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FDA Approves Lenvatinib and Pembrolizumab Combination for Advanced Renal Cell Carcinoma

Renal cell carcinoma.

The FDA has granted approval to the combination of lenvatinib (Lenvima®, Eisai) plus pembrolizumab (Keytruda®, Merck) for the treatment of patients with advanced renal cell carcinoma (RCC) who are undergoing first-line treatment.

"Lenvatinib in combination with pembrolizumab or everolimus has activity against advanced RCC," wrote Robert Motzer, MD, Jack and Dorothy Byrne Chair in Clinical Oncology at Memorial Sloan Kettering Cancer Center, and colleagues, in their publication of results of the phase 3 CLEAR trial (NCT02811861), on which the approval was based.

In this multicenter, open-label, randomized trial, 1,069 patients with untreated advanced RCC were assigned to receive either lenvatinib plus pembrolizumab (n=355), lenvatinib plus everolimus (n=357), or sunitinib (n=357). The primary end point was progression-free survival; overall survival and safety were secondary end points.

For patients receiving lenvatinib plus pembrolizumab, median progression-free survival was 23.9 months, which was significantly higher compared with patients receiving lenvatinib plus everolimus (14.7 months) and patients receiving sunitinib (9.2 months). Median overall survival was not reached, regardless of treatment arm. Lenvatinib/pembrolizumab produced higher rates of objective response (71% vs 36%) and complete response (16% vs 4%) compared with sunitinib.

The most common adverse events occurring in at least 20% of patients treated with lenvatinib/pembrolizumab in clinical trials were 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. Arterial thrombotic events occurred in in 5% of patients in the CLEAR trial, including myocardial infarction and cerebrovascular accident in 3.4% and 2.3% of patients, respectively.

"Lenvatinib plus pembrolizumab was associated with significantly longer progression-free survival and overall survival than sunitinib," concluded Dr. Motzer and colleagues in their April 2021 publication in The New England Journal of Medicine.

The recommended dose for lenvatinib is 20 mg orally once daily; the recommended dose of pembrolizumab is 200 mg administered intravenously over 30 minutes every 3 weeks or 400 mg administered intravenously over 30 minutes every 6 weeks for up to 2 years, until disease progression or unacceptable toxicity.

For More Information

Motzer R, Alekseev B, Rha SY, et al (2021). Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med, 384(14):1289-1300. DOI:10.1056/NEJMoa2035716

Clinicaltrials.gov (2021). Lenvatinib/everolimus or lenvatinib/pembrolizumab versus sunitinib alone as treatment of advanced renal cell carcinoma (CLEAR). NLM identifier: NCT02811861.

Lenvima® (lenvatinib) prescribing information (2021). Eisai. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s019lbl.pdf

Keytruda® (pembrolizumab) prescribing information (2021). Merck. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s102lbl.pdf

US Food & Drug Administration (2021). FDA approves lenvatinib plus pembrolizumab for advanced renal cell carcinoma. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-plus-pembrolizumab-advanced-renal-cell-carcinoma

Image credit: Nephron. Licensed under CC BY-SA 3.0


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