The Leningrad Regional Clinical Hospital’s own experience of treating non-clear cell renal cell carcinoma with a combination of lenvatinib and pembrolizumab

Background. Non-clear cell renal cell carcinoma (nRCC) is a heterogeneous group of malignancies, accounting for approximately 15–20 % of all kidney tumors. Results of the KEYNOTE-B61 phase II trial demonstrated high antitumor activity and a favorable safety profile for the combination of lenvatinib and pembrolizumab in patients with nRCC. Due to these clinically significant results, the combination of lenvatinib and pembrolizumab has been included in international and Russian guidelines, becoming the preferred first-line treatment for metastatic nRCC.

Aim. To confirm the efficacy of the combination of lenvatinib and pembrolizumab in real-world clinical practice at the Leningrad Regional Clinical Hospital in patients with nRCC.

Materials and methods. In this study, we conducted a retrospective analysis of real-world clinical data describing 10 patients with nRCC treated with combination therapy of lenvatinib and pembrolizumab.

Results. The objective response rate was 40 %, including 10 % of complete responses. Median progression-free survival was not achieved (follow-up 36-49 months for most patients). At the last follow-up, all patients remained progression-free. No new safety signals were identified.

Conclusion. The experience of the Leningrad Regional Clinical Hospital with the combination of lenvatinib plus pembrolizumab for the treatment of nRCC has confirmed its efficacy and safety in real-world clinical practice in a Russian patient cohort. The safety profile was predictable and manageable, with no treatment-related lethal outcomes. These findings support that the combination of lenvatinib plus pembrolizumab should be considered a standard first-line therapy for patients with advanced nRCC.