Lee Discusses Results From KEYNOTE-146 Trial of Lenvatinib Plus Pembrolizumab

Chung-Han Lee, MD, PhD, spoke about interesting findings that arose from the KEYNOTE-146 study for patients with metastatic renal cell carcinoma.

In an interview with CancerNetwork® during the 2022 Genitourinary Cancers Symposium,Chung-Han Lee, MD, PhD, assistant attending physician for the Genitourinary Oncology service at Memorial Sloan Kettering Cancer Center in New York City, discussed results of the KEYNOTE-146 study (NCT02501096) of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) in patients with metastatic renal cell carcinoma (RCC).


The KEYNOTE-146 study was a phase 1b/2 trial with multiple cohorts. Initially in the phase 1b portion, they [performed] dose finding of lenvatinib plus pembrolizumab in multiple different disease groups. This was later expanded to an RCC-specific cohort, looking at the efficacy of the regimen for people with clear cell kidney cancer. The initial design involved up to 2 prior systemic therapies, and all patients had to be treatment naive or IO [immuno-oncology] naïve. Later, they expanded this clinical trial to look specifically at patients who were previously treated with various IO systemic therapies.

We were able to demonstrate that the activity of this regimen still remains quite high. We were seeing this in multiple settings, [such as] high levels of activity in patients who are treatment naïve, in patients who’ve gotten TKI [tyrosine kinase inhibitor], and in people who are IO pretreated. The best indication of any predictive biomarkers has been quite limited. Right now, we’re seeing this across the board, which certainly surprised us. This is very encouraging from a patient perspective that, regardless of what type of patient they are, we’re still seeing great outcomes.


Lee CH, Rasco D, Rao A, et al. Association between biomarkers and clinical outcomes of lenvatinib + pembrolizumab in advanced renal cell carcinoma (RCC): Results from Study 111/KEYNOTE-146. J Clin Oncol. 2022;40(suppl 6):137. doi: 10.1200/JCO.2022.40.6_suppl.375