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Lenvatinib Plus Pembrolizumab in Renal Cell Carcinoma: Phase IB/II Trial Results

By: Lauren Harrison, MS
Posted: Friday, July 23, 2021

Dual therapy using the tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor pembrolizumab showed antitumor activity in metastatic renal cell carcinoma, including tumors that had been previously treated with immune checkpoint inhibition. Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues published the results of this early-phase study in The Lancet Oncology.

“Lenvatinib plus pembrolizumab might, therefore, be a future potential standard-of-care treatment for patients with metastatic clear cell renal cell carcinoma after disease progression with [immune checkpoint inhibitor] therapy,” concluded the authors.

A total of 145 patients with metastatic renal cell carcinoma enrolled in the study. Patients received 20 mg of oral lenvatinib once a day plus 200 mg of intravenous pembrolizumab every 3 weeks. Therapy was continued until disease progression, withdrawal of consent, or unacceptable toxicity. Patients were stratified by previous therapy: treatment-naive (n = 22), previously treated with an immune checkpoint inhibitor (n = 104), or previously treated without an immune checkpoint inhibitor (n = 17).

The median follow-up was 19.8 months across the entire cohort. At 24 weeks, 72.7% of treatment-naive patients had an objective response, as did 55.8% of patients who had previously been treated with an immune checkpoint inhibitor and 41.2% of patients who had been previously treated without immune checkpoint inhibitors. At the time of data cutoff, 68% of treatment-naive patients, 57% of patients with a history of immune checkpoint inhibitor therapy, and 71% of patients naive to immune checkpoint inhibitors had either disease progression or had died. The median progression-free survival among these three groups was 24.1 months, 12.2 months, and 11.8 months, respectively.

There were 82 (57% of patients) grade 3 treatment-related adverse events and 10 (7%) grade 4 adverse events. The most common grade 3 side effects were hypertension, fatigue, diarrhea, proteinuria, hypertriglyceridemia, and lipase elevations. Serious adverse events related to therapy occurred in 25% of patients.

Disclosure: For a full list of author disclosures, visit thelancet.com.



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