First-Line Pembrolizumab Monotherapy in Advanced Non–Clear Cell Renal Cell Carcinoma
Posted: Friday, April 16, 2021
Michael B. Atkins, MD, of Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, and colleagues conducted the KEYNOTE-427 study to evaluate the safety and efficacy of the PD-1 inhibitor pembrolizumab in advanced non–clear cell renal cell carcinoma. Published in the Journal of Clinical Oncology, their research discovered that pembrolizumab demonstrated “promising” antitumor activity with a consistent safety profile.
This phase II trial enrolled 165 adult patients with newly diagnosed or recurrent stage IV non–clear cell renal cell carcinoma. Patients had no prior systemic therapy and were classified based on histology (papillary, chromophobe, and unclassified) and PD-L1 expression. Participants were administered 200 mg of pembrolizumab once every 3 weeks until unacceptable toxicity, disease progression, or treatment completion (24 months or 35 doses).
The median therapy duration was 6.9 months. The objective response rate was 26.7%, the disease control rate was 43.0%, and the median duration of response was 29 months. The median progression-free survival was 4.2 months, and the median overall survival was 28.9 months.
Patients with a combined positive PD-L1 score of 1 or greater responded better to the treatment than those with a score of less than 1 in regard to overall response rate (35.5% vs. 12.1%), disease control rate (50.0% vs. 31.0%), duration of response (29.0 vs. 9.5 months), progression-free survival (5.6 vs. 3.7 months), and overall survival (30.0 vs. 26.6 months). The objective response rates for individuals with papillary, chromophobe, and unclassified histology were 28.8%, 9.5%, and 30.8%; the disease control rates were 47.5%, 33.3%, and 30.8%; the median progression-free survivals were 5.5, 3.9, and 2.8 months; and median overall survivals were 31.5, 23.5, and 17.6 months, respectively.
Treatment-related adverse events affected 69.7% of patients, most commonly pruritus (20.0%) and hypothyroidism (14.5%). Additionally, two deaths (cardiac arrest and pneumonitis) were considered to be related to treatment.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.