Eisai Co., Ltd. and MSD K.K., a subsidiary of Merck & Co., Inc., have submitted an application in Japan for an additional dosage and administration of LENVIMA (lenvatinib) in combination with WELIREG (belzutifan) for the treatment of unresectable or metastatic renal cell carcinoma (RCC) that has progressed after chemotherapy.
The application is based on the Phase 3 LITESPARK-011 trial results, which evaluated the combination therapy for patients with advanced RCC whose disease progressed following anti-PD-1/PD-L1 therapy. The data, presented at the 2026 ASCO Genitourinary Cancers Symposium, showed a significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 30% compared to cabozantinib.
The median PFS for the combination therapy was 14.8 months, compared to 10.7 months for cabozantinib. A trend toward improved overall survival was also observed, with a median of 34.9 months for the combination therapy versus 27.6 months for cabozantinib.
The safety profile of the LENVIMA and WELIREG combination was consistent with monotherapy reports, with no new safety signals identified. Grade 3 or higher treatment-related adverse events occurred in 71.6% of patients receiving the combination therapy, compared to 65.8% for those receiving cabozantinib.
Renal cell carcinoma accounts for approximately 85% of kidney cancers, with a high unmet medical need due to low survival rates in advanced stages. In 2022, around 435,000 people worldwide were diagnosed with kidney cancer, with 156,000 deaths reported.
In addition to the Japanese application, a supplemental New Drug Application for the combination therapy has been accepted by the U.S. FDA, with a target action date set for October 4, 2026.
Eisai and MSD have collaborated on LENVIMA since 2018, focusing on maximizing their contribution to cancer patients. LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor, is approved in combination with KEYTRUDA for the first-line treatment of unresectable or metastatic RCC in Japan. WELIREG, a first-in-class oral HIF-2α inhibitor, is approved for RCC that has progressed after chemotherapy.
Comments are closed.