Drugs in Context
Pembrolizumab plus lenvatinib in first-line metastatic renal cell carcinoma: a single-institution experience and a case of severe treatment-related toxicity with durable tumour control
By Andrea Malgeri, Grazia Sirgiovanni, Linda Cerbone and 3 others.
Abstract
Background
Pembrolizumab plus lenvatinib is a standard first-line treatment for metastatic renal cell carcinoma (mRCC) based on the phase III CLEAR trial. Real- world data are needed to assess effectiveness and toxicity management in routine practice. We report a retrospective single-institution experience and a case of grade 4 immune-related pancreatitis followed by sustained tumour control after treatment discontinuation.
Methods
We retrospectively analysed consecutive patients with mRCC treated with first-line pembrolizumab plus lenvatinib at IRCCS Regina Elena from March 2024 through March 2026, with clinical follow-up updated through September 2026. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS) and safety outcomes, including dose modifications and permanent treatment discontinuations. Survival was estimated by the Kaplan–Meier method.