LENVIMA Label Update: First-Line Treatment of Advanced Non-Clear Cell Renal Cell Carcinoma

Lenscima Label Update: First-Line Treatment of Advanced Non-Clear Cell Renal Cell Carcinoma

Eisai today announced a label update for LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, in the United States to include clinical efficacy data for the first-line treatment of advanced non-clear cell renal cell carcinoma (nccRCC). This update is based on data from KEYNOTE-B61, a Phase 2, single-arm trial evaluating KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, plus LENVIMA for the first-line treatment of adult patients with advanced nccRCC. While the label now includes efficacy data on the non-clear cell population, the approved indication for KEYTRUDA plus LENVIMA for the first-line treatment of adult patients with advanced RCC is unchanged. KEYTRUDA plus LENVIMA is the first and only immunotherapy and tyrosine kinase inhibitor (IO plus TKI) combination with data in both clear cell and non-clear cell advanced RCC in the FDA-approved label.

LENVIMA is an orally available 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 (PDGFRA), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.

Among the 160 patients, 158 patients received LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (400 mg every six weeks) for up to 24 months or until unacceptable toxicity or disease progression. LENVIMA could be continued as a single agent beyond 24 months until unacceptable toxicity or disease progression. Administration of LENVIMA with KEYTRUDA was permitted beyond RECIST-defined disease progression if the patient was considered by the investigator to be deriving clinical benefit.

Among the 158 treated patients, the baseline characteristics were: median age of 60 years (range: 24 to 87 years); 71% male; 86% White, 8% Asian, and 3% Black; The major efficacy outcome measure was objective response rate (ORR) as assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Additional efficacy outcome measures included duration of response (DOR) as assessed by BICR using RECIST 1.1. The ORR was 51% (95% CI, 43-59), with a complete response rate of 8% and a partial response rate of 42%, for patients who received KEYTRUDA plus LENVIMA. The median DOR was 19.5 months (range: 1.5+, 23.5+ (+ denotes ongoing response)). No new safety signals were observed.

Non-clear cell RCC is an aggressive, challenging-to-treat disease, and our goal is to address those unmet needs and advance care for these patients," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co. Ltd. "The addition of efficacy data from the KEYNOTE-B61 trial reinforces the important role of KEYTRUDA plus LENVIMA as a frontline treatment option for adult patients with advanced RCC regardless of histology. We are proud to realize this development through our collaboration with Merck to improve the lives of more people affected by cancer, and we are grateful to the patients and investigators whose involvement made this advancement possible."

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