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Eisai Announces Real-World Evidence on the Clinical Effectiveness of Lenvima Monotherapy for the Treatment of Patients with Radioiodine-Refractory Differentiated Thyroid Cancer

NUTLEY, N.J., Oct. 21, 2022. Eisai today announced final results from a real-world data (RWD) study assessing the clinical effectiveness of LENVIMA (lenvatinib) as a first-line therapy for patients with radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC). The poster summarizing the findings from the RWD study was presented at the 2022 Annual Meeting of the American Thyroid Association (ATA), being held in Montreal, Quebec on October 19-23, 2022.

The study included 308 patients who received lenvatinib monotherapy for RAI-refractory DTC in the first-line setting. The median age was 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. By the end of follow-up, 32.1% of patients had discontinued lenvatinib treatment, while 67.9% were still on therapy. Median duration of lenvatinib treatment was 17.5 months overall, 9.0 months in those discontinued, and 20.2 months in those still on therapy. Median time to discontinuation of lenvatinib was 49.0 months (95% CI: 38.5-54.2) by Kaplan-Meier analyses. Among the 99 patients who discontinued lenvatinib treatment, the most common reasons were disease progression (36.4%) and death (32.3%)

Final analyses of the RWD study showed that 72.4% of patients treated with LENVIMA had Best Overall Response (BOR) reported as a complete (26.9%) or partial (45.5%) response. The median progression-free survival (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 median overall survival (OS) was not reached at the data cut-off. The estimated OS rate at 24 months was 78.4% and 57.0% at 72 months.

"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 Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, 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."

"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," said Dr. Sanjay Gupta, Vice President, Head of Worldwide Real-World Evidence, Eisai Inc. "We plan to continue to generate quality real world evidence across different cancers in order to support public health."

The real-world evidence poster presented at ATA was based on data from a retrospective patient chart review study that assessed clinical outcomes, including provider-reported BOR, PFS and OS. Patient data were extracted by prescribing physicians from individual patients' electronic health records and captured via an electronic case report form. The study cohort included RAI-refractory DTC patients in the U.S. treated with first-line LENVIMA therapy between February 13, 2015, and September 30, 2020. All patient data were de-identified prior to analyses. The time-to-event endpoints were assessed using Kaplan-Meier methods.

The RWD study is subject to a few limitations. There could have been potential provider and patient selection bias. Efforts were made to minimize the bias by recruiting a physician sample across all regions in the U.S., limiting the maximum number of participating physicians per oncology practice, and by allowing each physician to provide data for approximately 5 randomly selected patients. Differences in clinical outcome assessment schedules and criteria used among participating oncologists were expected in real world clinical practice.

LENVIMA was approved by the U.S. Food and Drug Administration (FDA) in February 2015 for the treatment of patients with locally recurrent or metastatic, progressive, RAI-refractory DTC.

About Thyroid Cancer
Thyroid cancer is the most common endocrine malignancy and global figures show that its incidence is on the rise. In 2022, it is estimated that there will be 43,800 new cases of thyroid cancer in the U.S. and that women are three times more likely to develop thyroid cancer than men. The most common types of thyroid cancer, papillary and follicular (including Hürthle cell), are classified as DTC and account for approximately 90% of all cases. While most cases of DTC are curable with surgery and radioactive iodine treatment, the prognosis for those patients whose cancers persist or recur is poor.

About LENVIMA (lenvatinib)
LENVIMA, discovered and developed by Eisai, is a multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. The combination of LENVIMA and everolimus showed increased anti-angiogenic and anti-tumor activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signaling in vitro and tumor volume in mouse xenograft models of human renal cell cancer greater than each drug alone. In syngeneic mouse tumor models, the combination of lenvatinib with an anti-PD-1 monoclonal antibody decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity compared to either treatment alone.

About Eisai
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia, and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S. and EMEA).

LENVIMA is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

SOURCE Eisai Inc.

Posted: October 2022

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