Eisai and MSD's Lenvima (Lenvatinib) Submits New NDA in China for Differentiated Thyroid Cancer, Already Approved as First-Line Therapy for Hepatocellular Carcinoma

December 04, 2019 /BioValleyBIOON/ -- Japanese pharmaceutical company Eisai recently announced that the National Medical Products Administration (NMPA) of China has accepted its new indication application for the anticancer drug Lenvima (Chinese brand name: Le Wei Ma; generic name: lenvatinib) for the treatment of differentiated thyroid cancer (DTC). This is the second indication applied for in China for this drug, following the approval of its first-line treatment indication for hepatocellular carcinoma (HCC) in September 2018.

This application is primarily based on data from the global SELECT study (Study 303). Conducted in patients with radioactive iodine-refractory differentiated thyroid cancer, the study demonstrated that Lenvima significantly prolonged progression-free survival (PFS) compared with placebo, with a statistically significant difference (median PFS: 18.3 months vs. 3.6 months; HR=0.21 [99% CI: 0.14–0.31]; p<0.001). Furthermore, patients treated with Lenvima achieved rapid therapeutic response, with a median time to first objective response of 2.0 months. Compared with the placebo group, the Lenvima group also showed a statistically significant improvement in overall response rate (ORR) (64.8% vs. 1.5%, p<0.001). Notably, 1.5% of patients in the Lenvima group achieved complete response, whereas none did in the placebo group. The most common treatment-emergent adverse events associated with Lenvima in the study wereHypertension, diarrhea, fatigue or weakness, decreased appetite, weight loss, and nausea.

Eisai may leverage the results of the SELECT study to submit this application in advance, although the Phase III trial evaluating Lenvima for the treatment of patients with radioactive iodine-refractory differentiated thyroid cancer is currently being conducted in China.Clinical Trials(Study 308) is ongoing.

Thyroid cancer refers to malignancies arising in the thyroid tissue and is more common in women than in men. The most common types are papillary and follicular thyroid cancers, which are classified as differentiated thyroid cancer (DTC) and account for approximately 95% of all cases. The remaining cases are categorized as either anaplastic thyroid cancer (3–5%) or medullary thyroid cancer (1–2%). Although the majority of patients with DTC can be cured through surgery and radioactive iodine therapy, a small subset of patients remains unresponsive to treatment.

In China, approximately 190,000 new cases of thyroid cancer are diagnosed annually, with an estimated 8,600 deaths per year. Although most types of thyroid cancer are treatable, therapeutic options remain limited once the disease progresses. Consequently, thyroid cancer remains a condition with significant unmet medical needs.

The active pharmaceutical ingredient of Lenvima, lenvatinib, is an oral multi-receptor tyrosine kinase (RTK) inhibitor with a novel binding mode, in addition to inhibiting the involvement ofTumorIn addition to other receptor tyrosine kinases (RTKs) associated with pro-angiogenic and oncogenic signaling pathways involved in proliferation, it can also selectively inhibit the kinase activity of vascular endothelial growth factor (VEGF) receptors.

As of now, the approved indications for Lenvima include: thyroid cancer, hepatocellular carcinoma, combination with everolimus for the treatment of renal cell carcinoma (second-line therapy), and combination with Keytruda (pembrolizumab, PD-1Tumorimmunotherapy) for the treatment of advanced endometrial cancer. In Europe, lenvatinib is marketed under the brand name Kisplyx for the treatment of renal cell carcinoma.

In September 2018, Lenvima (Lenvatinib) was approved in China as a monotherapy for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy. China is the world'sLiver Cancerthe country with the largest patient population. In November 2018, Lenvima was launched in China, marking the first new systemic therapy for first-line treatment of unresectable hepatocellular carcinoma (HCC) in China in nearly a decade.

Liver cancer is the second leading cause of cancer-related deaths, causing approximately 750,000 deaths worldwide each year, with 780,000 new cases diagnosed annually. About 80% of these cases occur in Asia, primarily in China, followed by Africa. Specifically, in China, there are 395,000 new liver cancer cases and 380,000 deaths each year, accounting for approximatelyLiver Cancer50% of cases.(Bio Valley Bioon.com)

Original Source: Eisai