 2017;35(23):2692–2699. 4. Robinson B et al. J Clin Endocrinol Met 2016;101:4103–4109. 5. Gianoukakis AG et al. Endocr Relat Cancer 2018;25(6):699–704.

 

UK-LENA-23-00012  Date of preparation  January 2023

LENVIMA® safety profile

Summary of the safety profile of LENVIMA® in the Summary of Product Characteristics¹

The safety profile of LENVIMA® in the Summary of Product Characteristics is based on data from 452 DTC patients. The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (68.6%), diarrhoea (62.8%), decreased appetite (51.5%), decreased weight (49.1%), fatigue (45.8%), nausea (44.5%), proteinuria 36.9%), stomatitis (35.8%), vomiting (34.5%), dysphonia (34.1%), headache (34.1%) and palmar-plantar erythrodysaesthesia syndrome (PPE) (32.7%). Hypertension and proteinuria tend to occur early during LENVIMA®. The majority of Grade 3 to 4 adverse reactions occurred during the first 6 months of treatment except for diarrhoea, which occurred throughout treatment, and weight loss, which tended to be cumulative over time.

The most important serious adverse reactions were renal failure and impairment (2.4%), arterial thromboembolisms (3.9%), cardiac failure (0.7%), intracranial tumour haemorrhage (0.7%), posterior reversible encephalopathy syndrome (PRES)/reversible posterior leucoencephalopathy syndrome (RPLS) (0.2%), hepatic failure (0.2%) and arterial thromboembolisms (cerebrovascular accident [1.1%], transient ischaemic attack [0.7%], and myocardial infarction [0.9%].

In 452 patients with RAI-R DTC, dose reduction and discontinuation were the actions taken for an adverse reaction in 63.1% and 19.5% of patients, respectively. Adverse reactions that most commonly led to dose reductions (in ≥5% of patients) were hypertension, proteinuria, diarrhoea, fatigue, PPE, decreased weight and decreased appetite. Adverse reactions that most commonly led to discontinuation of LENVIMA® were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea and pulmonary embolism.

In the phase II SELECT trial, LENVIMA® had a safety profile that could be managed with standard clinical interventions or dose modifications²

Treatment-related adverse event (TRAE) of any grade in ≥10% of patients, of grade ≥3 in ≥2%, or both²

 

AE: adverse event, DTC: differentiated thyroid cancer, PPE: palmar-plantar erythrodysaesthesia, RAI-R DTC: radioiodine-refractory differentiated thyroid cancer.

See the Lenvima® SmPC for the complete list of adverse reactions

GB LENVIMA®4mg  Summary of Product Characteristics
GB LENVIMA®10mg  Summary of Product Characteristics

NI LENVIMA®4mg  Summary of Product Characteristics
NI LENVIMA®10mg  Summary of Product Characteristics

ROI LENVIMA®  Summary of Product Characteristics

 

References: 1. LENVIMA® Summary of Product Characteristics. 2. Schlumberger M et al. New Engl J Med 2015;372:621–630.

 

UK-LENA-23-00018  Date of preparation  January 2023

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store, or Ireland www.hpra.ie. Adverse events should also be reported to Eisai Ltd on +44 (0)845 676 1400 / +44 (0)208 600 1400 or EUmedinfo@eisai.net

UK-LENA-23-00013  Date of preparation  January 2023