The FDA has approved the combination of lenvatinib and pembrolizumab for advanced renal cell carcinoma

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August 2021: The combination of lenvatinib (Lenvima, Eisai) and pembrolizumab (Keytruda, Merck) has been approved by the Food and Drug Administration for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

CLEAR (Study 307/KEYNOTE-581; NCT02811861), a multicenter, open-label, randomised phase 3 trial in patients with advanced RCC in the first-line situation, looked into the efficacy of this combination. Patients were included regardless of whether or whether their tumours expressed PD-L1. Patients randomised to lenvatinib with pembrolizumab (n=355) were compared to those randomised to single-agent sunitinib (n=357) in the efficacy population that supported this approval.

The key effectiveness objectives were progression-free survival (PFS), as determined by independent radiologic assessment according to RECIST 1.1, and overall survival (OS). Patients who received pembrolizumab plus lenvatinib had a median PFS of 23.9 months (95 percent confidence interval: 20.8, 27.7), compared to 9.2 months (95 percent confidence interval: 6.0, 11.0) for those who received sunitinib (HR 0.39; 95 percent confidence interval: 0.32, 0.49; p0.0001). In all arms, the median OS was not met (HR 0.66; 95 percent CI: 0.49, 0.88; p=0.0049). On the combination and sunitinib arms, complete response rates were 16 percent and 4 percent, respectively, with objective response rates of 71 percent (95 percent CI: 66, 76) and 36 percent (95 percent CI: 31, 41; p0.0001).

Fatigue, diarrhoea, musculoskeletal pain, hypothyroidism, hypertension, stomatitis, decreased appetite, rash, nausea, decreased weight, dysphonia, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, hemorrhagic events, vomiting, constipation, and dysphonia were the most common adverse reactions reported in approximately 20% of patients who received lenvatinib and pembrolizumab in clinical trials In CLEAR, 5% of patients experienced arterial thrombotic events, including myocardial infarction (3.4%) and cerebrovascular accident (3.4%). (2.3 percent ).

For patients with advanced RCC, the recommended dosage is lenvatinib 20 mg orally once daily, followed by pembrolizumab 200 mg intravenous infusion over 30 minutes every 3 weeks or 400 mg intravenous infusion over 30 minutes every 6 weeks for up to 2 years, or until disease progression or unacceptable toxicity.



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