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

Share This Post

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.



Check details here.

Take second opinion on renal cell carcinoma treatment

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

درمان سرطان در تركيه
Start chat
Need help with cancer treatment?
Scan the code
Welcome to CancerFax !

CancerFax is the most trusted international patient facilitator working with top cancer hospital's in the world like MD Anderson, Dana Farber, Asan, NCC Japan, Sheba, Beijing Cancer Institute and Apollo to bring you best of therapies and drugs.

Let us know what services would you like to avail?

1) Cancer treatment in the USA, Japan, Israel, India, Korea or Singapore?
2) CAR T-Cell therapy treatment
3) Cancer vaccine
4) Online video consultation
5) Proton therapy