From the Guidelines
The KEYNOTE-804 trial is not directly mentioned in the provided evidence, but based on the available information from the KEYNOTE-426 trial, pembrolizumab plus axitinib has shown significant clinical benefit over sunitinib monotherapy in terms of overall survival and progression-free survival in patients with metastatic clear cell renal cell carcinoma. The KEYNOTE-426 trial demonstrated that pembrolizumab plus axitinib resulted in a higher overall response rate and complete response rate compared to sunitinib monotherapy, with a lower percentage of patients experiencing primary progressive disease 1. The study also showed that patients treated with pembrolizumab plus axitinib had a similar health-related quality of life compared to those treated with sunitinib monotherapy, despite a higher incidence of serious treatment-related adverse events 1. Some key points to consider when using pembrolizumab plus axitinib include:
- The standard regimen consists of pembrolizumab 200 mg intravenously every 3 weeks and axitinib 5 mg orally twice daily
- Treatment-related adverse events may lead to treatment interruption or discontinuation, and patients should be monitored for immune-related adverse events
- The combination of pembrolizumab and axitinib has been shown to improve overall survival and progression-free survival in patients with metastatic clear cell renal cell carcinoma, making it a potential first-line treatment option 1. It is essential to weigh the benefits and risks of pembrolizumab plus axitinib and consider individual patient factors, such as overall health and potential for adverse events, when making treatment decisions.
From the Research
Significance of KEYNOTE-804
- The KEYNOTE-804 trial is not directly mentioned in the provided studies, but the KEYNOTE series of trials are discussed in the context of pembrolizumab treatment for various cancers, including melanoma and head and neck squamous cell carcinoma 2, 3, 4.
- Pembrolizumab has been shown to be effective in treating advanced melanoma, with significant improvements in progression-free survival, overall survival, and overall response rates compared to ipilimumab and chemotherapy 2.
- The KEYNOTE-001 trial demonstrated the durable antitumor activity and tolerability of pembrolizumab in advanced melanoma, with a 5-year overall survival rate of 34% in all patients and 41% in treatment-naive patients 3.
- Other KEYNOTE trials, such as KEYNOTE-048, have shown that pembrolizumab alone or in combination with chemotherapy can improve overall survival compared to cetuximab with chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma 4.
Pembrolizumab Treatment
- Pembrolizumab is a humanized monoclonal antibody against programmed death receptor-1 (PD-1), which has been shown to be effective in treating various types of cancer, including melanoma and head and neck squamous cell carcinoma 2, 4.
- The recommended dosage of pembrolizumab is 2 mg/kg every 3 weeks, although other dosing regimens have been explored, such as pharmacokinetic-guided administration 5.
- Pembrolizumab has been shown to have a manageable safety profile, with immune-related adverse events being the most common type of adverse event 2, 3, 4.
Clinical Trials
- The KEYNOTE series of trials have been conducted to evaluate the efficacy and safety of pembrolizumab in various types of cancer, including melanoma and head and neck squamous cell carcinoma 2, 3, 4.
- Other clinical trials, such as the phase I/II trial of imatinib mesylate in combination with pembrolizumab, are being conducted to evaluate the efficacy and safety of pembrolizumab in combination with other therapies 6.