Eisai RWE on clinical effectiveness of LENVIMA® monotherapy against radioactive iodine-refractory differentiated thyroid cancer

Eisai announce final results from 5-year RWD study assessing the clinical effectiveness of LENVIMA^® (lenvatinib) as a first-line therapy for patients with radioactive iodine-refractory differentiated thyroid cancer.

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At the October 2022 Annual Meeting of the American Thyroid Association in Montreal, Quebec, Eisai presented a poster summarizing the findings from their 5-year RWD study of the clinical effectiveness of LENVIMA® (lenvatinib) monotherapy against radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC). Outcomes recorded from patients across the USA include provider-reported best overall response (BOR), progression-free survival (PFS)and overall survival (OS), and the findings are encouraging for oncologists and people living with RAI-refractory DTC.

Eisai has expressed its commitment to gathering RWD and generating RWE about the performance of their therapies in actual clinical practice. Sanjay Gupta, Eisai Inc. Head of Worldwide Real-World Evidence and VP said, “Our primary objective for generating robust scientific evidence using real-world data is to inform the healthcare community about the performance of therapies in actual clinical practice. We plan to continue to generate quality real world evidence across different cancers in order to support public health.”

LENVIMA, a multiple receptor tyrosine kinase inhibitor that inhibits kinases implicated in pathogenic tumor growth and cancer progression was discovered and developed by Eisai. It was approved by the FDA in 2015 for the treatment of patients with locally recurrent or metastatic, progressive, RAI-refractory DTC and is now also indicated for use against advanced renal cell, hepatocellular and endometrial carcinomas.

Thyroid cancer is the most common endocrine malignancy and global figures show that its incidence is on the rise (43,800 new US cases estimated for 2022), with women three times more likely to develop the disease than men. While most cases of DTC (e.g., papillary and follicular) are curable with surgery and radioactive iodine treatment, the prognosis for those patients whose cancers persist or recur is poor.

The current Eisai study focused retrospectively on 308 people treated with first-line LENVIMA monotherapy for RAI-refractory DTC between February 2015 and September 2020, with a median age 60 years at the time of treatment initiation, with 44.8% of patients diagnosed with stage III or IV disease and 89.6% of patients exhibiting metastases. Data were extracted from individual patients’ electronic health records by prescribing physicians and captured via an electronic case report form.

By the end of follow-up, 67.9% were still on LENVIMA therapy whilst 32.1% of patients had discontinued treatment due to disease progression (36.4%) or death (32.3%). Final analyses showed 72.4% of patients treated with LENVIMA had BOR reported as a complete (26.9%) or partial (45.5%) response. The median PFS was 49.0 months (95% CI: 37.0–54.2) with an estimated PFS rate of 68.2% at 24-months and 54.2% at 48-months. The estimated OS rate at 24-months was 78.4% and 57.0% at 72-months, and the median OS was not reached at the data cut-off.

“The evidence supporting the clinical effectiveness of LENVIMA in real-world clinical practice from the RWD study are encouraging for oncologists and people living with RAI-refractory DTC, a challenging condition in which cancer persists or recurs despite treatment with RAI,” said Takashi Owa, CSO and Senior VP, Eisai Co. Ltd. “Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer was our first approved indication for LENVIMA and we remain committed to addressing the needs and improving the lives of this patient population as part of our human health care (hhc) mission.”