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Lenvatinib Plus Pembrolizumab Approved by FDA for Advanced Renal Cell Carcinoma

By: JNCCN 360 Staff
Posted: Monday, August 16, 2021

The U.S. Food and Drug Administration (FDA) recently approved the tyrosine kinase inhibitor lenvatinib (Lenvima) in combination with the PD-1 inhibitor pembrolizumab (Keytruda) for first-line treatment of adults with advanced renal cell carcinoma. The recommended dosages for patients with advanced renal cell carcinoma are 20 mg orally once daily of lenvatinib with 200 mg of pembrolizumab given as an intravenous infusion over 30 minutes every 3 weeks or 400 mg administered as an intravenous infusion over 30 minutes every 6 weeks up to 2 years, until disease progression or unacceptable toxicity.

The FDA approval is based on the results of the multicenter, open-label phase III CLEAR (Study 307/KEYNOTE-581) trial. The study enrolled patients with advanced renal cell carcinoma in the first-line setting regardless of PD-L1 tumor expression status. About 355 patients were randomly assigned to receive lenvatinib plus pembrolizumab, and 357 patients were given sunitinib.

Patients given pembrolizumab plus lenvatinib had a longer median progression-free survival of 23.9 months compared with 9.2 months observed with sunitinib. The objective response rates were 71% in patients given pembrolizumab plus lenvatinib and 36% in patients given sunitinib. Additionally, the complete response rates were 16% and 4%, respectively. The median overall survival was not reached in either arm.

The most common adverse reactions observed in 20% or more of patients administered lenvatinib and pembrolizumab included fatigue, diarrhea, musculoskeletal pain, hypothyroidism, hypertension, stomatitis, decreased appetite, rash, nausea, decreased weight, dysphonia, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, hemorrhagic events, vomiting, constipation, hepatotoxicity, headache, and acute kidney injury. In addition, arterial thrombotic events occurred in 5% of patients in the CLEAR study, including myocardial infarction and cerebrovascular accidents.

For full prescribing information, visit accessdata.fda.gov for lenvatinib and accessdata.fda.gov for pembrolizumab.



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