Merck & & Co., Inc. and Eisai Announce WELIREG(R) (belzutifan) Plus LENVIMA(R) (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma
– First treatment program to show a statistically substantial enhancement in PFS for clients whose illness advanced following anti-PD-1/ L1 treatment, compared to cabozantinib in Phase 3 research study
– LITESPARK-011 marks the very first favorable Phase 3 research study of a HIF-2 alpha inhibitor in mix with a multi-targeted VEGF tyrosine kinase inhibitor
RAHWAY, NJ and TOKYO, October 28, 2025 – (JCN Newswire) – Merck & & Co., Inc., Rahway, NJ, USA (called MSD beyond the United States and Canada) and Eisai (Headquarters: Tokyo, CEO: Haruo Naito) today revealed that the Phase 3 LITESPARK-011 trial examining the double oral program of WELIREG ® (belzutifan), the first-in-class oral hypoxia-inducible factor-2 alpha (HIF2α) inhibitor from Merck & & Co. plus LENVIMA ® (lenvatinib), an orally readily available several receptor tyrosinekinase inhibitor (TKI) found by Eisai, fulfilled among its main endpoints of progression-free survival (PFS) for the treatment of clients with sophisticated kidney cell cancer (RCC) whose illness advanced on or after treatment with anti-PD-1/ L1 treatment.
At a pre-specified interim analysis, WELIREG plus LENVIMA showed a statistically substantial and scientifically significant enhancement in PFS compared to cabozantinib in these clients. The mix likewise revealed a statistically substantial enhancement in the trial’s essential secondary endpoint of unbiased action rate (ORR) compared to cabozantinib. A pattern towards enhancement in general survival (OS), the research study’s other main endpoint, was observed; nevertheless, this outcome did not reach analytical significance at the time of this interim analysis. OS will be evaluated at a subsequent analysis per the medical procedure.
The security profiles of WELIREG and LENVIMA in this trial followed those observed in formerly reported research studies for the private treatments; no brand-new security signals were observed.
Merck & & Co. and Eisai will talk about these information with regulative authorities around the world and will provide them at an approaching medical conference.
“Despite current treatment advances, numerous clients with innovative RCC might still experience illness development following treatment with a PD-1/ L1 inhibitor,” stated Dr. M.Catherine Pietanza, Vice President, Global Clinical Development, MSD Research Laboratories. “These favorable arise from LITESPARK-011 reveal the capacity of this unique mix to lower the danger of illness development or death for clients who need ingenious alternatives on or after treatment with immunotherapy.”
“We are motivated by the information observed in the LITESPARK-011 trial, which boost our belief in the function of LENVIMA in numerous mixes as a treatment alternative for clients affected by sophisticated RCC,” stated Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. “These outcomes even more show Eisai’s dedication to individuals coping with sophisticated RCC and stimulate our objective to deal with the unmet requirements of clients with difficult-to-treat cancers. We eagerly anticipate sharing these investigational findings with regulative authorities worldwide, with the objective of bringing this treatment alternative to clients as quickly as possible. We extend our genuine thankfulness to the clients, caretakers and detectives for their involvement in this research study and for assisting us move this crucial research study forward.”
LITESPARK-011 becomes part of a thorough late-stage medical advancement program for WELIREG consisted of numerous Phase 2 and Phase 3 trials in RCC, pheochromocytoma and paraganglioma, and von Hippel-Lindau disease-associated neoplasms. The Phase 3 LITESPARK-012 trial is assessing the addition of WELIREG to KEYTRUDA ® (pembrolizumab) plus LENVIMA in the first-line innovative RCC illness setting.
WELIREG is authorized in the U.S., European Union (EU), Japan and other nations for the treatment of adult clients with innovative clear cell RCC following a PD-1/ PD-L1 inhibitor and 1-2 VEGF-TKIs, based upon arise from the Phase 3 LITESPARK-005 trial.
KEYTRUDA plus LENVIMA is authorized in the U.S., the EU, Japan and other nations for the treatment of innovative RCC and specific kinds of sophisticated endometrial cancer. Lenvatinib is authorized as KISPLYX ® for innovative RCC in the EU.
LENVIMA in mix with everolimus is authorized in the U.S., EU and other areas for the treatment of adult clients with sophisticated RCC following one previous anti-angiogenic treatment.
For information, please go to: https://www.eisai.com/news/2025/pdf/enews202575pdf.pdf
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