New Efficacy Data Added for Non-Clear Cell RCC in LENVIMA US Label Supporting KEYTRUDA + LENVIMA

Eisai has announced a significant update to the U.S. label for LENVIMA, an oral multiple receptor tyrosine kinase inhibitor discovered by Eisai. This update includes clinical efficacy data for the first-line treatment of advanced non-clear cell renal cell carcinoma (nccRCC) based on data from the KEYNOTE-B61 trial. This trial evaluated the combination of KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, and LENVIMA.

KEYTRUDA plus LENVIMA is now the only combination therapy for first-line treatment of advanced RCC that includes data for both clear cell and non-clear cell RCC in its FDA-approved label. The approved indication for this combination remains unchanged for the first-line treatment of adult patients with advanced RCC.

KEYNOTE-B61 was a Phase 2, single-arm, multicenter trial that enrolled 160 patients with previously untreated nccRCC. The study investigated the efficacy of the immunotherapy and tyrosine kinase inhibitor (IO plus TKI) combination, with the primary efficacy outcome measure being the objective response rate (ORR), assessed by blinded independent central review using RECIST 1.1. Additional efficacy outcome measures included the duration of response (DOR).

The results showed an ORR of 51%, with 8% achieving a complete response and 42% achieving a partial response. The median DOR was 19.5 months, with some patients showing ongoing responses. Importantly, no new safety signals were observed during the trial.

Dr. Takashi Owa, Chief Scientific Officer at Eisai Co., Ltd., highlighted the update's importance, noting that non-clear cell RCC is a particularly aggressive and challenging disease to treat. The inclusion of efficacy data from the KEYNOTE-B61 trial enhances the role of KEYTRUDA plus LENVIMA as a frontline treatment option for advanced RCC. Dr. Owa expressed gratitude to the patients and investigators involved in the trial, emphasizing the collaboration with Merck to improve cancer treatment.

KEYNOTE-B61 enrolled 160 patients, with 158 receiving LENVIMA (20 mg orally once daily) and 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 under certain conditions. The baseline characteristics of the patients included a median age of 60 years, 71% male, and a majority being White (86%). Histologic subtypes were primarily papillary (59%), chromophobe (18%), and other less common subtypes.

The major efficacy outcome measure was the ORR, with additional measures assessing DOR, both using RECIST 1.1 criteria. Sites of metastases included lymph nodes (65%), lungs (35%), bones (30%), and the liver (21%).

Renal Cell Carcinoma (RCC) is a prevalent form of kidney cancer, with an estimated 81,610 new cases and 14,390 deaths expected in the U.S. in 2024. RCC is more common in men and often detected incidentally during imaging for other conditions. It consists of two subtypes: clear cell RCC, which accounts for 75% of cases, and non-clear cell RCC, making up the remaining 25%.

LENVIMA (lenvatinib) is available in 10 mg and 4 mg capsules and is an oral multiple receptor tyrosine kinase inhibitor. It inhibits the kinase activities of various receptors implicated in tumor growth and cancer progression. In animal models, LENVIMA has been shown to decrease tumor-associated macrophages and increase activated cytotoxic T cells, offering enhanced antitumor activity when combined with an anti-PD-1 monoclonal antibody, compared to either treatment alone.

The updated information for LENVIMA in the U.S. includes its indications for treating advanced RCC in combination with pembrolizumab or everolimus, as well as other cancers such as differentiated thyroid cancer (DTC) and hepatocellular carcinoma (HCC). The efficacy and safety data reinforce LENVIMA's role as a critical component in the frontline treatment of advanced RCC. The update highlights the ongoing efforts to address unmet needs in cancer treatment and improve patient outcomes through collaborative efforts.