Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), and Eisai announced results from the Phase 3 LITESPARK-011 trial evaluating a dual oral regimen of WELIREG (belzutifan) and LENVIMA (lenvatinib) in patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after anti-PD-1/L1 therapy.
The trial met one of its primary endpoints of progression-free survival (PFS). At a pre-specified interim analysis, the combination of WELIREG and LENVIMA demonstrated a statistically significant and clinically meaningful improvement in PFS compared to cabozantinib. The regimen also showed a statistically significant improvement in the key secondary endpoint of objective response rate (ORR) compared to cabozantinib.
A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed; however, this result did not reach statistical significance at the time of the interim analysis. OS will be assessed again in a subsequent analysis in accordance with the clinical protocol.
The safety profiles of WELIREG and LENVIMA in this study were consistent with previously reported data for the individual therapies. No new safety signals were identified. Merck & Co., Inc. and Eisai will discuss the results with regulatory authorities globally and will present the findings at an upcoming medical meeting.
“Despite recent treatment advances, many patients with advanced RCC may still experience disease progression following treatment with a PD-1/L1 inhibitor,” said Dr M. Catherine Pietanza, Vice President, Global Clinical Development, MSD Research Laboratories. “These positive results from LITESPARK-011 show the potential of this novel combination to reduce the risk of disease progression or death for patients who are in need of innovative options on or after treatment with immunotherapy.”
“We are encouraged by the data observed in the LITESPARK-011 trial, which bolster our belief in the role of LENVIMA in various combinations as a treatment option for patients impacted by advanced RCC,” said Dr Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. “These results further demonstrate Eisai’s commitment to people living with advanced RCC and invigorate our mission to address the unmet needs of patients with difficult-to-treat cancers. We look forward to sharing these investigational findings with regulatory authorities worldwide, with the goal of bringing this treatment option to patients as soon as possible. We extend our heartfelt gratitude to the patients, caregivers and investigators for their participation in this study and for helping us move this important research forward.”
The LITESPARK-011 study is part of a broader late-stage development programme for WELIREG, including Phase 2 and Phase 3 trials in RCC, pheochromocytoma, paraganglioma, and von Hippel-Lindau disease-associated neoplasms. The Phase 3 LITESPARK-012 trial is evaluating the addition of WELIREG to KEYTRUDA (pembrolizumab) plus LENVIMA in first-line advanced RCC.
WELIREG is approved in multiple global regions, including the United States, European Union and Japan, for advanced clear cell RCC following a PD-1/PD-L1 inhibitor and one to two VEGF-TKIs, based on the Phase 3 LITESPARK-005 trial.
KEYTRUDA plus LENVIMA is approved in several countries for advanced RCC and certain forms of advanced endometrial carcinoma. In the European Union, lenvatinib is approved as KISPLYX for advanced RCC, and LENVIMA in combination with everolimus is approved in multiple regions for advanced RCC following one prior anti-angiogenic therapy.