On January 30, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the first-line treatment of patients with advanced renal cell carcinoma (RCC) (Press release, Eisai, JAN 30, 2022, View Source [SID1234607492]). This marks the first approval for LENVIMA which will be used in combination with KEYTRUDA for advanced RCC in Asia.
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The approval is based on results from the CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination for the first-line treatment of patients with advanced RCC. These results were presented at the 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine. 1 In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in the primary efficacy outcome measure of progression-free survival (PFS), as well as the key secondary efficacy outcome measures of overall survival (OS) and objective response rate (ORR) versus sunitinib. For PFS, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; p<0.0001) with a median PFS of 23.9 months versus 9.2 months for sunitinib. For OS, LENVIMA plus KEYTRUDA reduced the risk of death by 34% (HR=0.66 [95% CI: 0.49-0.88]; p=0.0049) versus sunitinib. Additionally, the confirmed ORR was 71% (95% CI: 66-76) (n=252) for patients who received LENVIMA plus KEYTRUDA versus 36% with sunitinib (95% CI: 31-41) (n=129). LENVIMA plus KEYTRUDA achieved a complete response (CR) rate of 16% and partial response (PR) rate of 55% versus a CR rate of 4% and a PR rate of 32% for those who received sunitinib. 2 In this trial, the five most common adverse reactions (any grade) observed in the LENVIMA plus KEYTRUDA combination arm were fatigue, diarrhea, musculoskeletal disorders, hypothyroidism and hypertension. 2
Worldwide, it is estimated there were more than 430,000 new cases of kidney cancer diagnosed and more than 180,000 deaths from the disease in 2020. 3 In Taiwan, there were more than 1,400 new cases and more than 600 deaths in 2018. 4 Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC. 5 Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. 6 Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. 7,8 The prognosis for these patients is poor as survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 12% for patients diagnosed with metastatic disease. 8
Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.
*In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy pembrolizumab from Merck & Co., Inc., Kenilworth, N.J., U.S.A.