Dr Gruenwald on Tumor Responses With Lenvatinib Plus Pembrolizumab in Advanced RCC

Viktor Gruenwald, MD, PhD, professor, interdisciplinary genitourinary oncology, Essen University Hospital, West German Cancer Center, Clinic for Urology, Clinic for Medical Oncology, Essen, Germany, discusses key results from a post hoc analysis of the phase 3 CLEAR trial (NCT02811861) in advanced renal cell carcinoma (RCC), highlighting the clinical implications of these results.

The multicenter, open-label, randomized trial compared lenvatinib (Lenvima) plus pembrolizumab (Keytruda) with sunitinib (Sutent) for the treatment of patients with advanced RCC in the first-line. Previously reported results from the primary analysis showed that the combination improved progression-free survival outcomes and tumor shrinkage responses vs sunitinib in the overall cohort.

An exploratory analysis was conducted to assess tumor responses according to baseline metastatic characteristics from patients on study treatment at the time of the final prespecified overall survival (OS) analysis. Key baseline characteristics included the site of metastasis, number of metastatic sites, and baseline sums of diameters of target lesions.

Findings presented at the 2023 ESMO Congress showed that the combination of pembrolizumab and lenvatinib maintained efficacy and produced favorable tumor responses across all subgroups of interest, Gruenwald reports. The regimen's efficacy was particularly notable in patients with increased disease burden. A greater depth and breadth of tumor shrinkage was also observed in target lesions in specific organ sites (lung, lymph node, liver, and bone) for patients in the lenvatinib plus pembrolizumab arm vs the sunitinib arm. Moreover, the median duration of response was generally longer with lenvatinib plus pembrolizumab vs sunitinib. 

This information is valuable, as it helps oncologists understand the treatment's efficacy across diverse metastatic sites, ensuring a comprehensive and reliable response to treatment, Gruenwald states. The observed pattern of deep response and substantial tumor shrinkage reinforces the robustness of this combination therapy, and further supports the use of pembrolizumab and lenvatinib as a first-line standard of care in RCC, he emphasizes. Clinically, this consistency is crucial for healthcare providers when assessing and managing patients with RCC, offering insights into the treatment's effectiveness in different scenarios and contributing to informed decision-making in clinical practice, Gruenwald concludes.