First-Line Lenvatinib Plus Tislelizumab Demonstrates Promise for Patients With Fumarate Hydratase-Deficient Renal Cell Carcinoma
According to preliminary results from a phase 2 study, first-line lenvatinib plus tislelizumab demonstrated promising efficacy and safety among patients with fumarate hydratase-deficient renal cell carcinoma.
These results were presented by Wen Kong, PhD, Renji Hospital, Shanghai, China, at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco, California.
In this study, 17 patients with unresectable advanced or metastatic fumarate hydratase-deficient renal cell carcinoma received 20 mg of daily lenvatinib plus 200 mg of tislelizumab once every 3 weeks until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR). Key secondary end points included complete response rate, median time to response, progression-free survival (PFS), overall survival (OS), and safety.
At a median follow up of 7 months, 15 patients were eligible for efficacy assessment. The ORR was 93.3%, with a complete response rate of 20%. The median time to response was 6 weeks. There was 1 PFS and 1 OS event, and median PFS and OS were not achieved. The 6-month PFS rate was 93.3% and the 6-month OS rate was 100%. All grade adverse events occurred in 94.6% of patients and grade ≥3 adverse events occurred in 23.5% of patients. Eight patients discontinued treatment or underwent a dose reduction.
“Lenvatinib plus tislelizumab combination showed encouraging anti-tumor efficacy and acceptable toxicity profile, " concluded Dr Kong et al. “The potential of [tyrosine kinase inhibition]/[immune checkpoint inhibition] combination to be recommended as the first-line therapy in advanced FH-RCC patient[s] needs further evaluation.”
Source:
Kong W, Wu G, Xu Y, et al. Lenvatinib plus tislelizumab as first-line therapy for advanced fumarate hydratase-deficient renal cell carcinoma: A single-center, single-arm, phase II study. Presented at the 2025 ASCO Genitourinary Cancers Symposium. San Francisco, California. February 13-15, 2025. Abstract 443
