- The Phase 3 LITESPARK-011 trial showed WELIREG and LENVIMA improved PFS in advanced RCC patients post anti-PD-1/L1 therapy.
- The trial also showed a significant improvement in ORR compared to cabozantinib.
- Safety profiles were consistent with previous studies, with no new safety signals.
- Overall survival improvement was observed but not statistically significant at interim analysis.
Trial Overview
The Phase 3 LITESPARK-011 trial evaluated the combination of WELIREG, a HIF-2 alpha inhibitor, and LENVIMA, a multi-targeted VEGF tyrosine kinase inhibitor, in patients with advanced renal cell carcinoma (RCC) whose disease progressed after anti-PD-1/L1 therapy.
Key Findings
The trial demonstrated a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) compared to cabozantinib. A trend towards improved overall survival (OS) was observed, though it did not reach statistical significance at the interim analysis.
Safety Profile
The safety profiles of WELIREG and LENVIMA were consistent with previous studies, with no new safety signals identified. The data will be discussed with regulatory authorities globally and presented at an upcoming medical meeting.
Future Developments
LITESPARK-011 is part of a broader clinical development program for WELIREG, which includes several Phase 2 and Phase 3 trials in RCC and other conditions. Further analysis of overall survival will be conducted as per the clinical protocol.
